psychgirl
Has No Life - Lives on TB
Yes, please!
I must have missed that one from Geert.
It’s just been so hard keeping up especially now, with tracking MPX too.
CORONA Main Coronavirus thread
- Thread starter Heliobas Disciple
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I must have missed that one from Geert.
It’s just been so hard keeping up especially now, with tracking MPX too.
psychgirl
Has No Life - Lives on TB
Oh!
Just yesterday three separate families/client called in at work either to cancel their appointments, or as in one case she asked for a curbside exam.
All from having current cases of Covid.
Monday, just in the nick of time, my dentist office called to cancel my cleaning for Tuesday.
They’ve closed this entire week due to their hygienist having Covid. I dodged a bullet there! But now they’re backed up at least until October !
Second time this has happened with the dentist I’m pretty sure.
Just yesterday three separate families/client called in at work either to cancel their appointments, or as in one case she asked for a curbside exam.
All from having current cases of Covid.
Monday, just in the nick of time, my dentist office called to cancel my cleaning for Tuesday.
They’ve closed this entire week due to their hygienist having Covid. I dodged a bullet there! But now they’re backed up at least until October !
Second time this has happened with the dentist I’m pretty sure.
Tristan
Has No Life - Lives on TB
(fair use applies)
FDA Panel Advisor Admits Agency "LOST" Clinical Trial Data for Placebo Group Before Approving Experimental Vaccine for Babies and Toddlers (Video) | The Gateway Pundit | by Julian Conradson
Earlier this month the Food and Drug Administration (FDA) authorized the mRNA vaccine for emergency use in young children, aged six months to five years old, after its advisory committee voted in favor of the experimental treatment, claiming that it has passed its clinical hurdles and is...www.thegatewaypundit.com
FDA Panel Advisor Admits Agency “LOST” Clinical Trial Data for Placebo Group Before Approving Experimental Vaccine for Babies and Toddlers (Video)
By Julian Conradson
Published June 29, 2022 at 9:30pm
Earlier this month the Food and Drug Administration (FDA) authorized the mRNA vaccine for emergency use in young children, aged six months to five years old, after its advisory committee voted in favor of the experimental treatment, claiming that it has passed its clinical hurdles and is effective in preventing symptomatic infection without causing worrisome side effects.
However, in addition to ignoring the mountain of evidence showing the vaccines are regularly causing life-threatening injuries – especially in healthy children and young people, the FDA ‘experts’ have routinely skipped crucial steps in the testing process, allowing them to manipulate the data in order to suit their desired outcomes.
This inexcusable act of criminal malpractice was confirmed this month by the team leader of the FDA’s clinical review staff, Rachel Zhang, who explained during an advisory panel zoom call that the agency had lost the results from the placebo group during its clinical trials related to the decision to approve the experimental jab for America’s youngest children.
Without this data from the placebo group, the effectiveness of the vaccine cannot be measured against those who did not receive the treatment. Therefore, the clinical trial is meaningless. But the gaping hole in the results apparently doesn’t matter to the ‘experts’ at the FDA, who went ahead with the EUA approval anyway.
“There is no efficacy data,” Zhang explained. “I guess it will have to come from real-world effectiveness,” she added glibly.
In other words, babies and toddlers are essentially vaccine guinea pigs that will provide the lost data. Remember, Zheng is the team leader of the FDA’s clinical review staff, which oversees the approval of new medical treatments.
From Zheng:
“…We have lost the placebo groups, so we cannot really say anything about the duration of vaccine efficacy after that. There’s no more efficacy data, basically, after that time point. So, unfortunately, we are limited to – in this study – would be the results that we have shown you in the slide with the data cut off. The latest one [placebo group data] would be the May 31st one, and that still is, unfortunately, very few cases……I guess it will have to come from real-world effectiveness.”
How does something like this even happen? They don’t even have to come up with a viable excuse anymore. This is literally on par with the old ‘dog ate my homework’ line. What a joke.
"Three times is Enemy action..."
Zoner
Veteran Member
He mentioned an antibody test which better determines the amount of virus in the blood but it seems the PCR test still the standard.Yes, please!
I must have missed that one from Geert.
It’s just been so hard keeping up especially now, with tracking MPX too.
I liked what they said that if you want a negative test to swab your nostrils with alcohol which will kill everything and you will test negative.
Zoner
Veteran Member
URGENT: BA.4 & BA.5 omicron driven by VACCINE warrants nasal-oral washes with povidone iodine (PI) or hydrogen peroxide (no swallow); Flavio & Rapiti offers aggressive treatment for this BA.4/.5
I re-provide PI protocol & suggested treatments for BA 4 & BA 5 omicron; emerging reports indicate these are more symptomatic & stronger; talk to your doctor with the FLCCC program; VAX causing this
Dr. Paul Alexander
14 hr ago
BA.5 is reported as being more stronger. It appears BA.4 and BA.5 are worse for vaccinated persons. BA.2.12.1 appears to account for 50% of infections at this time.
What we feared is happening, or beginning to, I have written about this after consulting with Geert Vanden Bossche. Geert is the most incredible mind I have realized. The argument is that the blocking of severe infection in the lower respiratory tract would disappear (and soon) and severe illness could emerge with future variants. Early treatment can work as before and you have to consult your doctor and devise a plan.
Early treatment clinicians (e.g. Dr. Marik) are advising that BA 4 & BA 5 must be treated more aggressively with antibiotics and STEROIDS on day 1-3 (at the latest) with anti coagulants (anti-blood clotting drugs) added if the D-dimer elevated as replication appears far greater than for SARS Delta and the lungs are involved with viral inflammation and clotting in the initial few days.
Other clinicians indicate that in places like Brazil, treatment is as below as BA.5 is increasing. They use clinical signs of lung involvement by looking at SOB as the patient is talking, or walking 10 paces in the office or if they indicate that they have some dyspnea (SOB) on engaging in some effort. They are not relying on PCR or CT. Initial reports are that BA.4 & BA.5 are spreading more rapidly (maybe 50% of cases in US), and is driving increases in hospitalization.
Again, we told them to stop the COVID failed shots and they have caused this by pushing a failed non-neutralizing injection with non-neutralizing vaccinal antibodies pressuring the antigen (spike) during a pandemic with massive infectious pressure.
Povidone iodine program to kill the virus in the nostrils and oral cavity:
Remember POVIDONE-IODINE (PI) (aka Betadine), it is a simple program & nips COVID virus, all/most respiratory viruses in the nose, mouth, nasopharynx; 1/2 teaspoon of betadine mixed with 1.5 ounces of water
put that in a bulb syringe, stick it up your nose & washout each nostril 2x. Swish and spit orally, twice a day, and when you go outside and return; No swallowing; use hydrogen peroxide diluted if no PI or you cannot stand the bitter taste
Research suggests that PI or HP will kill most viruses we are in contact with…again, no swallow, and you dilute to taste. swish and spit orally, and Q tip bulb cleaning out nostrils etc. as far as can go.
We have added PI to the early treatment regimen at the top box if you look carefully for in some sense, if this is done routinely, one can argue there may be no need for early treatment and you can effectively stave off COVID and cold virus etc. routinely. Completely. Hydrogen peroxide (and there are oral versions too I have seen at least one) is used by some who find PI too bitter, but remember, no swallow and you dilute it.
This can be purchased OTC. Oral dental surgeons etc. cam forward and informed us they use similar programs before COVID to clean nostrils and mouths as they are inside people mouths daily in surgery and they use this as their own protection. Keeps them safe. We then dug further and studied it and boy, had we known earlier, this would have been out there to help protect more, even before early treatment. It defies logic why public health will not tell people these solutions that saves lives including for vitamin D.
palexander.substack.com
Subscribe to Substack Alexander COVID News evidence-based medicine
By Dr. Paul Alexander
I re-provide PI protocol & suggested treatments for BA 4 & BA 5 omicron; emerging reports indicate these are more symptomatic & stronger; talk to your doctor with the FLCCC program; VAX causing this
Dr. Paul Alexander
14 hr ago
BA.5 is reported as being more stronger. It appears BA.4 and BA.5 are worse for vaccinated persons. BA.2.12.1 appears to account for 50% of infections at this time.
What we feared is happening, or beginning to, I have written about this after consulting with Geert Vanden Bossche. Geert is the most incredible mind I have realized. The argument is that the blocking of severe infection in the lower respiratory tract would disappear (and soon) and severe illness could emerge with future variants. Early treatment can work as before and you have to consult your doctor and devise a plan.
Early treatment clinicians (e.g. Dr. Marik) are advising that BA 4 & BA 5 must be treated more aggressively with antibiotics and STEROIDS on day 1-3 (at the latest) with anti coagulants (anti-blood clotting drugs) added if the D-dimer elevated as replication appears far greater than for SARS Delta and the lungs are involved with viral inflammation and clotting in the initial few days.
Other clinicians indicate that in places like Brazil, treatment is as below as BA.5 is increasing. They use clinical signs of lung involvement by looking at SOB as the patient is talking, or walking 10 paces in the office or if they indicate that they have some dyspnea (SOB) on engaging in some effort. They are not relying on PCR or CT. Initial reports are that BA.4 & BA.5 are spreading more rapidly (maybe 50% of cases in US), and is driving increases in hospitalization.
Again, we told them to stop the COVID failed shots and they have caused this by pushing a failed non-neutralizing injection with non-neutralizing vaccinal antibodies pressuring the antigen (spike) during a pandemic with massive infectious pressure.
Povidone iodine program to kill the virus in the nostrils and oral cavity:
Remember POVIDONE-IODINE (PI) (aka Betadine), it is a simple program & nips COVID virus, all/most respiratory viruses in the nose, mouth, nasopharynx; 1/2 teaspoon of betadine mixed with 1.5 ounces of water
put that in a bulb syringe, stick it up your nose & washout each nostril 2x. Swish and spit orally, twice a day, and when you go outside and return; No swallowing; use hydrogen peroxide diluted if no PI or you cannot stand the bitter taste
Research suggests that PI or HP will kill most viruses we are in contact with…again, no swallow, and you dilute to taste. swish and spit orally, and Q tip bulb cleaning out nostrils etc. as far as can go.
We have added PI to the early treatment regimen at the top box if you look carefully for in some sense, if this is done routinely, one can argue there may be no need for early treatment and you can effectively stave off COVID and cold virus etc. routinely. Completely. Hydrogen peroxide (and there are oral versions too I have seen at least one) is used by some who find PI too bitter, but remember, no swallow and you dilute it.
This can be purchased OTC. Oral dental surgeons etc. cam forward and informed us they use similar programs before COVID to clean nostrils and mouths as they are inside people mouths daily in surgery and they use this as their own protection. Keeps them safe. We then dug further and studied it and boy, had we known earlier, this would have been out there to help protect more, even before early treatment. It defies logic why public health will not tell people these solutions that saves lives including for vitamin D.
URGENT: BA.4 & BA.5 omicron driven by VACCINE warrants nasal-oral washes with povidone iodine (PI) or hydrogen peroxide (no swallow); Flavio & Rapiti offers aggressive treatment for this BA.4/.5
I re-provide PI protocol & suggested treatments for BA 4 & BA 5 omicron; emerging reports indicate these are more symptomatic & stronger; talk to your doctor with the FLCCC program; VAX causing this
palexander.substack.com
Subscribe to Substack Alexander COVID News evidence-based medicine
By Dr. Paul Alexander
Heliobas Disciple
TB Fanatic
I found this describing testing. Molecular testing seems to be the most accurate.
What are the different types of tests to diagnose COVID-19?
Which COVID-19 Test Should You Get?
Yale Medicine experts explain the ins and outs of lab- and home-based tests.www.yalemedicine.org
You copied in full a post I made a few posts up (the substack from Dr, Alexander is in post 63,675, the 2nd to last post I made last night), but have left a few links without any content, such as this one! Please try to post all the articles you link to (it's actually a rule for TB, no blind links, but I don't think this thread is read by the Mods/Admin so you've been lucky!). For two reasons. Some are reading on phones or on limited bandwith and it's harder to open a new window, and also because sometimes things disappear so we have it archived here.
If you aren't able to, you can pm me the link and I'll post it at your request (as I do for Profit of Doom, whose links introduced me to substack a few months back for which I am extremely grateful).
Which COVID-19 Test Should You Get?
Yale Medicine experts explain the ins and outs of lab- and home-based tests.
www.yalemedicine.org
Which COVID-19 Test Should You Get?
BY CARRIE MACMILLAN
January 20, 2022
Yale Medicine experts explain the ins and outs of lab- and home-based tests.
[Originally published: Oct. 20, 2021. Updated: Jan. 20, 2022.]
Note: Information in this article was accurate at the time of original publication. Because information about COVID-19 changes rapidly, we encourage you to visit the websites of the Centers for Disease Control & Prevention (CDC), World Health Organization (WHO), and your state and local government for the latest information.
As the highly contagious Omicron variant continues to sweep across the country, people—even those who are fully vaccinated—are wondering if the onset of cold and flu symptoms is really a sign of COVID-19 infection.
But COVID testing has become a complicated issue. As Omicron surged, appointments at sites where results are processed by a laboratory became difficult to find in a timely manner. So, many turned to at-home COVID-19 tests. Often called rapid tests, such kits are sold in drugstores and online, allowing people to test themselves—and get results—in their own home in a matter of minutes.
Unfortunately, at-home tests have also become difficult—if not impossible—to find. The federal government hopes to alleviate the bottleneck by requiring private insurance companies to start reimbursing customers for at-home tests and by distributing 1 billion free rapid tests to Americans.
If you can get your hands on a test, you might find the different options confusing. In which situations is a laboratory-based (often called PCR) test best? If you are traveling and need to show a negative COVID test, which should you get? Are they all equally accurate? Do some produce results faster than others? And how far does that Q-tip go up your nose with each kind?
Some of these questions are easy to answer, while others are more difficult—particularly when it comes to accuracy. That’s because all of the tests—and there are hundreds of them, from a growing number of companies and laboratories—are offered through a Food and Drug Administration (FDA) emergency use authorization (EUA). Therefore, they have not been as rigorously tested or vetted as other medical tests with full FDA approval.
And since the virus is new, all the tests are also new, meaning we have neither a long track record of comparing results, nor a true gold-standard test yet.
Furthermore, with each new variant, new questions arise. Recently, there has been discussion about whether throat swabs or saliva samples are better at detecting Omicron compared to the more mainstream method of nasal swabs—or if rapid tests are less effective at detecting Omicron.
Sheldon Campbell, MD, PhD, a Yale Medicine pathologist and microbiologist, cautions against getting caught up in what he calls mostly anecdotal data.
“There is some PCR-based data that saliva is better, but the home tests are designed to work with a nasal swab and very few responsible people would think you should replace a nasal swab with a throat swab. That’s Twitter medicine,” says Dr. Campbell, referring to a #swabyourthroat hashtag that is trending. “And I have not seen good data that antigen tests are somehow less sensitive with Omicron than they are with other strains.”
Below, Dr. Campbell and Yale Medicine infectious disease experts get into the nuances of the various available COVID-19 tests.
What are the different types of tests to diagnose COVID-19?
Unlike antibody tests, which look for prior infection, COVID diagnostic tests look for current infection with SARS-CoV-2, the virus that causes COVID-19. They are broken into two categories: molecular and antigen (more below).
A summary of their differences
Because the samples are, for the most part, collected in the same way for both, the differences between the two kinds of tests are largely in how they’re processed.
Molecular tests are generally more accurate and mostly processed in a laboratory, which takes longer; antigen tests—or “rapid tests”—are processed pretty much anywhere, including at home, in doctors’ offices, or in pharmacies. You can get antigen test results in about 15 minutes, but they tend to be less accurate.
Health care providers typically rely on molecular tests, particularly when people have COVID-19 symptoms, whereas antigen testing is often used when quick results are needed or for general screening and surveillance.
Below, we take a closer look at the two categories.
Molecular COVID tests (also called nucleic acid amplification test, or NAAT)
The first test created to detect COVID—and still the most widely used—is a molecular test called PCR (polymerase chain reaction), Dr. Campbell says. “PCR and similar tests look for the COVID virus’s RNA,” meaning genetic material that comes only from the virus, he explains. “They tend to be quite sensitive, but even among these, they are on a continuum of sensitivity and vary a whole lot.”
“Sensitivity” measures how often a test correctly delivers a positive result for people with the condition that's being tested. A test that's highly sensitive will catch almost anyone who has the disease and not generate a lot of false-negative results.
How does the test work? A molecular test looks for genetic material from the virus. The test uses sophisticated chemicals and equipment to reproduce millions to billions of copies of viral-related DNA from even the smallest sample. Because of that, the test is considered highly sensitive, leading to very few false negatives.
How is a sample obtained? Usually with a swab inserted into your nose. There are three different methods for nasal collection:
- Nasopharyngeal: A health care professional inserts a long swab deep into your nostril to collect fluid from the back of your nose.
- Mid-turbinate: This method, which someone can be coached to do themselves or is done by a professional, involves placing a soft swab straight back into the nostril (less than one inch) to collect a sample.
- Anterior nasal swab: This test, which can either be self-administered and possibly supervised by a trained health care provider, or done by a health care professional, involves putting a swab three-quarters of an inch into the nostril and twirling it around at least four times to get a sample.
Other collection methods include:
- Oropharangeal (throat) swab: A trained health care provider collects a sample using a swab to the back of the throat.
- Saliva: You drool into a sterile, leak-proof cap container. For now, this type of testing is only offered at select locations.
Where can you get one? Molecular tests are offered at pharmacies, doctors' offices, and designated testing locations, such as health clinics, as well as locations set up by private or state and local public health systems.
How quickly can you get results? Because the tests are sent to a lab, it depends on lab capacity. Results are typically available within a range of one to seven days, depending on your location.
“Currently, Yale New Haven Health System is turning around about 76% of community test results within 24 hours and just over 95% within 48 hours,” says Scott Roberts, MD, a Yale Medicine infectious disease specialist.
How accurate are they? According to the Centers for Disease Control and Prevention (CDC), laboratory-based tests, such as PCR, have a “generally high” test sensitivity.
“PCR tests are considered the most accurate available,” Dr. Martinello says. “But because these tests are highly sensitive and specific, there is still a risk for a false positive.”
But limiting false negatives might be extremely important, especially with the rise of more transmissible variants. "It’s actually true for those who have—and who don’t have—symptoms, but if you do have symptoms, a PCR test is more likely than an antigen test to pick up an infection accurately,” says Dr. Campbell.
Antigen COVID tests
Whereas molecular tests require specialized equipment for processing samples, an antigen test is simpler, because it requires smaller devices that are easy to transport. Their design is similar to, say, a pregnancy test.
How does the test work? Antigen tests search for pieces of protein from the SARS-CoV-2 virus. The sample you provide is treated with a reagent and analyzed on the spot by a health care professional. Unlike molecular tests, these require a higher level of virus in the test sample before the test will turn positive. This means that an antigen test may sometimes lead to a false negative.
How is a sample obtained? As with molecular tests, a sterile swab is inserted into your nose or throat to obtain a specimen (see details above)—although throat swabs may be less common these days.
How is the test processed? The sample is self-applied to a test strip or cartridge. Similar to a home pregnancy test, results show a colored line to signify positive or negative.
Where can you get one? Antigen tests are offered in pharmacies, doctors' offices, and can be purchased to use at home.
How quickly can you get results? Results are typically available in 10 to 15 minutes.
How accurate are they? According to the CDC, antigen test sensitivity varies depending on the time in the course of one’s infection, but is considered to have “moderate to high” sensitivity during peak viral load. Compared to molecular tests, antigen tests are more likely to generate false negative results, especially when performed on people who don’t have symptoms.
ID NOW COVID Test
Complicating things a bit is the availability of ID NOW, a rapid molecular test used by some testing locations, such as pharmacies, that can read results on-site—in about 15 minutes.
According to the CDC, point-of-care tests (such as those administered at a drug store, including ID NOW), have a “moderate to high” test sensitivity.
But where does it fit in the molecular vs antigen test result accuracy spectrum?
“ID NOW is not a completely different thing than PCR, it’s just on the lower sensitivity end of the spectrum,” Dr. Campbell says. “So, more accurate than an antigen test.”
[continued next post]
Heliobas Disciple
TB Fanatic
[continued from post above]
What about home tests?
The home tests that give instant results are all antigen. However, there are home kits that require mailing a sample to a lab that use molecular technology. Whereas testing at pharmacies and doctors’ offices is typically free or covered by insurance, your insurance company may not cover the cost of a home test, which may cost anywhere from $24 for a set of two to $38 for one.
Home tests are useful if you need an immediate answer, Dr. Campbell says. “But the tricky part is that the cost can pile up and people don’t always do the test correctly, either,” he says. “It’s extremely important to follow the directions carefully.”
And since they are less sensitive than a molecular test, the FDA recommends doing serial testing—or taking multiple tests—over several days to improve the chance of catching asymptomatic infections.
But given the current shortage of tests, Dr. Campbell advises using them sparingly.
“If you can access a home antigen test, I would wait to take one until about three days after a known COVID exposure. If it’s negative, I would do it again at days five and seven,” he says. “Even that is a lot of tests. So, depending on the degree of your exposure and if you turn symptomatic, you might not need to keep testing, especially if you are vaccinated and a ‘low-risk’ person. Rather, test again when your symptoms have gone away and you are ready to go back to work.”
The overarching principle of testing in the medical world, Dr. Campbell explains, is that you should only test when a result will change what you do. Given the high case rate levels right now, if you are exposed to COVID and then develop symptoms, chances are you have the virus, he says. If your symptoms can be managed safely at home and you can isolate, then that is what you should do.
Another thing to remember, Dr. Campbell says, is that if an antigen test comes back positive right now, it is most likely accurate.
“People who have a positive antigen test right now are almost certainly infectious and contagious. People who are antigen negative at the very worst are less contagious. We can’t say they are absolutely not contagious because the studies are hard to do, but they are less contagious for sure,” he says. “When the incidence of disease is really low, false positives start to outnumber the true positives. But at this moment, when incidence is so high, false positives are extremely unlikely.”
What type of test should I get?
If you are exhibiting a fever, cough, trouble breathing, or other COVID-19 symptoms, you should get tested, regardless of vaccination status, health experts advise. If testing is available, consider testing three to five days after a high-risk exposure, adds Dr. Campbell.
Deciding which type of test to get can be challenging.
“A lot of this depends on access and what is readily available to you. We are thankful to have rapid antigen tests, but if you don’t have symptoms, their sensitivity is limited and we know that 40% of people who are contagious with COVID are asymptomatic,” Dr. Martinello says. “A NAAT test is more sensitive, but a lot still depends on the quality of the specimen.”
Still, for the diagnosis of people seriously ill (with a presumed case of COVID-19), doctors will generally use a PCR test, because false-negative tests might result in inadequate treatment.
Travel
If you are traveling, you might be required to get tested, too. The location you are visiting might require a certain type of test and approved testing locations as well.
“I think the test you can get makes the most sense for travel right now. If you can get PCR, great. If not, get an antigen,” Dr. Campbell says. “But you do want to test because you don’t want to be the one person who infects everyone else on the airplane.”
School and workplaces
Schools may have their own rules for how they conduct COVID-19 testing. But for surveillance, such as at schools or workplaces, antigen tests work well, Dr. Campbell says.
“Say you are testing kids in a school twice a week in perpetuity. You can do it much more quickly and easily and for less cost if you use antigen tests,” he says. “You want to answer the question of if kids are infectious now or not. Would PCR be better in that setting? Yes, but you won’t get the answer back in a day necessarily, and you would spend a lot of money to find a few positives. Sometimes, speed is the most important thing.”
General peace of mind
Some people might like to do regular COVID tests for peace of mind. Say you are vaccinated but plan to attend a crowded event and then visit an immunocompromised or elderly relative.
“If you are going to do something risky and then visit your 90-year-old mom, then what you really want to do is test before the event and make sure you’re not the person spreading virus,” he says.
After that, the timing of what to do next is complicated.
“If you went to a crowded concert and are worried about COVID, you don’t want to take any COVID test—molecular or antigen—the next day. You should wait three to five days after potential exposure,” says Dr. Campbell. “We think that you have to have a fair amount of virus present to be infectious to others, and we know that in the course of infection, the viral load goes up and down.”
If you have a limited number of tests, you should use them right before you visit vulnerable friends or relatives—or right before you go to an event with lots of people, adds Dr. Campbell. “Use them to keep from spreading infection,” he says.
Will any of the tests tell me which variant I have?
None of the COVID-19 tests you take, either at home or at a pharmacy, will tell you if you have a variant, such as Delta or Omicron. Detecting variants requires genetic testing done in a lab. Across the country, a selection of positive COVID-19 samples are sent to specialized labs, where they are anonymously sequenced to identify variants so that public health officials can monitor COVID-19 trends.
And not all positive specimens are tested; only sample amounts are taken. So, if you hear that 75% of cases in an area are a particular variant, for example, that reflects a computation based on the number of samples tested—and it is just an estimate. By January, Omicron made up about 95% of COVID-19 cases in the U.S.
Are there tests that look for COVID-19 and the flu?
Since the symptoms of COVID-19 and the flu are similar, it’s helpful to know there are molecular tests you can have that detect each virus using a single sample. In fact, there are even tests that diagnose COVID-19, flu, and RSV (respiratory syncytial virus), a virus that causes common cold symptoms, at once.
Such tests are offered at doctors' offices and clinics and need to be sent to a lab, and should come back in a day or less. These tests will become available closer to flu season, in October.
Even for physicians, COVID-19 testing can be confusing.
In the end, it’s best to remember the basics: get your vaccine, when in doubt wear a mask and social distance, and stay home and away from others if you feel sick, Dr. Campbell says.
What about home tests?
The home tests that give instant results are all antigen. However, there are home kits that require mailing a sample to a lab that use molecular technology. Whereas testing at pharmacies and doctors’ offices is typically free or covered by insurance, your insurance company may not cover the cost of a home test, which may cost anywhere from $24 for a set of two to $38 for one.
Home tests are useful if you need an immediate answer, Dr. Campbell says. “But the tricky part is that the cost can pile up and people don’t always do the test correctly, either,” he says. “It’s extremely important to follow the directions carefully.”
And since they are less sensitive than a molecular test, the FDA recommends doing serial testing—or taking multiple tests—over several days to improve the chance of catching asymptomatic infections.
But given the current shortage of tests, Dr. Campbell advises using them sparingly.
“If you can access a home antigen test, I would wait to take one until about three days after a known COVID exposure. If it’s negative, I would do it again at days five and seven,” he says. “Even that is a lot of tests. So, depending on the degree of your exposure and if you turn symptomatic, you might not need to keep testing, especially if you are vaccinated and a ‘low-risk’ person. Rather, test again when your symptoms have gone away and you are ready to go back to work.”
The overarching principle of testing in the medical world, Dr. Campbell explains, is that you should only test when a result will change what you do. Given the high case rate levels right now, if you are exposed to COVID and then develop symptoms, chances are you have the virus, he says. If your symptoms can be managed safely at home and you can isolate, then that is what you should do.
Another thing to remember, Dr. Campbell says, is that if an antigen test comes back positive right now, it is most likely accurate.
“People who have a positive antigen test right now are almost certainly infectious and contagious. People who are antigen negative at the very worst are less contagious. We can’t say they are absolutely not contagious because the studies are hard to do, but they are less contagious for sure,” he says. “When the incidence of disease is really low, false positives start to outnumber the true positives. But at this moment, when incidence is so high, false positives are extremely unlikely.”
What type of test should I get?
If you are exhibiting a fever, cough, trouble breathing, or other COVID-19 symptoms, you should get tested, regardless of vaccination status, health experts advise. If testing is available, consider testing three to five days after a high-risk exposure, adds Dr. Campbell.
Deciding which type of test to get can be challenging.
“A lot of this depends on access and what is readily available to you. We are thankful to have rapid antigen tests, but if you don’t have symptoms, their sensitivity is limited and we know that 40% of people who are contagious with COVID are asymptomatic,” Dr. Martinello says. “A NAAT test is more sensitive, but a lot still depends on the quality of the specimen.”
Still, for the diagnosis of people seriously ill (with a presumed case of COVID-19), doctors will generally use a PCR test, because false-negative tests might result in inadequate treatment.
Travel
If you are traveling, you might be required to get tested, too. The location you are visiting might require a certain type of test and approved testing locations as well.
“I think the test you can get makes the most sense for travel right now. If you can get PCR, great. If not, get an antigen,” Dr. Campbell says. “But you do want to test because you don’t want to be the one person who infects everyone else on the airplane.”
School and workplaces
Schools may have their own rules for how they conduct COVID-19 testing. But for surveillance, such as at schools or workplaces, antigen tests work well, Dr. Campbell says.
“Say you are testing kids in a school twice a week in perpetuity. You can do it much more quickly and easily and for less cost if you use antigen tests,” he says. “You want to answer the question of if kids are infectious now or not. Would PCR be better in that setting? Yes, but you won’t get the answer back in a day necessarily, and you would spend a lot of money to find a few positives. Sometimes, speed is the most important thing.”
General peace of mind
Some people might like to do regular COVID tests for peace of mind. Say you are vaccinated but plan to attend a crowded event and then visit an immunocompromised or elderly relative.
“If you are going to do something risky and then visit your 90-year-old mom, then what you really want to do is test before the event and make sure you’re not the person spreading virus,” he says.
After that, the timing of what to do next is complicated.
“If you went to a crowded concert and are worried about COVID, you don’t want to take any COVID test—molecular or antigen—the next day. You should wait three to five days after potential exposure,” says Dr. Campbell. “We think that you have to have a fair amount of virus present to be infectious to others, and we know that in the course of infection, the viral load goes up and down.”
If you have a limited number of tests, you should use them right before you visit vulnerable friends or relatives—or right before you go to an event with lots of people, adds Dr. Campbell. “Use them to keep from spreading infection,” he says.
Will any of the tests tell me which variant I have?
None of the COVID-19 tests you take, either at home or at a pharmacy, will tell you if you have a variant, such as Delta or Omicron. Detecting variants requires genetic testing done in a lab. Across the country, a selection of positive COVID-19 samples are sent to specialized labs, where they are anonymously sequenced to identify variants so that public health officials can monitor COVID-19 trends.
And not all positive specimens are tested; only sample amounts are taken. So, if you hear that 75% of cases in an area are a particular variant, for example, that reflects a computation based on the number of samples tested—and it is just an estimate. By January, Omicron made up about 95% of COVID-19 cases in the U.S.
Are there tests that look for COVID-19 and the flu?
Since the symptoms of COVID-19 and the flu are similar, it’s helpful to know there are molecular tests you can have that detect each virus using a single sample. In fact, there are even tests that diagnose COVID-19, flu, and RSV (respiratory syncytial virus), a virus that causes common cold symptoms, at once.
Such tests are offered at doctors' offices and clinics and need to be sent to a lab, and should come back in a day or less. These tests will become available closer to flu season, in October.
Even for physicians, COVID-19 testing can be confusing.
In the end, it’s best to remember the basics: get your vaccine, when in doubt wear a mask and social distance, and stay home and away from others if you feel sick, Dr. Campbell says.
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I think I remember that you also tested negative even though you had all the symptoms? so I think the tests are really a hit or miss and shouldn't be relied on totally. I know of others who were really sick, were surrounded by sick people in their family or at work and tested negative, even though they lost smell and taste and were obviously sick with Covid. A false positive isn't as dangerous as a false negative, because a false positive may be an inconvenience, but a false negative gives sick and contagious people the idea they are 'safe' to be mingling with others, when in fact the opposite is true. I think that's one of the reasons covid spread so fast, because everyone relied on faulty tests.
HD
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The interviewer owns a commerical lab so was able to do his own bloodwork. He tested himself daily and after he got sick did antibody tests on himself that aren't available generally, unless I guess your doctor orders it from a lab willing to do it. But he didn't have that hurdle as he owns the lab. He also I think sells test kits but I could've misheard that part. For other things beside Covid, but he's very knowledgeable in the field. Both he and Geert think (and I'm guessing we all agree) that antibody testing is the way to go and it's a unfortunate that that's not the avenue the CDC/etc pursued to handle the pandemic.
As for fooling the test - why would anyone want to do that? If you're sick - STAY HOME and stop spreading the disease. The only reason to try to fake out the test is to get around that protection for others. Until we're 100percent sure there is no spread of asymptomatic (and we're not there yet), the excuse that you're asymptomatic so the test is a bother to you doesn't fly for me.
HD
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I've lost power twice and been thrown off the internet twice since I first signed on. This happened to me yesterday too. It's very frustrating. I'm trying to get to all the posts. I came on to post something specific but wanted to answer the posts first. Hopefully I'll get to stay on for a while now... who knows...
HD
HD
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He wrote a substack article about it, linked in a lower tweet. Here it is:
Drug Cartel: Biden Admin agrees to pay Pfizer 56% more for their COVID shots
The pharma giant is already shattering profit records, and is expected to generate well over $100 billion in 2022 revenue.
dossier.substack.com
Drug Cartel: Biden Admin agrees to pay Pfizer 56% more for their COVID shots
The pharma giant is already shattering profit records, and is expected to generate well over $100 billion in 2022 revenue.
Jordan Schachtel
8 hr ago
Pfizer is already swimming in record profits, but that hasn’t stopped the drug company from gouging the American taxpayer for every last dollar.
On Wednesday, the Biden Administration signed off on a new vaccine supply deal with Pfizer for $3.2 billion for 105 million COVID injections, but that’s only for the first batch of mRNA shots. The contract will generate well over $9 billion for Pfizer, as this latest purchase agreement tops off at 300 million doses. Compared to previous settlements with Pfizer, this public-private no-bid arrangement will come at a much higher cost to the U.S. taxpayer.
The Biden Administration has justified the deal by claiming that it needs to restock supply to prepare for seasonal spikes. The data does not support such a claim. According to the CDC, almost 100 million taxpayer-funded Pfizer shots (and 169 million total shots) have gone unused, resulting in billions of dollars in waste.
The new arrangement allows for the Biden Administration to buy Pfizer’s authorization-pending COVID injections, which the company claims is reformulated for newer variants.
However, even the new formulation is already outdated. It was designed and trialed for an Omicron subvariant (BA.1) that was popular last Winter, but no longer exists in circulation, potentially rendering it just as useless as the Wuhan strain shot. The deal includes the infant and toddler formulations, which are based on the non-existent Wuhan strain.
None of the shots for this deal will be supplied under an FDA approved label. Instead, they will be distributed under emergency use authorization (EUA). Pfizer has never deployed its FDA-approved vaccine in the United States. The company recently acknowledged that it never intends on producing its original FDA approved vaccines.
The original deal with Pfizer was negotiated by the Trump Administration during the days of Operation Warpspeed. It paid the pharma giant $19.50 a dose. The new pact gives Pfizer $30.48 per dose, resulting in an astronomical 56% hike from the deal negotiated by the last administration.
The price hike conflicts with the probability that Pfizer’s costs are likely much lower than they were with the original purchase order. The infant and child shots have a fraction of the active agreement as the adult supply, and each vial stores more doses . Moreover, Pfizer has added an ingredient to the formula that allows for a significant shelf life extension, making the logistics much more cost effective.
Pfizer’s margins were already through the roof prior to the Wednesday announcement.
Pfizer’s May earnings report showed that the company logged a record breaking $26 billion in Q1 sales, marking a quarterly profit of $7.86 billion. Revenue was up 77% from 2021, while profit was up 61%. Now absorb these 2022 numbers in the context of Pfizer’s 2021 revenue outperforming its 2020 revenue by 95%.
Before the new vaccine purchase order, Pfizer was already on track to bring in over $100 billion in revenue and $32 billion in net income this year. In financial statements, the company has acknowledged that it has transformed itself into a COVID-19-driven business. All of its new income is coming from the American taxpayer and other government “customers” via their taxpayers, who have virtually no say in the matter.
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Now that I'm caught up, and still have power and internet, I have some very sad news to post.
Dr. Zelenko passed away this afternoon. He was a true hero. He saved many lives as the one who first promoted hydroxochloroquine and zinc (including to Pres Trump when he got sice) and was a vocal outspoken critic of the MRNA vaccination program. May his soul rest in peace.
And more sad news.
Dr. Carrie Madej was in a plane crash on Sunday (under very mysterious circumstances) and is in ICU. Her boyfriend was the pilot (with 20 years experience) and is also in ICU. They both need our prayers. Dr. Carrie was one of the first to speak out about the vaccines, even before they were released to the public. She's also a hero.
Dr. Zelenko passed away this afternoon. He was a true hero. He saved many lives as the one who first promoted hydroxochloroquine and zinc (including to Pres Trump when he got sice) and was a vocal outspoken critic of the MRNA vaccination program. May his soul rest in peace.
And more sad news.
Dr. Carrie Madej was in a plane crash on Sunday (under very mysterious circumstances) and is in ICU. Her boyfriend was the pilot (with 20 years experience) and is also in ICU. They both need our prayers. Dr. Carrie was one of the first to speak out about the vaccines, even before they were released to the public. She's also a hero.
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More on Dr. Carrie:
stopworldcontrol.com
(fair use applies)
Dr. Carrie Madej nearly died in devastating airplane crash
Our dear friend and phenomenal world leading freedom fighter doctor Carrie Madej was involved in a plane crash, which almost killed her.
Dr. Carrie Madej and her partner Billy - a private plane pilot with 20 years of experience - returned from Florida, where they enjoyed a meeting with likeminded people. In mid air the engine of the plane suddenly stalled, for no apparent reason. In a few seconds the rpm dropped to zero, and they dropped like a rock.
No one can figure out why this happened. Airplane engines are meticulously maintained and thoroughly checked, and there was no reason why the engine suddenly went dead. Dr. Madej told me: "It’s a miracle we are alive!"
Dr. Madej is currently in a hospital , but is recovering well. She has fractured her left lower leg and five vertebrates. Billy is in worse condition with several skull, facial and back fractures. Thankfully there is no brain bleed.
Right after they crash landed, it first looked as if Billy was dead, as he was unconscious and his head was bleeding profusely. After some 45 seconds he came by, much to the relief of Carrie.
It took more than half an hour for the rescue team to locate them. Carrie had tried to broadcast their location, but strangely enough nothing worked. The wifi didn't function and her phone overheated. She can't explain why this happened. Luckily she was able to find another phone on the plane, which she then used to pinpoint her location, so they could be found.
The rescuers shouted through megaphones to find them, and when she heard them, Carrie cried louder than she had ever done: "HELP!!!" which saved their life, as her cries led the rescuers to find them just in time.
[...]
Dr. Carrie Madej nearly died in devastating airplane crash
One of the world's foremost physicians who fight for the freedom of humanity, nearly lost her life in a devastating aircraft accident.
stopworldcontrol.com
Dr. Carrie Madej nearly died in devastating airplane crash
Our dear friend and phenomenal world leading freedom fighter doctor Carrie Madej was involved in a plane crash, which almost killed her.
Dr. Carrie Madej and her partner Billy - a private plane pilot with 20 years of experience - returned from Florida, where they enjoyed a meeting with likeminded people. In mid air the engine of the plane suddenly stalled, for no apparent reason. In a few seconds the rpm dropped to zero, and they dropped like a rock.
No one can figure out why this happened. Airplane engines are meticulously maintained and thoroughly checked, and there was no reason why the engine suddenly went dead. Dr. Madej told me: "It’s a miracle we are alive!"
Dr. Madej is currently in a hospital , but is recovering well. She has fractured her left lower leg and five vertebrates. Billy is in worse condition with several skull, facial and back fractures. Thankfully there is no brain bleed.
Right after they crash landed, it first looked as if Billy was dead, as he was unconscious and his head was bleeding profusely. After some 45 seconds he came by, much to the relief of Carrie.
It took more than half an hour for the rescue team to locate them. Carrie had tried to broadcast their location, but strangely enough nothing worked. The wifi didn't function and her phone overheated. She can't explain why this happened. Luckily she was able to find another phone on the plane, which she then used to pinpoint her location, so they could be found.
The rescuers shouted through megaphones to find them, and when she heard them, Carrie cried louder than she had ever done: "HELP!!!" which saved their life, as her cries led the rescuers to find them just in time.
[...]
LOL This is rigged. I would have been surprised if they weren't. At my age, if you are unvaxxed, no matter how many miles you drive (500,000!) you have a better chance of dying of covid than dying in a car crash. Probably any age. My results were just over 1% to die of a car crash but over 8% to die of covid unvaxxed. The graphs are . . . interesting. I have no faith in that at all.(fair use applies)
Online tool allows users to predict their likelihood of severe illness or death from COVID-19
Are you more likely to die from COVID-19 or in a car accident? A new risk assessment tool can help you figure that out.medicalxpress.com
Online tool allows users to predict their likelihood of severe illness or death from COVID-19
by Kathryn Kao, University of Georgia
June 29, 2022
Are you more likely to die from COVID-19 or in a car accident? A new risk assessment tool can help you figure that out.
Created by Cameron Byerley at the University of Georgia, the online tool is called COVID-Taser, and it allows users to adjust age, vaccine status and health background to predict the risks of the virus.
Byerley, an assistant professor in UGA's Mary Frances Early College of Education, said that most people assess risk based on their experience of the world.
"Like if you're trying to decide how dangerous it is to drive, you might think about how out of all your friends and all your family members, you know two people who died of driving in the past 20 years. So, it's risky enough that you should wear a seatbelt and drive sober, but it's not so risky that you shouldn't drive to a friend's house."
That way of thinking helps people compare unknown risks with known ones they interact with every day. The COVID-Taser capitalizes on those comparisons to give people a better idea of their risks of dying from COVID-19 or having adverse side effects from vaccination. Website visitors can then see how those risks stack up to others like dying in a car crash or being struck by lightning in their lifetime.
The website is part of a larger project that aims to investigate how people interpret media using quantitative data representations like graphs and charts.
Understanding health risks of COVID-19
After conducting surveys in both the U.S. and South Korea, the team created several tools and a series of K-12 lesson plans to help citizens and students use mathematical representations of COVID-19 to make data-informed decisions about their health.
"A big focus of the project is thinking about how to communicate information," said Byerley. "We're really interested in risk communication and providing information so people can make decisions for themselves by comparing COVID risks and vaccination risks to more familiar risks they have a sense of."
People can also use the Relative Risk Tool to toggle between different ages to see how the risk of being hospitalized or dying from COVID-19 changes according to age groups.
Additionally, the tool can be used to compare the risk of dying from the coronavirus for vaccinated people versus unvaccinated people, as well as unvaccinated people with various health conditions like rheumatoid arthritis, lupus, psoriasis and other immunosuppressive conditions.
"My dream goal is that people will see that the risk of vaccination is low compared to other risks that they're willing to take," said Byerley. "They'll see that vaccination is safer than driving, pregnancy, playing professional soccer and just safer than lots of things they're willing to do already. It's also far, far safer than getting a COVID infection … the benefits of vaccination far outweigh the risks."
Byerley is currently working on incorporating information on immunocompromised people who are both vaccinated and unvaccinated into the Relative Risk Tool.
Explaining the impact of masks, social distancing in fighting the coronavirus
COVID-Taser's projection tool, which was designed to explain models from the Institute of Health Metrics and Evaluation (IHME), is an educational resource that teaches people the difference between cumulative deaths, which is the total number of people who have died and a figure that will always increase over time, and average daily deaths, which can increase or decrease over time.
Byerley noted that media outlets cause confusion when they include graphs labeled "total deaths" with numbers decreasing over time when they really should be labeled "average daily deaths" because total deaths cannot decrease.
In addition to showing total deaths and daily deaths separately on the projection tool, IHME models also predict how deaths will either increase or decrease in the U.S. depending on whether mask mandates are implemented.
"We want people to understand what a model is and how it's kind of like what happens on your phone when you're using Google Maps to predict how long a trip will take, which is based on some sort of algorithm," said Byerley. "It's usually pretty good, but it's never perfect and it changes. So we want people to understand that epidemiological modeling is very helpful, even though those estimates aren't perfect. They still help people plan and are helpful tools."
The IHME model predicted that, during the middle of the pandemic, areas without mandates involving masks, large gatherings and shutdowns would likely experience an increase in daily deaths. On the other hand, if mask mandates were implemented across the entire U.S., the model predicted that daily deaths would decrease. These predictions were verified by varying death rates in states and other countries with different public health policies.
Although models are not exact, they still show the impact of masking and vaccination in reducing death from COVID-19, Byerley said.
"I'm hoping these tools can serve as a template for medical communication," said Byerley. "And when numbers are hard for people to understand, it helps them see the relative size of things even if they don't know percentages or place values or information like that from school. I want these tools to help people understand that the risk of COVID infection is worse than the risk of vaccination and that the risk of vaccination is lower than other things they already do."
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'The worst version' of COVID is spreading. Can we update our vaccines in time?
Viruses evolve, and vaccines should too. That was the big-picture takeaway from a pivotal meeting this week of the FDA’s expert advisory panel. The question before them was simple: Ahead of an expected winter surge, should vaccine manufacturers tweak their forthcoming booster shots to target...
'The worst version' of COVID is spreading. Can we update our vaccines in time?
Andrew Romano
Thu, June 30, 2022, 9:19 AM
For the last 18 months, the original COVID-19 vaccines — first as a two-dose series, then as boosters — have done an extraordinary job shielding us from illness, hospitalization and death. Globally, they saved nearly 20 million lives in 2021 alone. Even today, unvaccinated Americans are twice as likely as vaccinated Americans to test positive for COVID — and six times as likely to die from the disease.
But viruses evolve, and vaccines should too.
That was the big-picture takeaway from a pivotal meeting this week of the U.S. Food and Drug Administration’s expert advisory panel. The question before them was simple: Ahead of an expected winter surge, should vaccine manufacturers tweak their forthcoming booster shots to target Omicron — the ultra-infectious variant that has spent the last seven months surging throughout the world in one form or another — or should they stick with the tried-and-true 2020 recipe?
The panel voted 19-2 on Tuesday in favor of Omicron boosters. The question now, however, is which version of Omicron the next round of shots should target.
For anyone who hasn’t been paying attention, the Omicron strain that triggered last winter’s massive COVID wave (BA.1) is now extinct. In March, it was supplanted by the even more transmissible BA.2 … which was supplanted in May by the even more transmissible BA.2.12.1 … which is now being supplanted by the (you guessed it) even more transmissible BA.4 and BA.5.
Experts say BA.5 is the one to worry about: “The worst version of the virus that we’ve seen,” as Dr. Eric Topol, the founder of Scripps Research Translational Institute, recently put it. Together, the closely related BA.4 and BA.5 now account for the majority of new U.S. COVID cases, according to the latest data from the Centers for Disease Control and Prevention — but BA.5 (36.6%) is spreading a lot faster than BA.4 (15.7%). By early July, it will be the dominant strain in the U.S.
That’s troublesome for several reasons. To our immune system, the distance from BA.1 to heavily mutated BA.4 and BA.5 is “far greater,” Topol writes, than the distance from the original BA.1 virus to previous blockbuster variants such as Alpha and Delta — which makes them harder to recognize and respond to. According to the latest research, that could mean:
- More breakthrough infections, especially among people who previously had BA.1. Compared to BA.2, BA.2.12.1 is only modestly (1.8-fold) more resistant to antibodies from vaccinated and boosted individuals. But BA.4 and BA.5 are substantially (4.2-fold) more resistant.
- More symptoms. BA.4 and BA.5 are also better at replicating in lung cells than BA.2 — a shift that could mean, according to one experimental model, that they’re more “pathogenic” as well (i.e., more likely to make you sick).
- More resistance to treatments. At the same time, BA.4 and BA.5 appear to be 20-fold more resistant than BA.2 to Evusheld — an important monoclonal antibody treatment that has been providing preemptive protection for immunocompromised people.
But combined with waning vaccine protection and disappointing booster uptake among the elderly, the virus’s accelerating evolution and aggressive new trajectory — toward greater transmissibility, evasiveness and possibly pathogenicity — could cause significant reinfections and disruptions if not addressed.
It could also endanger vulnerable Americans in the months ahead.
In late April, BA.5 hit Portugal; by June, more Portuguese people were dying of COVID each day than during the country’s winter Omicron peak. To be sure, Portugal has a larger senior population (23%) than the U.S. (16%), but not by much. And the vaccination rate there is 87%, compared to just 67% in America. Portugal’s booster rate, meanwhile, is nearly twice as high as ours. Infection and hospitalization rates are now rising across much of the rest of Europe as well.
At Tuesday’s FDA advisory meeting, Justin Lessler, an epidemiologist at the University of North Carolina at Chapel Hill, presented a series of projections about how the virus could affect the U.S. in the months ahead. The most optimistic scenario? About 95,000 new deaths between March 2022 and March 2023. The most pessimistic? More than 200,000.
So given that BA.5 — which, again, is outcompeting its cousin BA.4 — will soon be everywhere, it seems logical that the next version of the vaccine should be tailored to fight it.
Yet that hasn’t necessarily been the plan. Both Pfizer and Moderna have already launched clinical trials for redesigned fall boosters … but those boosters are optimized to counter the now-nonexistent BA.1 rather than the soon-to-be-dominant BA.5. According to data presented Tuesday by Pfizer, their existing BA.1 booster generated a significantly lower level of neutralizing antibodies against BA.4 and BA.5 than against BA.1.
Yet in mice, at least, a booster containing BA.4 and BA.5 produced a higher neutralizing response to all Omicron variants (including BA.4 and BA.5) than the original vaccine.
Despite concerns about “scant” data about whether bivalent boosters (equal parts original strain and Omicron) work better than monovalent boosters (100% Omicron), and about whether it’s worth waiting for Novavax’s promising non-mRNA vaccine to hit the market, the panel mostly agreed that BA.4/BA.5 boosters make sense. The FDA is leaning that way as well. Pfizer said it was “prepared” to deliver the new boosters by the first week of October; Moderna, by the last week of October or early November — “assuming no clinical data requirements.”
That means no human trials — just animal trials and laboratory tests. That might sound scary to some, but regulators already use the same accelerated process to update the flu vaccine each year — and there is no mechanism by which minor mRNA tweaks will make revised Pfizer and Moderna shots any less safe than the billions of doses administered so far worldwide. Otherwise, the U.S. will miss its fall-winter deadline, and the fast-evolving virus will continue to outrun the vaccines.
The FDA itself will decide “very rapidly” what to recommend; manufacturers will follow their lead.
In the future, chasing variants may not prove to be the most effective or efficient approach to COVID vaccination. As Topol put it, “by the time a BA.5 vaccine booster is potentially available, who knows what … the predominant strain” will be? That’s why it was welcome news Wednesday when Pfizer and BioNTech announced that they plan to “start tests on humans of next-generation shots that protect against a wide variety of coronaviruses in the second half of the year,” according to a Reuters report.
These include “T-cell-enhancing shots, designed to primarily protect against severe disease if the virus becomes more dangerous,” and “pan-coronavirus shots that protect against the broader family of viruses and its mutations.” Nasal vaccines meant to stop infection before it starts are promising as well.
But those are all longer-term propositions. This year, at least, a BA.5 booster is probably our best bet to minimize infection, illness and death during another likely winter surge.
“I fully expect further evolution to occur in the coming months, but that this evolution will most likely be on top of BA.4/BA.5 — and so [it] shouldn’t dissuade vaccine updates,” virologist Trevor Bedford of the Fred Hutchinson Cancer Research Center in Seattle wrote earlier this week. “I believe that the decision making process can be boiled down to: of vaccine compositions that can be manufactured in time for fall distribution, which do we expect to generate the highest [protection] against BA.4/BA.5?”
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Infectious disease specialist recommends getting COVID shot once available
The updated shot is aimed at specifically targeting the highly contagious Omicron virus variant and could be available this fall.
Infectious disease specialist recommends getting COVID shot once available
Tori B. Powell - CBS News
Thu, June 30, 2022, 12:36 PM
Dr. Celine Gounder, an infectious disease specialist, encourages Americans to prepare themselves for a potential new COVID booster shot, after a U.S. Food and Drug Administration panel voted Tuesday to recommend modifying the COVID vaccine. The updated shot is aimed at specifically targeting the highly contagious Omicron virus variant and could be available this fall.
"I think we need to remember that the virus continues to mutate," Gounder told "CBS Mornings" on Thursday. "We need to try to keep up with the virus and even if you have gotten two boosters — so four doses — I would still strongly recommend getting the updated booster to better match the virus that is currently circulating."
The Omicron variant, Gounder said, emerged last fall and has continued to mutate, with it eventually becoming the country's most dominant strain. The updated booster shot is aimed at addressing the variant's mutations ahead of an anticipated winter surge of cases, she said.
"People are going to be back indoors, kids back in the classroom, people are very much going to be back at work in person definitely by then and these Omicron sub-variants, each of them has caused an increase every time they've emerged," she said.
She predicts in the short term that experts will recommend yearly booster vaccinations for elderly and immunocompromised people, as well as shots recommended for the general population when "there's a big variant switch." The infectious disease specialist added though that scientists "don't know what the tempo is going to be with the variant."
"I think the holy grail would be a universal coronavirus vaccine that would cover all variants," she said. "The problem is we're still years away from that. We don't have an operation warp speed, you know, with lots of funding and resources to move that along."
Gounder, who is editor-at-large at the Kaiser Family Foundation Health News, recommends those scheduled to receive the already-existing booster COVID vaccine to keep their appointments despite the potential new booster vaccine on the horizon.
"These updated vaccines won't be out until October at the earliest and we don't know what the supply is going to be in October," she said. "So i t's going to be a little while still yet before you can get that updated booster."
She also warned people about monkeypox — a rare but potentially deadly viral infection in the same family of viruses as smallpox that's recently been spreading around the world. While Gounder says the disease is actively spreading among "men who have sex with men," she noted that "it's only a matter of time before this spreads in the rest of the population."
The disease is passed on through direct contact with people who are infected with active lesions. A vaccine is currently being released to the public from the Strategic National Stockpile, Gounder said.
"We're really trying to nip this in the bud," she said.
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Tweaked COVID boosters in US must target newer omicron types
U.S. regulators told COVID-19 vaccine makers Thursday that any booster shots tweaked for the fall will have to add protection against the newest omicron relatives. The Food and Drug Administration said the original vaccines would be used for anyone still getting their first series of shots...
Tweaked COVID boosters in US must target newer omicron types
LAURAN NEERGAARD and MATTHEW PERRONE
Thu, June 30, 2022, 11:45 AM
U.S. regulators told COVID-19 vaccine makers Thursday that any booster shots tweaked for the fall will have to add protection against the newest omicron relatives.
The Food and Drug Administration said the original vaccines would be used for anyone still getting their first series of shots. But with immunity waning and the super-contagious omicron family of variants getting better at dodging protection, the FDA decided boosters intended for fall needed an update.
The recipe: Combination shots that add protection against the omicron relatives named BA.4 and BA.5 to the original vaccine. Those mutants together now account for just over half of new U.S. infections.
It's still a gamble as there's no way to know if an omicron relative still will be a threat as cold weather approaches or if a newer mutant will take its place. And the current Pfizer and Moderna vaccines still offer strong protection against COVID-19's worst outcomes as long as people have gotten already recommended boosters.
But the combination approach, what scientists call “bivalent” shots, would allow the boosters to retain the proven benefits of the original vaccine while adding to its breadth of protection. It’s a common vaccine strategy: Flu shots, for instance, can protect against four influenza strains and are tweaked annually depending on what's circulating.
The FDA’s decision comes after its scientific advisers earlier this week recommended that any boosters for a fall campaign should contain some version of omicron -- but left undecided whether it should be the omicron mutant that caused last winter’s surge or the genetically distinct relatives that have replaced it.
Pfizer and Moderna already were brewing and testing boosters updated against the first omicron mutant in anticipation of an October rollout. They found adding the extra protection was safe — and spurred production of more omicron-fighting antibodies than just getting another dose of today’s vaccine.
Pfizer had begun work on another experimental dose to target the newer strains the FDA ultimately settled on.
“We’re continuing to collect more data from our study on BA.4/5 and will be in touch as soon as we are ready to submit,” Pfizer spokeswoman Jerica Pitts said in an emailed message.
Moderna told FDA’s advisers that switching to the even newer strains now circulating might delay its booster update another month. A company spokeswoman said Moderna plans to submit its vaccine data to regulators.
The FDA’s order doesn’t guarantee that those combo shots would be offered in the fall. Manufacturers still have to provide key data before the agency decides whether to authorize modified boosters -- and the Centers for Disease Control and Prevention then would have to decide how they’re used.
For now, an all-important first booster of current vaccine already is urged for all Americans age 5 and older. People 50 and older are eligible for a second booster. With omicron, authorities say the shots' protection against COVID-19 hospitalization, while still robust, has slipped some in older adults and a second booster can help restore it.
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N. Korea suggests balloons flown from South brought COVID-19
North Korea suggested Friday its COVID-19 outbreak began in people who had contact with balloons flown from South Korea — a highly questionable claim that appeared to be an attempt to hold its rival responsible amid increasing tensions over its nuclear program. Activists for years have flown...
N. Korea suggests balloons flown from South brought COVID-19
HYUNG-JIN KIM - AP
Fri, July 1, 2022, 12:59 AM
SEOUL, South Korea (AP) — North Korea suggested Friday its COVID-19 outbreak began in people who had contact with balloons flown from South Korea — a highly questionable claim that appeared to be an attempt to hold its rival responsible amid increasing tensions over its nuclear program.
Activists for years have flown balloons across the border to distribute hundreds of thousands of propaganda leaflets critical of North Korean leader Kim Jong Un, and North Korea has often expressed fury at the activists and at South Korea’s leadership for not stopping them.
Global health authorities say the coronavirus is spread by people in close contact who inhale airborne droplets and it’s more likely to occur in enclosed, poorly ventilated spaces than outdoors. South Korea’s Unification Ministry said there was no chance South Korean balloons might have spread the virus to North Korea.
Ties between the Koreas remain strained amid a long-running stalemate in U.S.-led diplomacy on persuading North Korea to abandon its nuclear ambitions in return for economic and political benefits. South Korean and U.S. officials have recently said North Korea is ready for its first nuclear test in five years amid its torrid run of weapons tests this year.
The state media report said North Korea’s epidemic prevention center had found infection clusters in the town of Ipho near its southeastern border with South Korea and that some Ipho residents with feverish symptoms traveled to Pyongyang. The center said an 18-year-old soldier and a 5-year kindergartener had contact with “alien things” in the town in early April and later tested positive for the omicron variant.
In what it called “an emergency instruction,” the epidemic prevention center ordered officials to “to vigilantly deal with alien things coming by wind and other climate phenomena and balloons” along the inter-Korean border and trace their sources to the last. It also stressed that anyone finding “alien things” must notify authorities immediately so they could be removed.
The reports did not specify what the “alien things” were. But laying the blame on things flown across the border likely is a way to ease public complaints about its handling of the pandemic while repeating its objections to the ballooning activities of North Korean defectors and activists in South Korea, observers say.
Leafletting campaigns were largely halted after South Korea's previous liberal government passed a law criminalizing them, and there were no public balloon attempts made in early April.
An activist who is standing trial for past activities flew balloons carrying propaganda leaflets across the border in late April after halting them for a year. Park Sang-hak floated balloons twice in June, switching the cargo on those attempts to COVID-19 relief items such as masks and painkillers.
Police are still investigating the recent leafleting activities by the activist, Cha Duck Chul, a deputy spokesperson at the South’s Unification Ministry, told reporters Friday.
Cha also said the consensus among South Korean health officials and World Health Organization experts is that infections via contact with the virus on the surface of materials is virtually impossible.
In its previous dubious statements on COVID-19, North Korea also claimed the virus could spread through falling snow or migratory birds. Its pandemic-related restrictions even included strict bans on entering seawater.
Analyst Cheong Seong-Chang at South Korea’s Sejong Institute said North Korea wants its people to believe the coronavirus originated from leaflets, U.S. dollars or other materials carried across the border by the balloons.
Cheong said North Korea will likely sternly punish anyone taking such South Korean items covertly. He said North Korea could also try to shoot down incoming South Korean balloons, a move that would prompt South Korea to return fire and would sharply escalate animosities between the countries.
North Korea is infuriated by the leafletting campaign because it’s designed to undermine Kim’s authoritarian rule over a population that has little access to outside information. In 2014, North Korea fired at propaganda balloons flying toward its territory and South Korea returned fire, though there were no casualties.
North Korea's latest announcement on the virus contradicts the outside view that it spread after North Korea briefly reopened its northern border with China to freight traffic in January and it surged further following a military parade and other large-scale events in Pyongyang in April. Some outside experts have accused Kim of being largely responsible for the outbreak because he organized those events to boost public loyalty to the ruling Kim family amid economic hardships.
After maintaining a widely disputed claim to be coronavirus-free for more than two years, North Korea on May 12 admitted to the COVID-19 outbreak, saying an unspecified number of people in Pyongyang were diagnosed with the omicron variant.
North Korea has since reported about 4.7 million fever cases out of its 26 million population but only identified a fraction of them as COVID-19. It says 73 people have died, an extremely low fatality rate. Both figures are believed to be manipulated by North Korea to keep its people vigilant against the virus and prevent any political damage to Kim.
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U.S. Supreme Court nixes religious challenge to New York vaccine mandate
WASHINGTON (Reuters) -The U.S. Supreme Court on Thursday declined to hear a challenge to New York's mandate that healthcare sector workers be vaccinated against COVID-19 brought by a group of doctors, nurses and others who objected on religious grounds. Turning away an appeal by 16 healthcare...
U.S. Supreme Court nixes religious challenge to New York vaccine mandate
Andrew Chung
Thu, June 30, 2022, 11:22 AM
WASHINGTON (Reuters) -The U.S. Supreme Court on Thursday declined to hear a challenge to New York's mandate that healthcare sector workers be vaccinated against COVID-19 brought by a group of doctors, nurses and others who objected on religious grounds.
Turning away an appeal by 16 healthcare workers, the justices left in place a lower court ruling that rejected their claim that the mandate violates the U.S. Constitution's First Amendment prohibition against religious discrimination by the government. Most of the workers either resigned from their jobs, lost hospital admitting privileges or were fired for refusing the vaccine.
Conservative Justices Clarence Thomas, Samuel Alito and Neil Gorsuch, dissented from the decision to deny the appeal.
The Supreme Court previously rejected other challenges to vaccine mandates including one focusing upon Maine's lack of a religious exemption for healthcare workers.
New York's Department of Health last Aug. 26 ordered healthcare professionals who come in contact with patients or other employees to be vaccinated against COVID-19 as a safety measure during a pandemic that has killed more than a million Americans.
The state allows a narrow medical exemption for the small number of people with a serious allergic reaction to the COVID-19 vaccines.
The state has said that under the policy employers can consider religious accommodation requests and employees can be reassigned to jobs such as remote work. Healthcare workers in the state have also been subject to similar vaccine mandates measles and rubella, which also have no religious exemptions.
The dispute began when a group of doctors, nurses, therapists and other healthcare workers - mostly Catholics - sued in federal court under pseudonyms. Among the plaintiffs, three doctors lost admitting privileges, seven providers were fired or resigned, five chose to be vaccinated "under protest" and one eventually received a medical exemption.
Overall, nearly 37,000 New York healthcare workers either resigned, retired or were fired or furloughed for being unvaccinated, according to state data.
The plaintiffs have said they object to any COVID-19 vaccine whose testing or development relied on cell lines from aborted fetuses.
The COVID-19 vaccines used in the United States do not contain aborted fetal cells. Laboratory-grown cells that descended from the cells of an aborted fetus obtained decades ago were used in testing during the vaccine development process. The Vatican issued guidance to Catholics in 2020 that it is morally acceptable to use COVID-19 vaccines.
New York noted in a legal filing that use of such cell lines for testing is common, including for the rubella vaccination, which healthcare workers already take.
The Manhattan-based 2nd U.S. Circuit Court of Appeals rejected a bid by the plaintiffs for a preliminary injunction, finding last November that the mandate neutrally applied to everyone and likely was not biased against religion.
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Unvaxxed Army National Guard Members Face Discharge Tomorrow, Unless DOD Moves Deadline
July 1 is the deadline for Army National Guard members to comply with the U.S. military’s COVID-19 vaccine mandate or face separation — unless, as internal U.S. Army documents revealed could happen, officials push the deadline back.
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Unvaxxed Army National Guard Members Face Discharge Tomorrow, Unless DOD Moves Deadline
July 1 is the deadline for Army National Guard members to comply with the U.S. military’s COVID-19 vaccine mandate or face separation — unless, as internal U.S. Army documents revealed could happen, officials push the deadline back.
By Susan C. Olmstead
06/30/22
Today is the last day for Army National Guard (ARNG) members to comply with the U.S. Department of Defense (DOD) COVID-19 vaccine mandate or face separation — unless the DOD pushes back the July 1 deadline, an idea Army officials are considering, according to internal documents.
Under the military’s mandate, after June 30, ARNG members won’t be paid when they are activated on federal status, which includes their monthly drill weekends and their two-week annual training period, Associated Press (AP) reported.
“No Department of Defense funding may be allocated for payment of duties performed [by] members of the National Guard who do not comply with COVID-19 vaccination requirements,” the Pentagon announced in November 2021.
“We’re going to give every soldier every opportunity to get vaccinated and continue their military career,” Lt. Gen. Jon Jensen, ARNG director, on June 25 told AP. “Every soldier that is pending an exemption, we will continue to support them through their process.”
“We’re not giving up on anybody until the separation paperwork is signed and completed,” Jensen added. “There’s still time.”
But as reported June 22 by The Defender, an active-duty senior Army official with access to senior-level information revealed that with 120,000 troops then still unvaccinated, the U.S. Army was considering moving the July 1 deadline.
The whistleblower told The Defender, on condition of anonymity, that a June 2022 internal document revealed the Army is strongly considering pushing the deadline far into the future — but has not yet revealed a date change.
The DOD still plans to separate the unvaccinated soldiers, but instead of enforcing the June 30 deadline, “what they are going to do is hold off on separating soldiers on July 1,” and “will most likely push that into 2023 at the earliest,” the whistleblower said.
The June 2022 Army document confirms this, as it proposes that a “phased approach to involuntary separation” for unvaccinated service members would begin on October 1, 2022, with a “mandatory bar to reenlistment,” while “mandatory involuntary separations for COVID vaccine refusal” would begin January 1, 2023, and “last up to approximately 2 years.”
National Guard unique among service branches
Military branches had varying deadlines for their forces. The Air Force gave its active-duty service members until Nov. 2, 2021, to be vaccinated, while Air National Guard and Reservists had until Dec. 31, 2021, to comply.
The ARNG was given the longest amount of time to get the shots, mainly because it’s a large force of about 330,000 soldiers who are scattered around the country, many in remote locations, AP reported.
Just five days ago, Lt. Gen. Jon Jensen, director of the ARNG, told the AP about 1,500 soldiers a week around the country are “moving into the vaccinated category” with the help of vaccination events.
“We expect, as we approach the deadline, that we’ll see some larger growth,” he said.
On the June 29 episode of The Hill’s “Rising,” host Kim Iversen pointed out that the ARNG is “a different service.”
“A lot of [ARNG members] are not full-time, so a lot of them are working regular jobs, they have regular families and lives, and then they go and they serve the country … It’s not like they’re being deployed off to Germany or Japan,” she said. “I think there’s why there’s more hesitancy.”
“It is something they are facing that is very authoritarian in my view,” Iversen said, adding, “We need to have a conversation about the limits of the military and what they can and cannot command of individuals.”
According to internal documents shared with The Defender, in the ARNG, 280,678 members are fully vaccinated (84.6%), and 7,735 are partially vaccinated (1 dose) (2.3%) — leaving 43,269, or 13%, who have not yet received a single dose.
The documents show that in some states, such as Oklahoma, the vaccination rate for members of the ARNG is as low as 74.11%.
The document lists 15,698 members as “refusals” and 6,749 (2.0%) as going through an exemption process — with 6,257 (1.9%) requesting a religious exemption and 492 (0.1%) requesting a medical exemption.
The document also notes that 80% of unvaccinated soldiers in the ARNG are age 32 or younger, with an average age of 26.2 and median age of 24.
According to CBS News, vaccine compliance among ARNG members is the lowest in the U.S. military — the rate among active-duty Army, Navy, Air Force and Marine Corps is 97% or greater and the Air Guard uptake is about 94%, according to CBSNews.
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Twitter ‘Silenced’ Physicians Who Posted Truthful Information About COVID, Lawsuit Alleges
Three physicians are suing Twitter, alleging the company violated its own terms of service and community standards when it suspended their accounts for posting “truthful statements regarding COVID-19 policy, diagnosis and/or treatment.”
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Twitter ‘Silenced’ Physicians Who Posted Truthful Information About COVID, Lawsuit Alleges
Three physicians are suing Twitter, alleging the company violated its own terms of service and community standards when it suspended their accounts for posting “truthful statements regarding COVID-19 policy, diagnosis and/or treatment.”
By Megan Redshaw
06/30/22
Three physicians are suing Twitter, alleging the company violated its own terms of service and community standards when it suspended their accounts for posting “truthful statements regarding COVID-19 policy, diagnosis and/or treatment.”
Drs. Robert Malone, Peter McCullough and Bryan Tyson on Monday filed the lawsuit in Superior Court in California, San Francisco County.
The complaint alleges Twitter breached the terms of its contract when it permanently suspended the plaintiffs’ accounts, silenced their voices and failed to provide them with “verified” badges.
Plaintiffs allege Twitter’s actions were a substantial factor in causing them harm, and are asking the judge to order Twitter to reactivate their accounts.
All three doctors are represented by attorneys Bryan M. Garrie and Matthew P. Tyson (no relation to the plaintiff, Bryan Tyson).
Matthew Tyson on May 12, sent a letter to the directors and managing agents of Twitter requesting the company reinstate the accounts of five physicians, including the plaintiffs, and provide them with “verified” badges. Twitter failed to respond.
In the letter, Matthew Tyson acknowledged Twitter is a “private company” and its terms state it can “suspend user accounts for any or no reason.”
“However, Twitter also implemented specific community standards to limit COVID-19 misinformation on the platform, and Twitter was bound to follow those terms,” he added.
According to the complaint, Twitter’s content-moderation terms included removal procedures for ineffective treatments and false diagnostic criteria, and measures for “labeling” information as “misleading.”
Twitter has a “five-strike policy” as part of its COVID-19 misinformation guidelines and community standards.
Twitter’s website states:
“The consequences for violating our COVID-19 misleading information policy depend on the severity and type of the violation and the account’s history of previous violations. In instances where accounts repeatedly violate this policy, we will use a strike system to determine if further enforcement actions should be applied.”
Strike 1 is “no account-level action.” Strike 2 results in a 12-hour account lock. Strike 3 results in another 12-hour account lock. Strike 4 results in a seven-day account lock and five or more strikes lead to permanent suspension.
Plaintiffs claim they relied on Twitter to employ and enforce its terms in good faith and it was foreseeable to Twitter that plaintiffs would rely on the terms the company is obligated to follow.
According to the complaint, a “truthful tweet regarding COVID-19 policy, diagnosis and/or treatment” would not violate Twitter’s terms of service, community standards, content moderation policies or misinformation guidelines.
“None of these physicians posted false or misleading information, nor did they receive five strikes before suspension,” Matthew Tyson stated in his letter to Twitter.
“It’s no accident that Twitter violated its own COVID-19 misinformation guidelines and suspended the accounts of Drs. Zelenko, Malone, Fareed, Tyson and McCullough,” he wrote.
The letter stated:
“Twitter received express and implied threats from government officials to censor certain viewpoints and speakers, lest Twitter face the amendment or revocation of Section 230, or antitrust enforcement. This was a financial decision for Twitter.
“For the sake of profits, it chose to abandon its role as a neutral internet service provider and instead openly and intentionally collude with government to silence lawful speech.”
In an email to The Defender, lead attorney Garrie and co-counsel Matthew Tyson said:
“In this political climate, honesty is a rare commodity, and concerns over new and experimental vaccines and drug therapies and the safety and effectiveness of alternative outpatient treatments should be the subject of full and transparent public debate.
“Drs. Malone, Tyson and McCullough are highly qualified and credentialed physicians and scientists who posted truthful information on Twitter that contradicted the mainstream narrative regarding COVID-19 policy, diagnosis, and treatment.
“They shared fact-based information which furthered an important public interest as people around the world try to decide how to treat themselves and their loved ones for COVID-19. Twitter silenced them.
“Our clients seek to hold Twitter liable not as a Section 230 publisher, but as a counterparty to a contract, as a promisor who has breached the very terms it put in place to moderate tweets. We will hold Twitter accountable in court and prove the truth of our clients’ statements for the world to see.”
Twitter refused to verify physicians’ accounts
In addition to being suspended from Twitter, the company refused to verify the plaintiffs’ accounts even though the accounts met Twitter’s criteria for verification.
To be verified, an account must be “notable and active.”
Twitter defines a notable account to include “activists, organizers, and other influential individuals,” including “prominently recognized individuals.”
According to the complaint, Malone is an “internationally recognized scientist and physician” who completed a fellowship at Harvard Medical School as a global clinical research scholar and was scientifically trained at the University of California and Salk Institute Molecular Biology and Virology laboratories.
Malone is the “original inventor of mRNA vaccination technology, DNA vaccination and multiple non-viral DNA and RNA/mRNA platform delivery technologies,” and has “roughly 100 scientific publications, which have been cited more than 12,000 times.”
He holds an “outstanding” impact factor rating on Google Scholar and sits as a non-voting member on the National Institutes of Health [Accelerating COVID-19 Therapeutic Interventions and Vaccines] committee, which is tasked with managing clinical research for a variety of drug and antibody treatments for COVID-19.
The complaint states Malone used his Twitter account to post truthful statements regarding COVID-19 policy, diagnosis and/or treatment. He received no strikes for his content and he did not violate Twitter’s rules, yet his account was permanently suspended.
McCullough, according to the complaint, is a highly accomplished physician who is the founder and current president of the Cardiorenal Society of America.
He has been “published more than 1,000 times, made presentations on the advancement of medicine across the world and has been an invited lecturer at the New York Academy of Sciences, the National Institutes of Health, U.S. Food and Drug Administration and the European Medicines Agency.”
McCullough has also served on the editorial boards of multiple specialty journals and was a member or chair of data safety monitoring boards of 24 randomized clinical trials.
He was a “leader in the medical response to COVID-19, has more than 30 peer-reviewed publications on the infection, and has commented and testified extensively on COVID19 treatment, including before the U.S. Senate Committee on Homeland Security and Governmental Affairs,” the lawsuit states.
McCullough’s account was suspended, but Twitter allowed him to create a new account that is followed by more than 480,000 people. Yet, he is still unable to receive a “verified” badge.
In a June 28 tweet, McCullough said “trouble is on the horizon for the “common carrier” whose only role is to provide a platform for communications operations,” referring to the lawsuit.
Trouble on the horizon for the “common carrier” whose only role is is to provide a platform for communications operations. pic.twitter.com/92rnYitQz1
— Peter McCullough, MD MPH (@P_McCulloughMD) June 28, 2022
Tyson is a licensed physician with15 years of hospital and emergency medicine experience. He practices with Dr. George Fareed, who also was suspended from Twitter for posting what he claimed was truthful COVID-19 information.
Tyson and Fareed have “gained international recognition for providing successful early treatment to more than 10,000 COVID-19 patients, with zero patient deaths when treatment was started within 7 days,” the complaint states.
Tyson testified in various proceedings about early treatment protocols and co-authored a book about COVID-19.
He also ran as a candidate for the U.S. House of Representatives for California’s 25th Congressional District, yet was not deemed a “notable figure of public interest” regarding COVID-19 policy, diagnosis and/or treatment, which prohibited him from obtaining a “verified” badge on Twitter.
Tyson says he posted only truthful statements about COVID-19 policy, diagnosis and/or treatment with his account, and none of his tweets were classified as a “strike” or violated Twitter’s terms of service.
Like Malone’s, Tyson’s and Fareed’s accounts were permanently suspended.
“In a nutshell, these are five [physicians] of the most knowledgeable and helpful voices in the world regarding COVID-19 treatment,” Matthew Tyson wrote in his letter. “Disturbingly, Twitter silenced all of them.”
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New Hampshire Governor Vetoes Ivermectin Bill
www.theepochtimes.com
New Hampshire Governor Vetoes Ivermectin Bill
By Alice Giordano
June 30, 2022
New Hampshire Gov. Chris Sununu has vetoed a bill that would have made ivermectin available in the state without a prescription.
The Republican governor vetoed the bill on June 24, the same day that the U.S. Supreme Court overturned Roe v. Wade. Some fellow Republicans questioned the timing.
“It certainly seemed like a convenient way to bury a veto of a bill that won support from the vast majority of Republicans in New Hampshire,” J.R. Hoell, co-founder of the conservative watchdog group RebuildNH, told The Epoch Times.
Hoell is a former four-term House Republican who plans to seek reelection after a four-year hiatus from the New Hampshire Legislature.
Earlier this year, the New Hampshire Department of Children Youth and Family tried to take custody of Hoell’s 13-year-old son after a nurse reported him for giving human-grade ivermectin to the teen months earlier.
Several states have introduced bills to make human-grade ivermectin available without a prescription at brick-and-mortar stores. Currently, it can be ordered online from another country. In April, Tennessee became the first state to sign such a measure into law. New Hampshire lawmakers were first to introduce the idea.
Both chambers of the state’s Republican-controlled Legislature approved the bill.
In his statement explaining the veto, Sununu noted that there are only four other controlled medications available without a prescription in New Hampshire and that each was only made available after “rigorous reviews and vetting to ensure” before being dispensed.
“Patients should always consult their doctor before taking medications so that they are fully aware of treatment options and potential unintended consequences of taking a medication that may limit other treatment options in the future,” Sununu said in his statement.
Sununu’s statement is very similar to testimony given by Paula Minnehan, senior vice president of state government regulations for the New Hampshire Hospital Association, at hearings on the measure.
Minnehan also placed emphasis on the review that went into the four prescription medications the state made available under a standing order. They include naloxone, the generic name for Narcan, which is used to counter opioid overdoses, hormone replacement therapy drugs, and a prescription version of the morning-after pill.
It also includes a collection of smoking cessation therapy drugs such as Chantix, which has been linked to suicide, depression, and other neuropsychiatric conditions. Last year, Pfizer, the leading maker of the FDA-approved drug, conducted a voluntary recall of Chantix. Narcan has also been linked to deaths caused by severe withdrawals that have led to acute respiratory distress.
Rep. Melissa Blasek, a Republican co-sponsor of the New Hampshire ivermectin bill, told The Epoch Times that one could veto any drug-related bill under the pretense of overdose concerns.
“The reality is you can overdose on Tylenol,” she said. “Ivermectin has one of the safest track records of any drug.”
The use of human-grade ivermectin became controversial when some doctors began promoting it for the treatment and prevention of COVID-19. Government agencies including the FDA and CDC issued warnings against its use while groups such as Front Line COVID-19 Critical Care Alliance heavily promoted it.
Some doctors were disciplined for prescribing human-grade ivermectin for COVID-19 including a Maine doctor whose medical license was suspended by the state.
According to several published reports, 3 billion doses of human-grade ivermectin have been safely prescribed worldwide.
Though disappointed, Blasek said she wasn’t surprised by Sununu’s veto given his track record on other COVID-related bills including a bill born out of what some lawmakers saw as an overuse by Sununu of his ability to issue emergency orders under the pandemic. The measure sought to automatically expire the use of emergency orders by New Hampshire’s governor after the third use of the authority, making them renewable only upon approval by either the House or Senate.
Following his veto of the bill, Blasek referred to Sununu on social media as “a Republican suicide bomber with a veto pen.” In his criticism of the governor’s veto, Hoell said that “Governor Sununu should take a basic course in science before he vetoes a bill for medication safer than Tylenol.”
Sununu has also been heavily criticized by fellow Republicans for vetoing a bill that would have banned schools from instituting mask mandates and for pushing for the acceptance of $27 million worth of federal monies earmarked to promote the COVID-19 vaccine. During a hearing on the money in October 2021, eight New Hampshire residents who protested the acceptance of the money were arrested, most of them while they were sitting quietly in their seats.
The state dropped the case against them earlier this month without filing charges.
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COVID-19 vaccine protects people of all body weights from hospitalization and death, shows study of 9 million adults
COVID-19 vaccines have greatly reduced the number of cases of severe COVID-19 disease for everyone regardless of their body size, according to a new study published in The Lancet Diabetes & Endocrinology. Vaccine effectiveness was similar for those with a higher BMI and of a healthy weight, but...
COVID-19 vaccine protects people of all body weights from hospitalization and death, shows study of 9 million adults
by Lancet
June 30, 2022
COVID-19 vaccines have greatly reduced the number of cases of severe COVID-19 disease for everyone regardless of their body size, according to a new study published in The Lancet Diabetes & Endocrinology. Vaccine effectiveness was similar for those with a higher BMI and of a healthy weight, but slightly lower in the underweight group, who were also the least likely to have been vaccinated.
In a further analysis of vaccinated people only, among the fewer COVID-19 cases recorded, people of very low and very high BMI were more likely to experience severe disease than vaccinated healthy-weight people. This replicates the findings seen in a previous analysis before the vaccination program commenced.
Obesity was pinpointed as a risk factor for severe COVID-19 early in the pandemic, reflected in the UK vaccine rollout in 2021, which prioritized people with a BMI of over 40 as a high-risk group. However, little was known until now about the effectiveness of the COVID-19 vaccines for people with obesity. Previous work has shown that people with obesity are less likely to take seasonal flu vaccines and have modestly reduced benefits from flu vaccinations, although the reasons for this are not well understood.
"Our findings provide further evidence that COVID-19 vaccines save lives for people of all sizes. Our results provide reassurance to people with obesity that COVID-19 vaccines are equally as effective for them as for people with a lower BMI, and that vaccination substantially reduces their risk of severe illness if they are infected with COVID-19. These data also highlight the need for targeted efforts to increase vaccine uptake in people with a low BMI, where uptake is currently lower than for people with a higher BMI," says lead author Dr. Carmen Piernas of the Nuffield Department of Primary Care Health Sciences, University of Oxford, UK.
Researchers searched anonymized health records from more than 12 million patients across 1,738 GP practices in England taking part in QResearch—a secure database of healthcare information available to verified researchers. Of these, 9,171,524 patients who were over 18 years old, had BMI data, and had not previously been infected with SARS-CoV-2 were included in the study.
People were grouped based on their BMI according to four World Health Organization definitions of 18.5-24.9kg/m2 for healthy weight; below 18.5 for underweight; 25-29.9 for overweight; and 30 and over as obesity with levels adjusted for Asian people to reflect the higher health risks at lower BMI levels in this group. Characteristics such as age, sex, smoking status, and social deprivation were also accounted for in the analyses.
Of over 9 million people included in the study, 566,461 tested positive for SARS-CoV-2 during the study from 8 December 2020 (date of the first vaccine given in the UK) to 17 November 2021. Of those, 32,808 were admitted to hospital and 14,389 died.
At the end of the study period, 23.3% of the healthy weight group (817,741 of 3,509,231 people), 32.6% of the underweight group (104,488 of 320,737 people), 16.8% of the overweight group (513,570 of 3,062,925 people) and 14.2% of the group with obesity (322,890 of 2,278,649 people) had had no doses of any COVID-19 vaccine.
To understand vaccine effectiveness, the researchers compared risk of severe disease in vaccinated versus non-vaccinated people at least 14 days after a second dose. They found that being vaccinated offered high protection across all BMI groups, but that the effect was slightly lower in underweight people. Underweight vaccinated people had around half the likelihood of being hospitalized or dying compared with unvaccinated people of the same BMI.
In comparison, people in the healthy and high BMI groups who were vaccinated were around 70% less likely to be hospitalized than unvaccinated people. People with a healthy or a higher BMI were also around two-thirds less likely to die than their unvaccinated counterparts two weeks after a second dose.
By looking at data from vaccinated people only (among whom the number of COVID-19 cases were greatly reduced), the researchers found that following two doses of vaccine there was a significantly higher risk of severe disease at low and at high BMI compared with a healthy BMI. For example, a BMI of 17 was linked to a 50% increase in risk of hospitalization compared with a healthy BMI of 23, and a very high BMI of 44 had three times the risk of hospitalization compared with a healthy BMI.
The cause of the increased risk among people with obesity is unknown. It is consistent with the higher rate of seasonal flu infections in people with a higher BMI. The authors speculate that their findings may be explained, in part, by an altered immune response in heavier weight individuals. The reduced effectiveness of COVID-19 vaccines among people with a low BMI may also reflect a reduced immune response as a consequence of frailty or other conditions associated with low body weight. Further research is needed to explore the relationship between BMI and immune responses.
The authors acknowledge several limitations to the study, in particular, that some measurements of BMI were based on self-reporting, or on data recorded in GP records before the study onset that could be outdated. Furthermore, the limited numbers of people who had had three doses by the study close meant that the effects of booster jabs could not be investigated, and data did not allow for researchers to investigate between and among Pfizer, AstraZeneca or Moderna vaccines, nor virus variants.
Writing in a linked comment, Professor Annelies Wilder-Smith and Professor Annika Frahsa of the Institute of Social and Preventive Medicine, University of Berne, Switzerland (who were not involved in the study) note, "There was a higher vaccine uptake by persons with obesity. Conversely, underweight persons were less likely to be vaccinated, which may be an unintended result of public messaging that overweight persons have a higher risk of severe COVID-19 further corroborated by the UK risk-based strategy to vaccine rollout. These findings should prompt a shift towards more targeted and differentiated public health messaging to also address underweight persons who may perceive themselves at lower risk in order to enhance vaccine uptake in this group."
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Study: Boosted People Slowest to Clear COVID-19
That's why PAXLOVID does not work for them
igorchudov.substack.com
Study: Boosted People Slowest to Clear COVID-19
That's why PAXLOVID does not work for them
Igor Chudov
9 hr ago
A new study just came out:
It looked at how long “culturable virus” (that is, virus capable of infecting people) is present in Covid patients after the first positive test. The authors literally cultured swabs of patients, on various days past-diagnosis, and counted how many patients, by vaccination status, are still carrying live, replication-competent virus.
The result is shocking:
What this chart shows is that one-third of boosted people still carried live, culturable virus at 10 days after the beginning of the infection. This is contrasted with unvaccinated people, who had only 6% of persons still contagious at Day 10.
This means that the share of boosted people who are still contagious (31%) is over five times greater, than the share of still-contagious unvaccinated people (6%).
In other words: out of 100 boosted persons who catch Covid, fully one-third will be still carrying LIVE VIRUS on Day 10. Out of 100 unvaccinated persons, only one out of 16 would test positive on Day 10 — over five TIMES fewer people.
As a word of warning, the study involved a relatively small amount of people, so statistical significance is probably not quite what we’d like it to be — but it shows what we saw all along in other news.
It also means that boosted people, who might feel better in a few days, would be contagious for a few MORE days after recovery, thus becoming silent superspreaders of Covid. So much for “stopping the spread”!
This is why Paxlovid does Not Work for the Boosted
This study explains why Paxlovid does not work in vaccinated (and boosted) people. For the introduction into my paxlovid series, see the sad story of double-boosted Dr. Fauci, who relapsed on Paxlovid, with links to my Paxlovid articles shown chronologically:
What Paxlovid is, is a biomolecular “snooze button” that suspends viral replication for 5 days. However, as we can see, one-third of the boosted people still carry live virus at 10 days due to delayed, or disabled, immune responses. Those persons would be likely to rebound on Paxlovid.
The numbers also match other calculations: my guesstimate of unvaccinated Paxlovid rebound was 12% — that is not too far from 6% of unvaccinated people in this study who carried live virus on Day 10. 31% of boosted people who still have live virus on Day 10, matches Twitter reports of 40-50% rebound rates in vaccinated people.
In other words, while we had fairly certain evidence that Paxlovid does not work for vaccinated people, and suspected the vaccine, we were missing the most crucial proof: that of live virus not clearing in the boosted. The study I mentioned above, provides this proof.
It also exposes vaccines as merely “increasing tolerance” to Sars-Cov-2, as opposed to generating robust immune response that leads to rapid viral clearance.
Molnupiravir
I personally have not paid close attention to Merck’s Molnupiravir, due to it being a dead-end, mutagenic, cancer-causing, variant-generating, toxic-to-bones drug from hell, which is, fortunately, seeing little use. Our friend Modern Discontent discovered that Molnupiravir is also snake oil and does not work in vaccinated people.
PCR Tests
This study also provides an interesting glimpse into the world of PCR testing. In addition to testing “culturable virus”, which is the gold standard for truly verifying contagiousness, scientists also conducted PCR tests on Day 0, 5, 10 and 15.
It lets us compare PCR tests with actual contagiousness (culturable live virus)
On PCR tests, the vaccinated and boosted people look even worse, compared to the unvaccinated, on Day 10:
However, I decided to use “culturable virus” tests for my article, as they directly show the existence of live, replication-competent virus, as opposed to possibly detecting useless fragments of destroyed virions.
In this study, we can see that PCR tests can see a positive result, without replication-competent viruses being present. This provides great fodder for those of my respected subscribers, who like to criticize PCR tests. Now you guys have a great substantiation of your PCR criticisms, not that it is the first such substantiation.
The Bottom Line?
Getting boosted is a great way to become unable to clear a Covid infection in 10 days and become a Covid superspeader.
.
Heliobas Disciple
TB Fanatic
Molnupiravir COVID rebound just as possible as PAXLOVID's
The currently FDA approved SARS-COV2 antivirals don't appear to eliminate the virus, raising questions as to what is happening.
moderndiscontent.substack.com
Molnupiravir COVID rebound just as possible as PAXLOVID's
The currently FDA approved SARS-COV2 antivirals don't appear to eliminate the virus, raising questions as to what is happening.
Modern Discontent
Jun 29
Yesterday Igor posted an article on Dr. Fauci experiencing COVID rebound after taking PAXLOVID.
It’s pretty ironic because I was looking for something to write about (I’ll be late with my June post. Apologies!). I’ve been juggling a few ideas and reading a few papers, but for some reason I just decided to see what was going on with Molnupiravir since it’s been months since I last covered the drug.
Anyways, the situation was ironic because I happened to come across the following paper1:
Well, isn’t that a bit coincidental. This paper came out last week and it suggests that Molnupiravir recipients- not just PAXLOVID- may also experience COVID rebound.
This paper is really interesting since it provides more context for this somewhat grey area, as some people speculate that PAXLOVID rebound is a possible indication of immune dysfunction caused by the vaccines. I’ve been rather reticent in making such a claim without additional evidence, and with this new finding it does muddy the waters even a bit further.
PAXLOVID is comprised of two drugs: a protease inhibitor called Nirmatrelvir and a Cytochrome P450 enzyme inhibitor called Ritonavir. The pairing of a protease inhibitor and a P450 inhibitor is nothing out of the ordinary- it’s typically found as part of the antiviral cocktail against HIV, as the P450 inhibitor reduces metabolism of the protease inhibitor and quickly elevates its serum concentration. As to its use for a respiratory infection- this is rather new territory.
2D molecular structure of Nirmatrelvir (left) and Ritonavir (right).
However, as a protease inhibitor PAXLOVID targets the virus at a site downstream from its genetic code. This creates a problem since it doesn’t necessarily lead to eventual destruction of the virus, but instead leads to a temporary halt in its activities. Viral proteases are involved with chopping up recently translated proteins at specific sites, and so inhibition of a protease doesn’t turn off the protein production or the viral replication, but really just halts the final process.
Brian Mowrey has written extensively about this halting process as a possible explanation for viral rebound.
Molnupiravir, on the other hand, is a nucleoside analogue (an analogue of the nucleoside cytidine) and operates as a mutagen. Thus, it targets the virus during its replication process and hopefully leads to a form of mutagenic catastrophe (i.e. the virus will have accrued so many mutations that it just ceases to function properly and “dies”2 out.)
2D molecular structure of Molnupiravir (left) compared to the parent structure Cytidine (right). Note the structural difference circled in black on Molnupiravir, which confers mutagenic properties.
What’s important is that PAXLOVID targets a different site compared to Molnupiravir (protease vs polymerase), and so this shared rebound effect is something that shouldn’t be expected, and likely suggests something else may be happening.
With that, let’s get to the study.
COVID-19 rebound after Paxlovid and Molnupiravir during January-June 2022 (Wang, et. al. 2022)
This preprint is a retroactive study in which the researchers were interested by the current PAXLOVID rebound predicament. From there, they wanted to see if this rebound effect is occurring with Molnupiravir as well:
Recently case reports have documented that some patients treated with Paxlovid experienced rebound COVID-19 infections and symptoms 2 to 8 days after completing a 5-day course of Paxlovid3. The Centers for Disease Control and Prevention (CDC) has issued Health Alert Network Health Advisory to update the public on the potential for COVID-19 rebound after Paxlovid treatment4. However, the rate of COVID-19 rebound after Paxlovid treatment in real-world population remains unknown. In addition, questions remain as to whether COVID-19 rebound is unique to Paxlovid and whether there are patients who are more susceptible.
Considering that Molnupiravir hasn’t been as extensively used (PAXLOVID took that spotlight) it seems to have gone to the wayside and has not been prescribed to the same extent as PAXLOVID.
The researchers went through nationwide electronic health records (EHR) and looked for patients who were infected with COVID this year and were prescribed either Molnupiravir or PAXLOVID within 5 days of their infection. Patients were measured based on 3 outcomes:
- a) positive COVID test;
- b) COVID symptoms such as chills, fevers, cough, and shortness of breath;
- c) hospitalization
Since there were nearly 4X as many patients in the PAXLOVID group (11,270 vs 2,374 for Molnupiravir) patients were matched across different demographics. In these studies, matching means that you want people in one group to have a similar profile to those in another group. For example, if PAXLOVID included a white woman in her early 60s with a prior history of cancer you try to look for a patient with a similar history in the Molnupiravir group and make sure to include both in the study.
In general, most of the patients skewed older, female, and with several comorbidities, so keep that in mind when examining the data.
From Wang, et. al. Patient characteristics from EHR and PAXLOVID/Molnupiravir patients. Note the high level of comorbidities associated with those administered these drugs.
What’s really interesting about this group is that, as recorded in these patients EHRs, hardly any of these patients were vaccinated. Granted, as the researchers implied, it is likely that they were vaccinated but the information was not included in their records.
Continuation of the patient characteristics. Note the relatively low level of documented vaccine recipients (boxed above).
When looking at relative risk and outcomes the researchers looked at both matched and unmatched cohorts. When first looking at unmatched data Molnupiravir surprisingly showed higher rates of rebound (based on the 3 above outcomes) as compared to PAXLOVID. However, when matched the researchers argued that there was no statistical significance between the two groups, suggesting that the Molnupiravir treatment group generally skewed older with higher comorbidities (shown in the first two columns in the above patient characteristics) and likely played a factor in outcomes:
Among 11,270 patients treated with Paxlovid, 398 (3.53%) tested positive, 260 (2.31%) had COVID-19 related symptoms and 50 (0.44%) were hospitalized during the 7-day period of from 2 through 8 days after the last day of Paxlovid. COVID-19 rebound rates were higher in the 2,374 patients treated with Molnupiravir: 5.86% for rebound infections, 3.75% for rebound symptoms and 0.84% for hospitalizations (Figure 1a, top panel). As shown in Table 1, patients who took molnupiravi were older and had more comorbidities. After matching, 7-day risks for COVID-19 rebound in patients treated with Paxlovid did not differ from those treated with Molnupiravir: rebound infections (HR: 0.81, 95% CI: 0.63-1.05), rebound symptoms (HR: 0.74, 95% CI: 0.53-1.03), and hospitalizations (HR: 0.78, 95% CI: 0.40-1.51) (Figure 1b, bottom panel).
The researchers summarize this part of their study with the following:
In summary, COVID-19 rebound (infection, symptoms, and hospitalizations) occurred for both drug treatments. The risks for rebound did not differ between Paxlovid and Molnupiravir, indicating that COVID-19 rebound is not unique to Paxlovid. The rebound rates increased as the time elapsed after treatment, suggesting inadequate viral clearance by the treatments.
Lastly, the researchers wanted to examine who was experiencing rebound the most. I will not post the chart here (refer to Table 2 from the preprint) but as you can expect the rate of rebound was higher in those with higher numbers comorbidities. However, the researchers did note that rebound appears to be greater in those who were vaccinated, although remember that the actual level of those who were vaccinated was not clear and the percentages are not egregiously different based on the below table:
In summary, patients with COVID-19 rebound had higher prevalence of comorbidities that are known to be associated with higher risk for COVID-19 infection and for adverse outcomes than those without rebound. This is consistent for both Paxlovid and Molnupiravir. There were no marked demographic differences between patients with and without rebound. Patients without rebound had higher prevalence of adverse socioeconomic determinants of health. For both drugs, patients with rebound had higher vaccination rates recorded in their EHR records.
A spliced version of Table 2 from Wang, et. al. Although the higher rate of rebound in vaccinated patients was found to be statistically significant, there are questions as to the clinical significance of a few percentage points difference. Also, keep in mind that the true level of vaccinated individuals is not know.
The authors note this in their discussion [additional context included]:
Our study shows that COVID-19 rebound was not unique to Paxlovid and occurred also in patients treated with Molnupiravir. The 30-day rebound rates were higher for Molnupiravir than Paxlovid: 8.59% vs 5.40% for rebound infections, 8.21% vs 5.87% for rebound symptoms and 1.39% vs 0.77% for hospitalizations. However, patients who took Molnupiravir were significantly older and had more comorbidities than those who took Paxlovid. After propensity- score matching, there were no significant differences in COVID-19 rebound risks between the two treatment cohorts. These results further suggest that rebound was not unique to Paxlovid and may be associated with persistent viral infection in some patients treated with either of these two antivirals. There has been more attention to COVID-19 rebounds following Paxlovid treatment than Molnupiravir3,4, which may be attributable to more people being treated with Paxlovid. […]
This increase [increase in rebound up to 30 days post last treatment dosage] could occur if patients had inadequate viral clearance after treatment, patients did not complete the prescribed course of treatment or developed adverse drug effects and terminated treatment, if the dose was insufficient given pharmacodynamics in that individual, if reinfection occurred, or if viruses developed resistance to the drug. Future research is required to determine if this is the case and to evaluate instances when longer treatment duration might be indicated […]
Our study showed that the vaccination rates were higher in patients who developed COVID-19 rebound than in those who did not, suggesting that vaccination was not a major contributor for COVID-19 rebound. While both drugs were tested in clinical trials that included only un-vaccinated populations, our study provided evidence that rebound occurred in largely vaccinated (89.5%) real-world populations and that rebound increased over time.
In summary, these results are rather surprising. Not only does PAXLOVID experience viral rebound but so too does Molnupiravir, which begs the question as to why this may be occurring.[continued in next post]
Heliobas Disciple
TB Fanatic
[continued from post above]
Why the viral rebound?
The results of the Wang, et. al. study raises a lot more questions than it answers. With the above results, one must wonder what is going on to lead to these potentially ineffective treatments and the high rates of viral rebound.
Viral rebound with PAXLOVID
In Igor’s post he provided a screencap of a Daily Mail article. Going through that article I found out that there was a small (VERY small) study done to explain what may be happening with PAXLOVID.
After a bit of digging I was able to find the study3:
Virologic and Immunologic Characterization of COVID-19 Recrudescence after Nirmatrelvir/Ritonavir Treatment (Carlin, et. al.)
Recrudescence sounds like one of those big SAT words, but given the context you could probably figure out that it’s synonymous with recurrence or reemergence.
This study is essentially a case study in which 3 triple-vaccinated individuals travelling back to the US from South Africa tested positive for COVID and promptly given PAXLOVID. One of these individuals was found to have experienced viral rebound with COVID-like symptoms (they initially experienced improvement until after treatment was finished).
The virus was isolated from a nasopharyngeal swab and found to be of the Ba.2 Omicron variant.
Afterwards, the researchers wanted to answer if the rebound could be due to escape mutations that made PAXLOVID ineffective, or if the recipient was not fighting off the virus due to lack of neutralizing antibodies.
To answer the first question, the researchers incubated the isolated virions with Calu-3 human lung epithelial cells and incubated them with PAXLOVID. The researchers also used Remdesivir as a control reference:
Phenotypic analyses of the antiviral susceptibility of BA.2 PRSD01 (isolate), WA1/2020 (parental), B.1.617.2 (delta), BA.1 and BA.2.3 variants to NM and remdesivir were conducted in Calu-3 human lung epithelial cells. The half maximal inhibitory concentrations (IC50) of NM against BA.2 PRSD01 were 2.0, 1.8, 1.7, and 2.0 fold lower than the parental, delta, BA.1 and BA.2.3 strains, respectively (Figure 1A). As a control, we determined the IC50 for remdesivir, a drug to which this individual was not exposed, for each strain. The remdesivir IC50 for BA.2 PRSD01 was 2.0, 1.8, 1.1, and 1.3 higher than the parental, delta, BA.1 and BA.2.3 strains respectively (Figure 1A).
From Carlin, et. al. The above graph shows infection curves using the isolated virus from the rebound individual. Additional tests were conducted with other variants, and Remdesivir was used as a reference control. In general, the virus appears to be sensitive to PAXLOVID (given the reduce in percent infection) suggesting that the isolated virus did not mutate to escape PAXLOVID. Note that this means that the more of the drug that’s given the less Calu-3 cells are infected.
The above is an infection curve and measures the level of a drug needed to inhibit infection of cells. As you can imagine, higher levels of a drug should coincide with a lower rate of infection. From this we can extrapolate that PAXLOVID should still be considered an effective treatment, although Remdesivir appears to be more effective in this situation. We can also see that the variant isolated from the rebound individual (Ba.2 PRSD01) required lower doses in order to reduce infection. Overall, it suggests that, hypotheticall, PAXLOVID should still be effective as a therapeutic.
The next question asked by the researchers was if the rebound individual did not have a proper immune response (as measured by neutralizing antibody levels). Collecting sera from the individual the researchers looked at neutralization activity and measured it against the neutralizing capabilities of two controls (people who were vaccinated and boosted, with one control having had a prior infection).
The results of that neutralization assay are shown below:
Neutralizing antibodies were collected from the rebound individual and measured against the isolated variant, as well as the BA.1 variant and the original Wuhan strain. One triple-vaccinated individual and one triple-vaccinated & infected individual were used as controls. Although the actual extent of neutralization in the individual is unknown, the above results suggest that neutralization antibodies are likely to be circulating, and thus an inference can be made that the rebound individual is not immunocompromised.
The patient’s neutralizing capabilities fell in the middle of the two controls, which suggests that neutralization antibodies were present. However, this does not explain the general scope of immunity as neither B nor T cell responses were measured. It also doesn’t include a control who was only infected and not unvaccinated, so there’s no indication of the effects of natural immunity alone. We also don’t know exactly what the proper neutralization level should be, or if the levels above coincide with actual serum concentrations.
In short, this study looked only at one individual who experienced rebound but didn’t provide much context to work with. No patient data was provided so we don’t know if comorbidities may have played a role (such as indicated in the Wang, et. al. paper).
The researchers concluded with the following (emphasis mine):
This study suggests that neither development of NM resistance nor absence of neutralizing antibody were likely causes of the observed recrudescence. The phenomenon of relapse after NM/r has been described in a limited number of individuals, all of which developed virologic rebound approximately 9-14 days after symptom onset and were likely infected with omicron variants.2 A small percentage of both NM/r and placebo-treated individuals enrolled in the primary NM/r study, EPIC-HR, which was mostly conducted before omicron emergence, also 2 experienced increasing SARS-CoV-2 RNA levels after stopping NM/r treatment at day 10 or 14 after infection.3
Our in vitro NM antiviral testing as well as sequencing, from our and other studies 2,3, have not yet identified emergence of NM resistance. Since immune responses likely contribute to eradication of replication competent virus during NM/r treatment, we evaluated neutralizing antibody responses, but found no evidence of an impaired neutralizing antibody response in this immunocompetent individual, suggesting impaired humoral immunity is not required for NM/r recrudescence. Although we were unable to measure T cell responses or serum drug concentrations, we believe the most likely possibility for the observed recrudescence is insufficient drug exposure by individual pharmacokinetics or insufficient duration. Further, the clinical significance of COVID-19 recrudescence after treatment remains unclear, so additional studies are needed to define the etiology, frequency and clinical consequences (e.g., hospitalizations, deaths, transmissions) of such recrudescence.
Overall, does this study provide much in the way of explaining this rebound? I would argue that an analysis of one individual doesn’t speak much aside from requiring further research and studies. What’s important to note here is that the researchers comment that a few of the trial participants experienced increased RNA levels after treatment completion. If anything, this would actually argue that there was evidence even from the clinical trials of viral rebound being possible.
For now, I would argue that I would need a bit more evidence to suggest that vaccinated individuals are immunocompromised and thus this plays a role in rebound. It could also be an issue of pause rather than clearance that may be an issue with PAXLOVID.
However, I would also argue that this may be another example of a rush to market that likely overlooked evidence during clinical trials that should have raised concerns, such that viral rebound was always possible but was somewhat obfuscated due to the haphazard way in which these clinical trials were conducted.
Viral rebound with Molnupiravir
Considering that not many people have been prescribed Molnupiravir (likely due to it’s highly contentious mechanism of action) we may ask whether it’s worth considering even looking into this drug.
I have written about it quite a bit in my Molnupiravir Anthology Series, so I’ll defer a bit to those prior articles for those wishing to find additional information.
Instead, I’ll focus here on the contentious MoA of Molnupiravir as a possible explanation for the rebound.
Although Molnupiravir is considered a nucleoside analogue, its modification occurs on the nitrogenous base rather than the sugar ring. Typical nucleoside analogues such as AZT and Remdesivir have modifications that halt the replication process of the virus because their modifications exist on the sugar ring (usually some modification occurs at the 3’-OH position).
In short, remember that DNA/RNA replication occurs in the 5’ → 3’ direction, and most nucleoside analogues take advantage of this biochemical mechanism by introducing modifications that halt this elongation process. In doing so, you typically end up with unusable fragments of genetic material that leads to the eventual death of the virus.
However, Molnupiravir does not halt replication. Instead, Molnupiravir requires that replication occurs. When Molnupiravir is inserted during the first viral replication process it does not do anything: it generally sits there waiting until the next replication cycle.
During the next cycle the viral polymerase uses the old genome with Molnupiravir inserted as a template to create the next RNA strand. When it comes across Molnupiravir it may read it as two possible nucleotides: if it recognizes it as a Cytidine (C) then it correctly base pairs with a G (remember that Molnupiravir is a Cytidine analogue). However, if it incorrectly recognizes Molnupiravir as a uracil (U), then the polymerase will base pair with the wrong nucleotide: Adenosine.
In doing so, Molnupiravir introduces a mutation within the next viral genome, and theoretically after several of these introductions the proteins that would be created no longer function properly and thus the virus itself ceases to function (mutagenic catastrophe).
A schematic diagram can be seen below4:
From Kabinger, et. al. A schematic diagram of Molnupiravir’s mechanism of action (MoA). The First Step involves incorporation of Molnupiravir. During the viral replication phase Molnupiravir may be incorporated into the elongating strand. At this point the mutagenic properties of Molnupiravir are not at play. Afterwards, this new strand of viral RNA with Molnupiravir incorporated may be used as a template strand for additional replication. The Second Step requires recognition of Molnupiravir. If Molnupiravir is correctly recognized as Cytidine (C) the polymerase incorporates the proper G to base pair. However, if the polymerase improperly recognizes Molnupiravir as a Uracil (U) the polymerase will incorporate a G to base pair leading to the insertion of a mutation. Continuous insertion of these improper nucleotides hopefully leads to eventual mutagenic catastrophe.
All of this may sound a bit technical, but remember that it’s important to get into the technical details to figure out what’s going on.
All this to say that Molnupiravir doesn’t necessarily lead to viral clearance. In fact, Molnupiravir works with the hope that the virus has mutated so much that it does not work properly anymore. However, that doesn’t necessarily mean that this will happen. It could be that the mutations that accrue still lead to functioning proteins, and therefore the virus can continue to propagate.
In short, Molnupiravir’s MoA is more aligned with gambling (or RNG for gamers), such that you gamble with the hope that the virus hits those right mutations to kill itself off: it doesn’t mean that this is what would actually happen.
So in some sense this makes sense why viral rebound is likely to occur with Molnupiravir because some of these mutations can still lead to competent virions that can continue to replicate.
And it’s actually this reason that there should be huge concerns with Molnupiravir.
For anyone who payed attention to the FDA Committee Meeting you would know that several of the members were concerned that Molnupiravir’s mutagenic nature may lead to more virulent, pathogenic variants.
Merck mentioned that a few of the samples they sequenced showed indications of various mutations such as the N501Y and E484K mutations commonly seen in these variants. However, it’s hard to argue whether these mutations arose naturally or through Molnupiravir- we only know of their existence because these mutations conferred greater fitness in the variants that carried these mutations.
There was also an argument to be made that viral clearance should remove any concerns since, even if concerning mutations did arise, they would eventually die off anyways.
However, this recent evidence of Molnupiravir rebound should reignite this discussion about the emergence of possibly more virulent strains through Molnupiravir treatment.
Considering that several members of the committee went so far as to argue that patients receiving Molnupiravir should isolate themselves from family members in case they create more virulent strains, shouldn’t we reexamine the utility of Molnupiravir and raise concerns that this, in fact, is now a possible reality given that Molnupiravir may not lead to viral clearance?
This creates a much more concerning scenario, and one that should warrant further investigation and analysis. PAXLOVID as a drug may only be measured on its effectiveness, but for Molnupiravir there’s a real concern that inducing mutations may confer greater fitness on the virus.
It’s fortunate that the early consternations has inhibited generally widespread use of Molnupiravir, but this should raise huge red flags that should likely take Molnupiravir off the market.
The Current Predicament
There’s quite a lot going on right now, and with all of this noise it requires a bit of contextualization.
In short, this has been a novel situation for science. No time prior to this time has such a widespread push for vaccinations and therapeutics occurred for a disease that generally does not lead to severe illness for a majority of the population.
Prior to COVID it was extremely rare to hear of someone taking an antiviral to treat the flu- one would normally let it run its course and try some fever relievers and cough suppressants. As such, there’s a case that the current antiviral predicament is one in which we had no prior example to refer to.
It’s very shocking that both of the only at-home therapeutics allowed for SARS-COV2 appear to exhibit viral rebound. It raises a lot of questions as to what is actually happening. Although there’s quite a few theories out there, it appears that this may be just another failure of the state to properly assess the effectiveness of these treatments much in the same way that the safety and efficacy of the vaccines have not been properly tested.
The clinical trials likely overlooked the possibility of viral rebound occurring, and a rush to receive EUA approval may have obfuscated the need to look for such concerns.
This is also the first time that antivirals have been used extensively at home, which raises the question as to whether this is unique to SARS-COV2 or may be a feature for any respiratory infection- there really is a serious lack of evidence since this is the first time such a undertaking has occurred.
Overall, this raises many questions as to what may be happening. But for Molnupiravir, it certainly raises questions as to whether there is any real benefit to its use now that real concerns there is a possibility that its use may lead to more virulent strains.
More research and further investigation is required, and until more evidence is provided we are all left wanting.
.
Why the viral rebound?
The results of the Wang, et. al. study raises a lot more questions than it answers. With the above results, one must wonder what is going on to lead to these potentially ineffective treatments and the high rates of viral rebound.
Viral rebound with PAXLOVID
In Igor’s post he provided a screencap of a Daily Mail article. Going through that article I found out that there was a small (VERY small) study done to explain what may be happening with PAXLOVID.
After a bit of digging I was able to find the study3:
Virologic and Immunologic Characterization of COVID-19 Recrudescence after Nirmatrelvir/Ritonavir Treatment (Carlin, et. al.)
Recrudescence sounds like one of those big SAT words, but given the context you could probably figure out that it’s synonymous with recurrence or reemergence.
This study is essentially a case study in which 3 triple-vaccinated individuals travelling back to the US from South Africa tested positive for COVID and promptly given PAXLOVID. One of these individuals was found to have experienced viral rebound with COVID-like symptoms (they initially experienced improvement until after treatment was finished).
The virus was isolated from a nasopharyngeal swab and found to be of the Ba.2 Omicron variant.
Afterwards, the researchers wanted to answer if the rebound could be due to escape mutations that made PAXLOVID ineffective, or if the recipient was not fighting off the virus due to lack of neutralizing antibodies.
To answer the first question, the researchers incubated the isolated virions with Calu-3 human lung epithelial cells and incubated them with PAXLOVID. The researchers also used Remdesivir as a control reference:
Phenotypic analyses of the antiviral susceptibility of BA.2 PRSD01 (isolate), WA1/2020 (parental), B.1.617.2 (delta), BA.1 and BA.2.3 variants to NM and remdesivir were conducted in Calu-3 human lung epithelial cells. The half maximal inhibitory concentrations (IC50) of NM against BA.2 PRSD01 were 2.0, 1.8, 1.7, and 2.0 fold lower than the parental, delta, BA.1 and BA.2.3 strains, respectively (Figure 1A). As a control, we determined the IC50 for remdesivir, a drug to which this individual was not exposed, for each strain. The remdesivir IC50 for BA.2 PRSD01 was 2.0, 1.8, 1.1, and 1.3 higher than the parental, delta, BA.1 and BA.2.3 strains respectively (Figure 1A).
From Carlin, et. al. The above graph shows infection curves using the isolated virus from the rebound individual. Additional tests were conducted with other variants, and Remdesivir was used as a reference control. In general, the virus appears to be sensitive to PAXLOVID (given the reduce in percent infection) suggesting that the isolated virus did not mutate to escape PAXLOVID. Note that this means that the more of the drug that’s given the less Calu-3 cells are infected.
The above is an infection curve and measures the level of a drug needed to inhibit infection of cells. As you can imagine, higher levels of a drug should coincide with a lower rate of infection. From this we can extrapolate that PAXLOVID should still be considered an effective treatment, although Remdesivir appears to be more effective in this situation. We can also see that the variant isolated from the rebound individual (Ba.2 PRSD01) required lower doses in order to reduce infection. Overall, it suggests that, hypotheticall, PAXLOVID should still be effective as a therapeutic.
The next question asked by the researchers was if the rebound individual did not have a proper immune response (as measured by neutralizing antibody levels). Collecting sera from the individual the researchers looked at neutralization activity and measured it against the neutralizing capabilities of two controls (people who were vaccinated and boosted, with one control having had a prior infection).
The results of that neutralization assay are shown below:
Neutralizing antibodies were collected from the rebound individual and measured against the isolated variant, as well as the BA.1 variant and the original Wuhan strain. One triple-vaccinated individual and one triple-vaccinated & infected individual were used as controls. Although the actual extent of neutralization in the individual is unknown, the above results suggest that neutralization antibodies are likely to be circulating, and thus an inference can be made that the rebound individual is not immunocompromised.
The patient’s neutralizing capabilities fell in the middle of the two controls, which suggests that neutralization antibodies were present. However, this does not explain the general scope of immunity as neither B nor T cell responses were measured. It also doesn’t include a control who was only infected and not unvaccinated, so there’s no indication of the effects of natural immunity alone. We also don’t know exactly what the proper neutralization level should be, or if the levels above coincide with actual serum concentrations.
In short, this study looked only at one individual who experienced rebound but didn’t provide much context to work with. No patient data was provided so we don’t know if comorbidities may have played a role (such as indicated in the Wang, et. al. paper).
The researchers concluded with the following (emphasis mine):
This study suggests that neither development of NM resistance nor absence of neutralizing antibody were likely causes of the observed recrudescence. The phenomenon of relapse after NM/r has been described in a limited number of individuals, all of which developed virologic rebound approximately 9-14 days after symptom onset and were likely infected with omicron variants.2 A small percentage of both NM/r and placebo-treated individuals enrolled in the primary NM/r study, EPIC-HR, which was mostly conducted before omicron emergence, also 2 experienced increasing SARS-CoV-2 RNA levels after stopping NM/r treatment at day 10 or 14 after infection.3
Our in vitro NM antiviral testing as well as sequencing, from our and other studies 2,3, have not yet identified emergence of NM resistance. Since immune responses likely contribute to eradication of replication competent virus during NM/r treatment, we evaluated neutralizing antibody responses, but found no evidence of an impaired neutralizing antibody response in this immunocompetent individual, suggesting impaired humoral immunity is not required for NM/r recrudescence. Although we were unable to measure T cell responses or serum drug concentrations, we believe the most likely possibility for the observed recrudescence is insufficient drug exposure by individual pharmacokinetics or insufficient duration. Further, the clinical significance of COVID-19 recrudescence after treatment remains unclear, so additional studies are needed to define the etiology, frequency and clinical consequences (e.g., hospitalizations, deaths, transmissions) of such recrudescence.
Overall, does this study provide much in the way of explaining this rebound? I would argue that an analysis of one individual doesn’t speak much aside from requiring further research and studies. What’s important to note here is that the researchers comment that a few of the trial participants experienced increased RNA levels after treatment completion. If anything, this would actually argue that there was evidence even from the clinical trials of viral rebound being possible.
For now, I would argue that I would need a bit more evidence to suggest that vaccinated individuals are immunocompromised and thus this plays a role in rebound. It could also be an issue of pause rather than clearance that may be an issue with PAXLOVID.
However, I would also argue that this may be another example of a rush to market that likely overlooked evidence during clinical trials that should have raised concerns, such that viral rebound was always possible but was somewhat obfuscated due to the haphazard way in which these clinical trials were conducted.
Viral rebound with Molnupiravir
Considering that not many people have been prescribed Molnupiravir (likely due to it’s highly contentious mechanism of action) we may ask whether it’s worth considering even looking into this drug.
I have written about it quite a bit in my Molnupiravir Anthology Series, so I’ll defer a bit to those prior articles for those wishing to find additional information.
Instead, I’ll focus here on the contentious MoA of Molnupiravir as a possible explanation for the rebound.
Although Molnupiravir is considered a nucleoside analogue, its modification occurs on the nitrogenous base rather than the sugar ring. Typical nucleoside analogues such as AZT and Remdesivir have modifications that halt the replication process of the virus because their modifications exist on the sugar ring (usually some modification occurs at the 3’-OH position).
In short, remember that DNA/RNA replication occurs in the 5’ → 3’ direction, and most nucleoside analogues take advantage of this biochemical mechanism by introducing modifications that halt this elongation process. In doing so, you typically end up with unusable fragments of genetic material that leads to the eventual death of the virus.
However, Molnupiravir does not halt replication. Instead, Molnupiravir requires that replication occurs. When Molnupiravir is inserted during the first viral replication process it does not do anything: it generally sits there waiting until the next replication cycle.
During the next cycle the viral polymerase uses the old genome with Molnupiravir inserted as a template to create the next RNA strand. When it comes across Molnupiravir it may read it as two possible nucleotides: if it recognizes it as a Cytidine (C) then it correctly base pairs with a G (remember that Molnupiravir is a Cytidine analogue). However, if it incorrectly recognizes Molnupiravir as a uracil (U), then the polymerase will base pair with the wrong nucleotide: Adenosine.
In doing so, Molnupiravir introduces a mutation within the next viral genome, and theoretically after several of these introductions the proteins that would be created no longer function properly and thus the virus itself ceases to function (mutagenic catastrophe).
A schematic diagram can be seen below4:
From Kabinger, et. al. A schematic diagram of Molnupiravir’s mechanism of action (MoA). The First Step involves incorporation of Molnupiravir. During the viral replication phase Molnupiravir may be incorporated into the elongating strand. At this point the mutagenic properties of Molnupiravir are not at play. Afterwards, this new strand of viral RNA with Molnupiravir incorporated may be used as a template strand for additional replication. The Second Step requires recognition of Molnupiravir. If Molnupiravir is correctly recognized as Cytidine (C) the polymerase incorporates the proper G to base pair. However, if the polymerase improperly recognizes Molnupiravir as a Uracil (U) the polymerase will incorporate a G to base pair leading to the insertion of a mutation. Continuous insertion of these improper nucleotides hopefully leads to eventual mutagenic catastrophe.
All of this may sound a bit technical, but remember that it’s important to get into the technical details to figure out what’s going on.
All this to say that Molnupiravir doesn’t necessarily lead to viral clearance. In fact, Molnupiravir works with the hope that the virus has mutated so much that it does not work properly anymore. However, that doesn’t necessarily mean that this will happen. It could be that the mutations that accrue still lead to functioning proteins, and therefore the virus can continue to propagate.
In short, Molnupiravir’s MoA is more aligned with gambling (or RNG for gamers), such that you gamble with the hope that the virus hits those right mutations to kill itself off: it doesn’t mean that this is what would actually happen.
So in some sense this makes sense why viral rebound is likely to occur with Molnupiravir because some of these mutations can still lead to competent virions that can continue to replicate.
And it’s actually this reason that there should be huge concerns with Molnupiravir.
For anyone who payed attention to the FDA Committee Meeting you would know that several of the members were concerned that Molnupiravir’s mutagenic nature may lead to more virulent, pathogenic variants.
Merck mentioned that a few of the samples they sequenced showed indications of various mutations such as the N501Y and E484K mutations commonly seen in these variants. However, it’s hard to argue whether these mutations arose naturally or through Molnupiravir- we only know of their existence because these mutations conferred greater fitness in the variants that carried these mutations.
There was also an argument to be made that viral clearance should remove any concerns since, even if concerning mutations did arise, they would eventually die off anyways.
However, this recent evidence of Molnupiravir rebound should reignite this discussion about the emergence of possibly more virulent strains through Molnupiravir treatment.
Considering that several members of the committee went so far as to argue that patients receiving Molnupiravir should isolate themselves from family members in case they create more virulent strains, shouldn’t we reexamine the utility of Molnupiravir and raise concerns that this, in fact, is now a possible reality given that Molnupiravir may not lead to viral clearance?
This creates a much more concerning scenario, and one that should warrant further investigation and analysis. PAXLOVID as a drug may only be measured on its effectiveness, but for Molnupiravir there’s a real concern that inducing mutations may confer greater fitness on the virus.
It’s fortunate that the early consternations has inhibited generally widespread use of Molnupiravir, but this should raise huge red flags that should likely take Molnupiravir off the market.
The Current Predicament
There’s quite a lot going on right now, and with all of this noise it requires a bit of contextualization.
In short, this has been a novel situation for science. No time prior to this time has such a widespread push for vaccinations and therapeutics occurred for a disease that generally does not lead to severe illness for a majority of the population.
Prior to COVID it was extremely rare to hear of someone taking an antiviral to treat the flu- one would normally let it run its course and try some fever relievers and cough suppressants. As such, there’s a case that the current antiviral predicament is one in which we had no prior example to refer to.
It’s very shocking that both of the only at-home therapeutics allowed for SARS-COV2 appear to exhibit viral rebound. It raises a lot of questions as to what is actually happening. Although there’s quite a few theories out there, it appears that this may be just another failure of the state to properly assess the effectiveness of these treatments much in the same way that the safety and efficacy of the vaccines have not been properly tested.
The clinical trials likely overlooked the possibility of viral rebound occurring, and a rush to receive EUA approval may have obfuscated the need to look for such concerns.
This is also the first time that antivirals have been used extensively at home, which raises the question as to whether this is unique to SARS-COV2 or may be a feature for any respiratory infection- there really is a serious lack of evidence since this is the first time such a undertaking has occurred.
Overall, this raises many questions as to what may be happening. But for Molnupiravir, it certainly raises questions as to whether there is any real benefit to its use now that real concerns there is a possibility that its use may lead to more virulent strains.
More research and further investigation is required, and until more evidence is provided we are all left wanting.
.
Heliobas Disciple
TB Fanatic
covid vaccines and immune suppression in babies: fertile ground for inquiry
another black swan playing canary in a coal mine?
boriquagato.substack.com
covid vaccines and immune suppression in babies: fertile ground for inquiry
another black swan playing canary in a coal mine?
el gato malo
19 hr ago
there have been so many “black swans” lately that one might be forgiven for wondering if the white ones have gone extinct.
and here come some more this time from australia which, in a pleasing metaphoric symmetry, is from whence actual black swans hail.
alas, this one looks to be a much, much nastier breed.
something appears badly, badly wrong HERE
A concerning number of 'pandemic babies' with no immunity to respiratory viruses are ending up seriously ill in ICU.
Doctors have revealed children born during the Covid-19 pandemic are requiring intensive care 'from encountering viruses they haven't come across before', such as influenza, RSV and Covid.
The children had been born and raised when there were virtually no other viruses circulating in Australia, other than Covid-19.
The Children's Hospital at Westmead infectious diseases paediatrician Dr Philip Britton said an analysis of ICU admissions across shows babies are testing positive for influenza and Covid at the same time.
'Over the last month or so, we have seen four times the admissions to hospital for flu in children as for Covid,' Dr Britton told The Daily Telegraph.
a full 5% of babies that get both covid and flu are landing in the ICU. that’s a terrifying number.
and it’s exploding into severe pathologies in the sort of babies in which one would not expect to see it:
About half of the children had no pre-existing health conditions, with the elevated number of admissions putting pressure on the hospital system.
Some of the 'pandemic babies' are presenting with inflammation of the chest, brain and heart caused by influenza, Covid, and RSV.
RSV - respiratory syncytial virus - is a major cause of lung infections in children and can lead to pneumonia or bronchiolitis, which is particularly dangerous in young infants.
Severe cases can kill babies and toddlers, whose tiny airways have not yet fully formed and who struggle to cope with the infection.
'Among that group who are previously well … It's not just a chest infection, some of these children can be impacted with the flu affecting the heart and the brain,' Dr Britton told The Daily Telegraph.
A warning was sounded about RSV three weeks ago when there were just 355 cases a week in NSW, but three weeks later that has rocketed up to 3,775 in a week.
Around a fifth of those developed the potentially lethal bronchiolitis, with 40 per cent of them ending up in hospital.
over-isolated babies with lower immune function is possible, even plausible, but seeing them get colonized by multiple viruses at once in a manner unlike any i’ve seen before (though this is complex and possibly a function of testing as come HAVE ARGUED (though this is lower not upper tract)) seems more consistent with immune suppression, not failure to develop especially as this isolation issue is neither new nor localized, but this outcome is.
more or less no one got flu and covid at the same time. covid was a massive viral outcompete.
and suddenly, these babies are getting 2 and 3 viruses at once (possibly rare, possibly not well tested for previously) but more importantly, seeing a big spike in ICU rate.
trying to blame this on “lockdown” is a deeply unsatisfying explanation. if this were so, why did it not happen a year ago?
hmm, what was going on right around when these babies were conceived or in their first trimesters that no other babies before had experienced?
to be affecting babies born in q1-2 of 2022, we’re looking at the span from q2 last year to now with special focus on q3.
(this is full vaxx, first dose trended about 6 weeks earlier so we are right over the target here for current births to 6 mo olds)
this was pushed hard on pregnant women.
and it was not really tested beforehand.
let’s be very clear: this is a hypothesis and correlation does NOT prove causality. (it’s also possible this data is exaggerated) but, you’d be unwise to simply ignore a correlation like this, especially when we already know that covid vaccines were showing strong affinity for eggs, sperm, and having fertility effects.
we’re not randomly mining for association here, we have an a priori reason to suspect outcomes and the claims that “these vaccines are safe for pregnant women” have proven dangerously unfounded. we’ve seen high levels of miscarriage that, like so many things that turned out to happen here, were called “impossible.”
we’re also seeing a deeply unsettling drop in global birth rates that is hitting hard in Q1 2022, right where one would expect it if it were vaccine fertility suppression driven.
these two issue arising together are suggestive of linkage.
and if vaccines can affect sperm and eggs and birth rates, they can affect babies too.
the data is still circumstantial and somewhat patchwork, but it’s also stark. lockdowns did not do this and neither did past covid.
(SOURCE)
Birth Gauge @BirthGauge
Depopulation of TaiwanBirth Rate Dropped by 23% in ONE YEAR -- And it is NOT Covidigorchudov.substack.comthis is a double digit sigma event in many places. that’s basically supposed to be all but impossible even once. to happen a dozen times is like rolling yahtzee 1,000 times in a row.
it means there is a widespread external driver, we’re just trying to ascertain what it is.
we know these jabs are immuno-suppressive and are causing all manner of issues in the vaxxed along these lines and around immune fixation. could these same effects pass from mother to child and be driving the “pandemic baby” phenomenon?
it seems very possible.
i certainly would not call it proven, but there is quite a lot of provocative data coming from both directions: biology and statistical societal experience.
Q2 data should show us a great deal more. (we likely also need to be highly selective by vaccine type as we look at this as i know this is an issue for mRNA, but am not sure on the adenovirus vaxxes like AZ or JnJ and doubt it’s an issue in any using actual virus.)
a worrying aspect of this is that these sorts of disease issues tend to appear in the southern hemisphere first. it’s currently winter there and their variants and viral evolution tend to lead and spread to the north next season. (this gets used in flu vaxx design)
they are a sort of canary in the respiratory coal mine.
and this bird is not looking healthy.
maybe it’s idiosyncratic or misreported, but let’s face it, black swans are multiplying like rabbits.
and that means something bunny is going on here.
i would not go so far as to say that we know for sure what it is, but this issue warrants serious inquiry and NOW.
the fact that this is not an all hands on deck emergency at every global health agency would have shocked me to the bone 3 years ago. now it just seems par for the course.
that is not a good normal to which to acculturate.
this is the sort of work that should have been done LONG before going wide with a vaccine (and always would have in the past). this is triple true of one with such a novel method of action.
the fact that this is even a question is a nasty indictment of this whole drug approval and marketing process. (and for lockdowns)
the beatings will continue until you get politics out of science.
had enough yet?
.
Heliobas Disciple
TB Fanatic
US government buys 105 million more doses of pfizer vaxx for fall boosters
glenn-gottlieb glen ross
boriquagato.substack.com
US government buys 105 million more doses of pfizer vaxx for fall boosters
glenn-gottlieb glen ross
el gato malo
15 hr ago
JUST IN - US government buys 105 million doses of Pfizer’s mRNA vaccine for fall "booster" injections, with an option of 195 million more doses. businesswire.com/news/home/2022…
say what you will about scott gottlieb and his mysterious mid-term abdication of the reins at the FDA (and its subsequent decent into corruption and disfunction) but never let it be said that pfizer did not get their money’s worth adding this guy to their board.
the news is entirely against them, efficacy is gone (if it ever existed), cases are blowing out, side effects are unprecedentedly rampant, and glen-gottlieb glen ross just sold the US government the rust undercoating “upgrade” on every vehicle their fleet.
you almost have to stand back and admire the size of the scam.
this stuff sells for $19.50 a pop. that’s a $2 billion order with an option for nearly $4 billion more.
the wages of sin may or may not be death, but whoo doggie, the wages of pushing dodgy pharma on the public by using a purloined federal purchasing process aided and abetted by complicit regulators, well those look pretty darn good don’t they?
no sad steak knives for this hombre.
scotty is definitely taking home the cadillac.
covid is for closers.
for those who do not get this meme, have i got a movie for you.
total classic.
.
Heliobas Disciple
TB Fanatic
Interview with ARCHBISHOP CARLO MARIA VIGANÒ APOSTOLIC NUNCIO
A seasoned Vatican diplomat warns the world about globalism and the COVIDcrisis narrative
rwmalonemd.substack.com
Interview with ARCHBISHOP CARLO MARIA VIGANÒ APOSTOLIC NUNCIO
A seasoned Vatican diplomat warns the world about globalism and the COVIDcrisis narrative
Robert W Malone MD, MS
11 hr ago
Archbishop Carlo Maria Viganò was the Apostolic Nuncio to the United States from 2011 to 2016. He also previously served as Secretary-General of the Governorate of the Vatican City State from 2009 to 2011. He is notable for his role in bringing to light scandals and corruption within the hierarchy of the Catholic Church and in the world, especially in revealing the wide-spread cover-up of the abuses of Theodore McCarrick.
INTERVIEW WITH STEVE BANNON
BY ARCHBISHOP CARLO MARIA VIGANÒ APOSTOLIC NUNCIO
YOUR EXCELLENCY, after the psycho-pandemic, we now have the Russian- Ukrainian crisis. Are we in “phase two” of one single project, or can we now consider the Covid farce to be over and concern ourselves with the increase in energy prices?
If in the last two years we had been faced with a true pandemic, caused by a deadly virus for which no other cures existed except for a vaccine, we would be able to think that the emergency was not intended. But this is not what happened: the SARS-CoV-2 virus is nothing but a seasonal flu that could have been cured with existing treatments and effective prevention based on strengthening immune defenses. The prohibition of treatment, the discrediting of the effectiveness of drugs that have been in use for decades, the decision to hospitalize the elderly who became sick in nursing homes and the imposition of an experimental gene treatment that has been demonstrated not only to be ineffective but also harmful and often fatal – all this confirms for us that the pandemic has been planned and managed with the purpose of creating the greatest damage possible. This is a fact that has been established and confirmed by the official data, despite the systematic falsification of that same data.
Certainly, those who wanted to manage the pandemic in this way are not disposed now to yield easily, also because there are billionaire interests behind all of it. But what “they” want does not always necessarily happen.
In your opinion, Your Excellency, was the pandemic managed in this way due to inexperience? Or was it due to the corruption of those in positions of control who are in a conflict of interest because they are paid off by the pharmaceutical industry?
This is the second element to consider: the response to the pandemic was the same all over the world, where health authorities slavishly adapted to health protocols that were contrary to the scientific literature and medical evidence, instead following the directives of self-proclaimed “experts,” who have a record of sensational failures, apocalyptic predictions completely divorced from reality, and very grave conflicts of interest. We cannot think that millions of doctors all over the world have lost their basic knowledge of the art of medicine, believing that a flu should be allowed to evolve into pneumonia and then be treated with tachypirin or by placing patients on ventilators. If they have done this, it is due to pressure – even to the point of blackmail – by health authorities over medical personnel, with the help of a scandalous campaign of media terrorism and with the support of Western leaders. Most of these leaders are members of a lobby – the World Economic Forum – that trained them and placed them at the highest levels of national and international institutions in order to be certain that those who govern would be obedient. Klaus Schwab has publicly boasted, on many occasions, of being able to interfere even with religious leaders. These too are documented facts in all the nations that followed the directives of the WHO and the pharmaceutical companies. There is clearly a single script under a single direction: this demonstrates the existence of a criminal design and the malice of its creators.
In some of your other statements, you have spoken of a “golpe bianco” (a “silent coup”).
A “silent coup” is a coup d’état that takes place without the use of force, carried out by a government that exercises power in an unconstitutional way.
In this case the coup was carried out in all the Western nations almost simultaneously, beginning with the first years of the 1990s. For Italy, this coup began with the divestment of investee companies and the privatization of services that normally burdened the treasury, such as health and transportation services, following the directives given by high finance to Mario Draghi on June 2, 1992, on the yacht Britannia. Yes, Mario Draghi, who at the time was General Director of the Ministry of the Treasury and whom then- President of the Italian Republic Francesco Cossiga called a “cowardly businessman.” In other nations this coup took place in an analogous way, with a series of progressive transfers of sovereignty to supra-national entities like the European Commission, the European Central Bank, the International Monetary Fund, and the World Bank. With the introduction of the euro [in 2002], monetary sovereignty was removed from the nations adhering to the Maastricht Treaty, transferring it to the European Central Bank, which is a private bank. This bank decides the rate with which it finances national budgets, using money that these same nations have already given it. In practice, the European Central Bank demands interest on money that it only returns a penny at a time, and only on certain conditions: reforms, cuts in public spending, the imposition of laws promoting gender equality, abortion rights, the indoctrination of children, etc. The introduction of a balanced budget requirement into the [Italian] Constitution – as if the State was a company – was also part of the silent coup.
All the members of these bodies, including the same rulers who have been appointed at the recommendation of non-elected powers or have succeeded in winning election thanks to the manipulation of information, are at the same time the servants of high finance power groups or of large investment funds – some were their employees, such as Draghi of Goldman Sachs – others became employees after their term ended. Just like the drug agencies and health organizations are composed of former BigPharma employees, who often receive consulting contracts and who are paid by the very pharmaceutical companies they are supposed to be keeping an eye on.
Up until the pandemic, power was in practice still managed at least formally by individual nations, and laws were passed by Parliaments. But for the last two years, the Parliaments have been deprived of authority, and all those whom the World Economic Forum and other lobbies have succeeded in placing at the high levels of governments and international institutions have begun to legislate against the Constitution and the interests of the Nation, obeying orders given to them from on high – “from the markets,” they tell us – which in fact is made up of a very small number of multinational corporations that engulf competing companies, flatten professional skills with damage to the quality of the product, and reduce the protection and wages of workers thanks to the complicity of unions and of the Left.
In short, we are governed by a high command of usurers and speculators, from Bill Gates who invests in large farms right on the eve of the food emergency or in vaccines just before the outbreak of the pandemic, to George Soros, who speculates on the fluctuations of currencies and government bonds and along with Hunter Biden finances a bio-laboratory in Ukraine.
To think that there is no relationship between the instigators of these crimes and those who carry them out at the highest levels of national governments, the EU, and the UN is a sign of bad faith, because even a child could understand that we are held hostage by a group of technocrats who are ideologically deviant and morally corrupt. The peoples of the world need to reclaim their sovereignty, which has been usurped by the globalist elite.
The instigators of this crime show themselves proudly at the Davos Forum, at meetings of the Trilateral Commission or the Bilderberg Group along with the rulers, prime ministers, directors of newspapers and television broadcasters, CEOs of social bankers and directors of social platforms and multinational corporations, bankers and directors of ratings agencies, presidents of foundations and self-styled philanthropists. All of these share the same agenda – which they publish on their websites – and are so confident in their own power that they affirm it with impunity – as Soros and Schwab have recently done – that it is necessary to create a narrative to be conveyed through the mainstream media, in order to make their decisions acceptable to the people. They embrace censorship and mass manipulation as instrumentum regni, and we have had proof of this both with the pandemic farce as well as with the pro-Zelensky propaganda in Ukraine.
We must understand that our rulers are traitors of our Nation who are devoted to the elimination of populations, and that all of their actions are carried out in order to cause the greatest amount of harm to citizens. It is not a problem of inexperience or inability but rather of an intentio nocendi – a deliberate intention to harm. Honest citizens find it inconceivable that those who govern them could do it with the perverse intention of undermining and destroying them, so much so that they find it very hard to believe. The main cause of this very serious problem is found in the corruption of authority along with the resigned obedience of those who are governed.
The Catholic Church also, beginning with the revolution of Vatican II and above all during the last nine years of the Bergoglian “pontificate,” has experienced the same cognitive dissonance: the faithful and the Clergy have resigned themselves to obeying mere cynical officials – who are no less corrupt and perverted than their counterparts in the deep state – although it has been evident that the purpose of the alleged “reforms” has always been the systematic destruction of the Church by its highest leaders, who are heretics and traitors. And I note that the deep church has had recourse to the same false arguments in order to pass off the doctrinal, moral, and liturgical dissolution: first of all, the false contention that those reforms were requested “from the ground up” and not imposed with force from on high. Just like the reforms planned by the World Economic Forum, the Bilderberg group, and the Trilateral are adopted by their infiltrators in the highest levels of nations and international organisms, making it appear that their plans are ratified by popular consent.
And what do you advise, Your Excellency, to get out of this dead end?
Respect for authority is connatural to civilized man, but it is necessary to distinguish between obedience and servility. You see, every virtue consists of the just mean between two opposite vices, without being a compromise, but also as the peak between two valleys, so to speak. Disobedience sins by falling short, not wanting to submit to a good order of a legitimate authority; servility on the other hand sins by excess, submitting to unfair orders or orders given by an illegitimate authority. The good citizen should know how to disobey civil authority, and the good Catholic how to do the same with ecclesiastical authority, disobeying whenever the authority demands obedience to an iniquitous order.
Doesn’t such talk seem to be a bit revolutionary, Your Excellency?
Far from it. The anarchists and courtiers both have a distorted concept of authority: the former deny it while the latter idolize it. The just mean is the only morally viable way, because it responds to the order that the Lord has imprinted on the world and that respect the celestial hierarchy. We owe obedience to legitimate authority in the measure in which its power is exercised for the purposes for which authority has been established by God: the temporal good of citizens in the case of the State and the spiritual good of the faithful in the case of the Church. An authority that imposes evil on its subjects is for that very reason illegitimate and its orders are null. Let’s not forget that the true Lord from whom all authority comes is God, and that the earthly authority – civil as well as spiritual – is always vicarious, that is, it is subject to the authority of Jesus Christ, King and High Priest. Setting up the vicarious authority of rulers in the place of the royal authority of the Lord is a mad gesture and – yes – revolutionary and rebellious.
[continued next post]
Heliobas Disciple
TB Fanatic
[continued from post above]
What does the elite want to obtain? It promises us peace, security, prosperity, and work, but there are more than fifty armed conflicts currently taking place in the world; our cities are unlivable, full of criminals, immersed in decay and dominated by minorities of deviant people.
This is the third indisputable element that should not be overlooked: the pandemic was planned as an instrument for the establishment of a totalitarian regime, conceived by unelected technocrats who are devoid of any sense of democratic representation.
The same thing is happening with the Ukraine crisis: the majority of citizens is absolutely not in favor of sending weapons to Ukraine and imposing sanctions against the Russian Federation, and yet heads of government act as if they have the complete support of their own nations, supported by embarrassing falsifications of reality by the mainstream media. And in certain countries such as Italy, this is taking place in a situation of disturbing complicity by all the powers of the State, both in legitimizing the violation of fundamental rights under the anti-Covid regulations as well as in ratifying participation in a conflict even though there was never any deliberation about entering it by the Italian Parliament, and which even the President of the Republic, the guarantor of the Constitution, approves and encourages, to the applause of European technocrats. In this case too, those who govern are neither obeying the will of the people not pursuing the common good, but rather following orders handed down to them from supranational entities with their own interests, which we know are subversive.
When they speak of “transformation of goods into services,” of “sharing economy” through the digital sector, they intend to expropriate private property from citizens: “You will own nothing and you will be happy.” And when they impose the privatization of state goods or services, they want to appropriate the profits while leaving the costs on the shoulders of the community. But since not all countries are willing to do this “reset,” they are forcing them to accept it by provoking economic crises, pandemics, and wars. This is high treason and subversion.
The premeditated nature of this subversion is blatantly clear, as is the awareness of the disastrous consequences of the social, economic, and health decisions that have been made both with regard to the pandemic as well as the Ukraine crisis. Bergoglio has also admitted it: a head of state revealed to him, months before Putin’s military operation in Ukraine, that NATO and the European Union are deliberately provoking the Russian Federation, after having ignored for years the ethnic cleansing carried out by Kiev against the Russian-speaking minority in Donbass and the Crimea. The purpose of this provocation was to spark a conflict that would provide a cover to legitimize imposing sanctions against the Russian Federation and force Western nations to undertake the “green transition.” And at the same time, it would prostrate the economy of nations to the advantage of a few international investment funds and market speculation. In essence, the same premises are given that were made to justify the Enclosure Acts in England1 and later the Holodomor in Ukraine2 in order to transform the peasant masses into low-cost labor for the industrialization of the large cities. If war was to be avoided, NATO should not have been enlarged in violation of the treaties, and protection should have been assured for the Russian-speaking minority in Ukraine, as called for by the 2014 Minsk Protocol.
If this has not been done, it is because the real purpose that they have wanted to achieve has nothing to do with the apparent purpose they have publicly declared. And I note that these are not abstract speculations but concrete facts that were anticipated and planned decades ago by Great Reset theorists, with the aim of forcing a social change that nobody wants, making the economy and finance of the Western world start over from scratch – just like one restarts a computer.
The fact that this causes misery, bankruptcy, the failure of businesses, unemployment, social instability, and the widening of the gap between the rich and poor, the decline of the birth rate and the reduction of essential services is considered a negligible detail, with the sole concern of indoctrinating the masses with false arguments in favor of war or the control of every detail of people’s lives, criminalizing whoever dissents and pointing to
1 Beginning in the 17th century, the Enclosure Acts abolished the open field system of agriculture in England and enabled the government to take over the land for the purposes of efficiency and profitability.
2 The man-made famine of 1932-33 by which Stalin’s Soviet Union killed millions of Ukrainians.
them as the enemy of the people. It seems to me that this narrative is sinking under the weight of the lies of the elite and its accomplices.
Could you give us an example, Your Excellency?
The most obvious example is discovering that Richard Kalergi, one of the founding fathers of the European Union, wanted to pursue social engineering policies aimed at modifying European national societies through immigration and cross breeding, driving migration waves with the attractiveness of cheaper labor costs. Seeing the wicked obstinacy with which the waves of illegal immigrants continue to be welcomed, even when the impact that this phenomenon has on the safety of cities and on the general crime rate and the identity of national populations is obvious, demonstrates that the initial plan has been realized for the most part, and that action must be taken to prevent it from being completed.
And yet these are not things that are happening by chance: they have told us so.
You are absolutely right: what baffles me is noting with what impudence the proponents of the Agenda 2030 have told us well in advance which criminal projects they intended to impose on us against our will; despite this evidence, there are those who amazed that after years of unstoppable infiltration they are actually realizing their plans right in front of our eyes even as they accuse us of being “conspiracy theorists.” There is definitely a conspiracy, but the ones who must be put on trial are the ones who have carried it out, not those who denounce it.
Joe Biden lays responsibility for the crisis at the feet of Vladimir Putin. Do you agree with this judgment?
Americans are well aware that the price of gasoline had risen well before the Russian-Ukrainian crisis, and further increased due to sanctions – real or alleged – of the international community against the Russian Federation. Today we know that sanctions – as was foreseeable – have not affected Putin in the least, but the motive behind them is that they were supposed to strike Western nations, and in particular the nations of Europe, in order to provoke an economic and energy crisis by means of which to legitimize the ecological transition, rations, population control, and the censorship of information.
Putin did not take the bait offered him by the provocations of the deep state, limiting himself to intervening only as necessary to give security and protection to Russian-speaking Donbass. And he stormed the Azovstal steel plant, which hid one of the secret American biolabs that produced bacteriological weapons and carried out experiments with SARS-CoV-2. On the other hand, the Biden family had every interest in a having a war in Ukraine, in order to cover up the corruption cases involving Hunter Biden and to distract people from the impending scandals looming over Obama and Hillary Clinton for Russiagate and over the deep state for the electoral fraud carried out against Trump.
The US proxy war against the Russian invasion is in reality a war of the deep state against a nation that has refused to accept being engulfed by the delusions of globalist technocrats and that today has proofs of the crimes committed by the deep state. But while the EU can blackmail European nations, tying the disbursement of funds and interest rates on loans to the implementation of “reforms” – since these nations have limited monetary and fiscal sovereignty – the same is not true for Russia, which is a sovereign and independent nation, as well as self-sufficient in terms of raw materials, energy, and agricultural food resources.
Is this bipolar vision, which re-proposes the Cold War confrontation between the USA and the USSR, no longer valid?
The hegemonic Left has established a Manichean division between good and evil: left vs. right, liberalism vs. fascism, globalism vs. sovereignism, vaccinism vs. No-vax. The “good guys” are obviously those on the left: liberal but supportive, globalist, inclusive, ecumenical, resilient, and sustainable. The “bad guys” are just as obviously patriots, Christians, right-wingers, sovereignists, and heterosexuals.
What distinguishes the current structure of Western countries from the past?
The fusion of the worst of liberalism with the worst of collective socialism. Today we see, after two years of the pandemic farce, how globalist liberalism has made use of communist and dictatorial methods to impose itself with its Great Reset, and how the communist regimes are using liberal methods to enrich the upper echelons of the party without losing total control over the population. This demonstrates that the geopolitical balance is shifting towards a multi-polar vision and that bipolarism fueled by the deep state is in decline.
Is there any analogy between what is happening in the Catholic Church under the pontificate of Jorge Mario Bergoglio?
The deep church is an offshoot of the deep state, in a certain sense. For this reason it should not surprise us that we are witnessing the demolition of Faith and Morals in the name of ecumenism and synodality, applying liberal errors in the theological sphere; and on the other hand the transformation of the Papacy and the Roman Curia into a politburo in which ecclesiastical authority is both absolute and also released from its fidelity to the Magisterium, following the modalities of the exercise of power in a communist-type dictatorship. The law is no longer founded on Justice but rather on the convenience and utility of those who apply it: it is enough to see how harshly the clergy and faithful who are traditional are treated by the Vatican, and on the other hand with how much indulgence the Vatican praises notorious pro- abortion activists (I am thinking of Biden and Pelosi among the most striking cases) as well as the propagandists of LGBTQ ideology and gender theory. Here too, liberalism and communism have formed an alliance to demolish the institution from within, just as has happened in the civil sphere. But we know that contra legem fit, quod in fraudem legis fit – that which circumvents the law is done against the law.
Your Excellency, how do you think things in the United States can change in the near future?
The eventual return of Donald Trump to the White House would allow for real peace negotiations, once the deep state has been eradicated from the Administration and government agencies. But the reconstruction will certainly require the collaboration and sacrifices of everyone, and a solid spiritual vision that inspires the reconstruction of the social fabric. If all of this has happened through the demonstrated electoral fraud of the last Presidential election, Trump’s victory would be even more striking and would have strong repercussions on the ramifications of the deep state in Europe and in particular in Italy.
In any case, the mid-term elections could allow the Republicans to have a majority in the House and in the Senate, once the servants of the deep state – including first of all the “neo-cons” – have been ousted.
The failure of the effort to blame Trump for the farce of the assault on the Capitol ought to dissuade its organizers – among whom we cannot fail to number Nancy Pelosi – from trying to replicate the scene next fall, which would fall into the grotesque, in addition to being a case of déjà vu.
So has the Great Reset failed? Can we sing a victory song?
A victory song can be sung only when the war has been won. The Great Reset is ontologically destined for failure, because it is inspired by inhuman and diabolical principles. But its end, however inevitable, may still take some time, depending on our capacity to oppose it and also what is contained in the plans of Divine Providence.
If the Lord wants to grant us a truce, a period of peace after we have understood how horrible is the hell on earth that the enemies of God and man desire, then we must commit ourselves to rebuild – not “build back better” but just the opposite
– yes, rebuild what has been destroyed: the family, the bond
+ Carlo Maria Viganò, Archbishop
of marriage, the moral education of children, love for our country, dedication to hard work, and fraternal charity, especially towards those who are the most defenseless and needy. We must reaffirm the holiness and untouchable sanctity of life from conception to natural death; defending the complementary nature of the two sexes against the insanity of gender ideology, protecting children from corruption and guaranteeing the innocence to which they are entitled. We must finally set aside the logic of profit – which is typical of the liberal mentality – in order to regain the pride of fulfilling our duty even when no one is watching us, of producing what we make in a professional manner and selling it at an honest price. And we must stop considering ourselves inferior simply because someone has decided that in their godless model of dystopian society being honest, loyal, sincere, and God- fearing is something to be ashamed of. The ones who ought to be ashamed, rather, are those who call for the killing of children and the elderly, the planned extermination of the population through wicked vaccine campaigns, mass sterilization, sodomy, pedophilia, and all the most deviant aberrations.
Your Excellency, do you believe that the world can return to God?
The world can and must return to God: this is a necessity dictated by the divine order that the Creator has imprinted on creation. It must return to God, because only where Christ reigns can there by true justice and true peace. And the world can do this, but not in a collectivist or communitarian vision in which individuals disappear into the mass, but rather in a personal and individual vision, in which each one of us freely recognizes that nothing can be better than what Our Heavenly Father has prepared for us, since He loves us and wants to make us sharers in His glory.
If we all return to God, our Nations will also recognize His Lordship and will conform their laws to His Law. Let us pray therefore that what the Psalmist sings may be realized: Laudate Dominum omnes gentes; laudate eum omnes populi (Ps 116:1) – Praise the Lord, all you nations, praise him all you peoples. Quoniam confirmata est super nos misericordia ejus; et veritas Domini manet in æternum (Ps 116:2) – For his Mercy is confirmed upon us, and the Truth of the Lord remains forever.
21 June 2022
Saint Aloysius Gonzaga
What does the elite want to obtain? It promises us peace, security, prosperity, and work, but there are more than fifty armed conflicts currently taking place in the world; our cities are unlivable, full of criminals, immersed in decay and dominated by minorities of deviant people.
This is the third indisputable element that should not be overlooked: the pandemic was planned as an instrument for the establishment of a totalitarian regime, conceived by unelected technocrats who are devoid of any sense of democratic representation.
The same thing is happening with the Ukraine crisis: the majority of citizens is absolutely not in favor of sending weapons to Ukraine and imposing sanctions against the Russian Federation, and yet heads of government act as if they have the complete support of their own nations, supported by embarrassing falsifications of reality by the mainstream media. And in certain countries such as Italy, this is taking place in a situation of disturbing complicity by all the powers of the State, both in legitimizing the violation of fundamental rights under the anti-Covid regulations as well as in ratifying participation in a conflict even though there was never any deliberation about entering it by the Italian Parliament, and which even the President of the Republic, the guarantor of the Constitution, approves and encourages, to the applause of European technocrats. In this case too, those who govern are neither obeying the will of the people not pursuing the common good, but rather following orders handed down to them from supranational entities with their own interests, which we know are subversive.
When they speak of “transformation of goods into services,” of “sharing economy” through the digital sector, they intend to expropriate private property from citizens: “You will own nothing and you will be happy.” And when they impose the privatization of state goods or services, they want to appropriate the profits while leaving the costs on the shoulders of the community. But since not all countries are willing to do this “reset,” they are forcing them to accept it by provoking economic crises, pandemics, and wars. This is high treason and subversion.
The premeditated nature of this subversion is blatantly clear, as is the awareness of the disastrous consequences of the social, economic, and health decisions that have been made both with regard to the pandemic as well as the Ukraine crisis. Bergoglio has also admitted it: a head of state revealed to him, months before Putin’s military operation in Ukraine, that NATO and the European Union are deliberately provoking the Russian Federation, after having ignored for years the ethnic cleansing carried out by Kiev against the Russian-speaking minority in Donbass and the Crimea. The purpose of this provocation was to spark a conflict that would provide a cover to legitimize imposing sanctions against the Russian Federation and force Western nations to undertake the “green transition.” And at the same time, it would prostrate the economy of nations to the advantage of a few international investment funds and market speculation. In essence, the same premises are given that were made to justify the Enclosure Acts in England1 and later the Holodomor in Ukraine2 in order to transform the peasant masses into low-cost labor for the industrialization of the large cities. If war was to be avoided, NATO should not have been enlarged in violation of the treaties, and protection should have been assured for the Russian-speaking minority in Ukraine, as called for by the 2014 Minsk Protocol.
If this has not been done, it is because the real purpose that they have wanted to achieve has nothing to do with the apparent purpose they have publicly declared. And I note that these are not abstract speculations but concrete facts that were anticipated and planned decades ago by Great Reset theorists, with the aim of forcing a social change that nobody wants, making the economy and finance of the Western world start over from scratch – just like one restarts a computer.
The fact that this causes misery, bankruptcy, the failure of businesses, unemployment, social instability, and the widening of the gap between the rich and poor, the decline of the birth rate and the reduction of essential services is considered a negligible detail, with the sole concern of indoctrinating the masses with false arguments in favor of war or the control of every detail of people’s lives, criminalizing whoever dissents and pointing to
1 Beginning in the 17th century, the Enclosure Acts abolished the open field system of agriculture in England and enabled the government to take over the land for the purposes of efficiency and profitability.
2 The man-made famine of 1932-33 by which Stalin’s Soviet Union killed millions of Ukrainians.
them as the enemy of the people. It seems to me that this narrative is sinking under the weight of the lies of the elite and its accomplices.
Could you give us an example, Your Excellency?
The most obvious example is discovering that Richard Kalergi, one of the founding fathers of the European Union, wanted to pursue social engineering policies aimed at modifying European national societies through immigration and cross breeding, driving migration waves with the attractiveness of cheaper labor costs. Seeing the wicked obstinacy with which the waves of illegal immigrants continue to be welcomed, even when the impact that this phenomenon has on the safety of cities and on the general crime rate and the identity of national populations is obvious, demonstrates that the initial plan has been realized for the most part, and that action must be taken to prevent it from being completed.
And yet these are not things that are happening by chance: they have told us so.
You are absolutely right: what baffles me is noting with what impudence the proponents of the Agenda 2030 have told us well in advance which criminal projects they intended to impose on us against our will; despite this evidence, there are those who amazed that after years of unstoppable infiltration they are actually realizing their plans right in front of our eyes even as they accuse us of being “conspiracy theorists.” There is definitely a conspiracy, but the ones who must be put on trial are the ones who have carried it out, not those who denounce it.
Joe Biden lays responsibility for the crisis at the feet of Vladimir Putin. Do you agree with this judgment?
Americans are well aware that the price of gasoline had risen well before the Russian-Ukrainian crisis, and further increased due to sanctions – real or alleged – of the international community against the Russian Federation. Today we know that sanctions – as was foreseeable – have not affected Putin in the least, but the motive behind them is that they were supposed to strike Western nations, and in particular the nations of Europe, in order to provoke an economic and energy crisis by means of which to legitimize the ecological transition, rations, population control, and the censorship of information.
Putin did not take the bait offered him by the provocations of the deep state, limiting himself to intervening only as necessary to give security and protection to Russian-speaking Donbass. And he stormed the Azovstal steel plant, which hid one of the secret American biolabs that produced bacteriological weapons and carried out experiments with SARS-CoV-2. On the other hand, the Biden family had every interest in a having a war in Ukraine, in order to cover up the corruption cases involving Hunter Biden and to distract people from the impending scandals looming over Obama and Hillary Clinton for Russiagate and over the deep state for the electoral fraud carried out against Trump.
The US proxy war against the Russian invasion is in reality a war of the deep state against a nation that has refused to accept being engulfed by the delusions of globalist technocrats and that today has proofs of the crimes committed by the deep state. But while the EU can blackmail European nations, tying the disbursement of funds and interest rates on loans to the implementation of “reforms” – since these nations have limited monetary and fiscal sovereignty – the same is not true for Russia, which is a sovereign and independent nation, as well as self-sufficient in terms of raw materials, energy, and agricultural food resources.
Is this bipolar vision, which re-proposes the Cold War confrontation between the USA and the USSR, no longer valid?
The hegemonic Left has established a Manichean division between good and evil: left vs. right, liberalism vs. fascism, globalism vs. sovereignism, vaccinism vs. No-vax. The “good guys” are obviously those on the left: liberal but supportive, globalist, inclusive, ecumenical, resilient, and sustainable. The “bad guys” are just as obviously patriots, Christians, right-wingers, sovereignists, and heterosexuals.
What distinguishes the current structure of Western countries from the past?
The fusion of the worst of liberalism with the worst of collective socialism. Today we see, after two years of the pandemic farce, how globalist liberalism has made use of communist and dictatorial methods to impose itself with its Great Reset, and how the communist regimes are using liberal methods to enrich the upper echelons of the party without losing total control over the population. This demonstrates that the geopolitical balance is shifting towards a multi-polar vision and that bipolarism fueled by the deep state is in decline.
Is there any analogy between what is happening in the Catholic Church under the pontificate of Jorge Mario Bergoglio?
The deep church is an offshoot of the deep state, in a certain sense. For this reason it should not surprise us that we are witnessing the demolition of Faith and Morals in the name of ecumenism and synodality, applying liberal errors in the theological sphere; and on the other hand the transformation of the Papacy and the Roman Curia into a politburo in which ecclesiastical authority is both absolute and also released from its fidelity to the Magisterium, following the modalities of the exercise of power in a communist-type dictatorship. The law is no longer founded on Justice but rather on the convenience and utility of those who apply it: it is enough to see how harshly the clergy and faithful who are traditional are treated by the Vatican, and on the other hand with how much indulgence the Vatican praises notorious pro- abortion activists (I am thinking of Biden and Pelosi among the most striking cases) as well as the propagandists of LGBTQ ideology and gender theory. Here too, liberalism and communism have formed an alliance to demolish the institution from within, just as has happened in the civil sphere. But we know that contra legem fit, quod in fraudem legis fit – that which circumvents the law is done against the law.
Your Excellency, how do you think things in the United States can change in the near future?
The eventual return of Donald Trump to the White House would allow for real peace negotiations, once the deep state has been eradicated from the Administration and government agencies. But the reconstruction will certainly require the collaboration and sacrifices of everyone, and a solid spiritual vision that inspires the reconstruction of the social fabric. If all of this has happened through the demonstrated electoral fraud of the last Presidential election, Trump’s victory would be even more striking and would have strong repercussions on the ramifications of the deep state in Europe and in particular in Italy.
In any case, the mid-term elections could allow the Republicans to have a majority in the House and in the Senate, once the servants of the deep state – including first of all the “neo-cons” – have been ousted.
The failure of the effort to blame Trump for the farce of the assault on the Capitol ought to dissuade its organizers – among whom we cannot fail to number Nancy Pelosi – from trying to replicate the scene next fall, which would fall into the grotesque, in addition to being a case of déjà vu.
So has the Great Reset failed? Can we sing a victory song?
A victory song can be sung only when the war has been won. The Great Reset is ontologically destined for failure, because it is inspired by inhuman and diabolical principles. But its end, however inevitable, may still take some time, depending on our capacity to oppose it and also what is contained in the plans of Divine Providence.
If the Lord wants to grant us a truce, a period of peace after we have understood how horrible is the hell on earth that the enemies of God and man desire, then we must commit ourselves to rebuild – not “build back better” but just the opposite
– yes, rebuild what has been destroyed: the family, the bond
+ Carlo Maria Viganò, Archbishop
of marriage, the moral education of children, love for our country, dedication to hard work, and fraternal charity, especially towards those who are the most defenseless and needy. We must reaffirm the holiness and untouchable sanctity of life from conception to natural death; defending the complementary nature of the two sexes against the insanity of gender ideology, protecting children from corruption and guaranteeing the innocence to which they are entitled. We must finally set aside the logic of profit – which is typical of the liberal mentality – in order to regain the pride of fulfilling our duty even when no one is watching us, of producing what we make in a professional manner and selling it at an honest price. And we must stop considering ourselves inferior simply because someone has decided that in their godless model of dystopian society being honest, loyal, sincere, and God- fearing is something to be ashamed of. The ones who ought to be ashamed, rather, are those who call for the killing of children and the elderly, the planned extermination of the population through wicked vaccine campaigns, mass sterilization, sodomy, pedophilia, and all the most deviant aberrations.
Your Excellency, do you believe that the world can return to God?
The world can and must return to God: this is a necessity dictated by the divine order that the Creator has imprinted on creation. It must return to God, because only where Christ reigns can there by true justice and true peace. And the world can do this, but not in a collectivist or communitarian vision in which individuals disappear into the mass, but rather in a personal and individual vision, in which each one of us freely recognizes that nothing can be better than what Our Heavenly Father has prepared for us, since He loves us and wants to make us sharers in His glory.
If we all return to God, our Nations will also recognize His Lordship and will conform their laws to His Law. Let us pray therefore that what the Psalmist sings may be realized: Laudate Dominum omnes gentes; laudate eum omnes populi (Ps 116:1) – Praise the Lord, all you nations, praise him all you peoples. Quoniam confirmata est super nos misericordia ejus; et veritas Domini manet in æternum (Ps 116:2) – For his Mercy is confirmed upon us, and the Truth of the Lord remains forever.
21 June 2022
Saint Aloysius Gonzaga
Heliobas Disciple
TB Fanatic
Portugal cases & deaths today' as you see, curves do not get to baseline, but latest wave is headed down but we predict will rise again; see death curve, follows the cases; BA.4 & BA.5 are problematic
we see deaths rising 2-3 weeks post peak of case wave as the usual pattern; the question is we were seeing in omicron, that deaths were uncoupled from cases; not so anymore; VAX has caused damage
palexander.substack.com
Portugal cases & deaths today' as you see, curves do not get to baseline, but latest wave is headed down but we predict will rise again; see death curve, follows the cases; BA.4 & BA.5 are problematic
we see deaths rising 2-3 weeks post peak of case wave as the usual pattern; the question is we were seeing in omicron, that deaths were uncoupled from cases; not so anymore; VAX has caused damage
Dr. Paul Alexander
5 hr ago
I am saying to you that it seems the BA 4 and BA 5 sub-variants/clades are more problematic and early treatment works just as well but with your doctor, must be aggressively started 1-3 days infection etc. I shared protocols yesterday.
What we feared is coming through. We warned about this and GVB was prescient. The non-neutralizing vaccinal antibodies are pressuring the spike (sub-optimal mounting immune pressure) but not sterilizing the virus (eliminating it).
The binding of the vaccinal Abs (Yahi et al. Infection-enhancing anti-SARS-CoV-2 antibodies recognize both the original Wuhan/D614G strain and Delta variants. A potential risk for mass vaccination?) is dramatically increasing the infectiousness of the virus (omicron). Yet the variants are overcoming this vaccinal Abs pressure and new infectious variants are emerging.
This statement by Yahi is critical and you should keep in mind:
“We show that enhancing antibodies reinforce the binding of the spike trimer to the host cell membrane by clamping the NTD to lipid raft microdomains. This stabilizing mechanism may facilitate the conformational change that induces the demasking of the receptor binding domain. As the NTD is also targeted by neutralizing antibodies, our data suggest that the balance between neutralizing and facilitating antibodies in vaccinated individuals is in favor of neutralization for the original Wuhan/D614G strain. However, in the case of the Delta variant, neutralizing antibodies have a decreased affinity for the spike protein, whereas facilitating antibodies display a strikingly increased affinity. Thus, ADE may be a concern for people receiving vaccines based on the original Wuhan strain spike sequence (either mRNA or viral vectors).”
Original antigenic sin (OAS) and ADEI is prevalent here. What is the bottom line? Well, if we continue ‘these’ COVID injections, the pandemic will never ever end, and will be going on for 100 years, a forever pandemic, and there will be infectious variant after infectious variant, but one can at the same time emerge and and can devastate humanity.
Fauci, Francis Collins, Walensky, Bancel/Moderna, Bourla/Pfizer etc. know this. They are not stupid. Then ask yourself why?
We are seeing a blip now for death curve in Germany as the infections/cases increased. Let us wait a day or two to see if the increase is stable and not idiosyncratic.
Heliobas Disciple
TB Fanatic
Warning: coming many Americans, many people will die because of these COVID injections, many healthy children WILL die due to these shots; FDA, CDC, NIH, Moderna, & Pfizer secretly told me this
I was told in discussions with FDA, CDC, NIH, Moderna, & Pfizer officials in Washington at HHS July/August 2020, their grave concerns, why they must be silent as in fear for safety and careers; Toby!!
palexander.substack.com
Warning: coming many Americans, many people will die because of these COVID injections, many healthy children WILL die due to these shots; FDA, CDC, NIH, Moderna, & Pfizer secretly told me this
I was told in discussions with FDA, CDC, NIH, Moderna, & Pfizer officials in Washington at HHS July/August 2020, their grave concerns, why they must be silent as in fear for safety and careers; Toby!!
Dr. Paul Alexander
18 hr ago
They said, follow the $CIENCE. Fauci said he is the $CIENCE.
I have been trying to warn. I have written on this here in stack. I try again.
Everything you have been told by government, by CDC, by NIH, by Fauci, by Birx, by Bourla, by Pfizer, by all your government officials, were lies, distortions, exaggerations, meant to mislead you. All pure lies on everything about lockdowns and these failed COVID gene injections. All, every single part was a lie. A deception. This entire COVID pandemic, was a lie! Yes, we had an emergency, but everything done to us the last over 2 years was a fraud hoax, a lie. Every single COVID policy failed. Canada, US, UK, everywhere.
The entire lockdown lunacy failed! All school closures failed, just killed children. Everything was a lie! They knew it would never work but knew one thing, that you as people, as the population, crazily thought, that they as health officials and medical doctors, wanted to do good by them and they could ‘trust’ you. You would do them no harm.
Little did they know. Little did we know the corruptible malfeasants we were dealing with. I include many medical doctors in this.
Trump was right when he early on said it was hoax. He did not mean the virus was a fraud or hoax. He meant the repose. The response was, and he saw what the deepstate and media, and CDC and NIH and Fauci and Birx were doing to him. But he could not stop them. He could, he could have, but he was weak. He then did the unthinkable. He allowed Fauci and Birx to lead a crazy lockdown lunatic policy that harmed and killed thousands of Americans. None of it worked! Not one!
You will come to learn, that 2.5 years of your life was taken away, for a lie! A greed, power drunk lie! By sick malfeasant people. Their motives. That must all be investigated and if it is shown they did this deliberately and caused deaths, we jail them all! Yes, 2.5 years lost to these malfeasants. The COVID injection is a failed ineffective dangerous injection.
I am no anti-vaxxer, but I am against these injections.
I was told by these officials (FDA, CDC, NIH, Moderna, & Pfizer), in confidential secret discussions, that in about 6 to 6.5 years from roll-out, in those who take the injections, they feared mass auto-immune disease and deaths, they feared viral immune escape and very problematic variants, and they anticipated constant deaths from the injections but a major number of deaths to emerge. I could not even understand exactly what they did for it was so haphazard, but these were officials. And they wanted to talk to me. To tell me ‘their truths’.
They said based on all they knew, that the COVID injections could never work, especially the mRNA platform. It never worked in the animal model and was pathological. They told me that in about 6 to 6.5 years, there will be a surge in deaths in persons who take the injections (then about 1 year ago). This was their projection. They advised me they nor their families will never (especially their children) take any of the COVID injections.
The key is the injection works for some people and I argue we do not know how long and what the effects are and this is what I was told. But you understand that too. You cannot take a 15 year process and boil it down to a few months and declare it is safe. They were never safety tested to exclude harms and deaths longer term. We do not know exactly what is coming. But it certainly does not work for a whole bunch of people. Look around, you know people who have been harmed by these injections and died. Do you not? Something is very wrong with these injections. Very wrong and they just will not stop.
I am being open with you to inform you. I am sick and tired, years now, of the lies and fraud and disaster put out by the media, the alphabet health agencies etc. You trusted your public health officials, you think ‘they care about you’, well, they never cared about you, your family, or the truth. It is to them about the $CIENCE.
I think I shared prior that my office was on the 6th floor of the HHS building in DC, Operation warp speed and Moderna were stationed on the 7th floor. FDA, CDC etc. have sub-satellite offices at HHS. At least when I was there and Hahn, Redfield etc. came there daily after congress or White House to see their staff, various persons, persons in various offices.
These people I talked with, came to me out of anger and fear too, they knew who I was and wanted to tell me their stories and how worried they were for the population, and fearful for their lives and own careers as to the COVID injections (and other issues). If they spoke out openly so had to talk secretly.
They were very very dismayed and angered and worried as to why the agencies they worked for e.g. FDA and NIH and CDC etc. and the pharmaceuticals were not properly regulating and conducting the proper safety studies, proper durations of follow-up. They felt the COVID injection program was a pure disaster and should be stopped back then. This is 6 months or so before roll-out. They felt no healthy children should ever be given the very injections they were working on. They were that concerned.
I want to be clear again, based on all I know today, based on what I was told, many many children will die due to these injections. Healthy children will die, not ‘if’, but ‘will die. Healthy children, healthy people, normal people never needed and do not need these injections. I have told you before that (strong research and scholarship by Geert) we will be in a pandemic for 100 years if we continue these injections. It is the COVID injection itself that is driving the variants and these CDC, NIH, Moderna, and Pfizer officials are malfeasants IMO who are continuing this. There is no sound justification. These malfeasants know that they are vaccinating with the Wuhan strain (legacy strain) that has been gone many months now and omicron dominates. The vaccinal antibodies are to the original Wuhan strain and will not hit the omicron spike antigen (original antigenic sin (OAS)).
It is the COVID injection (and consequent non-neutralizing antibodies pressuring the spike antigen) that is causing the vaccinated to become infected, hospitalized, and die. The data is clear. Massive antibody-dependent enhancement, some refer to this as antibody mediated viral enhancement. Some pathogenic priming. All IMO the very same. The recall antibodies are to something that does not exist today. The key is to reduce viral pressure, infectious pressure on the population, so that the sub-optimal injections have less virus to put under pressure. We have effective chemoprophylaxis, we can do this. We have early treatment. This can worked effectively and this can thus help reduce viral transmission. At the same time, the best step is to stop these filed injections.
I want all of these people investigated in proper public and legal inquiries, and if it is shown they did wrong, in proper inquiries, I want them arrested. I want all who made policy decisions that costed lives, to be jailed! All their monies taken!
Dr. Rogers looked at the FDA June 28th meeting and his takeaway is bang on and what we have been saying here for near a year now here:
‘‘Yesterday, the FDA’s Vaccines and Related Biological Products Advisory Committee approved a bivalent Covid-19 shot with the Wuhan strain and the Omicron variant.
The vote was:
19 yes.
2 no.
A few thoughts:
The Wuhan strain is no longer in circulation. So they are vaccinating against a strain that no longer exists.
The Omicron variant that they are going to put into this shot is Omicron BA.4/BA.5:
1. By the time it gets to market in the fall, Omicron BA.4/BA.5 will likely no longer be in circulation.
2. There is no efficacy data whatsoever on vaccines against Omicron BA.4/5.
3. There is no safety data whatsoever on vaccines against Omicron BA.4/5.
4. They do not intend to gather any efficacy or safety data between now and when these shots will be released in the fall:
At the meeting, the manufacturers (Moderna, Pfizer, and Novavax) were asked what their production timelines are… and they said out loud, “So long as we don’t have to provide any clinical data, we’ll have them ready by fall.”
Dr. Rogers is a smart guy.
His work:
Source
Heliobas Disciple
TB Fanatic
A reinfection red flag
Why a new report is so troubling
Eric Topol
Jun 21
A new report on Covid reinfections is quite concerning. It’s currently a preprint but these same authors with access to the US largest healthcare system, the Veteran Affairs, have published numerous eye-opening studies during the pandemic, in leading peer-review journals, on topics which include Long Covid cardiovascular outcomes, diabetes, breakthrough infections, the toll on mental health, and kidney disease. I have not previously seen any substantive differences from their preprints compared with the final publications. So with that context let’s look at their findings from >250,000 people with 1 infection, ~39,000 people with 2 or more infections, and nearly 5.4 million uninfected controls. It’s the first study to characterize the risks of reinfection.
The first finding is the comparison of people with reinfections vs those with only 1 infection. Note the doubling of all-cause mortality, cardiovascular, and lung adverse outcomes, 3-fold risk of hospitalization, and impact on other health domains. The absolute excess burden is shown on the right panel.
Next is the durability of these adverse outcomes for this same comparison (reinfections vs 1 infection) in 30-day increments, indicating that much of the hit was up front, but persistent increased risk was evident for most endpoints throughout the 6 months follow-up (above the line of 1.0, hazard ratio, in the left hand panel).
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Finally, there is the “dose-response” effect of multiple reinfections. By that I mean with additional episodes of Covid, for every outcome there was a stepwise increased risk, both relative (left panel) and absolute (right panel).
Obviously these findings are worrisome since reinfection was quite rare before the Omicron wave hit, at 1% or less through the Delta variant wave. But now reinfections have become much more common. Why? The Omicron BA.2, BA.2.12.1, BA.4, and BA.5 have progressively increased immune escape and there is limited cross-immunity with BA.1, the Omicron version that about half of Americans got infected with early in 2022. We await an independent replication of these reinfection findings, but I note much of what these authors have thus far published from the Veterans Affairs information resource has indeed been replicated.
The new Omicron subvariants portend much more reinfections
Today’s CDC update of genomics shows we have 35% of new cases accounted by the BA.4/5 variants, which have the most immune-evasiveness of any variant since the pandemic began, and 56% by BA.2.12.1.
Reinfection risk is substantially increased due to the new spike mutations we are getting exposed to, as simplified below.
BA.2.12.1 presented the L452Q mutation and BA.4/5 add 2 other key mutations. BA.1 induces a fairly weak, narrow immune response which doesn’t help with exposure to the BA.2.12.1 and BA.4/5 subvaraints.
We’re not alone in facing a new BA.4/5 wave, which we saw initially in South Africa and Portugal, but now is occurring in the UK, many countries in Europe and Australia, with at least some increase in hospitalizations associated with these subvariants
Although we just saw a favorable report about less 50-70% less Long Covid with Omicron compared with Delta, remember the number of infections with Omicron and its subvariants is markedly higher than any previous wave, including Delta, such that the absolute risk of developing Long Covid is still real, no less the burden at the population level.
The Omicron BA.1-specific vaccine booster remedy?
The worry is centered about the immune escape of these subvariants, which was characterized in a recent Nature paper with the conclusion “Together, our results indicate that Omicron may evolve mutations to evade the humoral immunity elicited by BA.1 infection, suggesting that BA.1-derived vaccine boosters may not achieve broad-spectrum protection against new Omicron variants.” That is to say, besides vulnerability to reinfections, the Omicron BA.1 specific vaccines, due to become available this Fall, may not provide enhanced protection as anticipated. BA.4/5 are too different from BA.1 with respect to how our immune system sees them. Even the head of BioNTech has recently warned about the potential for further immune escape and the reduced impact of vaccines, including an Omicron-BA.1 specific one.
We are already seeing evidence of some less protection against severe Covid, that requiring hospitalization, with recent reports of vaccine effectiveness, such as 77% in 21 United States hospitals among immunocompetent individuals with 3 shots. Recall the mRNA vaccine effectiveness vs. hospitalization was 95% through Delta. We don’t have adequate data for vaccine protection vs BA.4/5 yet, but it is certainly possible there will be some attrition which has fortunately not been noted between BA.1 and BA.2.
What should we do about this?
Despite lack of warnings by CDC, there should be gearing up with N95/KN95 masks, distancing when possible, attention to ventilation, air filtration, and all of the non-pharmacologic measures that we have at our disposal to limit infections and reinfections.
Booster shots can help, especially when more than 4 months have elapsed from primary vaccination or a third shot. Children of all ages will benefit from vaccination, including the new approval for age < 5 years, even if they have had Omicron infections with BA.1, owing to the narrow and often insufficient immune response that may not protect from BA.4/5 and subsequent variants.
Beyond that is my #1 frustration as expressed here.
There is simply no excuse for why these vaccines are not being hyper-aggressively pursued, particularly given the trajectory of relentless increased SARS-CoV-2 immune-evasiveness (and resultant enhanced transmissibility), the new worry about reinfection sequelae and Long Covid, and the known unknown next Greek letter variant we may well be seeing in the months ahead. The lack of priority and resource allocation stems from the illusion that the pandemic is behind us, which is obviously off-base. If ever there was a callout for don’t just stand there, do something, this is it.
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jward
passin' thru
Chuck Callesto
@ChuckCallesto
BREAKING REPORT: New York City to mandate ALL CHILDREN RECEIVE THE COVID VACCINE in order to attend school this fall...
9:09 PM · Jul 1, 2022·Twitter Web App
Heliobas Disciple
TB Fanatic
Rapid viral evolution
20 min 34 sec
Jun 30, 2022
Dr. John Campbell
BA.5, immune escape Vaccines and previous infections are protective against severe disease Percentages of positives that were infected more than 90 days ago Progressively increasing Now, 12 % reinfections 3 months ago, 8% reinfections 6 months ago, 5% reinfections https://www.youtube.com/watch?v=TwQp3... R = 1.1 Up 27% on the week UK, 1 in 21 Scotland 1 in 15, highest ever rates Young people and young adults highest Will go up for a time, summer mixing, festivals Consistent with ONS data https://www.ons.gov.uk/peoplepopulati... One week ahead Hospital admissions up 37% List of covid symptoms Runny nose, 66% Sore throat, 65% Headache, 64% Persistent cough, 63% Fatigue, 62% Sneezing, 53% Hoarse, 44% Joint pains, 35% Fever, 31% Chills or shivers, 30% Muscle pains 29% Dizzy, 27% Brain fog, 24% Sore eyes, 22% Altered smell, 21% Lower back pain, 22% Swollen glands, 19% Skipped meals, 17% Chest pain, 15% BA.5 is milder than previous variants Still time off work Hospital admissions due to large numbers Official data UK https://coronavirus.data.gov.uk Coronavirus vaccines should be updated for fall https://www.fda.gov/advisory-committe... FDA advisory committee Deadline, vaccine formula for October, now BA.1 vaccine, in human tests for months Arnold Monto, FDA advisory committee We’re being asked, more or less, to have a crystal ball today New multi-strain vaccine, original and omicron Some wanted BA.4 and BA.5, others BA.1 Moderna, Novavax, Pfizer, each presented data to support their strategy Moderna, bivalent, for example, original version + BA.1 variant Pfizer BioNTech, only BA.1 Pfizer presented mouse data on BA.4 and BA.5 Novavax’s vaccine (not yet authorized in United States), additional doses of its existing vaccine could be protective ? will these new formulations apply to children without testing ? local or global Lyme disease