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Heliobas Disciple

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CDC Used Phone Location Data to Monitor Churches and Schools to Determine Whether Americans Followed Covid Lockdown Orders
By Cristina Laila
Published May 3, 2022 at 12:55pm

The Centers for Disease Control and Prevention used phone location data to track millions Americans in 2021.

The CDC monitored curfew zones, churches, schools, neighbor-to-neighbor visits and trips to pharmacies through SafeGraph, a controversial data broker.

The CDC purchased the phone data and used Covid-19 as an excuse to buy the data more quickly and in larger quantities according to documents exclusively obtained by Motherboard through a FOIA request.

The CDC used the data to determine whether Americans were complying with Covid lockdown orders.

Motherboard reported:

The documents reveal the expansive plan the CDC had last year to use location data from a highly controversial data broker. SafeGraph, the company the CDC paid $420,000 for access to one year of data to, includes Peter Thiel and the former head of Saudi intelligence among its investors. Google banned the company from the Play Store in June.​
The Centers for Disease Control and Prevention (CDC) bought access to location data harvested from tens of millions of phones in the United States to perform analysis of compliance with curfews, track patterns of people visiting K-12 schools, and specifically monitor the effectiveness of policy in the Navajo Nation, according to CDC documents obtained by Motherboard. The documents also show that although the CDC used COVID-19 as a reason to buy access to the data more quickly, it intended to use it for more general CDC purposes.​
The CDC used the data for monitoring curfews, with the documents saying that SafeGraph’s data “has been critical for ongoing response efforts, such as hourly monitoring of activity in curfew zones or detailed counts of visits to participating pharmacies for vaccine monitoring.” The documents date from 2021.​
Motherboard obtained the documents through a Freedom of Information Act (FOIA) request with the CDC.​
The documents contain a long list of what the CDC describes as 21 different “potential CDC use cases for data.” They include:​
    • "Track patterns of those visiting K-12 schools by the school and compare to 2019; compare with epi metrics [Environmental Performance Index] if possible.”
    • “Examination of the correlation of mobility patterns data and rise in COVID-19 cases […] Movement restrictions (Border closures, inter-regional and nigh curfews) to show compliance.”
    • “Examination of the effectiveness of public policy on [the] Navajo Nation.”

Read the full report by Motherboard here.
 

Heliobas Disciple

TB Fanatic
View: https://www.youtube.com/watch?v=Nn8Et_yG4Yc
Let it rip
19 min 3 sec
May 3, 2022
Dr. John Campbell

, seems to be what they are saying. Dr. Ashish K. Jha, White House, Covid-19 coordinator https://www.cdc.gov/coronavirus/2019-... https://www.nytimes.com/live/2022/04/... The new White House Covid czar says avoiding all virus infections isn’t the goal of U.S. pandemic policy. Relatively low number of new deaths, but still too high Hospitalizations, lowest point in the pandemic Rising number of cases, a promising inflection With such a contagious virus spreading, hard to ensure that no one gets Covid in America That’s not even a policy goal The goal of our policy should be: obviously minimize infections whenever possible, but to make sure people don’t get seriously ill we are going to see cases go up and go down during this pandemic as we head into the weeks, months and years ahead The more important reflections of progress, health care system strain, whether people are hospitalized with and dying from Covid-19 Paxlovid, push to reach the vulnerable Doctors are too hesitant to prescribe the drug https://www.fda.gov/media/155051/down... There are some people in this country who sometimes think that we can take a domestic-only approach to a global pandemic That’s not a thing. You can’t do that Increased contagion https://covid.cdc.gov/covid-data-trac... BA.2 68.1% BA.2.12.1 28.7% Dr. Janet Woodcock, FDA It’s hard to process what’s actually happening right now, which is, most people are going to get Covid What we need to do is make sure the hospitals can still function, transportation, other essential services are not disrupted while this happens England, 10 January and 3 February 2022 New antibody saliva test https://www.lshtm.ac.uk/newsevents/ne... 97% of secondary school pupils tested positive 46% vaccinated and tested positive for antibodies 51% unvaccinated and tested positive for antibodies China https://www.theguardian.com/world/202... https://www.youtube.com/watch?v=p5J1j... Beijing Cases, + 54 ban dining-in negative Covid tests to visit public spaces Labour Day holiday. Prepared 4,000 temporary hospital beds Shanghai Cases, + 10,700 New cases, among quarantined or restricted groups
 
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Heliobas Disciple

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Choice Quotes from Bill Gates’s New Book
By Jeffrey A. Tucker
May 3, 2022

Imagine yourself sidled up to a bar. A talkative guy sits down on the stool next to you. He has decided that there is one thing wrong with the world. It can be literally anything. Regardless, he has the solution.

It’s interesting and weird for a few minutes. But you gradually come to realize that he is actually crazy. His main point is wrong and so his solutions are wrong too. But the drinks are good, and he is buying. So you put up with it. In any case, you will forget the whole thing in the morning.

In the morning, however, you realize that he is one of the world’s richest men and he is pulling the strings of many of the world’s most powerful people.

Now you are alarmed.

In a nutshell, that’s what it’s like to read Bill Gates’s new book How to Prevent the Next Pandemic. The main theme is implied in the title. With enough money, intelligence, and power, along with technological know-how at the helm, the next pathogen to come along can be stopped in its tracks. Where the bug goes after that he never explains. Presumably it just disappears. Like a computer virus, it exists but doesn’t ruin your harddrive.

What are the historical examples of such a thing? There are none via avoidance, testing, contract tracing, and control of the human population. This theory of virus control – the notion that muscling the population makes a prevalent virus shrink into submission and disappear – is a completely new invention, the mechanization of a primitive instinct.

Smallpox occupies a unique position among infectious diseases as the only one affecting humans that has been eradicated. There are reasons for that: a stable pathogen, a great vaccine, and a hundred years of focused public health work. This happened not due to lockdowns but from the careful and patient application of traditional public-health principles.

Can that same experience be repeated in every case? It’s worth investigating and thinking about. The reason is that the attempt to crush a respiratory virus through universal avoidance could be worse than allowing endemicity to it to develop throughout the population.

Eradication is not the same thing as perpetual pathogenic avoidance. The former is great but the latter is deeply dangerous: the only thing more dangerous to human life than governments is a naive immune system. Gates’s plan, even if it had a chance of working which it does not, could create exactly that. Not to understand the difference is an egregious intellectual error.

The error here probably traces to Gates’s fundamental confusion. He doesn’t say this in the book but it becomes very apparent that he thinks a biological virus works just like a computer “virus.” He seems not to know that the application of this term to computing is purely metaphorical.

The goal of computer security is to block all viruses no matter what. Applying that same principle to human biology would create calamity. That’s because pathogens do not disappear when everyone complies with the rule of “stay home and stay safe.” They are still waiting out there, looking for vulnerable people to infect. With a virus like SARS-CoV2, this keeps happening until we reach herd immunity. The less exposed a population is to a mostly mild pathogen, the more
vulnerable they are in the future to more severe outcomes.

Please don’t get bored with this review because you already know this. It is taught to everyone in 9th grade biology class. And there’s no sense in repeating this here, much less explaining the basics of human immunology.

The point, sadly, is that Gates somehow avoided this knowledge his entire life. He wants to scrub the human body the way he worked to scrub the Windows operating system. It’s the kind of basic error anyone would make who has surrounded himself with sycophants for the better part of his career.

If you understand this one simple point about Gates’s thinking, you get the entire book. All that matters is avoidance. The more avoidance the better. There is no such thing as being too free of pathogenic exposure. To him, the single goal of all public health is to keep the population away from as many germs as possible.

So yes, I’m sorry to report that the entire book is a study in mysophobia, more worthy of study by a student of abnormal psychology than a public health official, much less a scientist. That no one has ever pointed this out to him is a disgrace. It’s the trouble with being so rich that you become uncriticizable.

The very rich can make for fascinating character studies. Not all but many. I’ve known a few and had the chance to get to know their thinking. Too often they conclude their own life successes are due to their extraordinary prowess and ability to depart from conventions, never pure luck or good intuition.

That’s partly correct but the realization can create an eccentric habit of mind. They can conclude that all known knowledge and conventions should be presumed to be wrong. If you believe this, you are often only a small step away from full-blown crankism. The history of phrenology, eugenics, and countless dietary cults proves that.

The danger here of course is that they can also exercise outsized influence over others due purely to the size of their bank accounts and their demand that everyone around them behave in ways that are insufferably obsequious. To be at such a dinner party with a person like this, having kissed the ring for hours, means breathing a huge sigh of relief once you are in the car headed home.

In any case, we all know that Gates is a main promoter and funder of lockdown ideology. It’s been going on for the better part of 15 years. No surprise that has gained converts to this view. But one might suppose that after the world calamity this ideology created, he would be rethinking things. Maybe he is just a bit. It’s hard to tell.

Here is what the book says.
  • The Chinese government had taken unprecedented safety measures to lock down Wuhan, the city where the virus emerged—schools and public places were closed, and citizens were issued permission cards that allowed them to leave their homes every other day for thirty minutes at a time.
  • During the first wave of COVID, Denmark and Norway implemented strict lockdowns early on (when fewer than thirty people in each country had been hospitalized), while the government of neighboring Sweden relied more on recommendations than requirements, keeping restaurants, bars, and gyms open and only encouraging but not requiring physical distancing. One study found that if Sweden’s neighbors had followed its lead instead of locking down stringently, Denmark would have had three times as many deaths as it did during the first wave, and Norway nine times as many as it did. Another study estimated that NPIs in six large countries, including the United States, prevented nearly half a billion COVID infections in the first few months of 2020 alone.
  • Even though lockdowns have clear benefits for public health, it’s not always clear whether in lower-income countries they are worth the sacrifice. In such places, closing down sectors of the economy can lead to acute hunger, drive people into extreme poverty, and increase deaths from other causes. If you’re a young adult and spend your day working outside—as many people in low-income countries do—COVID will not seem as scary as the possibility of not having enough food to feed your family.
  • The human suffering caused by these separations is incalculable, literally—no one can put a number on the pain of not being able to say goodbye in person. But the policy saved so many lives that it will be worth adopting again if the circumstances call for it.
  • Lockdowns are a great example. The evidence is clear that they reduce transmission, and that stricter lockdowns reduce transmission more than looser ones do. But they’re not equally effective everywhere, because not everyone is able to comply by staying in one place.
  • Lockdowns may not be necessary in places where the disease burden is modest. They’re also more effective in countries where residents have less of a voice in the country’s affairs, and the government is in a position to strictly enforce lockdowns and other mandates. What this all means is that there is no single ideal mix of NPIs that works equally well everywhere. Context matters, and protective measures need to be tailored for the places where they’ll be used.
  • This is good news, because NPIs are our most important tool in the early days of an outbreak. There’s no lab time required to put mask mandates in place (assuming we can provide the masks), figure out when to cancel big public events, or limit how many people can sit in a restaurant. (Though we will need to make sure that whatever NPIs we deploy are appropriate to the pathogen we’re trying to stop.)
  • The economy was bad when businesses shut down, but it could have been even worse if the virus had been allowed to run rampant and kill millions more people than it already had. By saving lives, lockdowns can make it possible to start the economic recovery sooner.
And here he adds a little graphic.

Screen-Shot-2022-05-03-at-12.09.52-PM.png

  • The pandemic forced us to rethink what is acceptable for many activities. Digital alternatives that were once viewed as inferior were suddenly seen as preferable.
  • I want to add a caveat to the idea that long-term school closures shouldn’t be necessary. That will be true if the next outbreak is one with a profile like COVID’s—in particular, one that rarely makes kids severely ill. But we have to be careful not to get caught fighting the last war. If a future pathogen is markedly different from COVID—if, for instance, its impact on children is a lot worse—then the risk/benefit calculus could change, and closing schools might be prudent. We’ll need to stay flexible and, as always, follow the data.
  • Also, not all overreactions—or apparent overreactions—are created equal. Closing borders, for example, did slow the spread of COVID in some regions. But border closures are a hammer that needs to be wielded very carefully. By cutting off trade and tourism, they can crater a country’s economy so badly that the cure becomes worse than the disease.
  • It’s stunning how little we know about superspreaders. What role does biology play? Are some people more prone to being a superspreader than others? There’s also certainly a behavioral component. Superspreaders seem not to pose more of a risk to small groups than other infected people do, but in crowded indoor public spaces, such as bars and restaurants, there’s a better chance that you’ll encounter one or more superspreaders, and they’ll have the opportunity to infect a lot of people. Superspreaders are one of the mysteries of disease transmission that needs a lot more study.
  • In the meantime, the six-foot rule is a good one to follow, unless it’s very difficult to maintain, such as in a classroom. People need clear, easily remembered guidelines. It is not a helpful public health message to say, “Keep your distance, but the exact distance depends on the situation, so it might be three feet, or six feet, or maybe more.”
  • The quick rollout of PCR tests and quarantine policies explains in large part why some countries, such as Australia, had dramatically fewer infections and excess deaths than others. Governments need to learn from these examples and figure out how they will ramp up testing very quickly—and give people an incentive to get tested by also offering treatment to anyone who tests positive and is at significant risk of severe disease.
  • This is a little hard to admit, because the power of inventing things is so central to my worldview, but it’s true: We may never devise a cheaper, more effective way to block the transmission of certain respiratory viruses than a piece of inexpensive material with a couple of elastic straps sewn onto it.
  • The real benefit comes with universal masking, where both people are double masking or improving the fit of their surgical masks: It reduces the risk of exposure by 96 percent. That’s an incredibly effective intervention that can be manufactured for just a few cents.
  • If everyone had masked up early on—and if the world had had enough supplies to meet the demand—it would have blunted the spread of COVID dramatically.
I’m not going to fact check the above simply because we do this every day on Brownstone. Suffice it to say that much of what he claims is unproven or completely false.

What matters here is the big picture. To me, he seems to be saying that in an ideal world, we would live with rolling lockdowns forever, on the say-so of experts in his pay. Indeed, he proposes the creation of a new division of the World Health Organization, staffed with 3,000 employees.

I call it the GERM—Global Epidemic Response and Mobilization—team, and the job of its people should be to wake up every day asking themselves the same questions: “Is the world ready for the next outbreak? What can we do to be better prepared?” They should be fully paid, regularly drilled, and prepared to mount a coordinated response to the next threat of a pandemic. The GERM team should have the ability to declare a pandemic and work with national governments and the World Bank to raise money for the response very quickly.

Just in case you think this is about helping sick people to get well, Gates corrects you: “You might have noticed one obvious activity that’s missing from GERM’s job description: treating patients. That’s by design.”

Oh.

Presumably, if we can ever claw our way back to traditional public health, we will also return to things like treating patients rather than brutalizing populations in the name of achieving what is not only impossible but also undesirable: the creation of a pathogen-free world.

This book deserves a more extensive critique, especially the claim that urbanization and travel make the world a dirtier and less healthy place, a view exactly aligned with Fauci’s own. The opposite is likely true but you have to have the subtle mind of Sunetra Gupta to understand why.

All that said, I’m glad Gates put pen to paper. Just like finding yourself sitting at a bar with a crazy person, such an experience can be very interesting, provided the drinks are flowing and he is picking up the tab. Just don’t put them in charge of anything. Otherwise, we will in fact lose all voice in public affairs, exactly as Gates seems to desire.

Thank you @BillGates for sending a copy of your new book. I fully agree that we must act on #COVID19’s lessons and innovate so that we can deliver swift, equitable health solutions to prevent the next pandemic. @gatesfoundation pic.twitter.com/E69PyBdgB9
— Tedros Adhanom Ghebreyesus (@DrTedros) April 15, 2022
 

Heliobas Disciple

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On What Basis Did Pfizer Claim 95%?
By Sonia Elijah
May 3, 2022

Buried within the FDA’s briefing document for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on December 10, 2020, for the Pfizer-BioNTech COVID-19 Vaccine- there is alarming data and a concerning issue which should be addressed.

Firstly, it’s worth pointing out that Pfizer used a ‘central laboratory’ (see page 13 of the document) of its choice, to confirm COVID-19 cases using a PCR test. ‘If, at any time, a participant develops acute respiratory illness, an illness visit occurs. Assessments for illness visits include a nasal (mid-turbinate) swab, which is tested at a central laboratory using a reverse transcription-polymerase chain reaction (RT-PCR) test.’

I’ve previously written an in-depth investigative report on the PCR test. The cycle threshold (CT) value used, greatly impacts the outcome of a test.

According to a study by Jaafar et al., the authors found that when running PCR tests with 35 cycles or more – the accuracy dropped to 3%, meaning up to 97 % of positive results could be false positives.

There is no information given on the CT value used at this ‘central laboratory.’

Given what we know, that Pfizer’s pivotal clinical trial was a de facto, unblinded one – their unblinding guidelines are clearly stated within their own study protocol and for potential COVID-19 cases, the trial site staff were immediately unblinded. This means, trial staff knew whether a particular symptomatic participant had the placebo or the vaccine.

Pfizer’s widely touted vaccine efficacy rate of 95%, arose from PCR test results generated from this central lab. The unblinding of clinical trials leads to strong bias and a severe loss of data integrity, so potentially the CTs could have been ramped up for the unvaccinated (placebo) participants suspected of having COVID-19, leading to almost guaranteed Covid positive results. For those who had the vaccine, the CT value used could have been much less, making it more likely to generate a negative result.

On page 24 of the document, the results showing 95% VE (vaccine efficacy) for the vaccine can be found below.

pfizer2-800x415.png


The 95% VE (vaccine efficacy) arises from the 8 confirmed Covid cases from the vaccinated group (from at least 7 days after Dose 2) compared to 162 from the placebo group. These two data points are essentially what Pfizer hang their hat on to prove their vaccine was a success.

This is the data that the FDA and other regulatory bodies around the world relied upon to grant EUA (Emergency Use Authorisation) for the Pfizer-BioNTech COVID-19 vaccine and for billions of doses to be shipped around the world with some countries enforcing highly controversial draconian vaccine mandates.

A key section buried within this document, which alludes to possibly the real VE at that time, is the following damning data below (found on page 42).

https-bucketeer-e05bbc84-baa3-437e-9518-adb32be77984.s3.amazonaws.com-public-images-d6ab220b-634b-4932-a060-453381e25bc8_1538x162-800x84.png


These were people showing actual symptoms. If you calculate the VE from these numbers, it’s a staggeringly low 12%. VE is calculated by dividing the difference between the case numbers in the placebo and vaccine groups, by the case number in the placebo group x 100 = VE of 12 %

This is a vast climb down from the 95% VE generated by easily manipulated PCR tests, conducted in a central lab chosen by Pfizer. What’s even more alarming, is that this data was known almost a year and a half ago, by the FDA themselves.

Republished from Substack
 

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Hidden benefit: Facemasks may reduce severity of COVID-19 and pressure on health systems, researchers find
by McMaster University
May 4. 2022

McMaster University researchers who study the dynamics of infectious disease transmission have investigated the population-level consequences of a potentially significant––and unobvious––benefit of wearing masks.

For the study, the researchers developed a model to investigate COVID-19 "variolation"––an incidental but potentially beneficial form of immunization achieved by inhaling smaller doses of the virus than would be inhaled without a mask.

A form of variolation was deliberately used in the 18th century to control smallpox. It involved infecting a healthy individual with small doses of the live virus taken from a dried scab or pustule of a person infected with smallpox.

Variolated individuals often experienced far less severe disease than those who were infected naturally, but nevertheless were immune to further infection.

Early in the COVID-19 pandemic, it was suggested that people who were infected while masked might experience mild illness and could be considered "variolated".

The new mathematical model allows researchers to estimate the potential impact of this effect on the population as a whole.

"If the variolation effect is strong, then the number of severe cases, and consequently pressure on health-care systems, could be substantially reduced if most people wear masks –– even if masks don't prevent them from being infected," says senior author David Earn, Faculty of Science Research Chair in Mathematical Epidemiology and Professor of Mathematics at McMaster and Canada's Global Nexus for Pandemics & Biological Threats.

The model suggests effective masking could drastically slow the spread of COVID-19, reduce the magnitude of the pandemic peak by "flattening the curve," and reduce the prevalence of severe cases from that point forward.

"Our qualitative findings are that the value of masking is under-appreciated in a public health context, especially as COVID-19 transitions from pandemic to endemic, and we should think twice about getting rid of mask mandates," says Zachary Levine, lead author of the study and a former undergraduate in the Arts and Science program at McMaster. Levine is now a graduate student at the Weizmann Institute of Science in Israel.

"As we prepare for the next pandemic, understanding how different infection control strategies could affect disease dynamics could help us understand which policies are worth pursuing," he says.

The results of this research are potentially applicable to any respiratory infection that is transmitted by inhaling infectious particles. For future COVID variants or other infectious diseases, the model can be used to study how increasing the proportion of mild cases affects the overall dynamics of disease spread.

"If wearing a mask protects you in addition to those in the room around you, it could also have significant impacts for everyone who may not be in the room," says Levine.

The study was published online in the Journal of the Royal Society Interface.
 

Heliobas Disciple

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Binding efficiency of SARS-CoV-2 virus can withstand large physical forces
by Utrecht University Faculty of Science
May 3, 2022

A team of biophysicists reports that SARS-CoV-2 can withstand large physical forces, which could be one of the reasons for its success. In the scientific journal PNAS, the researchers, led by Prof. Jan Lipfert, who recently joined Utrecht University, presented their method and suggested the finding could lead to the formulation of drugs designed to prevent the coronavirus from binding.

Breathing, coughing and sneezing

The first, critical step in a coronavirus infection is when the virus attaches to a receptor on the human cell surface with its spike protein. Most corona infections begin in the mouth and throat, where SARS coronaviruses bind to these so-called ACE2 receptor before introducing their genetic material into cells, allowing the infection to run its course.

After initial binding to the receptor, however, the viruses are exposed to numerous forces: breathing, coughing and sneezing generate air currents through the mouth and nose and can dislodge the viruses from potential host cells. From the perspective of the virus, it is essential that their binding to ACE2 can withstand external forces to enable successful infections.

Withstand twice as much force

Jan Lipfert, who was appointed professor in Biophysics at Utrecht University a few months ago, is an expert in force spectroscopy, a collective term for techniques that can be used to study the behavior of (bio)molecules under force. In his lab in Munich, Lipfert and his colleagues found that SARS-CoV-2 can withstand twice as much force as SARS-CoV-1, the virus that caused a much smaller pandemic in 2002–2003. "This finding explains why SARS-CoV-2, in contrast to SARS-CoV-1, can also affect the upper respiratory tract, where turbulent air currents generate higher forces than in the deep lungs," says Lipfert.

This difference is thought to have contributed to the very different course that the 2002–2003 pandemic took, compared to the current pandemic. Lipfert: "Infections in the deep lungs with the old SARS-CoV-1 caused patients to become very sick more quickly, but that made it easier to isolate them and thus stop the spread of the virus."

Pull on the spike proteins

Although the binding success of a virus is mostly studied in the light of biochemistry, Lipfert focuses on the role of force stability. "First, we used an atomic force microscope, AFM for short, to pull on the proteins, a method that can apply high forces and perform fast measurements. In parallel, we employed so-called magnetic tweezers, which are extremely sensitive and can resolve very small forces. Using these methods, we imitated the forces in the mouth and throat and analyzed which of them are necessary to separate the virus from its binding partner. We were able to cover the entire physiologically relevant force range."

Currently, the team is using the approach to look at the variants of the corona virus. "Corona research moves quickly. We are now already studying force stabilities of the more recent variants of SARS-CoV-2. This might turn out to be part of the answer to the question why omicron is so much more contagious than delta. And force stability might even lead to help predict future variants of concern."
 

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Catching COVID-19 during pregnancy increases risk of hospitalization, premature birth, study finds
by University of British Columbia
May 3, 2022

1651656084954.jpeg

Adverse Maternal Outcomes Associated With SARS-CoV-2 Diagnosis in Pregnancy From March 1, 2020, to October 31, 2021 (N = 6012). Points are offset a small amount along the x-axis for visualization. Whiskers show 95% CI from binomial tests using a χ2 approximation. Eight completed pregnancies with missing dates are not included. Credit: JAMA (2022). DOI: 10.1001/jama.2022.5906

As Canada faces a sixth wave of COVID-19 infections, researchers at the UBC faculty of medicine are urging people who are pregnant to remain vigilant based on data from Canada's first national, peer-reviewed study on COVID-19 in pregnancy.

The findings, published today in JAMA, show that pregnant people who catch COVID-19 are at greater risk of being hospitalized, being admitted to intensive care units (ICUs) and experiencing an early birth.

"Despite the easing of many restrictions across Canada, COVID-19 is still with us and people who are unvaccinated and pregnant remain particularly vulnerable to adverse outcomes," says Dr. Deborah Money (she/her), a professor in UBC's department of obstetrics and gynecology who is leading the national research project.

"It is important that pregnant people consider the increased risk and take appropriate steps to protect themselves and their infant by getting vaccinated, getting boosted and avoiding exposure to COVID-19 where possible."

Understanding the impacts of COVID-19 on pregnancy

In March 2020, Dr. Money launched the CANCOVID-Preg research program in collaboration with researchers across the country and with support from the Public Health Agency of Canada and the Canadian Institutes for Health Research.

Since then, the team has been collecting and analyzing data from six Canadian provinces to understand how COVID-19 impacts pregnancy and pregnant individuals.

"When we started out there were very limited data on COVID-19 in pregnancy. After all, we were dealing with a new virus," adds Dr. Money. "We knew we needed to get a better understanding of what happens when someone gets sick with COVID-19 during pregnancy and what the impacts are on the baby and the parent."

As of Oct. 31, 2021, there had been a total of 8,786 recorded cases of COVID-19 in pregnancy in Canada. The researchers analyzed maternal and pregnancy outcomes from 6,012 of these cases, comparing the results with non-pregnant women and with pregnant people who did not contract COVID-19.

"We started accumulating data and it quickly became clear that we were seeing an increase in complications among pregnant women who contracted COVID-19," Dr. Money says.

Increased risk of hospitalization, ICU admission

Among the 6,012 cases of COVID-19 in pregnancy, 466 (7.75%) required hospitalization and 121 (2.01%) were admitted to an ICU.

"It's concerning when you compare these numbers to the rates among non-pregnant individuals," explains Dr. Elisabeth McClymont (she/her), a UBC postdoctoral fellow and first author of the study. "Overall, people who are pregnant are 2.65 times more likely to require hospitalization and 5.46 times more likely to be admitted to ICU than non-pregnant individuals."

According to the study, this risk increased with age, pre-existing high blood pressure and if individuals were further along in their pregnancy at the time of diagnosis.

The good news, say the researchers, is that none of the patients who received two vaccine doses experienced any adverse maternal outcomes.

"Vaccination continues to be safe during pregnancy and the most effective way for people who are pregnant to protect themselves and their baby," adds Dr. McClymont.

Increased risk of early labor

The researchers also looked at whether or not COVID-19 infections led to an increase in adverse pregnancy outcomes. While the rates of stillbirth did not increase significantly among COVID-19 affected pregnancies, the study did find that women who contracted COVID-19 were more likely to experience preterm birth.

Overall, the rate of preterm birth (before 37 weeks of pregnancy) was 11.1% among COVID-19-affected pregnancies, compared to only 6.8% among those that were unaffected. This elevated risk was present even for mild cases of COVID-19 that did not require hospitalization.

"Preterm births can result in serious and lifelong impacts on the infant," says Dr. McClymont. "Our results emphasize the importance of preventative measures, such as vaccination, that can help reduce COVID-19 infection among pregnant people."

Going forward, the research team will be looking more closely at infants born to mothers with COVID-19, seeking to understand if there are health impacts over the short and long term.
 

Heliobas Disciple

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Vaccine Shedding Finally Proven!
Statistically Significant Vaccine Shedding from Parents to Children
Igor Chudov
May 2

Do vaccinated people shed their vaccine byproducts to us? We definitely, for sure, knew that vaccine shedding was not a thing, because “health experts and fact checkers” told us so. And we “believe science” and our “health experts”. Right?




Except that it is WRONG and vaccine shedding has just been proven by science!

Even I believed that there was no plausible mechanism for vaccine shedding. I thought that it was a baseless conspiracy theory. Stupid me. It turned out that I WAS WRONG and vaccine shedding is real and can be measured.

A study “Evidence for Aerosol Transfer of SARS-CoV2-specific Humoral Immunity” was just released.

Evaluation of samples in this fashion revealed that high intranasal IgG in vaccinated parents was significantly associated (p-value = 0.01) with a 0.38 increase in the log transformed intranasal IgG gMFIs within a child from the same household (Fig 1F).



Let me try to explain it. First, these scientists from the University of Colorado looked at face masks, worn by vaccinated health care workers. They found that those workers shed antibodies generated by vaccination, and some antibodies got trapped in the masks and could be detected. This means that vaccinated people are literally “shedding” vaccine-caused antibodies.

Interested in that, scientists looked further: they compared unvaccinated children living with unvaccinated parents, to similarly unvaccinated children, but living with vaccinated parents.

It turned out that vaxxed parents actively shed vaccine-produced particles onto their children so that the kids acquired “humoral immunity” following shedding from their parents! Not only was this finding evident in the data, it actually was STRONGLY statistically significant with p-value of 0.01! This means that this was not a chance finding.

It remains to be explained WHY children have intranasal IgG. The authors seem to think that it is because of antibody shedding via droplets. In other words, they seem to propose that what is transferred is IgG itself in saliva droplets. They may be right. That said, there is a possibility that children DEVELOP intranasal IgG because other vaccine byproducts or exosomes are being shed.

It could even be due to lipid mRNA nanoparticles themselves shed and being transferred via saliva, like a virus. In fact, considering two replies to this article that I quoted at the bottom, mRNA lipid nanoparticle shedding is most likely. Why? Because the responders report experiencing STRONG IMMUNE REACTIONS.

Such byproducts would be CAUSING intranasal IgG in children as an immune reaction in children, rather than those IgGs being essentially mechanically spat from parents onto their children.

The article, while very interesting, is only the first step in researching vaccine shedding and I hope that further light will be shed (pun intended) on this phenomenon!

The authors, possibly in hopes of getting their article approved by science censors, call it a good thing:

Our results suggest that aerosol transmission of antibodies may also contribute to host protection and represent an entirely unrecognized mechanism by which passive immune protection may be communicated. Whether antibody transfer mediates host protection will be a function of exposure, but it seems reasonable to suggest, all things being equal, that any amount of antibody transfer would prove useful to the recipient host.

I am not sure if I can call it a good thing myself. Antibodies or mRNA nanoparticles from vaccines NOT approved by the FDA for children are being shed from parents to children, without consent or knowledge of either parents, or children. All of this is followed by denials by authorities.

Do you think that it is a good thing?

Please share this article widely!


P.S. Some amazing comments added here:



 

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Regulatory scientists are quiet about EUA, kids vax, Paxlovid and boosters
High standards for Aduhelm, but indifference to Paxlovid-- Why?
Vinay Prasad
9 hr ago

Many scientists made a career fighting for better regulatory standards. Strangely, when it comes to the regulatory policy around COVID-19, they are dead quiet.

First, consider that EUA ( emergency use authorization ) is like accelerated approval. Both require lower levels of evidence, and are predicated on the fact that we're dealing with a situation that is dire, with few available options. That's the justification for lower standards, including acceptance of surrogates.

Next, consider that COVID-19 is a life-threatening illness in an older person, for instance someone over the age of 80. For an older person, it rivals cancer or heart disease.

But also consider that COVID-19 is a flu-like illness for most children, particularly in the era of Omicron. It would be incorrect to say children have ever faced an 'emergency'.

Now think about what regulatory experts have said for years. We should be cautious with accelerated approval. We should use it sparingly, and when appropriate. We can't use accelerated approval for high blood pressure.

It's naturally follows from this logic that the use of EUA for kids was unjustified. There was no emergency in those ages. The IFR was always comparable with flu. The appropriate regulatory pathway was biological licensing authorization.

However, with the exception of a single article that I co-authored in the BMJ, I'm not aware of any one making this case.

Regulatory experts have told us for year that if outcomes are generally favorable, you need a very large randomized control trial to show a benefit. You can't use a surrogate endpoint. They say, you have to use a measure of what matters to people. This means we should not accept disease-free survival, as it is an unreliable surrogate for adjuvant breast cancer.

But now think of boosting a 20-year-old man. Antibody titers are also an unreliable surrogate endpoint. Boosting 20-year-olds should not come under the auspices of an EUA. You should do a very large randomized trial to show it has a benefit. And if you can't run the trial because the sample size is too large that tells you something about how marginal the effect size is.

Think about what regulatory experts said about aducanumab. They said that only 6% of all Alzheimer's patients would be eligible for the trial. Therefore, we should be careful about generalizing.

Similarly, take Paxlovid. The only trials that have been published to support its use are in unvaccinated people. There are zero trial data published for vaccinated people. And yet the majority of the uses in vaccinated people.

Why are the experts who say you can't extrapolate aducanumab to all's Alzheimer's patients not saying you can't extrapolate Paxlovid to all vaccinated people?

Why are those who say accelerated approval is abused not saying that EUA authority is abused when you move to children, who face thousandfold less times the risk?

Why are the same people who say we need large randomized trials for clinical outcomes for blood pressure pills dead silent on the question of boosting adolescents?

There are at least 3 possible reasons:

Number one. They have not made the connection between the same principles in their mind. This explanation should be rejected. Because you would have to be quite dense to not see the parallels.

Number two. They think that it is a stronger argumentative position to press the issue in the world of non COVID-19 drugs than COVID-19 drugs. This is the great blunder of their thinking. When you push for the equal application of rational principles, you must push for the equal application of rational principles. If you think you can omit or make sacrosanct some category, then you are irrational. And your opponents can rightly argue that their categories should be exempted.

Why should cancer have a higher standard than COVID?

If you want to persuade people on issues, you won't persuade them if you don't issue principles. Consistency and clarity hallmarks of clear thinking.

Number three: They are scared to voice their opinion on COVID-19 issues because they are afraid of the mob. Quite possibly, this is it. And this is likely paired with the fact that it is to there career benefit to not comment on issues outside their perceived scope. And thus they can go to conferences for another 40 years saying the same thing they've always said without any progress or advancement. Or, as a friend of mine likes to say, no new ideas.

I'm fear the right answer is number three. Even though most of these people run large groups or have tenure. They still are thinking of themselves.

And I think it has logical consequences. It's the reason why people don't want to be in the academy. You don't have the freedom, or the incentive to fight when it actually matters. You labor under a curse. You can't speak of the things that truly matter, when they matter. Your focus is narcissistic, and you will not accomplish any meaningful goals. And we will all fail together. Because regulatory science is just going to get worse and worse. And the industry is going to take advantage of the crack we have shown in our foundation.
 

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Did Moderna Trial Data Predict ‘Pandemic of the Vaccinated?’
A new study based on Moderna’s Phase 3 clinical trial data suggests recipients of Moderna’s COVID-19 vaccine may be more likely to suffer repeated infections, perhaps indefinitely.
By Madhava Setty, M.D.
05/04/22

A new study suggests recipients of Moderna’s COVID-19 vaccine may be more likely to suffer repeated infections, perhaps indefinitely.

The study, still in preprint, found participants in Moderna’s adult trial who received the vaccine, and later were exposed to the virus, did not generate antibodies to a key component of the virus as often as did those in the placebo group.

The authors’ findings, which are corroborated by U.K. data that demonstrate the rates of infection are significantly higher in the vaccinated, suggest Moderna knew of this safety signal in 2020 when the vaccine maker was conducting its trials.

The authors of “Anti-nucleocapsid antibodies following SARS-CoV-2 infection in the blinded phase of the mRNA-1273 Covid-19 vaccine efficacy clinical trial“ wrote:

“Among participants with PCR-confirmed Covid-19 illness, seroconversion to anti-N Abs at a median follow up of 53 days post diagnosis occurred in 21/52 (40%) of the mRNA-1273 vaccine recipients vs. 605/648 (93%) of the placebo recipients (p < 0.001).”
Vaccinated participants in the trial who developed breakthrough COVID-19 — meaning they received a positive PCR test — mounted an antibody response to the nucleocapsid portion of the SARS-CoV-2 virus less often than did placebo recipients who tested positive for the virus.

The difference was statistically significant, leading the authors to conclude:

“Vaccination status should be considered when interpreting seroprevalence and seropositivity data based solely on anti-N Ab testing.
“As a marker of recent infection, anti-N Abs may have lower sensitivity in mRNA-1273-vaccinated persons who become infected.”
In other words, the authors found that using the presence of anti-nucleocapsid (anti-N) antibodies to determine whether a person was exposed to SARS-CoV-2 will miss some infections. Thus, the sensitivity of this kind of test, when applied to vaccinated individuals, is not ideal.

However, there are more important implications of these findings, as Igor Chudov and others were quick to recognize.
Specifically, the study implies that the reduced ability of a vaccinated individual to produce antibodies to other portions of the virus may lead to a greater risk of future infections in the vaccinated compared to the unvaccinated.

It is important to note that this is not just another argument for the superiority of natural immunity.

Rather, this is evidence suggesting that even after a vaccinated person has a breakthrough infection, that individual still does not acquire the same level of protection against subsequent exposures that an unvaccinated person acquires.

This is a troubling finding, and something investigators conducting the Moderna vaccine trial likely knew in 2020.

Let’s establish some background facts:
  • Anti-nucleocapsid antibodies are antibodies specific to the nucleocapsid portion of the SARS-CoV-2 virus, the virus responsible for COVID-19.
  • One method of determining whether an individual has been exposed to the virus (recently or in the past) is by detecting antibodies specific to the virus in the person’s serum.
  • Because those who have been vaccinated will, ostensibly, have anti-spike-protein antibodies, using anti-spike levels to diagnose prior or recent infection is impossible in those people.
    However the presence of anti-nucleocapsid antibodies after exposure should, in theory, be unaffected by vaccination status.
  • Though the presence of an anti-N antibody is not necessarily indicative of immunity, having a broad set of antibodies to different components of the virus offers more robust protection than having antibodies to a single component, e.g. the spike protein.
    This is one reason natural immunity is superior to mRNA vaccine-mediated immunity.
  • The paper does not offer any new findings. Instead it presents an analysis of what should have already been known from Moderna’s vaccine trial.
Breakthrough infections result in N-antibody production less often than in primary infection

Moderna enrolled more than 30,000 subjects in its trial, randomizing them equally to the vaccine or placebo.

At the end of the initial observation period, 13 times more placebo recipients contracted COVID-19, allowing the investigators to boast a Vaccine Efficacy (VE) of 93.2%.

The U.S. Food and Drug Administration (FDA) subsequently authorized the vaccine for emergency use. The rest is history.
This recent study examined the presence or absence of anti-nucleocapsid antibodies in all trial participants who contracted COVID-19, based on a positive PCR test, during the trial period.

As stated earlier, the placebo recipients produced anti-N antibodies more than twice as often as their counterparts who were vaccinated. (Chudov offers a good explanation of the significance of anti-N antibodies here.)

This is a puzzling finding. Why would vaccination suppress a person’s ability to produce antibodies to different parts of the virus when exposed to the entire virus?

One possibility is that if the vaccine is protective, viral loads will be lower, leading to fewer seroconversions.

However, this study also found that at any given viral load, the unvaccinated produced a larger anti-N response than the vaccinated:

unvaccinated anti-N response


The plot on the left (A) shows the number of placebo and vaccine recipients who seroconverted after exposure to SARS-Co-V2 at varying levels of viral copies. We can see that regardless of vaccination status, lower viral copy numbers result in fewer seroconversions than at higher viral copy numbers.

But there is a significant difference between the vaccinated and placebo recipients.

This is demonstrated in Plot B, which shows that for any given viral copy number, the placebo recipients were significantly more likely to seroconvert. The difference is most prominent at lower viral copy numbers.

This is not a spurious finding. The UK Health Security Agency publishes weekly surveillance data and monitors the levels of anti-N antibodies in their blood donors.

They noted the lower levels of these antibodies in vaccinated individuals who had breakthrough infections. However, they attributed this lower level to the protective benefit of the vaccine.

According to a March 22 report by the U.K. agency:

“These lower anti N responses in individuals with breakthrough infections (post-vaccination) compared to primary infections likely reflect the shorter and milder infections in these patients.”

Though vaccination may for some time decrease severity of the disease, “shorter and milder” (less severe) infections are associated with lower viral load.

As the data above demonstrate, the vaccinated have a lower anti-N antibody conversion rate than the unvaccinated at all levels of viral load.

This is one of the most significant findings of the study because it overturns the heretofore unchallenged idea that decreased seroconversion in the vaccinated is due to less severe infection in this population — which is a benefit provided by the vaccine.

However, this new study shows that even at low viral loads, the unvaccinated are more likely to seroconvert than those who are vaccinated.

In fact, the difference in seroconversion rates is the greatest at lowest viral loads.

The decrease in conversion rates is not a result of a benefit from the vaccine. It is a consequence of it.

Once vaccinated, there may be no going back

The authors also uncovered another important finding: Participants in the Moderna trial who were PCR-positive and seronegative at baseline, prior to inoculation with vaccine or placebo, eventually seroconverted equally — independent of whether they received the vaccine or placebo.

This was also true in participants who received only one dose.

This means that vaccination status at the time of exposure is predictive of seroconversion rate in the future, and the effect is dose-dependent.

Whether or not seroconversion results in more robust immunity is yet to be determined. However, data from the U.K. and elsewhere suggest lower conversion rates may explain why infection rates are higher in their vaccinated population. This data is presented below.

Will repeated bouts of COVID-19 eventually lead to seroconversion in the vaccinated? The study could not answer this question.

More importantly, how will regular boosting affect seroconversion rates as time goes on? This is another important question yet to be answered.

There is no question that vaccine-mediated immunity against COVID-19 wanes and is waning faster as time goes on. The Centers for Disease Control and Prevention (CDC) recommended a first booster after five months and a second after only four.

Israeli data surrounding the effectiveness of a second booster demonstrated that effectiveness in preventing “severe disease” (not hospitalization) fell to just above 50% within seven weeks.

If a third booster is offered, it will probably be recommended sooner than four months after the second, based on this disappointing data.

There is more disappointing data coming from the U.K. In their last weekly surveillance report, which includes case rates between the unvaccinated and boosted citizens, the Health Security Agency offered this disquieting table:

unadjusted rates covid


The first two columns demonstrate that the COVID-19 case rate in the boosted was three to four times higher than in the unvaccinated in all ages except for under 18.

The agency warns us to interpret these numbers with caution. Vaccinated people may demonstrate less cautious behavior than the unvaccinated. And there is also no risk stratification based on comorbidities.

However, the chart does account for the biggest factor — age.

[continued next post]
 

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[continued]

So what could explain such a large increase in infection rates among the boosted?

Interestingly, the authors further warn that the unvaccinated may have contracted COVID-19 prior to the observation period — in other words, they may have acquired natural immunity previously, giving them added protection.

But shouldn’t this apply to the boosted as well? It should, but the authors don’t mention that.

Because it is not mentioned, we can safely say the authors assume the unvaccinated are more likely than the boosted to have succumbed to a previous infection. Thus, there will be more people in the unvaccinated pool enjoying the advantage of natural immunity.

But their own data tells the opposite story. The boosted are more likely to contract the disease — by a factor of 3 to 4.
How do we know whether the larger infection rates in the boosted are due to more robust immunity in the unvaccinated because of prior infection or due to an immune deficiency in the boosted?

The question can be definitively answered by examining the trend of infection rates. Here is the equivalent table from two months earlier:

covid infection trends


There is still a greater infection rate among the boosted, but it is only two to three times higher. If the authors’ hypothesis was correct, the more recent data should have shown less of a difference, not more.

The growing spread between the vaccinated and unvaccinated is a trend that has been in effect for months. Curious readers can examine the data for themselves here.

If anything, their data support the finding that the decreased seroconversion rates in the vaccinated may be causing a greater risk of repeated infections.

However, without knowing how many of the infections in the boosted are second or third bouts of COVID-19, we can only speculate.

The U.K. data are not outliers. Latest data from Walgreens further demonstrate the boosted are getting infected at nearly twice the rate of the unvaccinated.

Unfortunately, the Walgreens data also do not specify how many of these infections are reinfections.

How many people have already been exposed or infected?

The CDC on April 29 released its latest Morbidity and Mortality Weekly Report (MMWR) titled, “Seroprevalence of Infection-Induced SARS-CoV-2 Antibodies — United States, September 2021–February 2022.”

In its report, the CDC estimates the percentage of the population that has been previously infected with SARS-CoV-2. The agency determined this through a seroprevalence study looking for anti-N antibodies in serum collected from more than 45,000 people from 52 different jurisdictions.

Based on the percentage of anti-N antibodies in serum samples, estimates are that 57.7% of the U.S. population has been exposed to SARS-CoV-2 as of February.

However, this estimate does not consider the fact that the vaccinated do not seroconvert at the same rate as those who are unvaccinated.

This percentage is significantly higher than COVID-19 cases that have been reported to date. As of April 24, there were approximately 70.5 million cases, which amounts to only 21.4% of the population (estimated at 330 million).

The reason for this difference is that seroprevalence studies will pick up all cases and exposures, including in the asymptomatic. In that sense, seroprevalence studies will offer a more accurate estimate of the portion of the population that has been exposed.

Notably, seroprevalence varied significantly between age groups: 75.2% of sera from children ages 0-11 were positive for anti-N antibodies, compared to 33.2% in people 65 and older.

The CDC did not report on the seroprevalence by vaccination status. Instead the agency acknowledged its findings “might underestimate the cumulative number of SARS-CoV-2 infections because infections after vaccination might result in lower anti-N titers.”

Interestingly, the CDC authors cited the very same preprint study discussed above to explain this possibility.

What does this mean for children?

Though the CDC inconveniently chose not to report seroconversion rates in the vaccinated versus the unvaccinated, we can still make some reasonable and important estimations from this weekly report based on our recent understanding of seroconversion rates in the vaccinated.

As stated above, the CDC reported that serum samples drawn from children ages 11 and under tested positive for anti-N antibodies 75.2% of the time.

A central question is, what portion of the seropositive samples were found in the unvaccinated?

Though the FDA does not consider seropositivity a surrogate for immunity, knowing whether or not a child has been exposed to SARS-CoV-2 will be useful when weighing the risk versus benefit of vaccination.

Vaccine uptake is only 28.6% in ages 5 to 11. Children under 5 are ineligible for vaccination. If we assume that few, if any, children under 5 received the COVID-19 vaccine, only 16.4% of children under 12 have been vaccinated based on population data in that age group.

If 16.4% of children under 12 have been vaccinated, the unvaccinated outnumber the vaccinated by approximately 5 to 1. If the vaccinated seroconvert as frequently as the unvaccinated we would expect that one-sixth of the seropositives came from the vaccinated and five-sixths came from the unvaccinated.

However, data from the Moderna trial demonstrate that the vaccinated convert only 40% of the time compared to 93% in the unvaccinated. The vaccinated seroconvert (40/93) = 0.43 times as often as the unvaccinated.

We can then say that the ratio of vaccinated seropositives to unvaccinated seropositives is 0.43 to 5, or 1 to 11.63. This means that 1/12.63, or 7.9% of the seropositives are from vaccinated children.

The remaining 92.1% (11.63/12.63) are from unvaccinated children.

Thus if 75.2% of sera from children are testing positive for anti-N antibodies, 68.4% (75.2% x 0.921) of unvaccinated children have already seroconverted.

There are potential errors in this calculation:
  • The samples used in the survey may not be representative of the population with regard to vaccination status.
  • Seroconversion rates among the vaccinated may be higher than what was found in the moderna trial.
  • Seroconversion rates may be different in people vaccinated with a different vaccine than Moderna (Pfizer, in this case).
  • Seroconversion rates may be different in children.
Nevertheless, we can say with reasonable confidence that a substantial proportion of unvaccinated children have already been exposed to SARS-CoV-2.

With known risks of adverse events that now include a reduced ability to generate anti-N antibodies after exposure, there is no justification for requiring or even recommending the vaccine to children without assessing their antibody levels first.

Though the FDA continues to maintain that antibody levels are not necessarily indicative of immunity, it nonetheless granted Emergency Use Authorization (EUA) for Pfizer’s product in children ages 5 to 11 based on antibody responses after vaccination.

Summary
Sixteen months have passed since the FDA granted Moderna EUA for its vaccine. More than 200 million doses of this product have been given to people in the U.S. alone.

Did the vaccine manufacturer know in 2020 that its product could potentially impede recipients from mounting broad antibody responses after exposure to SARS-CoV-2?

Does this potential adverse effect occur in other mRNA COVID-19 “vaccines”?

Vaccinated individuals are at increased risk for contracting COVID-19 compared to the unvaccinated.

But what happens after a breakthrough infection? Have these products permanently mitigated our ability to fight off future SARS-CoV-2 infections?

With the majority of children having been already exposed, is there any reason to inoculate even one healthy child before these questions are answered definitively?

Yet the vaccine manufacturer is pushing the FDA to authorize its product for children under age 6.

If these inoculations prevent people from acquiring proper immunity after exposure, they are, in fact, creating a pandemic of the vaccinated.

Less than 10 months ago, CDC Director Dr. Rochelle Walensky warned, “There is a clear message that is coming through. This is becoming a pandemic of the unvaccinated.”

Which is more ironic? Her statement? Or that the statement is coming from an organization called the Centers for Disease Control and Prevention?

The views and opinions expressed in this article are those of the authors and do not necessarily reflect the views of Children's Health Defense.
 

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Pfizer hopes to give FDA vaccine data for children under five by early June
Rival Moderna has already submitted data to the FDA.
By Sophie Mann
Updated: May 4, 2022 - 12:29pm

Pharmaceutical giant Pfizer hopes by late this month or early June to share with U.S. regulators that its COVID-19 vaccine works in children younger than five.

The company is testing three extra-small doses of the vaccine in that age group. Two shots of the vaccine previously did not prove strong enough. Results were initially expected last month, but the company revised its timeline this week during its quarterly earnings call.

Presently, in the U.S., only children age 5 and older can be vaccinated with Pfizer. An estimated 18 million young children have been left unvaccinated as a result.

Moderna hopes to beat Pfizer to market with its vaccine rollout for youngsters. Last week, the company filed data with the Food and Drug Administration that it hopes will prove two of its low-dose shots will be effective in children younger than five.

The agency has currently set dates in June to publicly review data on COVID vaccines for children below age 5 from both or either company.
 

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FDA Investigating Reports of COVID Relapses Following Use of Pfizer’s Pill
By Zachary Stieber
May 4, 2022

The U.S. Food and Drug Administration (FDA) is investigating reports of relapses among people who took Pfizer’s COVID-19 pill.

The FDA “is evaluating the reports of viral load rebound after completing paxlovid treatment and will share recommendations if appropriate,” an agency spokesperson told The Epoch Times in an email.

In a recent preprint case report, Veterans Affairs researchers reported that a 71-year-old male who took the pill, also known as nirmatrelvir, experienced a “rapid and progressive reduction” in the viral load of SARS-CoV-2, the virus that causes COVID-19.

But four days after completing the treatment course, there was a “surprising rebound of viral load and symptoms,” they reported.

The report “highlights the potential for recurrent, symptomatic SARS-CoV-2 replication after successful early treatment” with the pill, the researchers said.

A number of others have said they saw renewed symptoms after taking paxlovid.

In the FDA’s evaluation (pdf) of data on paxlovid, which the agency cleared on an emergency basis in 2021, the agency reported that in an ongoing phase 2/3 trial run by Pfizer, several participants “appeared to have a rebound” in viral load five to nine days after completing their treatment courses.

In light of the new reports, additional analyses of the paxlovid trial data were performed and showed that 1 to 2 percent of the patients had one or more positive COVID-19 tests after testing negative, or an increase in the amount of viral load, after completing the treatment, Dr. John Farley of the FDA said in an interview the agency published on May 4.

“This finding was observed in patients treated with the drug as well as patients who received placebo, so it is unclear at this point that this is related to drug treatment,” he said, adding that, at this time, the reports “do not change the conclusions from the paxlovid clinical trial which demonstrated a marked reduction in hospitalization and death.”

As part of the authorization agreement, the FDA said Pfizer must later submit information regarding “prolonged virologic shedding or rebound in clinical trials.”

Pfizer did not respond to a request for comment.

The company told Bloomberg that the rate of rebound in its trial was not higher among people who took paxlovid than in people who took a placebo.

“This suggests the observed increase in viral load is unlikely to be related to paxlovid,” the company said.

Dr. Clifford Lane, deputy director for clinical research at the National Institute of Allergy and Infectious Diseases, told the outlet that the agency will study the issue, calling it “a priority.”

Lane and the agency did not return queries.

The FDA authorized paxlovid for the treatment of mild to moderate COVID-19 in Americans 12 years or older. To get the pill, a person must test positive for COVID-19 and be deemed at high risk of progressing to severe disease.
 

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Beijing Steps Up COVID-19 Curbs With Shanghai Still Under Lockdown
By Reuters
May 5, 2022

BEIJING/SHANGHAI—The Chinese capital Beijing shut dozens of metro stations and bus routes on Wednesday in its campaign to stop the spread of COVID-19.

The Chinese regime’s uncompromising battle against the coronavirus, which is believed to have emerged in Wuhan city in late 2019, is undermining its growth and hurting the international companies invested there, according to the latest forecasts and data.

The central city of Zhengzhou, home to 12.6 million people and a factory of Apple’s iPhone manufacturer Foxconn, announced work-from-home and other COVID-19 curbs for the coming week late on Tuesday, joining dozens of big cities under some form of lockdown.

The capital shut more than 60 subway stations, about 15 percent of the network, and 158 bus routes, service providers said. Most of the suspended stations and routes are in the Chaoyang district, the epicenter of Beijing’s outbreak.

With dozens of new cases a day, the Chinese regime hopes that mass testing will find and isolate the virus before it spreads.

China’s COVID-19 data is difficult to verify, as the Chinese regime routinely suppresses or alters information.

The city of 22 million people has closed schools, restaurants, gyms, and entertainment venues, as well as some businesses and residential buildings in high-risk areas.

In what will be a worrying sign for Beijing residents, workers in protective gear were seen setting up a two-meter high blue metal wall around a residential complex, with a sign at the gate reading “Entry only. No exit.”

Twelve out of 16 Beijing districts conducted the second of three rounds of tests this week, having done three screenings last week.

Blockchain Memories

In Shanghai, there’s no end in sight for the lockdown.

After more than a month, most people in mainland China’s biggest city are still not allowed to leave their housing compounds.

Some residents have benefited from a tentative easing of precautions since Sunday, with usually just one member of a household allowed out for a quick stroll and grocery shopping.

The strict isolation has fueled rare outbursts of discontent, with social media users playing a cat-and-mouse game with censors to keep evidence of the hardship circulating.

Some have turned to blockchain technology to protect videos, photos, and artwork around the topic from deletion.

Such acts of defiance are awkward for the ruling Communist Party in a sensitive year in which Chinese leader Xi Jinping is expected to secure a third term.

Growth Forecast Cut

The regime’s zero-COVID policy is hurting domestic consumption and factory output, disrupting key global supply chains and shrinking revenues for some of the biggest international brands, such as Apple, Gucci-parent Kering, and Taco Bell-owner Yum China.

Capital Economics estimates COVID-19 has spread to areas generating 40 percent of China’s output and 80 percent of its exports.

“Recent mobility trends suggest that China’s growth momentum deteriorated significantly in April, with traffic congestion, subway passenger volume and other high-frequency indicators at their weakest since … early 2020,” Fitch Ratings said in a note.

Fitch cut its 2022 growth forecast to 4.3 percent, from 4.8 percent, well below China’s official 5.5 percent target.

Starbucks Corp. said on Tuesday its sales in China, where the chain has rapidly expanded in recent years, declined 23 percent, overshadowing 12 percent growth in North America.

Foxconn said on Wednesday it was continuing production in Zhengzhou.

Numerous factories were shut after Shanghai went into lockdown from March. While some have started reopening, getting workers back, while dealing with snarled supply chains, has proven difficult.

International trade is also facing disruption.

A study by Royal Bank of Canada analysts found that a fifth of the global container ship fleet was stuck in ports.

At Shanghai’s port, 344 ships were awaiting berth, a 34 percent increase over the past month. Shipping something from a warehouse in China to one in the United States takes 74 days longer than usual, they said.
 

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High number of Strokes caused by the Covid-19 Vaccines may explain why so many of the Vaccinated are also going Blind
By The Exposé on April 26, 2022

Since the first Covid-19 vaccine was authorised for use in the United Kingdom, and administered on the 8th December 2020, there have been hundreds of thousands of adverse reactions reported to the MHRA Yellow Card scheme. But there is one particular adverse reaction which is both concerning and strange, and the number of people suffering from it is increasing by the week – Blindness.

The MHRA Yellow Card scheme analysis print for the Pfizer / BioNTech mRNA jab shows that since the first jab was administered on the 9th December 2020, and up to 6th April 2022, 163 people have reported suffering total blindness due to the injection. Another 6 people have also reported central vision loss, whilst a further 4 people have reported sudden visual loss.

Twenty-one people have also reported an adverse reaction known as ‘blindness transient’ due to the Pfizer vaccine. This is where a person suffers visual disturbance or loss of sight in one eye for seconds or minutes at a time. And a further twenty people have reported an adverse reaction known as ‘unilateral blindness’. This is where a person is blind or has extremely poor vision in one eye.

In total there have been 8,016 eye disorders reported as adverse reactions to the Pfizer jab as of 6th April 2022.


Source – Page 17

The AstraZeneca viral vector injection has also caused hundreds of people to go blind. As of 6th April 22 the MHRA has received 324 reports of blindness, 3 reports of central vision loss, 5 reports of sudden visual loss, and 29 reports of blindness transient among 14,895 eye disorders reported as adverse reactions to the jab.


Source – Page 18

The Moderna mRNA injection, which was first administered in June and has the lowest number of injections administered in the UK, has also caused several people to suffer blindness.

As of 6th April 22, the MHRA have received 34 reports of blindness, 56 reports of visual impairment, and 6 reports of as adverse reactions to the Moderna injection. blindness transient among 1,519 eye disorders reported as adverse reactions to the Moderna jab.


Source – Page 10

In all, when including adverse reactions reported where the brand of vaccine was not specified, there have been 24,516 eye disorders reported as adverse reactions to the Covid-19 injections, with 525 of these reactions being complete blindness.

“Fact-checkers” alongside authorities have been on the case to sweep this data under the carpet and have labelled it as unreliable. Their reasoning is that “just because someone reports the event after having the vaccine, it doesn’t necessarily mean it is due to the vaccine”.

But what they’re not telling you is that it also doesn’t necessarily mean it is not due to the vaccine, and we imagine every single person who has reported an adverse reaction would disagree with the fact checkers and authorities attempts to play down these reports.

For instance one person, who goes by the name of Louis, documented the story of his wife on Twitter in the days, weeks and months following her getting the AstraZeneca Covid vaccine.

Unfortunately, his wife went completely blind in her left eye and 30-60% blind in her right eye after having the AstraZeneca jab and the neurologist treating her, categorically told her not have the second dose.



As you can see the misery which the fact checkers are disregarding as “not necessarily the fault of the vaccine” is very real for the people who are reporting them.

But why are the Covid vaccines causing people to go blind?

Well there is another extremely concerning adverse reaction that has been reported to the MHRA Yellow Card scheme, one which has occurred an astronimical amount of times, and that adverse event is a stroke.

As of 6th Feb 22, the MHRA has received 786 reports of stroke due to the Pfizer mRNA injection, which is now the primary booster jab being administered to Brits, and the only jab being administered to children.

These reports include 19 reports of subarachnoid haemorrhage, which is an extremely rare type of stroke, 64 reports of cerebral haemorrhage, 61 reports of ischaemic stroke, and 487 reports of cerebrovascular accidents.

Sadly these 786 reported strokes have resulted in 65 deaths.


Source – Page 71

Unfortunately the AstraZeneca vaccine has also caused hundred of strokes. Up to 6th April 22, the MHRA has received 2,355 reports of stroke as adverse reactions to the jab resulting in 170 deaths.

The 2,355 strokes include 202 cerebral haemorrhages, 119 subarachnoid haemorrhages (supposed to be rare), 166 ischaemic strokes, and a shocking 1,369 cerebrovascular accidents.


Source – Page 82


Source – Page 83

But what does this have to do with people going blind? Well this helpful fact sheet provided by the Stroke Foundation in Australia provides the answer as to why.

According to the fact sheet around one-third of stroke survivors suffer visual loss, and most sadly never fully recover their vision.


Source

The reason strokes cause blindness is that vision depends on a healthy eye to receive information and a healthy brain to process that information. The nerves in the eye travel from the eye through the brain to the occipital cortex at the back of the brain, allowing you to see.

Most strokes affect one side of the brain. Nerves from each eye travel together in the brain, so both eyes are affected. If the right side of your brain is damaged, the left side vision in each eye may be affected. It is rare for both sides of the brain to be affected by stroke. When it does happen, it can result in blindness.

So if you’ve been wondering how on earth the experimental Covid-19 injections could cause a person to go blind, you now know why.

It’s the vast amount of strokes the Covid injections are causing that is contributing to this devastating and life-changing adverse event. Strokes will not be the only contributing factor of course, but the numbers suggest they are most likely the main adverse reaction at fault.

Sources/References
 

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CDC report admits 74.2 million people in the USA have not had a single dose of a Covid-19 Vaccine, & another 157 million have refused a 2nd or 3rd dose
By The Exposé on May 4, 2022

The American people have seen right through President Biden’s propaganda and lies on the effectiveness of the Covid-19 injections because according to CDC data, 70% of the entire population of the USA have not had either a first, second or third dose of the Covid-19 vaccine.

image-5.png



President Joe Biden has lied to the American people and is still lying to the American people. In July 2021, Biden falsely stated that “You’re not going to get COVID if you have these vaccinations,” and “If you’re vaccinated, you’re not going to be hospitalized, you’re not going to be in the ICU unit, and you’re not going to die.”

Then in December 2021, Biden falsely claimed “This is a pandemic of the unvaccinated. The unvaccinated. Not the vaccinated, the unvaccinated. That’s the problem. Everybody talks about freedom and not to have a shot or have a test. Well guess what? How about patriotism? How about making sure that you’re vaccinated, so you do not spread the disease to anyone else.”

There is plenty of evidence out there that proves the above statements made by President Biden are outright lies (see here), but the most hilarious evidence of all must be the recent outbreak that occurred due to journalists and Government leaders attending the ‘Gridiron Dinner at the beginning of April 2022. An annual event in Washington DC.

All guests at the event were required to show proof of vaccination. A week later at least 72 of the 630 fully vaccinated/boosted guests tested positive for Covid-19.

But it would appear the majority of the American people can already see through President Biden’s lies without us needing to put the record straight. Because according to data published by the US Centers for Disease Control, 74.2 million Americans are still completely unvaccinated, and a further 157 million Americans have refused a second or third dose of the Covid-19 injection.

Meaning 50% of the entire country has potentially become wise to the propaganda and lies spouted by the American Government, Dr Anthony Fauci, and the mainstream media over the past two years.

The Centers for Disease Control (CDC) provides the following data on Covid-19 vaccinations in the United States –

Data for Dose 1

image.png

Source

Date for Dose 2

image-1.png

Source

Data for Dose 3

image-2.png

Source

We’ve created the following chart based on the figures provided by the CDC above, showing the total vaccination uptake vs the total vaccination refusal in the USA per dose –

image-3.png


As we can see from the above according to the CDC, 257 million people have had a single dose, 219.7 million people have had a second dose, and 100.7 million people have had a third dose as of May 2nd 2022.

This means on top of the 74.2 million unvaccinated, a further 38 million people who had the first dose refused the second dose, and a further 119 million people who had the second dose refused the third dose.

This equates to 70% of the entire population of the USA who have not had either a first, second or third dose of a Covid-19 injection.

However, the above chart includes children under the age of 5 who are not eligible for Covid-19 vaccination. So we’ve created the following chart based on the figures provided by the CDC above, showing the total vaccination uptake vs the total vaccination refusal in the USA per dose among those who are eligible for vaccination –

image-4.png


On top of the 54.7 million people eligible for Covid-19 vaccination who have chosen to remain unvaccinated, a further 37.9 million people who had the first dose refused the second dose, and a further 90.2million people who had the second dose refused the third dose.

This brings the possible number of people who have now woken up to the lies and propaganda spouted by the Government and mainstream media over the past two years to 182.8 million; 55% of the entire population of the USA.

Approximately 183 million people in the USA are now refusing to partake in the largest real-world experiment ever conducted, even though their “elected” President told them it was their patriotic duty to get vaccinated because he falsely claimed the vaccinated do not spread Covid-19.

President Biden is probably breathing a sigh of relief that so many people have chosen to ignore his lies. Because a study of official data published by the Government of Canada has found triple vaccinated individuals are now four times more likely to be infected with Covid-19, 2 times more likely to be hospitalised with Covid-19, and 2 times more likely to die of Covid-19 than unvaccinated individuals.

One reason why this could be occurring is that the Covid-19 injections are causing Vaccine-Associated Enhanced Disease and antibody-dependent enhancement. But this would not explain the increased risk of infection.

But there’s another condition that would explain the increased risk of infection as well as the increased risk of hospitalisation and death.

And that condition is Acquired Immune Deficiency Syndrome.
 

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View: https://www.youtube.com/watch?v=iax-dL7F3qw
Paxlovid, evidence base?
21 min 17 sec
May 4, 2022

Paxlovid, it this an evidence based intervention in May 2022? Paper FDA EMU was based on https://www.nejm.org/doi/full/10.1056... EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) 1120 patients received nirmatrelvir plus ritonavir 1126 received placebo Relative risk reduction Risk of progression to severe Covid-19, 89% lower than the risk with placebo Absolute risk reduction https://www.precisionvaccinations.com... 7% down to 1% symptomatic, unvaccinated, non hospitalized adults at high risk for progression to severe coronavirus disease 2019 July 16 and December 9, 2021 If vaccinated people and previously infected people are partly protected More people would need to be treated to prevent one adverse event Pfizer press release (5th November 2021) https://www.pfizer.com/news/press-rel... our oral antiviral candidate, … has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations Pfizer Shares In Vitro Efficacy of Novel COVID-19 Oral Treatment Against Omicron Variant https://www.pfizer.com/news/press-rel... https://www.yalemedicine.org/news/12-... https://www.fda.gov/media/155051/down... The results showed in all cases that nirmatrelvir was a potent inhibitor of its target. PAXLOVID™ for Post-Exposure Prophylactic Use https://www.pfizer.com/news/press-rel... Evaluated data from 2,957 adults Pfizer observed risk reductions of 32% (5 day course) 37% reduction (10 day course) These results, however, were not statistically significant and, as such, the primary endpoint of reducing the risk of confirmed and symptomatic COVID-19 infection in adults who had been exposed to the virus through a household contact was not met. FACT SHEET FOR PATIENTS, PARENTS, AND CAREGIVERS EMERGENCY USE AUTHORIZATION (EUA) OF PAXLOVID FOR CORONAVIRUS DISEASE 2019 (COVID-19) https://www.fda.gov/media/155051/down... PAXLOVID is not an FDA-approved medicine in the United States. PAXLOVID is an investigational medicine Some medicines may interact with PAXLOVID and may cause serious side effects. If you take too much PAXLOVID, call your healthcare provider or go to the nearest hospital emergency room right away. Possible side effects of PAXLOVID are: Allergic Reactions trouble swallowing or breathing, swelling of the mouth, lips, or face, throat tightness, hoarseness, skin rash Liver Problems. Tell your healthcare provider right away, loss of appetite, yellowing of your skin and the whites of eyes (jaundice), dark-colored urine, pale colored stools and itchy skin, stomach area (abdominal) pain. Other possible side effects include: altered sense of taste, diarrhea, high blood pressure, muscle aches Dr. Ashish K. Jha, White House, Covid-19 coordinator The new White House Covid czar says avoiding all virus infections isn’t the goal of U.S. pandemic policy. Paxlovid, push to reach the vulnerable Doctors are too hesitant to prescribe the drug https://en.wikipedia.org/wiki/Ashish_Jha Senior Advisor at Albright Stonebridge Group https://www.politico.com/newsletters/... The firm advises clients on international policy and global markets Patrick Vallance From 2012 to 2018, he was President of Research and Development at global pharmaceutical company, GlaxoSmithKline (GSK) https://www.telegraph.co.uk/news/2020... Cashed £5,000,000 GSK shares Future jobs of FDA’s haematology-oncology reviewers https://www.bmj.com/content/354/bmj.i... https://www.npr.org/sections/health-s... More than a quarter of the Food and Drug Administration employees (who approved cancer and hematology drugs from 2001 through 2010) left the agency and now work or consult for pharmaceutical companies,
 

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COVID transmission 1,000 times more likely from air vs. surfaces, says study
by Alan Mozes Healthday Reporter
May 4, 2022

If you're still wiping down groceries, doorknobs and light switches in an attempt to thwart COVID-19, maybe you can relax a little: You're 1,000 times more likely to get COVID from the air you breathe than from surfaces you touch, a new study suggests.

University of Michigan researchers tested air and surface samples around their campus and found odds are greater for inhaling virus particles than picking them up on your fingers.

"In this study, we set out to better understand potential exposures to the SARS-CoV-2 coronavirus—the virus which causes COVID-19—in several college campus settings," explained study author Richard Neitzel, a professor of environmental health sciences and global public health.

The settings included offices, classrooms, performance spaces, cafeterias, buses and a gym. However, the samples were taken during the pandemic lockdown, so these were relatively empty spaces.

"We also used information on campus COVID-19 infections to estimate the probability of infection associated with our environmental measurements," added Neitzel.

"The overall risk of exposure to the virus was low at all of the locations we measured," he said.

However, "Our results suggest that there was a much higher risk of infection from inhalation than from contact with surfaces like door handles, drinking fountains, keyboards, desks, sinks and light switches," he noted.

To get a handle on relative risk, between August 2020 and April 2021, Neitzel and his colleagues used air pumps and swabs in various locales across the locked-down campus.

In all, more than 250 air samples were gathered, of which 1.6% tested positive for the virus that causes COVID. Of over 500 surface samples, 1.4% were positive.

The most risky setting was the gym, with positive indications found for 75% of air samples and 50% of all surface samples. Most of the contaminated gym surfaces involved drinking fountain buttons; no samples taken from gym equipment turned up positive.

Overall, far fewer positive readings were found in office spaces or around computer keyboards, light switches, tabletops, microwaves, fridge handles or student desks.

But after stacking up positive samples against actual COVID cases on campus, the team determined that the probability of getting COVID after exposure to airborne virus particles was roughly 1 per 100 exposures.

The researchers determined the probability of illness from a contaminated surface to be 1 for every 100,000 exposures.

Still, Neitzel stressed that the findings reflect a time and place in which strict surface cleaning protocols were enforced, and when crowds were nonexistent. "Our results," he cautioned, "may not be completely representative of other community settings."

Nevertheless, the results suggest people should be more concerned about inhalation risks from the coronavirus than the risks from touching surfaces, "at least in an environment where surfaces are cleaned regularly, as was the case with our campus," Neitzel added.

Elizabeth Scott, a professor emerita at Simmons University in Boston, said, "There has been a growing recognition that COVID-19 is predominantly airborne."

Yet Scott, who was not part of the study team, cautioned that "the relative importance of surface transmission may be higher in homes, dorms [or] where people are living together and repeatedly touching the same surfaces."

That kind of private space risk, she stressed, was not evaluated by the study. Also, it's important to note that "other respiratory viruses and other bacterial infections are spread predominantly via contact surfaces," added Scott, former co-director of the Simmons Center for Hygiene and Health in Home and Community.

In her view, "we need to continue effective and holistic hygiene practices for hands and surfaces, as well as respiratory and air hygiene, to protect against all the other community-borne infections that were an issue before COVID-19, and will be with us for the future," Scott said.

The findings were published April 27 in the Journal of Exposure Science & Environmental Epidemiology.
 

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Resistance to COVID-19 drug detected in lab study
by Vanderbilt University Medical Center
May 4, 2022

The virus that causes COVID-19 can develop partial resistance to the antiviral drug remdesivir during infection of cultured cells in the laboratory by more than one mechanism.

The results of the laboratory study led by researchers at Vanderbilt University Medical Center and published in the journal Science Translational Medicine support the importance of monitoring for resistance and its mechanisms, tracking specific mutations and developing combination therapies.

"Remdesivir is a critical antiviral in our armamentarium to treat COVID infections and limit illness, hospitalization and death," said Mark R. Denison, MD, an internationally known authority on coronavirus biology at VUMC who led the study with colleagues from the University of Alberta, Canada, the University of North Carolina at Chapel Hill, and Gilead Sciences.

"To date, there have been very few reports of resistance to remdesivir in clinical practice," said Denison, the Edward Claiborne Stahlman Professor of Pediatric Physiology and Cell Metabolism at VUMC. "We must be sure that we can continue to use this antiviral against COVID, future human coronaviruses and potentially even against our known human coronaviruses."

"So, it is critical to understand how coronaviruses might try to escape from the drug, and to use that data to monitor for any potential emergence of resistance in COVID-19 patients," he said.

Denison's lab and collaborators contributed to the initial development of remdesivir, which was approved by the U.S. Food and Drug Administration as the first drug treatment for COVID-19 in both hospitalized and non-hospitalized patients as young as 12. Last month the FDA approved its use in high-risk children as young as 28 days.

Given by intravenous injection, remdesivir stops the virus, SARS-CoV-2, by preventing its RNA genome from being copied.

In the current report, the investigators led by Laura Stevens, MS, and Andrea Pruijssers, Ph.D., at VUMC showed that upon repeated exposure to the parent nucleoside (compound) of remdesivir in cell culture, SARS-CoV-2 developed mutations in the polymerase enzyme that copies its RNA genome.

These mutations, which emerged after prolonged passaging of virus in the presence of the drug, enabled SARS-CoV-2 to partially evade remdesivir's antiviral effect. The mutations also could confer resistance in a mouse coronavirus that does not infect humans.

Biochemical studies from the laboratory of Matthias Götte, Ph.D., at the University of Alberta showed that the mutations resisted remdesivir by two distinct mechanisms.
 

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International study finds nearly 13% of COVID-19 hospitalized patients had serious neurologic symptoms
by Boston University School of Medicine
May 4, 2022

Overwhelming evidence shows that infection with severe acute respiratory syndrome (SARS-CoV-2) causes dysfunction of multiple organ systems, including the nervous system. Neurologic symptoms are frequently reported even in patients with mild illness and for some, these neurologic symptoms may persist as part of long-haul COVID.

To describe the prevalence, associated risk factors and outcomes of serious neurologic manifestations among patients hospitalized with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, researchers from Boston University School of Medicine (BUSM) studied 16,225 patients from 179 hospitals in 24 countries as part of the Society for Critical Care Medicine's Viral Infection and Respiratory Illness University Study.

The researchers found nearly 13% of patients admitted for COVID-19 in the first year of the pandemic developed serious neurologic manifestations. Specifically, 1,656 (10.2%) had encephalopathy (any diffuse disease of the brain that alters brain function or structure) at admission, 331 (2.0%) had a stroke, 243 (1.5%) had a seizure, and 73 (0.5%) had meningitis or encephalitis at admission or during hospitalization.

"Our findings show that encephalopathy at hospital admission is present in at least one in 10 patients with SARS-CoV-2 infection, while stroke, seizures and meningitis/encephalitis were much less common at admission or during hospitalization," explains corresponding author Anna Cervantes-Arslanian, MD, associate professor of neurology, neurosurgery and medicine at BUSM.

Additionally, they discovered all serious neurologic manifestations were associated with increased disease severity, greater need for ICU interventions, longer length of stay, ventilator use and higher mortality.

According to the researchers, patients with neurologic manifestations were more likely to have medical comorbidities. Most notably, a history of stroke or neurologic disorder increased the odds of developing a neurologic manifestation.

Moreover, they found neurologic manifestations differed by race. Black patients had an increased frequency of stroke, seizure and encephalopathy when compared with white patients. "Given the association of neurologic manifestations with poorer outcomes, further study is desperately needed to understand why these differences occur and what can be done to intervene," added Cervantes, who also is a neurologist at Boston Medical Center.

These findings appear online in the journal Critical Care Explorations.
 

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Scientists develop test that easily detects variants causing COVID-19
by Rutgers University
May 4, 2022

Rutgers scientists have developed a lab test that can quickly and easily identify which variant of the virus causing COVID-19 has infected a person, an advance expected to greatly assist health officials tracking the disease and physicians treating infected patients.

Details of the PCR (polymerase chain reaction) test have been published in The Journal of Molecular Diagnostics. The paper, which was published online prior to its inclusion in the April 2022 issue of the journal, includes directions for how to employ so-called "molecular beacons," a powerful technique that seeks out molecules that carry genetic information to make proteins, co-invented by one of the paper's authors, Sanjay Tyagi, a professor of medicine at the Public Health Research Institute at Rutgers New Jersey Medical School.

"We were able to make a PCR test, just like the ones involved in a normal COVID-19 diagnosis, that detects not only the SARS-CoV-2 virus, but also identifies which variant is present," said Ryan Dikdan, a doctoral student in Tyagi's lab who is first author on the paper. "This is significant because we can now identify the variants as they emerge in every sample, very rapidly."

Most PCR COVID-19 tests taken by patients—often offered via drive-through pharmacy windows or mail-in packets—only detect the presence of the virus and don't identify any particular strain. If public health experts want to obtain data on variants to track how and if the virus is mutating, they generally must physically visit the areas where outbreaks are known to have occurred, obtain samples, and then run an extremely complex sequencing process. The Rutgers test could be used in concert with any COVID PCR test, yielding more specific information.

The scientists want to share the technology with other labs and testing companies so that variant information, often crucial when coordinating the use of treatments such as monoclonal antibodies, is readily available.

"Since PCR machines are now almost as common as coffee machines, strain typing can be done anywhere without missing any cases," said Tyagi.

The professor and his former student, Arjun Raj, were recognized with the Edison Patent Award from the Research and Development Council of New Jersey for the invention of their fluorescent probes. "The test will enable more accurate treatment for severe COVID since a rapid PCR test to identify the variants can now be carried out in the local hospital setting," Tyagi said.

PCR tests employ a technique known as the polymerase chain reaction, a widely used method that allows researchers to take a tiny sample of DNA and amplify it to a large enough amount so that it can be studied.

The molecular beacon technology co-invented by Tyagi involves microscopic, biochemical probes so precise they can distinguish among different gene-sequence targets that differ by only a single chemical base. Once the probes latch on to the target, they become fluorescent—serving as beacons for scientists scouring the genetic soup of viral particles.

Several COVID-focused PCR tests have been developed earlier, but they target only single mutations in the "spike" protein, which leads the virus's attack on human cells, and can't discriminate between many variants circulating in the population. The Rutgers test detects eight different mutations in the spike protein—ones that have been demonstrated to increase the transmissibility of the virus and evade the human body's immune defenses.

Because such mutations are likely to be conserved in new emerging variants, the scientists expect the test will be useful for detecting new variants that arise from a new combination of mutations.

Other Rutgers authors on the paper include Salvatore Marras, an assistant professor of microbiology, biochemistry and molecular genetics at the Public Health Research Institute.
 

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New study proves correct dosage for ultraviolet disinfection against COVID
by Binghamton University
May 4, 2022


1651736844682.jpeg
Kaiming Ye and Guy German from Binghamton University, State University of New York developed a machine to disinfect personal protective equipment such as facemasks. Credit: Binghamton University, State University of New York

When the COVID-19 pandemic emerged in early 2020, ultraviolet radiation became one of the go-to methods for preventing the spread of the SARS-CoV-2 virus, along with facemasks, hand sanitizer and social distancing.

The problem: There was little research showing what UV dosage kills the virus. What wavelength? How long? And could UV systems be installed in public places such as airports, bus stations and stores without causing long-term damage to people?

In a newly published study, researchers from Binghamton University's Thomas J. Watson College of Engineering and Applied Science answer many of those questions and lay the foundation for health standards about what offers true disinfection.

The paper, titled "Systematic evaluating and modeling of SARS-CoV-2 UVC disinfection" and published in Scientific Reports, is written by Distinguished Professor Kaiming Ye, chair of the Department of Biomedical Engineering; BME Associate Professor Guy German and BME Professor Sha Jin, along with Ph.D. student Sebastian Freeman; Zachary Lipsky, Ph.D. '21; and Karen Kibler from the Biodesign Institute at Arizona State University.

The idea for the research came when shortages of personal protective equipment (PPE) early in the pandemic inspired Ye, German and Binghamton University staff members to quickly build UV disinfection stations for hospitals in the region, so that N-95 masks and other items could be reused.

"There is a lot of research on UV dosages in the scientific literature, but not in a systematic way," Ye said. "When we started this project, there were really no data or experiments that had been done because the pandemic happened very quickly."

The Binghamton team added a retrovirus similar to SARS-CoV-2 to three different media (a cell-culture medium, water and an artificial re-creation of human saliva) and exposed them to three different wavelengths in the UVC range. UVC kills viruses and other microorganisms by damaging their DNA and RNA, which are the bioorganic building blocks for life.

"The disinfection efficiencies are greatly influenced by the media where the virus is," Ye said. "We used the same dosage, the same light intensity and the same wavelengths when the virus was suspended in saliva, water and a cell-culture medium, but the efficiency was completely different."

The best results during the study came from a range of 260 to 280 nanometers, which is commonly used in LED UVC lights. Wavelengths below 260 nanometers can be deployed only in unoccupied spaces because they can damage human skin and eyes.

"There are so many companies that are purporting to say their products completely disinfect and are completely safe," German said. "However, in this article, we demonstrate that both far (222 nanometers) and regular UVC light (254 nanometers) degrade the mechanical integrity of the stratum corneum, the skin's top layer, causing higher likelihood of cracking. That means nasty bacteria and other microorganisms can get into and potentially infect your skin."

Based on the results of the research, Ye and German have designed an LED light disinfection system that should cause less damage to human skin. They are doing additional testing before applying for a patent on it.

"We are waiting for the data, and then we are pretty much finished. We know it will work," Ye said.

Also, the Binghamton team found that two amino acids (L-tryptophan and L-tyrosine) and a vitamin (niacinamide) are strong absorbers of UVC, and that discovery could lead to lotions that would block exposure and prevent skin damage if UVC disinfection becomes more prevalent in public spaces.

Ye believes the most important part of this research is that it offers a scientific basis for standardizing and regulating claims from manufacturers of UV disinfectant devices.

"The system we came up with can become the model for anybody who wants to standardize the dosage," he said. "This is how to determine the eradication of SARS-CoV-2 using UVC—maybe also SARS-CoV-3, SARS-CoV-4, SARS-CoV-5. We hope we never get there, but we need to be prepared."
 

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The new rules of medicine
In case you missed the memo.

Steve Kirsch
Apr 30

In case you missed the memo from the CDC that went out about the new rules of medicine, here’s a copy.

Date: January 20, 2021
From: Rochelle Walensky, Director of the CDC
To: Everyone
Subject: New rule changes to both science and medicine in response to the COVID-19 pandemic

Due to the unprecedented number of deaths due to COVID-19, the following changes to science and medicine shall apply until further notice. It’s for the greater good:
  1. Doctors should always follow the guidance of the CDC and NIH, even when it is wrong.
  2. Any doctor who contradicts what the CDC or NIH say shall have their license to practice medicine revoked.
  3. The CDC, FDA, and NIH are always right. So is the IDSA. However, in the event of a disagreement, the CDC always wins.
  4. Unless you are an infectious disease specialist, your opinion on infectious diseases does not matter because you are not qualified to render an opinion.
  5. All the vaccines are safe and effective. We aren’t making any all-cause mortality or morbidity available because they are both strongly negative. Very few people are even smart or aware enough to ask for the actual mortality/morbidity data. If they ask to see this data, or ask “why isn’t this data available,” you need to quickly end the conversation, e.g., “Oh, I have to go.” Or try gaslighting them telling them that they aren’t an infectious disease expert and that you should stay in your lane.
  6. Everyone should help ensure that deaths and adverse events are never associated with the vaccine. You are doing a great job so far. In particular, doctors at hospitals shouldn’t report any adverse events or deaths to VAERS, pharmacies who give the vaccine to the elderly should never ask for their Medicare numbers (since that would add it to their record), coroners, medical examiners, and embalmers should never ask for the COVID vaccine status of the dead, the COVID vaccine status should never be listed on their death certificate, and the mainstream media should never talk about when the person who died unexpectedly was vaccinated. All of these measures go a long way to ensuring that nobody finds out how dangerous the vaccines really are. Your model here is Dr. Nath at the NIH. He’s seen dozens of vaccine injured patients where multiple adverse events all started right after the vaccine. He publicly proclaims there is no link between the vaccine and the injuries even though there is no other explanation. This is exemplary behavior that allows him to keep his medical license and his job.
  7. Ivermectin doesn’t work. There will always be “insufficient evidence” to recommend it, no matter how much evidence there is.
  8. Peer-reviewed published systematic reviews and meta-analyses are now considered to be “insufficient evidence” even if there are multiple ones (like there are for ivermectin).
  9. Early treatments for COVID using cheap repurposed drugs don’t work, no matter what the evidence says. The fact that George Fareed and Brian Tyson were able to treat 10,000 COVID patients without a single death was just due to good luck.
  10. If you see something that contradicts the narrative, don’t say anything. This is known as the “See something, say nothing” policy. This is particularly important for doctors who are seeing massive numbers of deaths from the vaccine and from school nurses who are seeing large number of myocarditis cases. In all cases, you don’t want to speak out because we assure you that you are the only one seeing ridiculously high safety signals and if you speak out, you’ll just create “vaccine hesitancy.” Besides, the press won’t cover it since they don’t want to alarm the public. For example, at Monte Vista Christian School, they have 4 myocarditis cases in fewer than 400 boys. They are saying nothing publicly about this.
  11. The vaccines don’t work, but just tell people who get COVID after being vaccinated that it would have been so much worse if they weren’t vaccinated. This works every time. Nobody questions you how you know it.
  12. Nobody should analyze what is in the vaccine vials. There is simply no reason to do this. It’s for the greater good. Don’t you trust us?
  13. While vaccine mandates have been ruled unconstitutional in Italy and India, it doesn’t apply in the US. There is nothing unconstitutional about mandating a vaccine that has killed over 500,000 Americans.
  14. For the elderly, there is no all-cause mortality data showing a benefit, but who needs data? Just recommend it. We’ll get the data later, trust us. OK, well maybe we’ll get the data later. But data doesn’t matter which is why we aren’t even collecting it. Why bother? After all, nobody is asking for it except one guy and we had MIT thoroughly gaslight him.
  15. Medical journals are prohibited from publishing papers that go against the narrative. Sometime, mistakes happen, and a counter-narrative paper gets published like the Rose-McCullough paper on myocarditis which had a very incriminating graphic. We had the publisher of the journal pull the paper. Here’s the original. See the graph on page 18? Nobody should see that so we had the paper pulled. We’ve been telling people it’s “a slightly elevated risk” that you’ll get myocarditis from the COVID vaccines. This paper makes us look like we lied to people. So the paper has to be suppressed.

  16. “Misinformation” is defined any information that contradicts the current mainstream narrative, even if it is true.
  17. You are not allowed to spread “misinformation” online anymore. If you do, we’ll take away your license to practice medicine. You are also not allowed to make comments that are not in your area of expertise. So if you actually find excess deaths in VAERS, shut up about it and stay in your lane. The UK is in the process of making this standard medical practice as well.
  18. Never agree to debate any “misinformation spreaders;” they are evil people. In particular, if Steve Kirsch contacts you for a scientific debate, ignore it no matter how much he is offering. It won’t end well. Our collective reputations are worth more than any money he is offering. If the truth gets out, we are all screwed for decades.
  19. The “misinformation spreaders” have a list of questions they want us to answer. They promise that if we do that, they’ll stop spreading misinformation. We can’t answer any of those questions, so it’s important that we have a good excuse to give people for declining to answer their questions. Just tell people that the questions are easy to answer but you are working on “more important things.” They will never ask you for details.
  20. Expert opinion, formerly the lowest level of evidence, is now at the top of evidence-based medicine if and only if the experts are from a government agency like the CDC.
  21. You don’t need any clinical evidence to prescribe a drug or vaccine if the CDC says it is safe. As NEJM Editor Eric Rubin has said, “We’re never going to learn about how safe this vaccine is unless we start giving it.”
  22. Always trust the drug companies and their clinical trials, even when there is clear fraud. Also, if the drug company claims that the deaths weren’t related to the drug, no evidence is required. The FDA should never ask if the proper tests were done during the autopsy. Heck, who needs an autopsy? Those are old fashioned.
  23. There is no stopping condition for COVID vaccines. Doesn’t matter how many people are killed by the vaccine itself. It only matters how many COVID lives we may theoretically save.
  24. Risk benefit analyses should not look at all-cause mortality anymore. That is a distraction. What’s important is only the relative risk reduction, RRR.
  25. Fraud never happens in clinical trials run by big pharma, even when it does.
  26. Whistleblowers will be prosecuted to the full extent of the law.
  27. If you work for the mainstream media, never acknowledge that there are differing opinions to the government narrative.
  28. When science and politics disagree, politics always wins.
  29. Any scientist who disobeys these rules will have their NIH funding cut off. Forever.
[continued next post]
 

Heliobas Disciple

TB Fanatic
[continued]​
30. Vaccines only need to be tested for a few months to be deemed safe.​
31. Make sure Medicare patients do NOT show need to show their Medicare card when getting a vaccine. You don’t want it tied it to their Medicare record. That way, anyone looking at the Medicare records is going to see the vaccinated as the unvaccinated and there won’t be a difference between the two groups and we can show everyone the numbers and say, “See? No difference between the groups!” This is going to fool most people.​
32. If it looks like the vaccine works, always make sure everyone in the placebo group gets the vaccine when the trial is over. Who needs a comparison group after 6 months? After all, we really don’t want to let people find out that the drug was only marginally effective with the initial variant and not effective for later variants. So getting rid of the control group is fine. They will trust us.​
33. When doing a vaccine study, if people get really sick from the drug, just kick them out of the trial. You no longer have to count them as an adverse event. This just experimental error. You don’t want this data to pollute the effectiveness data.​
34. The unvaccinated are a clear danger to public health of the vaccinated. There is even a thoroughly discredited study by our friend Professor Fisman showing this. You are to avoid reading any of the many articles and comments that discredit the Fisman study.​
35. There is no need to wait for data on pregnant women and birth rates before recommending a new vaccine for pregnant women.​
36. Kids are at severe risk for COVID, even when they aren’t. This is especially true for young kids. It’s about keeping them safe from dying from COVID, even if there are no deaths in healthy kids from COVID. So what if the risk benefit analysis shows the vaccines will kill 100 kids for every kid we might save? The focus is solely on saving kids from dying from COVID. If a child dies from a cardiac, clotting, or brain hemorrhage issue from the vaccine, those don’t count. Those are just anecdotes.​
37. If you aren’t sure about what you are allowed to say, try posting it on Twitter, Facebook, LinkedIn, or YouTube. If you get censored, stop saying it.​
38. A doctor’s first duty is to keep his/her job, not to serve patients.​
39. Autopsies are discouraged. The vaccine is safe so there is no reason to check to see if this caused the death.​
40. For anything unusual (like dramatic drops in live births, increase in stillbirths, excess cardiac ambulance calls, etc), just assure the public that the CDC is looking into it.​
41. There are no vaccine injured. These people are just under a lot of stress or are faking their symptoms to try to get money. Look, if there were any vaccine injuries, Dr. Nath at the NIH would be the very first first to publicly admit it. Check out this article on Dr. Nath. See? No injuries. He couldn’t find a link!​
42. Never measure D-dimer or troponin levels after the COVID vaccine. Why would you want to do that? It’s a waste of time.​
43. Informed consent means you were informed that you were going to be vaccinated and consented to it willingly. There is no need to reveal all the side-effects and risk of death; that would just scare people.​
44. If you work in a hospital, always follow what the hospital says. You will be compensated on your ability to follow hospital protocol, no matter how many of your patients die unnecessarily. The hospital administrators know best.​
45. You need to be fully vaccinated with the latest booster. If you are, there is no need to take a COVID test, even if you are feeling sick. Patient safety is #1.​
46. When one of your patients dies from a vaccine injury, never ever mention the vaccine. It’s just an “unexpected death.”​
47. People who think the vaccines are unsafe are simply mentally unfit. Avoid them or suggest psychiatric help.​
48. If a patient says they are vaccine injured, tell them you can’t treat them.​
49. If anyone asks about adverse vaccine reactions say that there is no proof of causation. So for example, just because the blindness happened right after the jab for lots of people doesn’t mean that the jab caused the blindness. It’s just a “coincidence.” Similarly, when formerly healthy people suffer from 12 or more adverse events that are elevated in VAERS for the COVID vaccines right after taking a shot, that’s just a “really unfortunate coincidence.” It is never caused by the vaccine. For there to be causality, you’d have to have an admission from the CDC first. There can’t be any causality without that.​
50. If anyone points out the huge spike in death reports in VAERS, tell them VAERS is voluntary reporting and thus unreliable and walk away as quickly as you can.​
51. Online newspapers that report what is really going on like The Epoch Times and The Daily Expose should be censored and deplatformed. Payment companies like Stripe and PayPal should refuse to do business with them.​
52. Do not watch this video where Tucker Carlson points out “Would you allow people who disagree with you to talk? If you wouldn’t, you are a tyrant.” That is misinformation. The new rules are clear: Do not allow anyone who disagrees with you to talk. Also, you certainly don’t want to give them a platform to spread their views either. That’s why debates must be avoided.​
53. Never log adverse reactions or deaths on VAERS. They can’t be vaccine related so all you are doing is wasting everyone’s time and alarming people. It also gives misinformation spreaders material to use.​
54. If you work at the CDC and find data that goes against the narrative, don’t let anyone know about it. This is important because negative data can be used by misinformation spreaders to create vaccine hesitancy.​
55. If a patient dies with COVID, it’s a COVID death, even if COVID didn’t cause the death.​
56. Always wear a mask when seeing patients. You want everyone to know you follow “best practices.”​
57. Masks work. Even when there is no science to back it up. They work because we say it works. We don’t need science.​
58. The COVID vaccines shall be mandated even when there is no scientific proof that mandates have a societal all-cause mortality benefit. Who needs data when you have a decision from Tony Fauci? If you have all-cause mortality data that shows that people who got the vaccine died at a higher rate than the unvaccinated, you are required to hide it. The medical journals won’t publish it anyway.​
59. Do not include any COVID vaccination date on the death record. This way, nobody will find out that vaccinated people are dying at a higher rate than the unvaccinated. Clever, isn’t it?​
60. Successful comedians who attempt to use humor to break the mass formation such as J.P. Sears, must be deplatformed. Humor is one of the most successful ways to reach people and change their minds and break the mass formation. These comedians should be identified and censored and their channels labelled as “violating our community standards.”​
61. Do not listen to UCSF Professor Vinay Prasad. He wrote an op-ed in April 2020 entitled “Scientists who express different views on Covid-19 should be heard, not demonized.” Prasad is wrong. Do the opposite. Demonize them and make sure they are not allowed to be heard. In particular, try to pass laws like they are doing in California, to ensure that doctors cannot speak out against the narrative. That is what any civilized society does: controls the narrative and suppresses free speech.​
62. Prasad also called out President Biden’s new Ministry of Truth as the worst idea ever. Again, he’s wrong. It’s the best idea ever. Why? Because we said so.​
63. We will provide huge monetary incentives to hospitals and nursing homes for categorizing deaths as COVID-19 deaths, even if the patient didn’t die from COVID-19. This keeps the public in fear which we need for them to be willing to follow any ridiculous directives we order such as mandatory vaccination, facecoverings, social distancing, and lockdowns (which have never been proven to work, but they don’t know that).​
64. Be sure to stay 6 feet away from people at all times. To be honest, there is no science behind the 6 foot rule since the virus is transmitted as an aerosol which can stay in the air for hours and days. If anyone asks for the science behind the 6 foot rule, just look at them like they are stupid, shake your head, and walk away. Never admit there is no science behind this rule or we’ll all look really stupid.​
65. It is safe to remove your mask while sitting down and eating because everyone knows you can’t get COVID while you are eating. OK, that really isn’t true but the thing is if we required masking at restaurants, there would be too much public outrage, so we’ve adjusted the rules to avoid this.​
66. People are not considered vaccinated until 2 weeks after their last shot. So if they die after the shot, but before the two weeks, the death must be counted as an “unvaccinated death.”​
67. In the monthly CDC tracking of deaths, the reason there is no column for deaths due to the COVID-19 vaccine because these vaccines are safe.​
68. There shall be no objections to these new rules from anyone, especially scientific leaders. In particular, no Dean of Science in the US, including MIT Dean of Science Nergis Mavalvala, shall speak out about the changes except to endorse them.​
69. Those are the new rules. You are required to follow them. If you don’t like them, I suggest you find a new profession. Now.​

Please share this widely as it’s important that everyone knows the new rules and follows them. It’s for the greater good. Trust us.

Steve Kirsch
May 1·edited May 1

I missed one, maybe the most important. Added at the end: "There shall be no objections to these new rules from anyone, especially scientific leaders. In particular, no Dean of Science in the US, including MIT Dean of Science Nergis Mavalvala, shall speak out about the changes except to endorse them."
 
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Heliobas Disciple

TB Fanatic
(fair use applies)

FDA Dismisses Paxlovid Concerns, Gaslights Recurrence Sufferers
Viral Rebounds are Extremely Rare, Says the FDA
Igor Chudov
5 hr ago

Yours truly and many other substackers brought up evidence that Paxlovid does not work well in vaccinated people. We discussed viral symptoms resurfacing around Day 10, and Brian explained biomolecular mechanisms of those rebounds.

My first article was posted on April 13. For a good summary of further developments after that article, look at my subsequent summary and discussion:


Well today, we have big news! FDA finally responded.

FDA Response: Gaslight and Ignore



Guess what the FDA did? Did the FDA request more data from Pfizer? Did the FDA reach out to hospitals? Did the FDA ask patients for input? Perhaps the FDA reached out to health insurance companies for more data? I mean, the FDA cares about us, so it should definitely get more information, would you agree?

The answer to all of the above questions is NO.

Instead, the FDA’s Dr John Farley, made a curious statement that ignored ALL current data. He also gaslit numerous victims of recurrence by saying that they are only 1-2%, so they are rare and effectively do not matter.

This ridiculous statement deserves to be published in full. It is most notable for what it does NOT say. Read on!



You can see that the FDA basically gaslights all current recurrence sufferers, by saying that their recurrences only happen in 1-2% of cases, implying that they are extremely rare. FDA bases its conclusion on the “Paxlovid trial" that involved only unvaccinated people.

Despite deciding to give Paxlovid to vaccinated people, on whom Paxlovid was never tested, the FDA seems to NOT want any new data on the effects of Paxlovid on the vaccinated.

FDA’s statement has ZERO indication of receiving or asking for additional data.

I also have a problem with veracity of their stated rebound rate of 1-2%. Take a look at the rebound chart from the EPIC-HR trial. (buried in the FDA analysis)



Does this look like only 1-2 percent of people had a rebound? It looks, to me, that a lot more than 2% had a rebound!

What most disappoints me is dismissal: instead of taking these reports seriously, the FDA basically ignores them, refers to the old study, and calls rebounds extremely rare.

Have we heard that sort of thing before? Sure. Those same people gaslit and dismissed reports of COVID vaccine injuries, with the same exact attitude.

Who is Dr. John Farley, MD?

Dr. Farley is one of the persons who played a role in approval of Remdesivir. Remdesivir, a hepatotoxic antiviral, showed NO STATISTICALLY SIGNIFICANT SURVIVAL BENEFIT in COVID patients. Despite acknowledging this, Dr. Farley is proud to have approved it, oddly enough.



This same article acknowledges that Remdesivir has no statistically significant survival benefit.



So, John Farley is happy to approve Remdesivir despite being toxic to the liver (hepatotoxicity) as well as providing no statistically significant survival benefit.

He is similarly happy to ignore and gaslight vaccinated people taking Paxlovid, who experience recurrences. Dr. Farley, strangely, bases his dismissal of problems with vaccinated people, on a trial involving only unvaccinated people
.
In my opinion, we need a new trial of Paxlovid involving vaccinated people, with time to recovery and viral rebound carefully re-analyzed. Paxlovid’s real life benefits outside of Pfizer’s clinical trial, may be greatly overstated.
 

Heliobas Disciple

TB Fanatic
(fair use applies)

meanwhile, back in the northeast
covid hospitalizations among the old were surging out of season
el gato malo
10 hr ago

i realize that things move pretty fast these days and that “out of season surges of covid hospitalization in the most highly vaxxed and boosted people in the US” is so “4 things ago” but this one has really been sticking with me as it seems to tie a lot of ends together around OAS, antigenic fixation, and the myths of severe disease suppression for current variants.

the trends in the northeast (apart from NH who is now rigging the definitions to avoid reporting apples to apples and will be omitted for that reason) look both out of season and increasingly worrying.

as our marker, i will continue to use the NYT data for “hospitalizations for covid” in the 70+ age group, a group that is 95% vaxxed there and heavily boosted as well.

this area continues to be about the only CONUS cases hotspot going (apart from what seems to be some border crossing issues in TX)



and it’s flowing into the hospitals. but it’s, for the most part, only affecting the old. and the pattern looks the same pretty much everywhere (and may be understated in recent days as this series can take time to fully update)



vermont is right at the highs from the january peak.

others are rising rapidly in a period that should be declining and all are up materially from a year ago.



as last year this time was dropping and this year is rising, expect this % variance to become more pronounced in coming weeks if this trend continues.

this looks nothing at all like herd immunity. this looks like the other thing…

two weeks ago, certain internet felines were heard to say:



well, the test keeps coming and so far, this looks like we’re seeing the signs of vaccine driven evolution driving covid to variants that are advantaged in the vaxxed and boosted and this is becoming an issue of severity on top of just spread.

this is, unfortunately, pretty much what was predicted here:

bad cattitude
homogenizing herd level antigenic fixation
antigenic fixation is a well studied issue, especially around influenza. how it came to have the oddly religion invoking name of “original antigenic sin” (OAS) is anyone’s guess, but it probably giv…
2 months ago · 749 likes · 362 comments · el gato malo


i keep hoping this is not going to be the awful set out outcomes that seem emergent and i could, of course, still be wrong, but in the battle of biology vs ideology, biology remains undefeated and the intersection of leaky vaccines and antigenic fixation is a very high risk place and that risk rises over time.

no one seems to want to talk about this trend just now, but i think it bears serious watching.

something untoward is going on in the northeast and if it keeps getting bigger at this rate, it’s going to pop back up on the radar soon.
 

Heliobas Disciple

TB Fanatic
(fair use applies)

FDA Debunks Pfizer’s Claim: ‘No Evidence’ that Retaking Paxlovid Pill Stops Recurring Covid-19 Symptoms
By Jim Hoft
Published May 5, 2022 at 5:07pm

U.S. Food and Drug Administration said on Wednesday that using Pfizer’s Paxlovid pill has “no evidence of benefit at this time for a longer course of treatment” in patients with recurrent Covid-19 symptoms, contradicting Pfizer’s CEO Albert Bourla’s comments.

As the Gateway Pundit previously reported, there are more and more reports of patients who were taking Pfizer’s antiviral pill experiencing a second round of Covid-19 shortly after recovering and doctors were baffled.

In cases where virus levels rebound, “then you give a second course, like you do with antibiotics, and that’s it,” Pfizer CEO Albert Bourla told Bloomberg on Tuesday.

The FDA released a statement on Wednesday debunking Pfizer’s chief executive claims that patients can take more
additional information as it becomes available. However, there is no evidence of benefit at this time for a longer course of treatment (e.g., 10 days rather than the 5 days recommended in the Provider Fact Sheet for Paxlovid) or repeating a treatment course of Paxlovid in patients with recurrent COVID-19 symptoms following completion of a treatment course,” according to John Farley, director of the Food and Drug Administration’s (FDA) Office of Infectious Diseases.

Bloomberg reported:

There is “no evidence” that a second course of Pfizer Inc.’s Paxlovid will help Covid-19 patients whose symptoms return after an initial course of the antiviral, a U.S. Food and Drug Administration official said a day after Pfizer executives advocated the idea.
Doctors and virologists have been struggling to understand a number of patient reports of viral rebounds after completion of a five-day course of the Covid treatment. In an interview Tuesday, Pfizer Chief Executive Officer Albert Bourla said doctors could prescribe a second course of treatment to patients who suffer a rebound.
Some physicians have suggested a longer course of Paxlovid might prevent symptoms from returning.
No data support a longer course of treatment or two separate five-day courses to treat or prevent relapse, John Farley said Wednesday in a post on the agency’s website.
“We are continuing to review data from clinical trials and will provide additional information as it becomes available.”
A Pfizer spokesman said Thursday that the Paxlovid emergency authorization label does not preclude a patient later being prescribed a second round of Paxlovid if the virus recurs after the first course is completed.

Last month, Pfizer released a statement admitting that it failed to reduce the risk of confirmed and symptomatic COVID-19 infection in adults living with someone who had been exposed to the virus.

“While we are disappointed in the outcome of this particular study, these results do not impact the strong efficacy and safety data we’ve observed in our earlier trial for the treatment of COVID-19 patients at high risk of developing severe illness, and we are pleased to see the growing global use of PAXLOVID in that population,” Bourla said in a statement.
 

Heliobas Disciple

TB Fanatic
https://www.bloomberg.com/news/articles/2022-05-04/fda-contradicts-pfizer-s-advice-on-second-course-of-covid-drug-l2rv2yfh
(fair use applies)

Pfizer’s Advice on Retaking Covid Drug Contradicted by FDA
By Robert Langreth
May 4, 2022, 1:36 PM EDT Updated onMay 4, 2022, 4:59 PM EDT
  • No data support longer or second treatment for viral rebound
  • Relationship of relapse to drug treatment remains unclear
There is “no evidence” that a second course of Pfizer Inc.’s Paxlovid will help Covid-19 patients whose symptoms return after an initial course of the antiviral, a U.S. Food and Drug Administration official said a day after Pfizer executives advocated the idea.

Doctors and virologists have been struggling to understand a number of patient reports of viral rebounds after completion of a five-day course of the Covid treatment. In an interview Tuesday, Pfizer Chief Executive Officer Albert Bourla said doctors could prescribe a second course of treatment to patients who suffer a rebound.

In cases where virus levels rebound, “then you give a second course, like you do with antibiotics, and that’s it,” Bourla said Tuesday. Some physicians have suggested a longer course of Paxlovid might prevent symptoms from returning.

No data support a longer course of treatment or two separate five-day courses to treat or prevent relapse, John Farley, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said Wednesday in a post on the agency’s website.

“There is no evidence of benefit at this time” for either repeat dosing or a longer course of treatment, Farley said in the post. “We are continuing to review data from clinical trials and will provide additional information as it becomes available.”
A Pfizer spokesman said Thursday that the Paxlovid emergency authorization label does not preclude a patient later being prescribed a second round of Paxlovid if the virus recurs after the first course is completed.

Meanwhile, the drugmaker studied a 10-day course of treatment in an early-stage clinical trial, and will keep the public informed on whether it plans to conduct a separate study of the treatment over that duration of time, Pfizer spokesperson Jerica Pitts said.

“As always, patients should consult directly with their physician,” she said.

Analyses of earlier clinical trial data showed that roughly 1% to 2% of people in an earlier trial had positive polymerase chain reaction, or PCR, tests following a course of Paxlovid course and an initial negative test, Farley said. However, some people who received a placebo also experienced viral rebound, he said.

“It is unclear at this point that this is related to drug treatment,” Farley said in the update. Pfizer has also said that the phenomenon is unlikely to be related to the drug.

The government considers Paxlovid the “preferred therapy for the management of non-hospitalized adults with Covid-19,” the FDA said Wednesday in a statement, citing National Institutes of Health treatment guidelines.

Shares of Pfizer fell 0.4% as of 1:26 p.m. in New York.

— With assistance by Riley Griffin, and Madison Muller
(Adds additional Pfizer comment sixth paragraph)
 
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Heliobas Disciple

TB Fanatic
(fair use applies)

NIH Investigating Why Patients Relapse After Taking Pfizer’s COVID Antiviral Pill, Paxlovid
Responding to reports of patients relapsing after completing a five-day course of Paxlovid, Pfizer CEO Albert Bourla suggested patients just take more, prompting a rebuke from a U.S. Food and Drug Administration official.
By Julie Comber, Ph.D.
05/05/22

National Institutes of Health (NIH) researchers said they will investigate how often and why coronavirus levels rebound in some patients who complete a five-day course of Pfizer’s COVID-19 antiviral pill, Paxlovid.

“It is a priority,” Clifford Lane, deputy director for clinical research at the National Institute of Allergy and Infectious Diseases, told Bloomberg. It’s “a pretty urgent thing for us to get a handle on.”

Lane said the agency is discussing with scientists at the Centers for Disease Control and Prevention possible epidemiological and clinical studies to examine post-Paxlovid rebound.

In response to reports of patients relapsing after taking Paxlovid, Pfizer CEO Albert Bourla on Tuesday suggested they take more of the treatment, contrary to the established protocol.

Bourla’s comment prompted a U.S. Food and Drug Administration (FDA) official on Wednesday to contradict Bourla, FiercePharma reported.

John Farley, M.D., director of the Office of Infectious Diseases, in the FDA Updates on Paxlovid for Health Care Providers wrote:
“There is no evidence of benefit at this time for a longer course of treatment (e.g., 10 days rather than the 5 days recommended in the Provider Fact Sheet for Paxlovid) or repeating a treatment course of Paxlovid in patients with recurrent COVID-19 symptoms following completion of a treatment course.”

Bloomberg and ABC News reported on accounts of viral rebound after treatment with Paxlovid that were posted on social media or described by physicians and patients.

People described feeling better rapidly after starting the five-day course of Paxlovid, testing negative on a rapid test after treatment and resuming normal activities, only to have their symptoms come roaring back within days of their last dose. Some patients tested positive again.

The only case of viral rebound reported in the medical literature so far is a preprint study released April 26.

Pfizer last week issued a press release stating Paxlovid did not prevent COVID-19 infection in people who were exposed to a household member infected with the virus.

The FDA in December 2021, granted Emergency Use Authorization (EUA) for Paxlovid, a combination of nirmatrelvir and ritonavir tablets, for patients at high risk of progressing to severe COVID-19.

This EUA was based on Pfizer’s Phase 2-3 double-blind, randomized, controlled trial. Participants were included in the trial if they had symptomatic COVID-19, were unvaccinated, were not hospitalized, were adults and were at high risk for progression to severe COVID-19.

The trial data, recently published in The New England Journal of Medicine, showed an 89% relative risk reduction of progression to severe COVID-19 for this high-risk group, meaning, those in the trial who took a five-day course of Paxlovid had a lower risk of progressing to severe COVID-19.

However, for those who were already immune to COVID-19, the absolute risk reduction was about 1%.

On the basis of the Pfizer trial data, President Biden in March announced the “Test to Treat” initiative, a plan that allows Americans who test positive for COVID-19 at a pharmacy to get free antiviral pills immediately, including Paxlovid.

The Paxlovid EUA is for high-risk people. In the Test to Treat centers, patients are instructed to bring a list of medications with them and to ask the healthcare provider at the center if they are eligible for oral antiviral treatment.

The Test to Treat healthcare provider will then decide if the patient is at high risk.

As reported in The Defender, the taxpayer-funded initiative is a huge windfall for Pfizer, especially coming on top of the multi-billion-dollar government contracts for the drugmaker’s COVID-19 vaccine.

John Campbell, Ph.D., in the video below pointed out that Pfizer’s Paxlovid trial took place from mid-July to early December 2021, when the Delta variant was dominant. [scroll up for video, posted yesterday]

The time period during which the trial occurred also is when fewer people had naturally acquired or vaccine-induced immunity to COVID-19, raising questions about whether the $530 five-day treatment is even effective against the newer variants predominant today.

The FDA granted the EUA for children 12 and older and for COVID-19-vaccinated people — even though both groups were excluded from the clinical trials.

Despite concerns about viral rebound, Pfizer executives said the use of Paxlovid has increased by nearly 10-fold in recent weeks, as infection rates across the U.S. rise.

Pfizer foresees $54 billion in global sales this year — $32 billion from its COVID-19 vaccine and $22 billion from Paxlovid.
 

Heliobas Disciple

TB Fanatic
(fair use applies)

US restricts use of Johnson & Johnson Covid vaccine over rare blood clot risk
The Food and Drug Administration said the shot should be given only to those who request it or cannot receive other vaccines

Associated Press
Thu 5 May 2022 17.53 EDT

US regulators on Thursday strictly limited who can receive Johnson & Johnson’s Covid-19 vaccine due to a rare but serious risk of blood clots.

The Food and Drug Administration said the shot should only be given to adults who cannot receive a different vaccine or specifically request Johnson & Johnson’s vaccine. US authorities for months have recommended that Americans starting their Covid-19 vaccinations use the Pfizer or Moderna shots instead.

FDA officials said in a statement that they decided to restrict Johnson & Johnson’s vaccine after taking another look at data on the risk of life-threatening blood clots within two weeks of vaccination.

The decision is the latest restriction to hit Johnson & Johnson’s one-dose vaccine, which has long been overshadowed by the more effective two shots from Pfizer and Moderna.

In December, the Centers for Disease Control and Prevention (CDC) recommended prioritizing the Moderna and Pfizer shots over Johnson & Johnson’s because of its safety concerns. Previously US officials had treated all three vaccines similarly because they’d each been shown to offer strong protection.

But follow-up studies have consistently shown lower effectiveness for Johnson & Johnson’s vaccine. And while the blood clots seen with Johnson & Johnson’s shot are rare, officials say they are still occurring.
 

Heliobas Disciple

TB Fanatic
(fair use applies)

Georgia Governor Signs Bill Barring COVID-19 Vaccine ‘Passports’
By Zachary Stieber
May 5, 2022

Georgia’s governor has signed a bill that bans state and county agencies from requiring proof of COVID-19 vaccination.

After signing the bill on May 3, Gov. Brian Kemp said that “we will always stand up for the rights of our people against government overreach.”

The legislation, Senate Bill 345, prohibits state and local governments from mandating “vaccine passports,” or requiring proof that a person has gotten the COVID vaccine.

The bill “simply bans the ability of the state of Georgia to mandate the COVID-19 vaccination—that’s it,” state Sen. Jeff Mullis, a Republican and the bill’s sponsor, told a state Senate panel earlier this year.

Previously, Georgia residents could have been excluded from governmental functions such as speaking about proposed legislation at the state Capitol or attending school, state Rep. Bonnie Rich, a Republican who sponsored the House version of the bill, said on the House floor.

The legislation was altered after being introduced, including making clear that it doesn’t apply in cases when an agency would violate federal law by following it.

One such example is hospital systems, which are largely governed by the U.S. Centers for Medicare and Medicaid Services. That agency has a COVID-19 vaccine requirement in place for employees at systems that receive Medicare or Medicaid funding.

Another change to attempt to appease critics is a sunset provision.

The law will be repealed on June 20, 2023.

Mullis said he plans to revisit the matter by then, saying it’s possible the prohibition could be extended, perhaps permanently.

Sponsors said the bill still allows school systems to require COVID-19 vaccination, although the final version says the word agency means, among other entities, every school district in the state.

The final vote in the House was 99–67. The Senate approved the measure in a 34–20 vote.

State Sen. Michelle Au, a Democrat and a doctor, was among those voting no.

“This bill undermines public trust in the COVID vaccine,” she claimed on the Senate floor, describing the vaccines as safe and effective.

Kemp, who is running for reelection, in May 2021 issued an executive order that barred state agencies from requiring vaccine passports.

The new bill goes further by including agencies on the county level.

Kemp, Mullis, and Rich all said they are vaccinated, but feel people shouldn’t be mandated to get the jab. ...
 

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Therapies That Can Help Ease Long COVID Breathlessness, Fatigue
By Dennis Thompson
May 5, 2022

Occupational therapy or low-impact exercise might be the key to relieving long-haul COVID symptoms like extreme fatigue, breathlessness and brain fog, a pair of new studies from Ireland suggest.

The studies reflect two different — in some ways, opposite — approaches to dealing with symptoms that tend to plague long COVID patients.

One study taught long COVID patients through a four-week occupational therapy program how to better manage their fatigue, with an emphasis on energy planning, stress management and sleep hygiene.

The other attempted to improve long-haul symptoms through a six-week exercise program aimed at gradually increasing patients’ stamina.

“The main problem is extreme fatigue that is unrelenting,” said Louise Norris, lead researcher of the first study and a senior occupational therapist with St. James’ Hospital in Dublin. “People think they need to rest more in this situation, but actually too much rest is just as bad as too little. Introducing a balanced routine to prevent highs and lows in energy consumption is key.”

At least one in 10 COVID patients suffer from symptoms that linger months past their initial infection, according to tracking estimates from the Johns Hopkins Bloomberg School of Public Health, in Baltimore.

These folks suffer from post-infection lethargy similar to that of patients with Lyme disease or chronic fatigue syndrome, said David Putrino, director of rehabilitation innovation for the Mount Sinai Health System in New York City.

For the studies, two separate research groups at St. James’ Hospital tried to relieve these symptoms by asking patients to take part in weeks-long virtual programs, according to findings presented last week at the European Congress of Clinical Microbiology & Infectious Diseases annual meeting in Lisbon, Portugal. Such research is considered preliminary until published in a peer-reviewed journal.

Norris’ pilot program recruited 53 long COVID patients, nearly all of whom reported moderate to severe fatigue that affected their ability to take part in everyday activities. Nearly three of four said they had breathing difficulties, while half had brain fog.

The participants took part in three 1.5-hour group-based sessions delivered online by an occupational therapist over a four-week period.

Emphasis was placed on helping the participants identify their body and brain’s limits during day-to-day activities, so that they could conserve their energy and take a break before reaching the point of exhaustion.

“The program will help the person tailor their personal energy demands to prevent this. For example, a common complaint was difficulty doing the groceries for the week without forgetting some essentials. We advised people to try online shopping, as they can go back and add more items to the basket if they remember something,” Norris said.

“Some people experience total wipe out and don’t have the energy to get dressed, others have COVID brain fog and can’t think clearly in work or figure out bus time tables. Some people have a mixture of both physical fatigue and cognitive fatigue at different times of the day,” Norris continued.

“So, it is important to understand from the outset how your own body is responding to daily energy demands. Knowing this gives the individual confidence to figure out what time of day is optimal for certain activities,” she explained. “This is the first really valuable lesson and gives the individual confidence.”

Preliminary analysis of results showed that the participants experienced significant improvements in their levels of fatigue, quality of life and concerns over their well-being, Norris reported.

“At the end of the program, people subjectively felt they could control their fatigue levels on their own,” Norris said.

The other study involved 60 long COVID patients at St. James’ Hospital who were asked to participate in two 50-minute virtual exercise classes a week for a minimum of six weeks. The intensity of the sessions increased gradually over time as patients built up their exercise tolerance.

Preliminary data from the first 40 patients to complete the program found a significant increase in the distance participants could walk in six minutes. They were able to walk 34% further on average by the end of the study, with significant improvement observed in more than nine out of 10 patients, the researchers said.

Patients also experienced improvements in their breathlessness, fatigue and quality of life. For example, they reported that they were better able to perform everyday activities like climbing stairs or carrying groceries.

Fatigue levels improved significantly in more than 70% of patients, while 23% experienced no change in their fatigue. None were more fatigued than before, the researchers noted.

Putrino said it makes a lot of sense to use occupational therapy to help long COVID patients self-manage their energy levels.

“We converse with people with long COVID about concepts like energy windows and energy conservation techniques,” Putrino said. “We educate about the idea that exertion doesn’t necessarily just mean physical exertion — it can be emotional exertion, it can be cognitive [mental] exertion — and being cognizant of all of those facts as you’re planning out your day and your energy expenditure to make sure that you stay within those windows.”

However, Putrino sounded a note of skepticism when it comes to using an exercise program to improve stamina in long COVID patients.

Putrino noted that people with Lyme disease or chronic fatigue syndrome tend to crash hard within a couple of days of physical exercise, a phenomenon known as post-exertional malaise or post-exertional symptom exacerbation.

“You can be fine in the moment while you’re exerting yourself, and it’s not until up to two days later that you experience these symptoms,” Putrino said. “These exercise-based rehabilitation approaches encourage aerobic exercise and pushing people past their energy barriers, rather than being respectful of people’s activity and exertion limitations — that old fashioned ‘no pain, no gain’ approach,” he explained.

“I fear we’re completely ignoring decades of literature that folks with other infection-associated illnesses such as Lyme disease and myalgic encephalomyelitis/chronic fatigue syndrome have published,” Putrino continued. “We’re just repeating the mistakes of the past.”

Both programs did share one innovative approach that could cost-effectively extend long COVID therapy to many patients, said Dr. Siddharth Singh, director of the Post-COVID-19 Cardiology Clinic in the Smidt Heart Institute at Cedars-Sinai, in Los Angeles.

“They were able to reach out to multiple people at the same time in a virtual setting. So this may not be as cost intensive as one-on-one coaching,” Singh said.

However, Singh noted that neither study included a control group against whom to compare the people taking the therapy, and that both relied on patients to self-report their symptoms rather than using objective measurements.

“The important thing is going to be replicating this in a larger sample size with a control group, and then also use some more objective measures” of physical activity, fatigue and cognitive ability, Singh said.

More information

The U.S. Centers for Disease Control and Prevention has more about long COVID.

SOURCES: Louise Norris, senior occupational therapist, St. James’ Hospital, Dublin, Ireland; David Putrino, PhD, director, rehabilitation innovation, Mount Sinai Health System, New York City; Siddharth Singh, MD, director, Post-COVID 19 Cardiology Clinic, Smidt Heart Institute at Cedars-Sinai, Los Angeles; European Congress of Clinical Microbiology & Infectious Diseases annual meeting, Lisbon, Portugal, April 23 to 26, 2022


Thompson, a HealthDay senior staff reporter, has been a reporter for over 25 years, serving primarily at Gannett newspapers on both coasts of the United States. He has also worked for over 10 years as a freelance health reporter, writing articles for a variety of online and print news companies.

This story was originally published on the HealthDay site.
 

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Remdesivir Has ‘No Significant Effect’ on Ventilator COVID-19 Patients: Study
By Jack Phillips
May 5, 2022

Remdesivir has little effect on hospitalized COVID-19 patients who are on ventilators, according to results from a World Health Organization-backed (WHO) randomized trial and analysis.

The results, published in The Lancet (pdf), evaluated 14,221 patients from 454 hospitals in 35 countries, including 8,275 who were randomly assigned to receive up to 10 daily infusions of remdesivir or a control drug between March 2020 and January 2021—coming before the emergence of the Delta and Omicron COVID-19 variants.

About 602 patients of 4,146, or 14.5 percent, who were given remdesivir died. That’s compared with 643 deaths out of 4,129, or 15.6 percent, who were in the control group, according to the study’s authors.

Some 42.1 percent of patients, or 151 out of 359, who were already on a ventilator and were given remdesivir died, the study found. That’s compared with 134 deaths among 347 ventilator patients, or 38.6 percent, who were in the control group, researchers said.

“Remdesivir has no significant effect on patients with COVID-19 who are already being ventilated. Among other hospitalized patients, it has a small effect against death or progression to ventilation (or both),” the researchers concluded in an abstract of the study.

Researchers found in their trial and analysis that the drug may give a slight benefit to COVID-19 patients who are receiving oxygen but are not on a ventilator. Of the patients who were only receiving oxygen, 14.6 percent of those who received remdesivir died, while 16.3 percent of those in the control group died.

“However, given that high-flow and low-flow oxygen were not recorded separately at enrollment into Solidarity, it is not known whether any protective effect in non-ventilated patients extends to those on high-flow oxygen,” they noted.

Following their analysis, the researchers said that better COVID-19 treatments and drugs are needed.

“Regardless of how these findings are interpreted, better drugs to treat COVID-19 will continue to be needed. Oral antiviral agents, various immune modulators, and monoclonal antibodies against currently circulating variants of concern are now emerging that might prove more effective, more convenient, or less expensive than daily remdesivir infusions, but large-scale randomized evidence will be needed to evaluate and compare them,” they wrote.

But Dr. Carolina Garcia-Vida, of University of Barcelona in Spain, and Dr. Maurizio Sanguinetti of the Fondazione Policlinico Universitario A Gemelli in Rome, wrote in a Lancet-published commentary on the study that the trial has some limitations.

“A clear limitation of the trial is not including data on days since symptom onset to remdesivir use, viral load as measured by cycle threshold values, or viral antigen levels (or even viraemia). These factors might prove more suitably integral in evaluating the effectiveness of remdesivir,” they jointly said. Viremia is when viruses enter the bloodstream and then have access to the rest of the body.

Earlier this year, a study found that a combination of remdesivir and a concentrated solution of antibodies did not perform well in people hospitalized with the virus.

Researchers stated that “there was no evidence that patients who received a single infusion of hIVIG in addition to remdesivir and other standard of care had better clinical outcomes at day 7 after randomization than patients who received placebo plus remdesivir and standard of care.”

Nonetheless, the U.S. Food and Drug Administration on April 25 expanded approval of Veklury, or remdesivir, to include pediatric patients who are 28 days and older, weigh at least 7 pounds, and have tested positive for COVID-19.

Possible remdesivir side effects include increased liver enzyme levels, which may be a sign of hepatotoxicity, or liver injury, as well as various allergic reactions such as blood pressure changes, low blood oxygen levels, shortness of breath, fever, swelling, sweating, shivering, or nausea.



~~~~~~~~~~~~

Posting my own disclaimer here. If your doctor recommends a therapy for you, listen to your doctor. Don't take the advice of internet articles over your own doctor. If you don't trust your doctor, find one you do trust. But once you have a trustworthy doctor, listen to them. /end my comment
 

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Why do some people get sicker from COVID than others?
by Andrew Thurston, Boston University
May 5, 2022

COVID-19 vaccines have saved at least a million lives in the United States alone, but for many people, a lingering fear remains: If—or when—they get hit by the coronavirus, just how bad will it be? Will they breeze through with little more than a sore throat—or will it saddle them with long-term complications, perhaps even push them to the brink of death?

Since SARS-CoV-2 first began storming around the world in early 2020, COVID-19 has claimed six million lives and counting, according to the World Health Organization. And yet, the vast majority of people who've contracted COVID—some 99 percent of the more than 500 million confirmed cases—have survived their brush with the disease.

So, why is it that some people are so badly affected by COVID when many are barely scratched by it? Age and other health conditions increase the risk of getting really sick, but a new study suggests that those who escape the worst symptoms might also have the right balance of a type of immune cells called macrophages.

White blood cells found in every tissue, macrophages—part of a group of cells called myeloid cells, the guards of the immune system—are healers. They're crucial in wound repair, streaming to an injury to help the body patch itself up. They also take on invaders, gobbling up and digesting anything that looks like it doesn't belong in the body, from dead cells to harmful bacteria. That attack mode helps keep us healthy, but it also seems to be a factor in severe COVID-19 cases. Evidence has been growing that many COVID deaths are caused by a hyper-immune response: rampaging macrophages attacking not just the virus, but also our bodies, causing excessive inflammation and damaging heart and lung tissue.

In a study published in Cell Reports, a team of researchers at Boston University's National Emerging Infectious Diseases Laboratories (NEIDL) and Princeton University looked at why that was happening, examining COVID's impact on those who get dangerously sick—and those who don't. By studying lungs that seem to easily deflect SARS-CoV-2 or quickly bounce back from infection, they found a set of genes that determine whether immune cells mount a solid defense—or turn rogue and land someone on a ventilator. The findings could help efforts to develop new drugs that better prime immune systems for taking on the virus.

"If you can understand why most people are protected against COVID and how their body protects them, then you could potentially harness this knowledge to develop therapeutics and other advances," says Florian Douam, a BU School of Medicine assistant professor of microbiology who coled the study.

Why are some lungs protected against COVID?

After two years of sickness and swabbing, there's a lot scientists know about how SARS-CoV-2 is transmitted and how our bodies react when we get it—but there's also a lot they don't understand. Take the lungs: We know COVID-19 can leave lungs full of liquid and inflamed, sometimes scarred by sepsis. But most of what's known about COVID in the lungs is driven by samples taken from those who died from the disease—not those who lived through it.

"You can only access the lung when the patient dies," says Douam, who's based at NEIDL. "You cannot obviously get someone who had a mild disease and tell them, 'Oh, give me your lung.' In contrast to lung autopsy samples from diseased patients, the lungs from milder or asymptomatic patients are just much harder to access. When you have the diseased lung, you get a snapshot of the end-stage disease."

To get around this challenge, Douam and the research team developed a new model—a mouse engrafted with human lung tissue and bolstered with a human immune system derived from stem cells—for monitoring the different stages of SARS-CoV-2 infection and COVID-19 disease. Douam says that mice with human lung tissue, but without the human immune system, don't react well to infection—the lung tissues are damaged in a similar way to people with a severe case of the disease. But when they studied mice that also had a humanized immune system, it was different. "We were barely seeing any virus in the lungs," he says. "The lung was protected. Then we asked the question, 'Why is the lung protected?' And this is where we found the macrophages."

'Protection-defining genes'

According to Devin Kenney, a Ph.D. student in Douam's lab and lead author on the latest paper, one signature of lungs that were more severely impacted by COVID was a lack of macrophage diversity. They were dominated by a pro-inflammatory macrophage—the cells that usually respond to viruses and bacteria—called M1.

"It seems they drive this hyper-inflammatory response," says Kenney, "and it leads to a more severe disease state."

By contrast, those immune systems that mixed in more of the cells that typically help in wound repair—M2 or regulatory macrophages—fared better.

"If you have a more diverse macrophage population that has both regulatory and inflammatory macrophages, you can more effectively regulate the signals driving antiviral responses, shutting them off when appropriate," he says. "Then, the immune system can clear the virus really rapidly, protect the tissue."

The researchers tied this positive antiviral response to a set of 11 genes they called "protection-defining genes." In cases of effective resistance, these genes were working harder, or what's known as upregulated.

"We now know not only that macrophages can promote protection in the lung tissue," says Douam. "We also know the key set of genes that these macrophages need to express to protect the lung."

What they don't know yet is why some people can put a diverse mix of macrophages to work while others can't. That's a target for future studies.

"What we're doing here is really upstream," says Douam. "If you can generate knowledge and better understand the molecular processes driving lung protection from COVID-19, then once you get this really good comprehensive picture of what's happening, you can start designing potential immunotherapy strategies."

And that's the end goal of this work. Knowing that some genes are critical in the COVID fight gives potential fresh targets for drugs. With new coronavirus variants springing up and taking root at a rapid rate, says Douam, it's important that scientists find alternatives to medications that target the virus itself.

"The virus, over time, can start escaping these types of drugs," he says. "It's not the virus itself that makes you critically ill, it's an overreaction of the immune system."

Finding drugs that help patients have a more balanced immune response could "complement the antiviral strategy."
 

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Investigational COVID mucosal vaccine protects against disease and transmission
by Duke University Medical Center
May 5, 2022

1651826807197.jpeg
Oral and intranasal r-Ad-S vaccination induced robust IgG and IgA antibodies in golden hamsters. Index hamsters were immunized with oral r-Ad-S, intranasal (IN) r-Ad-S, intramuscular (IM) spike protein (S) or mock (oral) (n = 4 per group) and inoculated with SARS-CoV-2 seven weeks later. (A) Experimental design schematic. Figure created with BioRender.com (B) Serum anti-spike protein IgG antibody endpoint titers were measured at weeks 0, 3 and 6 post immunization by enzyme-linked immunosorbent assay (ELISA). (C) Serum anti-spike protein IgG antibody endpoint titers were measured at week 6 post immunization against the spike protein of the Wuhan, Beta, and Delta SARS-CoV-2 variants by ELISA. (D) Surrogate neutralizing antibodies (antibodies capable of blocking binding of SARS-CoV-2 spike protein to ACE2) titers were measured in serum at week 6. (E) Serum anti-spike protein IgA antibody titers were measured (MSD arbitrary units (AU)/sample) at weeks 0, 3, and 6 post immunization using the MSD platform and normalized to day 0 AU values. (F) anti-spike protein IgA antibodies were measured in BAL fluid using the MSD platform. Data were analyzed by a one-way ANOVA and Dunnett’s multiple comparisons. Comparisons were made between vaccinated groups and mock (oral) controls for (B, D, E and F). Error bars represent the standard error of the mean (SEM). *P<0.05, **P<0.01, ***P<0.001, ****P<0.0001. Credit: Science Translational Medicine (2022). DOI: 10.1126/scitranslmed.abn6868


In animal studies that mimic human exposures, an investigational COVID vaccine designed to be taken orally not only protects the host, but also decreases the airborne spread of the virus to other close contacts.

The study, led by Duke researcher Stephanie N. Langel, Ph.D., demonstrated the potential of a COVID vaccine that works through the mucosal tissue to neutralize the SARS-CoV-2 virus, limiting infections and the spread of active virus in airborne particles.

The findings are published today in the journal Science Translational Medicine.

"Considering most of the world is under-immunized—and this is especially true of children—the possibility that a vaccinated person with a breakthrough infection can spread COVID to unimmunized family or community members poses a public health risk," Langel said. "There would be a substantial benefit to develop vaccines that not only protect against disease, but also reduce transmission to unvaccinated people."

Langel and colleagues—including teams from the vaccine developer Vaxart, and a clinical research non-profit, Lovelace Biomedical Research Institute—tested a vaccine candidate that uses an adenovirus as a vector to express the spike protein of the SARS-CoV-2 virus. The human vaccine is designed to be taken as a pill.

In studies using hamsters, the vaccine elicited a robust antibody response in blood and the lungs. When the animals were exposed to the SARS-CoV-2 virus at high levels, prompting breakthrough infections, they were less symptomatic than non-vaccinated hamsters, had lower amounts of infectious virus in the nose and lungs. Because of this, they did not shed as much virus through normal airborne exposures.

Unlike vaccines that are injected into the muscle, Langel said, mucosal immunizations increase production of immunoglobulin A (IgA)—the immune system's first line of defense against pathogens—in the nose and lungs. These mucosal ports of entry are then protected, making it less likely that those who are vaccinated will transmit infectious virus during a sneeze or cough.

"Our data demonstrate that mucosal immunization is a viable strategy to decrease the spread of COVID through airborne transmission," Langel said.

Langel said the study focused on the original SARS-CoV-2 virus, and new studies will be designed to test the vaccine against Omicron variants.

In addition to Langel, study authors include Susan Johnson, Clarissa I. Martinez, Sarah N. Tedjakusuma, Nadine Peinovich, Emery G. Dora, Philip J. Kuehl, Hammad Irshad, Edward G. Barrett, Adam Werts, and Sean N Tucker.
 

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Rapid antigen COVID-19 tests may not be keeping pace with variants of concern, researchers find
by Jacqueline Mitchell, Beth Israel Deaconess Medical Center
May 5, 2022

By now, many have become all too familiar with rapid antigen tests for diagnosis of COVID-19. Slightly less accurate than the genetic tests administered by healthcare professionals, the rapid antigen tests' ease-of-use allows the general public to monitor themselves for COVID-19 infections at home and make timely decisions to help stop the spread. The home tests, however, were developed and granted federal authorization for use with the original SARS-CoV-2 viral strain that emerged late in 2019. Since then, the virus has evolved countless times, and several viral variants of concern have emerged, including the highly infectious delta and omicron variants that swept across the United States last summer and winter respectively.

In a recent study, scientists at the Harvard T.H. Chan School of Public Health and Beth Israel Deaconess Medical Center used live virus culture to assess how well four rapid antigen tests are able to detect these COVID variants of concern. The findings suggest that while the rapid antigen tests remain a useful tool for the detection of COVID-19 infections, continuous assessment and updating is likely needed in the context of variants of concern. Their work is published in the Journal of Clinical Microbiology.

"Unlike the sensitive molecular tests that detect multiple SARS-CoV-2 genes, rapid antigen tests target a single viral protein," said co-corresponding author James Kirby, MD, director of the Clinical Microbiology Laboratory at BIDMC. "As the pandemic continues, however, some hypothesize that the performance of available antigen test may vary among the COVID variants of concern."

Using three strains of cultured live virus, the team assessed differences in the limits of detection (LoD)—the smallest amount of viral antigen detectable at 95 percent certainty—of four commercially available rapid antigen tests; the Binax, CareStart, GenBody and LumiraDx tests. The researchers found that all four tests were as sensitive to the omicron variant, if not more, as they were to original SARS-CoV-2 viral strain, known as WA1. Three tests, however, showed less sensitivity to the delta strain, with only the CareStart demonstrating equal detection of all three strains.

"We expect that the observed loss in delta sensitivity could have resulted in a 20 percent or more loss of detection in potentially infectious individuals—nevertheless, the most infectious individuals still should have been detected," said Kirby, also a professor of pathology at Harvard Medical School. "However, our findings suggest that antigen test performance needs to be reevaluated for emerging variants to ensure they still meet the intended public health testing goals of the pandemic."
 

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Vaccines induce multiple immune system mechanisms to protect against severe COVID-19 illness
by Public Library of Science
May 5, 2022

Globally, breakthrough COVID-19 infections among vaccinated people are increasing, raising concerns about the durability of protection against emerging, highly contagious variants of concern. A study publishing May 5th in the open access journal PLOS Biology, by Galit Alter at Harvard University, Cambridge, U.S. and colleagues, suggests that while vaccine-induced neutralizing antibody responses protect against infection, control of viral replication is mediated by responses that involve T cells and the antibody-binding Fc receptor.

While vaccine-induced neutralizing antibody responses (that is, antibodies that directly bind the virus and "neutralize" infection) provide the primary protection against infection and severe disease, other, less well understood, immune responses contribute to protection. To better understand the protective role of each immune mechanism, the researchers immunized five groups of five rhesus macaques with different doses of COVID-19 vaccine or a sham control. They then challenged all macaques with SARS-CoV-2 infection and analyzed viral replication in the upper and lower respiratory tracts 1, 2, 4, 7 and 10 days after the viral challenge.

The researchers found that the immunity mechanisms responsible for controlling viral replication following infection were dose dependent, indicating an important role in protection against severe illness and death. These additional immune responses which control viral replication are mediated by the so-called Fc receptor (a cell-surface molecule that recognizes the invariant part of antibodies, and can trigger the destruction of infected cells) and by T-cell responses, complementing the other antibody responses that directly neutralize the virus.

According to the authors, "The continued emergence of several SARS-CoV-2 variants with enhanced infectivity and immune evasive capacity have further complicated the worldwide vaccination effort. These data provide critical insights in the context of the current pandemic, where emerging variants of concern have the capability of breaking through vaccine mediated protection, but vaccine induced immunity still elicits a response against several variants and provides some level of protection against severe disease and death."

Coauthor Daniel Zhu adds, "Following our comprehensive profiling of the effects of neutralizing antibodies, T cell immunity and non-neutralizing alternate antibody mechanisms of action, we found correlates of immunity in the context of both complete protection and mitigation of viral burden in breakthrough infection. We also observed differences in the robustness of key immune response features across vaccine doses, insights that could help guide future vaccine design and boosting."
 

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Study finds neighborhood poverty and crowding associated with higher rates of COVID-19 in pregnancy
by Children's Hospital of Philadelphia
May 5, 2022

Neighborhood characteristics, including poverty and crowding within homes, were associated with higher rates of SARS-CoV-2 in pregnancy during the pre-vaccination era of the pandemic, according to a new study led by researchers at Children's Hospital of Philadelphia (CHOP). The findings, which were published today in the journal Obstetrics and Gynecology, may partially explain the high rates of COVID-19, the disease caused by SARS-CoV-2, among Black and Hispanic patients.

"By now it is well understood that the COVID-19 pandemic has disproportionately affected Hispanic and Black communities in the United States, and our study identifies potential factors that contribute to this phenomenon in pregnancy," said Heather H. Burris, MD, MPH, an attending neonatologist with the Division of Neonatology at Children's Hospital of Philadelphia and first author of the study. "Addressing the structural racism that has led to persistently different living conditions by race and ethnicity in the United States, and investing in residential communities, will be key to advancing health equity."

Studies have shown that Hispanic and Black people are 2.8 times more likely to be hospitalized and twice as likely to die from COVID-19 compared with white counterparts. These disparities have also been reported among pregnant patients, with Hispanic and Black patients more likely to have a positive test result for SARS-CoV-2 infection during pregnancy. Indeed, in prior research, CHOP investigators reported that positivity for SARS-CoV-2 was five times higher among pregnant Black and Hispanic patients compared with pregnant white patients in a hospital-based cohort in Philadelphia. However, the factors contributing to such racial and ethnic disparities were not fully understood.

To better understand the role neighborhood environments might play in driving these disparities, the researchers analyzed a cohort of 5,991 pregnant patients who gave birth at two hospitals in Philadelphia between April 13 and December 31, 2020. Using serum samples obtained for clinical purposes, researchers led by Scott Hensley, Ph.D. at the University of Pennsylvania Department of Microbiology tested the samples for antibodies to SARS-CoV-2, which would indicate current or prior infection, given that vaccines were not yet available and antibodies persist for some time after infection. Race and ethnicity were determined based on patients' self-reported answers in their medical record. The researchers also geocoded patients' residential addresses to assess three census tract variables: community deprivation, based on factors such as the proportion of residents with income below the federal poverty line, without a high school degree, and lacking medical insurance; racial segregation, based on to what extent a neighborhood was all Black or all white or somewhere in between; and crowding, defined as the proportion of residences with more humans than rooms in the house.

Examining the entire cohort, the researchers found that 9.4% of all patients tested positive for SARS-CoV-2 antibodies. Higher rates of positivity were seen among Hispanic (19.3%) and Black (14%) patients, compared with Asian (3.2%) and white (2.7%) patients, as well as those of another race or ethnicity (5.9%). Using statistical tools, the researchers found that deprivation and crowding were associated with positivity for SARS-CoV-2, whereas segregation was not. Their statistical analysis showed that crowded housing might explain 6.7% of the Hispanic-white disparity and neighborhood deprivation might explain 10.2% of the Black-white disparity.

Although the paper did not examine why deprivation and crowding led to increased SARS-CoV-2 positivity, the researchers hypothesized that close quarters likely led to shared ambient air, insufficient ventilation, and an inability to quarantine, allowing the virus to spread more easily. Additionally, the authors noted that Hispanic and Black women are more likely to be essential personnel who could not work from home, which may have placed Hispanic and Black patients at higher risk for SARS-CoV-2 exposure.

"This study adds to the body of work demonstrating that neighborhoods affect health and that pregnant people with fewer resources are at higher risk for complications, including infection with SARS-CoV-2," said senior author Karen M. Puopolo, MD, Ph.D., an attending neonatologist at Children's Hospital of Philadelphia and Chief of the Section on Newborn Medicine at Pennsylvania Hospital. "The pandemic has underscored the need for structural changes to support health equity, which will lead to better outcomes for pregnant patients and their families."
 
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