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VP Harris Has COVID, White House Claims "Not Close Contact" Of Biden
by Tyler Durden
Tuesday, Apr 26, 2022 - 12:52 PM

Vice President Kamala Harris tested positive for COVID-19.

She becomes the latest in a string of high-profile political figures to test positive and the highest-ranking Biden administration official to report being infected.

House Speaker Nancy Pelosi, Attorney General Merrick Garland, Commerce Secretary Gina Raimondo, Agriculture Secretary Tom Vilsack, Maine Senator Susan Collins, White House Press Secretary Jen Psaki and her deputy, Karine Jean-Pierre, were among those infected. Former President Barack Obama and a number of other congressional Democrats also said last month they caught the virus.

The Vice President Harris reportedly tested positive for COVID-19 on rapid and PCR tests, according to her office.

"She has exhibited no symptoms, will isolate and continue to work from the Vice President’s residence."

But the most notable comment from a Harris spokesperson was that "she has not been a close contact" to President Biden or the First Lady.

Only invisible man is considered close contact of the president pic.twitter.com/Enhzkx8KU5
— WhoWantSmoke (@WhoWant_Smoke) April 26, 2022

"She will follow CDC guidelines and the advice of her physicians. The Vice President will return to the White House when she tests negative," the statement added.

Double-masked and quad-vaxx'd?

We are sure she is "blessed" that she is not feeling symptoms because of her vaccine... or some such virtuous tripe...

Yesterday I received my second COVID-19 booster shot. We know that getting vaccinated is the best form of protection from this virus and boosters are critical in providing an additional level of protection. If you haven’t received your first booster—do it today.
— Vice President Kamala Harris (@VP) April 2, 2022

Second Gentleman Doug Emhoff said he tested positive on March 15, prompting the vice president to cancel several public appearances at the time.
 

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Vitamin D Supplementation Is Effective in Preventing COVID-19, Study Suggests
By Gabrielle Stephenson
April 26, 2022

Vitamin D supplementation can help prevent COVID-19 without serious adverse events, regardless of the individual’s vitamin D status, a study suggests.

The peer-reviewed study, published in the Archives of Medical Research, enrolled 321 frontline health care workers from four hospitals in Mexico City, who all tested negative for COVID-19 at the start of the study.

“The results of our double-blind, placebo-controlled, prospective study demonstrate that vitamin D supplementation is effective in preventing SARS-CoV-2 infection in high risk, frontline healthcare personnel,” researchers said in their report.

“To our knowledge, this is the first controlled study evaluating the role of [Vitamin D] supplementation as a prophylactic measure to prevent SARS-Cov-2 infection and therefore has profound clinical and public health implications,” the researchers also noted.

In the study, the health care workers were enrolled between July 15 and Dec. 30 in 2020. They were randomly assigned to receive 4,000 international units (IU) of vitamin D, or a placebo each day for 30 days. Real-Time PCR tests were taken at the start of the study, and were repeated if a person showed any COVID-19 symptoms during follow-up appointments.

Researchers also had the study participants undergo serum 25-hydroxyvitamin D3 and antibody tests at the start of the experiment, and again at day 45. The levels of 25-hydroxyvitamin D3 in the blood are generally regarded as a good indication of a person’s levels of vitamin D.

A total of 94 people in the vitamin D group and 98 people in the placebo group completed follow-up in the study.
Researchers found that the infection rate of COVID-19 in the vitamin D group was lower than in the placebo group, at 6.4 percent compared to 24.5 percent, respectively, with a p-value of less than 0.001. A p-value of less than 0.05 is normally considered statistically significant.

The authors found the risk of contracting COVID-19 was “lower in the [vitamin D group] than in the [placebo group] … and was associated with an increment in serum levels of 25-hydroxyvitamin D3 … independently of [vitamin D] efficiency.” They also noted no significant adverse events.

The authors concluded that supplementation with vitamin D in highly exposed individuals “decreases the susceptibility for SARS-CoV-2 infection,” and the preventive effect is “independent of vitamin D status.” They also said that medium doses of vitamin D (4,000 IU daily) “seems safe for short periods of supplementation.”

Vitamin D also contributes to bone, heart, and brain health. Studies have suggested that low levels of vitamin D are associated with autoimmune and inflammatory diseases, cardiovascular diseases, infectious diseases, as well as diabetes and cancer. In foods, vitamin D can be found in beef liver, cod liver oil, egg yolk, herring, salmon, sardines, and mushrooms.

A review published in The Journal of the American Osteopathic Association in 2018 said that vitamin D cannot be metabolized without sufficient magnesium levels. “People are taking Vitamin D supplements but don’t realize how it gets metabolized. Without magnesium, Vitamin D is not really useful or safe,” a co-author of the study, Mohammed S. Razzaque, said in a statement at the time.

On the other hand, extremely large doses of vitamin D can be toxic. According to the Mayo Clinic, taking 60,000 IU a day of vitamin D for several months has been shown to cause toxicity. In vitamin D toxicity, there is a buildup of calcium in the blood that can cause nausea and vomiting, weakness, and frequent urination.

The U.S. Recommended Dietary Allowance (RDA) for most adults is 600 IU of vitamin D a day.

“Doses higher than the RDA are sometimes used to treat medical problems such as vitamin D deficiency, but these are given only under the care of a doctor for a specified time frame. Blood levels should be monitored while someone is taking high doses of vitamin D,” the Mayo Clinic states on its website. “As always, talk to your doctor before taking vitamin and mineral supplements.”
 

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WHO Backs Pfizer’s Oral COVID-19 Therapy for High-Risk Patients
By Reuters
April 27, 2022

The World Health Organization (WHO) on April 21 endorsed the use of Pfizer Inc.’s oral COVID-19 antiviral treatment in high-risk patients after an analysis of trial data by the U.N. agency showed the therapy dramatically cut the risk of hospitalization.

Of existing COVID-19 treatments, Pfizer’s Paxlovid is by far the most potent, the WHO said.

Other therapies include Merck & Co.’s rival pill molnupiravir, Gilead Sciences’ intravenous remdesivir, and antibody treatments.

A WHO analysis of two Paxlovid clinical trials involving nearly 3,100 patients suggested it reduced the risk of hospitalization by 85 percent. In high-risk patients—those with over 10 percent risk of hospitalization—using Paxlovid could lead to 84 fewer hospitalizations per 1,000 patients, the agency said.

However, there are challenges that could limit the adoption of Paxlovid. Given it needs to be taken in the early stages of disease to be effective, access to quick and accurate tests are imperative to identify patients.

It can also interact with many common medications, complicating its use. In addition, Paxlovid has not been investigated for use in pregnant women, breastfeeding women, or children.

These factors have caused Paxlovid supply to eclipse demand in countries where it has been available for some time.
Pfizer has, and continues to, strike deals to sell the treatment in a number of countries, but details around pricing remain largely confidential.

Earlier this year, the company said it expected Paxlovid to bring in $22 billion in sales in 2022. The U.S. drugmaker has agreed to sell up to 4 million treatment courses to UNICEF for use in 95 low-income countries that encompass just over half the world’s population.

This deal accounts for just over 3 percent of Pfizer’s projected production of 120 million courses this year.

More than 30 generic drugmakers have also been allowed to manufacture cheaper versions of the drug to sell in the 95 countries, but these copycat versions from quality-assured sources will unlikely be ready in the short term, the WHO said, highlighting the lack of pricing transparency could mean that low- and middle-income countries will be pushed to the end of the queue, as happened with COVID vaccines.

Separately, the WHO also updated its recommendation on Gilead’s remdesivir, saying it should be used in mild or moderate COVID-19 patients at high risk of hospitalization.

It had previously recommended its use in all COVID-19 patients, regardless of disease severity.
 

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Ask A Doctor
Covid ‘Vaccine Fog’ and What to Do About It
BY Health 1+1 and Dr. Yuhong Dong
April 26, 2022

People in most countries in the world are already generally vaccinated—by official counts, over 5 billion of the world’s population has received at least one dose of COVID-19 vaccine.

But we also know there has been widespread reporting of COVID-19 vaccine injuries, unlike with any other kind of vaccine.
We were informed that a 15-year-old girl who took one shot of the BioNTech, Pfizer vaccine was experiencing brain fog the next day, and her doctor could not identify the cause of the symptom. The smart and diligent young student received the Covid vaccine dose on Sept. 28, and the next day she felt exhausted, could not concentrate, and nothing seemed to be able to register in her mind.

Two weeks later, on Oct. 11, she went to the library to prepare for an upcoming exam, and it wasn’t long before she went home instead, in tears. She told us that she couldn’t seem to remember anything, all the thoughts were far away, distanced and blocked. She felt like her brain was broken and she was no longer in control of herself. Since then, she even had difficulty smiling and was often depressed.

A neurologist examined her and found nothing wrong with her. The doctor suggested she exercise more and gave her medication (Piracetam) to increase blood flow to the brain. Her symptoms only became worse the next day, after taking the drug, and she had to stop.

She’s far from alone—we’ve received a number of messages from viewers who expressed similar situations after receiving Covid vaccines. All this tells us this is not at all an isolated phenomenon.

In an article in Science magazine about how COVID-19 vaccines are causing long Covid-like symptoms, they write: “the scientific community is uneasy about studying such effects. ‘Everyone is tiptoeing around it.’” Clinicians and researchers don’t want to touch it.

So this week, we turned to Dr. Yuhong Dong, infectious disease and antiviral drug development expert, to talk about adverse reactions caused by the vaccines, why they happened, and how we can help people better recover from these injuries.

COVID-19 Causes Brain Fog

Brain fog is not a new concept. It refers to loss of the ability to concentrate or remember, issues thinking, and a feeling of drowsiness. Just like walking into a foggy forest and losing our sense of direction, our brain’s sense of orientation seems to “break.”

Many people are complaining about how they seem to forget things that just happened. But these are people who have not had the virus, ruling out long Covid, and often these people did get Covid vaccines.

One case cited in the Science article sounds striking like our readers’ stories:

“Dressen had never had COVID-19. But that November, she’d received a dose of AstraZeneca’s vaccine as a volunteer in a clinical trial. By that evening, her vision blurred and sound became distorted—“I felt like I had two seashells on my ears,” she says. Her symptoms rapidly worsened and multiplied, ultimately including heart rate fluctuations, severe muscle weakness, and what she describes as debilitating internal electric shocks.”

No public health organization is actively tracking these cases, making it impossible to analyze comprehensive data.
Symptoms have ranged from fatigue, severe headaches, nerve pain, blood pressure swings, and short term problems.

Because of the lack of complete and transparent data, some are convinced these cases are very rare, and others are convinced these are common, based on the anecdotal experiences from their circles. Such online communities can include many thousands of participants. But numbers aside, we know there are ways to treat brain fog.

How COVID-19 and Its Vaccines Cause Neurological and Autoimmune Issues

What is causing “vaccine fog”?

“SARS-CoV-2 can induce multiple types of brain damage including decreasing neuronal survival, causing encephalitis in mice, inducing brain inflammation and Lewy body formation (feature of Parkinson’s Disease) in monkeys and reducing brain volume in patients. The vaccines contained synthetic mRNA based on the genetic sequence of SARS-CoV-2. Since the virus is harmful to human neurons, it’s likely that the vaccine may do a similar job,” Dr. Dong explained.

“Furthermore, the S1 protein of SARS-CoV-2 crosses the blood–brain barrier in mice according to a paper in Nature Neuroscience.”

“The complexity of the body’s response to synthetic mRNA goes far beyond the natural response of the body producing antibodies induced by mRNA vaccine. It has been found that the mRNA vaccines may induce the immune system to attack different components of itself,” she said. “We are familiar with the problem of vaccine-induced blood clots, VITT, and the mechanism is that the vaccine induces the immune system to produce antibodies that attack platelets.”

“A review article on International Journal of Vaccine Theory, Practice, and Research has pointed out that people who took the mRNA vaccination face chronic autoimmune disease, “as a consequence of excessive antibody production in response to the vaccine, which was not necessary in the first place.”

A Nature journal article by scientists from Yale School of Medicine entitled, “Diverse functional autoantibodies in patients with COVID-19” founds that infected individuals showed “a high prevalence of autoantibodies against immunomodulatory proteins (including cytokines, chemokines, complement components and cell-surface proteins).”

That is what’s often described as the autoimmune disease.

What organs and cells does the immune system target with this autoimmune response? A Harvard University report published on Clinical Immunology saw that patients with Covid-19 infections had antibodies produced against viral proteins that could attack the nervous system, connective tissue, musculoskeletal system, cardiovascular system, gastrointestinal tract, liver, and at the cellular level it may attack the nucleus and mitochondria, affecting the body’s energy supply, explaining the lingering deep fatigue of long Covid patients.

“In fact, the phenomenon of autoimmunity caused by viruses has been demonstrated and studied in how the Epstein-Barr virus links with multiple sclerosis,” Dr. Dong added.

Dr. Dong gave us a summary of the human immune system, in which there are two parts, or roles.

The innate (non-specific) immune response is like the forward in a football game; its role is to charge on the front line, it is the fastest response, and is not affected by virus mutations and has no adverse consequences of autoimmunity, she said.

The acquired (specific) immune response is more like the full back in a football game, a second line defender with a later response time, and a slower response time. If the virus mutates, this system needs to start all over again, and there are autoimmune side effects. Its key function is to reduce the rate of severe symptoms and fatality, she said.

Kharrazian from Harvard and Vojdani from Loma Linda University commented in their article that “In light of the information discussed above about the cross-reactivity of the SARS-CoV-2 proteins with human tissues and the possibility of either inducing autoimmunity, exacerbating already unhealthy conditions, or otherwise resulting in unforeseen consequences, it would only be prudent to do more extensive research regarding the autoimmune-inducing capacity of the SARS-CoV-2 antigens.”.

UC Davis researchers also pointed out the spike protein in COVID-19 patients and in COVID vaccine can cause autoimmune.

In the reported Pfizer vaccine adverse events, relatively large numbers are symptoms associated with autoimmune, Dr. Dong pointed out, like autoimmune demyelinating, autoimmune myocarditis; autoimmune hepatitis; autoimmune myositis; autoimmune nephritis, and so on.

Problems are not isolated to the mRNA vaccines. Other Covid vaccines of the inactivated vaccine type also create similar problems, because they contain the entire virus, including the spike protein. However, currently we have many studies and reports concerning the mRNA vaccines, and few studies have been done on the inactivated vaccines, Dr. Dong said.

Covid Vaccines Interfere With Immune Response

Dr. Dong has explained to our readers in-depth before about how the immune system works. What we learned this time is how the Covid vaccines can negatively interfere with our natural immunity.

“Normal cells, when stimulated by some specific substances, can produce interferon. According to a Frontiers in Immunology paper, the spike protein suppresses the mRNA expression of ACE2 and type I interferons in the primary cells of lung bronchoalveolar lavage (BAL) from naïve rhesus macaques—meaning this downregulation of ACE2 and type I interferons directly contributes to the Covid related lung diseases.”

Epoch Times Photo


“The Covid vaccine also contains fragments of spike protein, which will put the body’s lung immune cells in a more vulnerable state, making it more susceptible to the virus. This further explains the breakthrough infection of Covid induced after vaccination. Among the adverse reactions to the Pfizer vaccines are many viral infections of other sorts, such as Parainfluenza virus, respiratory syncytial virus, herpes virus, and so on,” Dr. Dong said.

In fact, even in a country like Taiwan, the number of deaths from adverse reactions to the vaccines has exceeded the number of deaths from infection in a report from Oct. 9, 2021.

Does that mean that after these Covid vaccines, we are more susceptible to colds, flus, and inflammation? Should we be concerned about viral and bacterial infections?

Dr. Dong told us that, unfortunately, this is the case. “Being susceptible to infection suggests that there may be some malfunctions in the immune system. It is a reminder that the immune system needs to be improved,” she said.

Repairing the Brain After Vaccine-Induced ‘Fog’ or Injury

So what options do we have if we, or a loved one, is experiencing neurological issues after getting vaccinated for Covid?

“The human body is a sophisticated, complex, and self-maintaining and repairing system created by God. It has its own rules of operation, and has the ability to protect itself from foreign viruses. It has the ability to self-recover under the inducement of disease,” Dr. Dong said.

It’s why doctors often recommend recuperation to let the body heal itself.

“It’s to maintain our inherent immunity and self-healing power,” she said. “Repair the inner mechanism of the body—it’s not unsimilar to repairing a dropped chain in a bicycle. By letting it run slowly, the dropped chain will reach its original position, connecting with other chains. Gradually, it will resume its function.”

“To fix brain fog, you have to remove the factors that damage nerve cells, and help nerve cells repair themselves,” Dr. Dong said.

She stressed these three must-do things.

Control Intake of Sugary Foods

Recent research has done much to link refined sugar and excessive sugar intake to Alzheimer’s. The Alzheimer’s-like symptoms of vaccine injuries require similar recovery methods.

Julie Wells, a mom of three in North Carolina, found her ability to concentrate declined over the past half year, to the point where it was difficult to find words to express what she meant to stay. She discovered that her love of chocolate and sweet tooth habit was worsening her cognitive ability, and when she took the initiative to stop eating sugary things, her brain fog was lifted.

The brain needs sugar, and uses 60 percent of the body’s glucose as fuel to run smoothly. But eating too much sugar will instead damage the brain.

A Boston University School of Medicine study showed that just one extra serving of fruit juice was associated with lower total brain volume, and immediately lowered Delayed Logical Memory scores. Excess sugar also impairs brain-derived neurotrophic factor (BDNF)—thought to play an important role in reducing anxiety, fear, and stress responses.

If you have prolonged symptoms, your body needs your help to heal. Be strict about your sugar intake for at least a few weeks, and give your brain one less thing to battle.

Epoch Times Photo


Prioritize High Quality Sleep

“Memory and information are stored in the brain, like a library. Good memory is like a good librarian. Sleep is the librarian who helps to sort the information and keep them in the cerebral cortex. The hippocampus, in charge of short-term memory, is like random access memory (RAM); and the cerebral cortex, responsible for long-term memory, is like a hard drive,” Dr. Dong said.

“One of the most important steps in the process of memory consolidation is relying on high-quality sleep.”

Good sleep will motivate the self healing of the brain. Make getting high quality sleep—getting enough hours, regular sleep and wake times, no screen disruptions around bedtime to cause dysregulation—a priority of yours, in order to make time for your brain to heal.

Check Your Attitude

Maintaining a positive attitude will also have an effect on your health on every level from the spiritual, mental, to the physical, cellular level.

“The study of psychoneuroimmunology (PNI) found that the human mind, nervous system, and immune system are closely linked as a whole. Spirit is a finer and more subtle substance, which can change the gene expression state of human cells from the microscopic material level,” Dr. Dong said.

Proceedings of the National Academy of Sciences research has found that people with more altruistic mentalities have lower levels of inflammatory factors, and higher levels of interferon expression, which is more conducive to the self-repair of cells and tissues,” she said.

“As mentioned earlier, the vaccine causes a decrease in the level of interferon production in the cells. From this inference, chronic inflammation is prone to occur. Therefore, if people with a relatively healthy mentality are vaccinated, because their cellular self-repair mechanism is relatively strong, it can offset the negative effects of vaccines on human cells.

Epoch Times Photo


In summary, whether someone is suffering from long Covid or vaccine induced injury, the body has an innate ability to heal if we can remove barriers to healing. Many symptoms that appear are signals of dysfunction in the organs’ self-recovery process. By focusing on restoring our bodies’ healing and repairing mechanisms by adjusting diet, sleep, emotions, and eliminating bad habits such as poor sleep patterns, eating too much sugar, and holding onto anxiety.
 

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Waning vaccine efficacy in the UK
18 min 8 sec
Apr 26, 2022
Dr. John Campbell

Beijing, 70 cases since Friday Three P.C.R. tests over five days zero Covid strategy https://assets.publishing.service.gov... Effectiveness against symptomatic disease After 2 doses of the AstraZeneca Against the Omicron variant Starts at 45 to 50% Drops to almost no effect, 25 weeks after the second dose With 2 doses of Pfizer or Moderna Effectiveness dropped from around 65 to 70% Down to around 15% by 25 weeks after the second dose Two to 4 weeks after a booster dose Effectiveness ranges from around 60 to 75% Dropping to almost no effect from 20+ weeks after the booster Effectiveness against hospitalisation Alpha and Delta variants Higher levels of protection against hospitalisation with all vaccines Omicron 18 to 64 year olds All COVID-19 cases admitted via emergency care VE after a booster peaked at 82.4% Dropped to 53.6% by 15+ weeks after the booster Needed oxygen/ventilated VE 97.1% down to 75.9% Also Omicron generally causes milder disease, in particular among younger individuals All individuals who are hospitalised are tested for COVID-19 An increasing proportion of individuals hospitalised with a positive COVID- 19 test are likely to have COVID-19 as an incidental finding rather than the primary reason for admission. All 3 vaccines give similar protection against hospitalisation Effectiveness against mortality Alpha and Delta Over 90% protection against mortality with all 3 vaccines Vaccine effectiveness against mortality with Omicron At 25-plus weeks following the second dose, vaccine effectiveness was around 60%
 

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Is global vaccination still required
16 min 59 sec
Apr 26, 2022
Dr. John Campbel

No need for global vaccination? Direct link to featured report and channel, https://www.youtube.com/watch?v=o9YfC... https://www.youtube.com/c/WefwafwaAndrew https://www.nytimes.com/2022/04/23/he... WHO, fully vaccinate 70% in every country by June 2022 African Union also wants 70% At 70% Bangladesh, Bhutan, Cambodia Nepal Most others under 20% Dr. Seth Berkley, chief executive Gavi, Covax This pandemic is not over yet — far from it — and it’s imperative that countries use the doses available to them to protect as much of their population as possible Gavi, secured $4.8 billion Africa’s vaccination rate Fewer than 17% have received a primary immunization Last month, vaccinations down 35% in Arica Dr. Isaac Adewole, Nigeria, Africa Centers for Disease Control and Prevention. Would like 70% There was a time people were very desperate to get vaccinated, but the vaccines were not there. And then they realized that without the vaccination, they didn’t die White House, global covid summit in May, hopes for renewed funding Democratic Republic of Congo Covid death rate very low Surge in measles threatening 20 million children Christopher Mambula, Doctors Without Border, East Africa DRC government cannot spare resources for supplementary measles vaccinations Serum Institute of India Stopped producing covid vaccines last December Before omicron At least 66% of Africans already infected Shabir Madhi, professor, University of the Witwatersrand There’s very little value to it. In fact, we will gain much more by getting to more than 90% above the age of 50
 

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mRNA Vaccines Show No Mortality Benefit - Danish Study
36 min 37 sec
Premiered 8 hours ago
Peak Prosperity

The mRNA vaccines have been endlessly billed as “Safe & Effective.” But are they? A lot depends on what one means by “safe” (which is always a relative term, as nothing is ever perfectly safe) and what the definition of “effective” is. By effective, I think we can all agree that a vaccine designed to be mass adopted in the midst of a pandemic ought to reduce deaths from the pandemic disease. That means it ought to reduce overall mortality. Hopefully, we can agree that’s the right metric, because if a vaccine reduces some deaths in this part of the equation, but induces a similar amount of deaths over in some other part of the health equation, then it’s not actually being "effective" in terms of reducing mortality. A new Danish study (pre-printed in The Lancet) shows that mRNA vaccines offer no all-cause mortality benefits. Zero. Nada. So, let's list what the vaccines don't do: they don't stop infection or transmission and they don't reduce deaths. Using only RCT trial data from the pharma companies themselves, the pooled results from the mRNA vaccines show no discernible mortality benefit. Alternatively, and quite happily, the adenovirus vector vaccines – that’s J&J and Astra-Zeneca – do show a VERY positive mortality benefit from Covid and, intriguingly, even from non-Covid deaths. How can this be? I don’t know, but it’s the sort of data that begs for more inquiry and understanding. One does not need a PhD in public health policy to understand that the only appropriate response to this data would be to promote the adenovirus vaccines over the mRNA vaccines. But the exact opposite happened and that’s quite a scientific, medical and public health mystery. Certainly, we could make allowances for that to happen in the first early months of the pandemic. But now? A full 16 months after the launch of the vaccines? It’s very difficult to explain what the CDC, NIH and FDA were up to with their collective tens of billions of dollars of budgetary funding. These are legitimate questions and concerns to address and the only question I have is “will the Big Tech censors allow us to ask them, or will this be taken down too?” REFERENCES https://papers.ssrn.com/sol3/papers.c... https://brownstone.org/articles/have-... https://www.usmortality.com/#unitedst...
 

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New modeling shows that 'shielding' strategies instead of lockdowns would have led to tens of thousands more deaths
by University of Bath
April 26, 2022

Shielding those vulnerable to COVID-19, while allowing the virus to spread, largely unmitigated, through the rest of the population, would have failed according to a new modeling paper published today in PLOS Global Public Health by University of Bath scientists.

Shielding strategies or "focused protection", as advocated for in the Great Barrington Declaration, would have been impossible to implement in practice and would have likely led to far worse outcomes. Even if implemented perfectly, the modeling reveals that allowing the infection to spread through less vulnerable groups prior to vaccination would have overwhelmed health care capacity in the UK and led to tens of thousands of unnecessary deaths. In reality, practical considerations would have meant that large numbers of vulnerable people who were supposed to be protected would also have died.

The unprecedented scale of the public health crisis posed by the COVID-19 pandemic forced governments around the world to impose restrictions on social contact to suppress transmission of the coronavirus. However, the social and economic costs of these measures, especially lockdowns, have been high, drawing substantial opposition from some sections of the media, members of the public, and a small, but vocal group of scientists.

An alternative and widely discussed strategy would have been to temporarily focus protection on ("shield") those who were most vulnerable to COVID-19 (the elderly and those with certain pre-existing conditions), with the aim of achieving herd immunity by allowing a largely unmitigated epidemic in the rest of the population. However, this approach has received little scrutiny in the form of mathematical modeling.

In this new study, published today, the researchers assessed a hypothetical large city in England with a population of 1 million inhabitants, using an SEIR (Susceptible, Exposed, Infected, Removed) model. They compared the outcomes from no shielding, with imperfect and perfect shielding, with shielding restrictions lifted when cases fall below a given threshold.

The research concludes that while shielding may have protected the vulnerable in theory, it required extremely restrictive conditions that were impossible to achieve in practice. For example, because shielding in real populations would have been imperfect, infections in the lower-risk population would have leaked through to vulnerable people who were shielding. In addition, if lower-risk individuals reduced social contact to avoid infection it may have been impossible to achieve herd immunity, meaning a second wave of infections would have occurred after shielding had ended. Even if herd immunity was achieved, care homes would still have been at risk of local outbreaks because immunity would have been unevenly distributed in the population.

To be effective, shielding would have required those who were at higher risk to not only be rapidly and accurately identified, but also to shield themselves for an indefinite period, rendering the strategy impractical to implement. The modeling also suggests that in even the most optimistic shielding scenario, critical care capacity in hospitals would have been exceeded at least ten-fold at the peak of the outbreak. This is not to mention the huge healthcare burden associated with the large number of cases of long COVID that would result from mass infection. Waning immunity, and new immunity-evading variants would only have served to make a shielding-only strategy even more untenable.

Although vaccines are now available and have been successfully rolled out in many countries, modeling studies such as this are critical to determine whether shielding would have been a viable strategy for dealing with COVID-19, or, indeed, the next pandemic. Many countries have poor vaccine coverage and so the choice between shielding and measures that are more restrictive at a population level is likely to remain for some time. In future, new variants may continue to emerge that are able to escape immunity, which may require a renewed choice between lockdowns and shielding.

In summary, the new study exposes critical weaknesses of shielding (or focused protection): even with the most optimistic assumptions, tens of thousands of lower-risk individuals would have died and critical care capacity would have been rapidly exceeded. With more realistic assumptions, shielding would have failed to protect the most vulnerable, achieving little more protection than an unmitigated epidemic.

Dr. Kit Yates, senior lecturer in the Department of Mathematical Sciences at the University of Bath and one of the study's authors, explains: "Our study shows how misguided the idea of shielding the vulnerable and letting the virus rip through the rest of the population would have been.

"Even if we could have managed perfect shielding, our healthcare system would still have been quickly overwhelmed. In reality, some inevitable leakiness in the shielding system would almost certainly have led to big outbreaks amongst the vulnerable and resulted in huge numbers of deaths as well."

Dr. Cameron Smith, another of the study's authors, added: "Our model captures some important features which represent how immunity is likely to be distributed in the population. As a consequence of this heterogeneity, potential shielding strategies would have had limited success in reducing the number of deaths."

Dr. Ben Ashby, the study's other author said: "Despite the success of the vaccination program, the recent omicron wave shows that we are not out of the woods yet. If in future a new variant emerges that substantially escapes existing immunity, then it's possible we may have to choose between lockdowns and shielding once again (or indeed, in future pandemics). Although lockdowns are costly for many reasons, attempting to shield the vulnerable while letting the virus spread through the rest of the population is far worse."
 

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Study finds COVID-19 misinformation linked to vaccination hesitancy, refusal
by Indiana University
April 26, 2022

Misinformation posted online about the COVID-19 vaccine was associated with hesitancy toward inoculation and lower vaccination rates in some geographical areas of the United States, according to a paper written by a team of researchers from Indiana University's Observatory on Social Media, known as OSoMe.

"Online misinformation is linked to early COVID-19 vaccination hesitancy and refusal," published April 26 in the journal Nature Scientific Reports, also found that counties whose residents were more hesitant to receive vaccinations were more likely to have a higher number of Republican voters or Black residents.

The research was a collaboration between OSoMe and the Polytechnic University of Milan in Italy. The researchers studied the relationship between misinformation, behaviors and health outcomes, specifically the way COVID-19 vaccination rates and vaccine hesitancy correlate with levels of misinformation online.

"Misinformation is generally assumed to have a big impact on behavior, but there are few studies that investigate this topic," said John Bryden, executive director of OSoMe. "We hope this work adds to the picture."

Bryden said the researchers considered the question of how misinformation affects vaccination behavior after seeing a lot of misinformation posted online during the vaccine rollout and wondering why some states were lagging behind others in vaccination rates.

In 2021, the OSoMe team developed CoVaxxy, a publicly available dashboard, to explore the relationship between misinformation on Twitter and attitudes about COVID-19 vaccines. They used CoVaxxy to collect data from Twitter from Jan. 4 to March 25, 2021. The timeline was chosen because once the vaccine became available to everyone, the issue was no longer supply but demand, said Filippo Menczer, director of OSoMe.

Vaccination has been the key to fighting the SARS-CoV-2 coronavirus, and populations must reach a threshold rate to achieve herd immunity. However, examples of misinformation about the COVID-19 vaccine have included claims that they genetically manipulate the population, or contain microchips that interact with 5G networks, the researchers said in the paper.

Misinformation was identified by considering tweets that contained links to articles from a list of low-credibility sources, as compiled by a politically neutral third party.

The researchers also collected vaccine hesitancy results from surveys posted on Facebook, and obtained state- and county-level vaccination rates from the Centers for Disease Control and Prevention. Vaccine uptake was measured by the number of daily vaccinations in each state from March 19 to 25, 2021, according to CDC measurements.

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The research shows a link between online misinformation and lower vaccination rates. Credit: Francesco Pierri

More than 22 million individual responses to daily surveys on Facebook in February and March 2021 found high levels of vaccine hesitancy, with about 40 to 47 percent of American adults hesitant to take the COVID-19 vaccine, the researchers wrote.

The research found that political partisanship was strongly associated with lower vaccination rates, notably in conservative regions. Republican-majority states and counties showed higher levels of misinformation, greater vaccine hesitancy and lower vaccination rates.

"It was not initially obvious that there would be a connection with politics, but it turned out to be," Menczer said.

Ethnicity also had a big impact on hesitancy, with Black Americans having a lower vaccination rate. Historical disparities in how Black people and other minorities have been treated in the U.S. health care system compared to white people could have been an additional factor contributing to hesitancy and lower vaccination rates, Menczer said.

The study, for the time period examined, confirmed previous results that linked a number of factors to COVID-19 vaccine hesitancy, the researchers said, with hesitancy rates in the U.S. highest among three groups: African Americans, women and conservatives.

The researchers wrote that the data predict COVID-19 will remain a problem in the U.S., and they explain the importance of combating misinformation.

"While people have a constitutional right to free speech, it is important to maintain an environment where individuals have access to good information that benefits public health," the researchers said.

Francesco Pierri, the paper's first author and a post-doctoral researcher in the Department of Electronics, Information and Bioengineering at the Polytechnic University of Milan, was brought into the research as a visiting scholar at OSoMe because of his research on understanding the spread of misinformation, disinformation and digital misbehavior in online social networks.

The paper's other authors were Matthew R. DeVerna, Kai-Cheng Yang and Alessandro Flammini, from OSoMe, and Brea L. Perry, from the Department of Sociology in the IU Bloomington College of Arts and Sciences.
 

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Why breakthrough COVID? Antibodies fighting original virus may be weaker against omicron
by Johns Hopkins University School of Medicine
April 26, 2022

If you're wondering why after two vaccination doses and a booster shot, you still got sick from the Omicron strain of the virus that causes COVID-19, one possible answer may have been found in a recent study by researchers at Johns Hopkins Medicine and the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH).

The research findings, first posted online April 7, 2022, in the Journal of Clinical Investigation Insight, suggest that while fully vaccinated and boosted people produce a high level of antibodies that work against the original strain of SARS-CoV-2, the same tiny defenders don't do as well in preventing the Omicron strain from attacking healthy cells.

"Previous research has shown vaccine-induced antibodies respond to the original strain of SARS-CoV-2 by inhibiting the virus's ability to bind to angiotensin-converting enzyme 2 [commonly known as ACE2], the receptor on a cell's surface through which SARS-CoV-2 gains entry," says study senior author Joel Blankson, M.D., Ph.D., professor of medicine at the Johns Hopkins University School of Medicine. "Our study suggests those same antibodies yield less ACE2 inhibition with the Omicron strain, opening the door to a breakthrough COVID-19 infection."

To conduct their study, Blankson and his colleagues analyzed both the humoral (SARS-CoV-2 specific antibodies circulating in the bloodstream and produced by B lymphocytes, or B cells) and cellular (direct attack on the virus by T lymphocytes, or T cells) immune responses in 18 healthy and fully vaccinated people, ages 23 to 62 (mean age of 30), who experienced breakthrough infections within 14 to 92 days (median of 50 days) after receiving a booster COVID-19 vaccine. Fourteen participants received a booster of the Pfizer-BioNTech messenger RNA (mRNA) vaccine, one was boosted with the Moderna mRNA vaccine and the remaining three had an mRNA booster following their initial dose of the Johnson & Johnson viral vector vaccine.

The humoral and cellular immune responses of those participants with breakthrough infections were compared with those from a control group of 31 participants, ages 21 to 60, who received similar COVID-19 vaccinations and boosters, and had no prior infection with SARS-CoV-2.

Although the researchers were not able to document that the breakthrough infections were from the Omicron strain, they say it's a strong probability because the Omicron variant accounted for more than 90% of the COVID-19 cases treated at The Johns Hopkins Hospital (where the study was conducted) during the time when the study participants became symptomatic.

"When we tested antibody-mediated inhibition of SARS-CoV-2 spike protein binding to ACE2, we found that serum from study participants with breakthrough COVID-19—most likely the result of Omicron infection—had antibodies that strongly stopped binding by the original strain virus as expected but didn't carry out that function as well when responding to the Omicron strain," says Blankson.

The levels of antibodies that inhibited spike protein binding to ACE2—high for original strain virus but reduced for Omicron—were similar for both the participants with breakthrough infections and those in the control group.

The specific reduction in ACE2-inhibiting antibodies responding to Omicron, Blankson says, differs from what was seen in previously studied breakthrough infections with the alpha variant. In those cases, infected individuals were found to have lower overall antibody levels to the original virus strain.

This was shown in a second recent study, also co-authored by Blankson, looking at the blood plasma of 15 mRNA vaccine recipients.

"The comparable strong T cell responses for the original and Omicron strains in both studies could explain why people, like our study participants, who have breakthrough COVID-19 cases typically experience only mild symptoms during the course of their illness," he explains.
 

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Retina is not spared by SARS-CoV-2
by University of Geneva
April 26, 2022

The list of diseases caused by SARS-CoV-2 infection is growing and now includes the retina. This is what is suggested by a prospective study by the Geneva University Hospitals (HUG) and the University of Geneva (UNIGE), in collaboration with the Adolphe de Rothschild Memorial Clinical Research Center for Ophthalmology. This research reveals that 11% of people hospitalized for respiratory distress due to COVID-19 disease have retinal damage. This study can be found in the Journal of Clinical Medicine.

Since the first pandemic wave of SARS-CoV-2, scientists and physicians have observed neurological and vascular damage in infected individuals. Since the retina is part of the nervous system and offers a direct and non-invasive observation pathway to the vessels, a research team from the HUG, the UNIGE and the Adolphe de Rothschild Memorial Clinical Research Centre in Ophthalmology performed fundus examinations on patients admitted to the HUG Internal Medicine Department for pneumonia due to COVID-19 and placed on oxygen therapy.

"A photograph of the back of the eye gives access to the vascular system of the retina, a godsend for studying COVID-19 vessel disease in an easy way," says Eleonora Riotto, then a student at the UNIGE Faculty of Medicine and the first author of this study that takes into account 172 people infected with SARS-CoV-2.

White spots on the retina

The research team performed these examinations using a camera that photographed the retina without pupil dilation. These examinations revealed white spots on the retinas in 11 percent of cases. "These spots are known as cotton wool spots. They are signs of retinal suffering secondary to small artery occlusion. They can be caused by embolism or inflammation of the retinal vessels, with vasculitis creating an obstruction to blood circulation and potentially a lack of oxygen and nutrients. They are mostly seen in people with diabetes or hypertension," says Dr. Gordana Sunaric Mégevand, medical director of the Adolphe de Rothschild Memorial Clinical Research Center for Ophthalmology and the study's final author.

An alteration correlated with COVID-19

These data were then cross-referenced with the health status of the individuals and their symptoms. A history of diabetes, overweight, and elevated C-reactive protein—whose expression reflects inflammation following infection or tissue damage—were more frequently observed in patients with cotton wool spots. However, although there was a correlation with diabetes, the study showed that nearly 64% of the participants with retinal abnormalities did not previously have diabetes.

The same was true for hypertension, since nearly 90% of the patients with retinal damage had no history of hypertension to explain this phenomenon. "Our results therefore argue for a retinal alteration mainly due to viral infection, although cotton wool sports are known to be the first ophthalmological finding of diabetic or hypertensive retinopathy," said Dr. Christophe Marti, assistant physician at the HUG's Department of General Internal Medicine, private doctor at the Department of Medicine of the Faculty of Medicine of the UNIGE and co-author of the study.

The research team then reviewed each patient three months after hospitalization. They found that all the spots had disappeared and that no one had any vision problems. "The study participants will be followed up to confirm these reassuring findings," says Dr. Gordana Sunaric Mégevand.

Three possible causes

The study does not investigate the causes of these transient retinal injuries. Nevertheless, the research team believes that three different mechanisms could explain them. First, direct tissue damage by virus infiltration into the endothelial cells of vessels could cause inflammation and vascular obstruction. A second explanation is the potential occlusion of retinal arterioles caused by a state of hypercoagulability in relation to the deposition of fibrin clots observed in many studies with COVID-19.

The last hypothesis suggests that the cotton wool spots occur as a result of under-oxygenation related to the acute respiratory distress of the study subjects or the elevated blood pressure typically seen in the early phase of COVID-19 disease.

"Regardless of the cause, our analysis confirms that retinal vessels can be affected by the virus. The retina may only be a reflection of the overall damage. Further studies will be necessary to understand whether retinal damage in a COVID-19 positive patient can provide prognostic information on his or her overall health," concludes Dr. Gordana Sunaric Mégevand.
 

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New tool to assess Long COVID symptoms
by University of Birmingham
April 26, 2022

A comprehensive tool that can assess the symptoms of Long COVID has been developed at the University of Birmingham for use in research and clinical care.

Developed with patients that have lived experience of Long COVID, the tool can capture symptoms and their impact on everyday life.

Currently more than 200 symptoms are associated with Long COVID which can affect people for months after the original coronavirus infection has gone. These can affect many organs in the body and include breathlessness, fatigue, or brain fog and are estimated to affect around 1.3 million people in the UK and more than 100 million people worldwide.

Healthcare providers and researchers need reliable ways of measuring these symptoms as they are experienced by patients to help them develop new treatments and provide the best possible care.

A team from the University of Birmingham's Center for Patient-Reported Outcomes Research designed the Symptom Burden Questionnaire for Long COVID to address this challenge. Patients can use it to report symptoms and the data can be used to help identify treatments, and test whether these are safe and effective. The approach is published today (27 April 2022) in the BMJ.

"People living with Long COVID say they experience a huge range of symptoms but getting these recognized by healthcare practitioners and policy-makers has been a struggle," said senior author, Dr. Sarah Hughes. "We designed and tested this tool with our patient partners to ensure it is as comprehensive as possible, while also not being burdensome for patients to complete."

Public partner Karen Matthews from LongCOVID SOS noted "I participated in a study quite early on in my condition and the questionnaire used didn't capture the breadth of what I was feeling. Being able to shape something that could record that experience more effectively is worthwhile and I hope it gives researchers and people like me taking part in future studies some valuable evidence."

The resulting questionnaire measures different symptoms of Long COVID and the impact of these symptoms on daily life. It was developed with extensive patient input following regulatory guidance, meaning its scores may be used to support regulatory decisions around the approval of new therapies for Long COVID and by policymakers.

The study was carried out in partnership with patient data technology specialist, Aparito Ltd, and funded by the National Institute for Health Research and UK Research and Innovation. The team plans to carry out more development and testing to explore how the tool can be used in routine clinical practice, including translating it for use in other countries and minority ethnic communities.
 

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EXPLAINER: COVID-19 pills must be taken within 5 days
by Tom Murphy
April 26, 2022

Newly infected COVID-19 patients have two treatment options that can be taken at home. But that convenience comes with a catch: The pills have to be taken as soon as possible once symptoms appear.

The challenge is getting tested, obtaining a prescription and starting the pills in a short window.

U.S. regulators authorized Pfizer's pill, Paxlovid, and Merck's Lagevrio late last year. In high-risk patients, both were shown to reduce the chances of hospitalization or death from COVID-19, although Pfizer's was much more effective.

A closer look:

WHO SHOULD TAKE THESE PILLS?

The antiviral pills aren't for everyone who gets a positive test. They are intended for those with mild or moderate COVID-19 who are more likely to become seriously ill. That includes older people and those with other health conditions like heart disease, cancer or diabetes that make them more vulnerable.

Both pills were OK'd for adults, while Paxlovid also is authorized for children ages 12 and older.

WHO SHOULDN'T TAKE THESE PILLS?

Merck's Lagevrio is not authorized for children because it might interfere with bone growth. It also isn't recommended for pregnant women because of the potential for birth defects.

Pfizer's pill isn't recommended for patients with severe kidney or liver problems. It also may not be the best option for some because it may interact with other medications.

The antiviral pills aren't authorized for people hospitalized with COVID-19.

WHAT'S THE TREATMENT WINDOW?

The pills have to be started as soon as possible, within five days of the start of symptoms. Cough, headache, fever, the loss of taste or smell and muscle and body aches are among the more common signs. The Centers for Disease Control and Prevention offers a website to check your symptoms.

Dr. Cameron Wolfe, an infectious disease specialist at Duke University Hospital, advises getting a test as soon as you have symptoms of COVID-19.

"If you wait until you have started to get breathless, you have already to a large extent missed the window where these drugs will be helpful," Wolfe said.

WHERE CAN YOU GET THE PILLS?

Pharmacies, community health centers, hospitals and urgent care centers are among the sites stocking the antiviral pills, but prescriptions must come from a doctor or other authorized health worker.

The oral treatments are currently available in about 20,000 locations around the country, but President Joe Biden's administration expects that total to jump to around 40,000 in the next few weeks.

The administration also is working to expand the number of sites that can test patients and then provide the treatments in one visit. There are currently 2,200 of these so-called test-to-treat sites, including all 1,200 MinuteClinic locations inside CVS drugstores. Patients can find find test-to-treat locations by checking the U.S. government's COVID.gov website.

Supplies of the pills were limited initially, but ample amounts are now available.

ARE THERE OTHER OPTIONS FOR NEW COVID-19 PATIENTS?

Yes, but it isn't as easy to use as a pill.

In February, the Food and Drug Administration authorized a new injected drug from Eli Lilly, bebtelovimab, that targets the omicron variant with virus-fighting antibodies. Regulators cleared that drug for adults and adolescent patients with mild-to-moderate cases of COVID-19 who are at high risk of hospitalization and death.

Earlier this year, regulators revoked emergency use authorization for another Lilly treatment and drugs from Regeneron and GlaxoSmithKline because they were no longer effective against the evolving virus.

WHAT OTHER TREATMENTS MIGHT BE COMING?

Japanese drugmaker Shionogi is testing another antiviral pill.

Unlike Paxlovid, the company's drug does not require taking a second antiviral to boost its effectiveness against COVID-19. That could reduce some of the potential drug interaction problems associated with the Paxlovid combination.

The Shionogi drug is also designed to be taken once daily for five days. That's simpler than Paxlovid's dosing, which must be taken twice daily for five days.

In mid-stage testing Shionogi said its drug significantly reduced COVID-19 viral levels and shedding in patients treated within five days of symptoms. The company is conducting a large global study in patients with increased risk of hospitalization or death due to age or other health issues. Early results from that study—which is being funded by the U.S. National Institutes of Health—are expected by the fall.

The company has already requested approval in Japan and plans to also file applications with regulators in the U.S. and Europe.
 

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Testing cuts leave world 'increasingly blind' to COVID spread: WHO
April 26, 2022

A dramatic drop in testing for COVID-19 has left the world blind to the virus's continuing rampage and its potentially dangerous mutations, the World Health Organization warned Tuesday.

The UN health agency said that reported COVID cases and deaths had been dropping dramatically.

"Last week, just over 15 thousand deaths were reported to WHO—the lowest weekly total since March 2020," WHO chief Tedros Adhanom Ghebreyesus told reporters.

While this is "a very welcome trend," he warned that the declining numbers could also be a result of significant cuts in testing for the virus.

"This makes us increasingly blind to patterns of transmission and evolution," Tedros said.

"When it comes to a deadly virus, ignorance is not bliss."

William Rodriguez, who heads the global diagnostics alliance FIND, also decried that many governments in recent months simply stopped looking for COVID cases.

Speaking at the press conference hosted by WHO, he pointed out that in the past four months, amid surging COVID cases from the Omicron variant, "testing rates have plummeted by 70 to 90 percent worldwide."

The plunging testing rates came despite the fact that there is now more access to accurate testing than ever before.

"We have an unprecedented ability to know what is happening," Rodriguez pointed out.

"And yet today because testing has been the first casualty of a global decision to let down our guard, we're becoming blind to what is happening with this virus."

The COVID-19 pandemic has officially caused more than six million deaths since the virus first surfaced in China in late 2019, but the true toll is believed to be at least three times that high.

While many countries have been removing measures and trying to move back to a semblance of normality, the WHO stresses that the pandemic is still not over.

"This virus won't go away just because countries stop looking for it," Tedros said, pointing out that "it is still spreading, it is still changing, and it is still killing."

He cautioned that "the threat of a dangerous new variant remains very real."

"And although deaths are declining, we still don't understand the long-term consequences of infection in those who survive."
 

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Exercise warnings over long COVID recovery
by University of Leeds
April 26, 2022

Patients experiencing long COVID are receiving "inconsistent advice" on how to resume physical activities, according to a major study.

It found that some health care professionals were recommending patients should gradually increase their physical activity levels, but the researchers warn this could result in symptoms getting worse.

Instead, they say patients should be encouraged to "pace" their return to exercise, doing enough to stay within their energy reserves so as not to cause a flareup of symptoms.

Writing in the International Journal of Environmental Research and Public Health, the researchers from the University of Leeds said physical activity is likely to play a part in helping people to recover from long COVID, but a delicate balance had to be found between doing too much and not enough.

The researchers added, "The development of individualized physical activity programs that could mitigate the negative health consequences of physical inactivity without worsening long COVID symptoms and facilitate a return to independence should be considered a clinical priority."

Nearly 500 people with long COVID were surveyed as part of the study. On average, they had been living with the condition for more than a year.

The vast majority (75%) reported that physical activity made their symptoms worse, 20% said physical activity sometimes improved symptoms and sometimes made symptoms worse, 1% noted it improved them, with the remainder noting it had no effect on symptoms. Many of the respondents said when they were able to be active, it helped improve their mental health and well-being.

Dr. Manoj Sivan, Associate Professor in the School of Medicine at Leeds who co-supervised the research, said, "It is estimated that around two million people in the UK are now living with long COVID. Many struggle to be independent and rely on family, friends and caregivers to support them with daily living tasks. People are unable to work or work part time.

"The relationship between physical activity and the condition is not similar to other long-term conditions—in that pushing for more activity is not always good in long COVID, and there needs to be careful planning and a structured tailor-made program to become active again."

Pacing strategy

Dr. Sivan, who also is the World Health Organization advisor for COVID rehabilitation policy in Europe, led a team to write the WHO self-management booklet on long COVID, which provides a comprehensive strategy for returning to physical activity using a cautious pacing approach.

Dr. Sarah Astill, Associate Professor in the School of Biomedical Sciences who co-supervised the research, said, "Individuals with long COVID who are inactive run the risk of other chronic health problems such as cardiovascular disease, depression and reduced quality of life.

"We urgently need to find the best way to manage the growing numbers of people now living with long COVID."

Advice from health care professionals

The survey looked at the sources of information long COVID patients received about resuming physical activity. Just under half (46%) received advice from a health care professional.

The second most popular form of advice was for patients to follow graded exercise therapy, where activity is incrementally increased to improve exercise tolerance. The researchers say graded exercise therapy risks some patients doing too much, too soon.

A paced return to exercise, which is the recommended form of therapy in most long COVID cases, was the fourth most popular form of advice.

The researchers call on policymakers to ensure healthcare professionals are given clear advice on how to ensure people with long COVID get the best possible advice when it comes to recommending ways to resume physical activity.

Legacy of long COVID

The survey identified the devastating effect long COVID has had on patients.

Pre-COVID, 84% of the people taking part in the study were meeting the UK Chief Medical Officer's guidelines for physical activity levels. With long COVID, that has dropped to 8%.

The researchers say some patients may never be able to return to the physical activity levels they had prior to becoming infected with COVID and the emphasis needs to be on helping people become independent.

Research led by Dr. Manoj Sivan has developed a picture of the range of symptoms associated with long COVID and on the best way the condition can be treated and managed. They have also help develop a mobile phone app to help patients and clinicians chart the improvement in patients.

The participants in the study were recruited through a social media campaign. The 477 participants were predominantly white (93%) and female (89%).
 

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The Psychology of Mimetic Contagion
By Aaron Kheriaty
April 26, 2022

My friend and colleague Dr. Mary Talley Bowden recently posed this important question, which has puzzled many people during the pandemic:
Such a great question. A friend of mine from the age of 5 won’t have anything to do with me now because of my Covid views. I know we’ve all experienced this. @akheriaty can you explain the psychopathology? https://t.co/qdbMT6HOgK
— Mary Talley Bowden MD (@MdBreathe) February 26, 2022

I suggest that two accounts of social psychology—the mass formation theory of Matthias Desmet and the mimetic contagion theory of Rene Girard, help to answer this question. These two theories also go a long way toward explaining some of the more puzzling behaviors we saw emerge during the pandemic.

The first theory, mass formation, was brought to public attention when my friend Robert Malone briefly summarized it on Joe Rogan’s podcast. The internet blew up as people searched to learn more about the concept. The tech overlords at Google intervened to bury information on the theory when people searched for “mass formation”. This interview landed Malone in permanent Twitter prison and brought the furies down on Rogan.

But Desmet’s theory is based on a body of sound social theory and psychology that has accumulated over the past hundred years. As Professor Desmet of the University of Ghent describes, under conditions of mass formation, people buy into a narrative not because it is true, but because it cements a social bond they desperately need.

Mass (or crowd) formation emergences in a society under very specific conditions. The first condition is that people experience a lack of connectedness to other people, a lack of meaningful social bonds. Consider the the loneliness epidemic which was worsened by the lockdowns. Our only bonds were virtual, an impoverished replacement for real human connection.

The second condition is a lack of meaning in life, which follows directly from the lack of embeddedness in social networks—familial, professional, religious, etc. Desmet mentions in this connection that Gallup polls in 2017 found 40% of people experienced their job as completely meaningless, with another 20% reporting a strong lack of meaning in their work. Only 13% found their work meaningful.

Other social theorists from Max Weber to Emile Durkheim have documented this trend toward social atomization and loss of the religious dimension over the last two centuries in the West. The occurrence of mass formation thus became more frequent in the 19th and 20th Centuries, when a mechanistic view of man and the world began to predominate.

The third condition for mass formation is high levels of free-floating anxiety in the population. One does not need studies, charts, and graphs—though there are plenty now—to demonstrate this condition worldwide during the pandemic. Free-floating anxiety is a form of fear not directed toward a specific object or situation. If I am afraid of snakes, I know what I fear and so can manage this by not going to the reptile section of the zoo and not hiking in the desert.

Free-floating anxiety, such as the anxiety produced by an invisible virus, is extremely intolerable because one does not have the means to modulate or control it. People stuck in this state chronically are desperate for some means to escape it. They feel helpless because they don’t know what to avoid or flee in order to manage this aversive state of mind.

The fourth condition, which follows from the first three, is a high level of frustration and aggression in the population. If people feel social disconnected, that their life makes no sense or lacks meaning (perhaps because they cannot work or go to school under lockdown conditions), that they are beset by free-floating anxiety and psychological distress without a clear cause, they will also feel frustrated and angry. And it will be hard to know where to direct this anger, so people look for an object to which they can connect their anxiety and frustration.

If under these conditions a narrative is advanced through the mass media indicating an object of anxiety and providing a strategy to deal with this target. But this is very dangerous: people become remarkably willing to participate in a strategy to exclude or even destroy the object of anxiety indicated in the narrative.

Because many people participate in this strategy collectively, a new kind of social bond—a new solidarity—emerges. The new social bond takes people from a highly aversive mental state to an almost euphoric relief, which spurs them to participate in the formation of a social mass. People begin feeling connected again, thus resolving part of the crisis. Life with this common bond starts to make sense, resolving the problem of meaning by uniting against the object of anxiety, which also allows an outlet for their frustration and aggression. But the pseudo-solidarity of the mass is thus always directed against a stigmatized outgroup; theirs is a common bond cemented by anger and disgust.

People buy into the narrative, even when it becomes absurd and out of touch with facts on the ground, not because they believe in the narrative, but precisely because it creates a social bond that they don’t want to relinquish. As in hypnosis, their field of vision becomes excessively narrowed, focused exclusively on the elements of the accepted narrative. They may be dimly aware of collateral damage or contradictory facts, but these have little to no cognitive or emotional impact—evidence simply ceases to matter.

The anger of the new social mass gets directed precisely against the people who do not want to participate in the mass formation, who reject the basis for the new social bond. For months, with high profile figures from the President to public health officials lamenting the “pandemic of the unvaccinated,” it became clear who was the designated target: those who declined social distancing, mask wearing, vaccination, or other covid measures.

For the mass that energizes around these measures, they become ritualistic behaviors that cement the social bond.

Participation in the ritual, which lacks pragmatic advantages and requires sacrifice, demonstrates that the collective is higher than the individual. For this portion of the population, it doesn’t matter whether the measures are absurd. Think of walking into a restaurant with a mask on, and removing it as soon as one sits down, for example.

Desmet’s research suggests that approximately 30% of the total population, typically those who are temperamentally prone to hypnosis, fully embrace the narrative that drives this mass formation process. Another 40 or 50% don’t fully embrace the narrative but also don’t want to publicly resist and incur the censure of the 30% segment of true believers. Another 10 to 20% of the general population is not readily hypnotized and remains highly resistant to the process of mass formation, even trying to resist its destructive excesses. One’s level of intelligence does not correlate to which of these groups one ends up in, though some personality factors likely do.

Individuals in the mass are impervious to rational argumentation, and respond instead to vivid visual images, including numbers and statistics presented in charts and graphs, and repetition of the messages central to the narrative. Desmet furthermore claims that—as in a hypnotized state where one can be insensitive to pain, allowing even for surgery without anesthesia—someone caught up in the process of mass formation becomes radically insensitive to other important values in life. All kinds of goods can be taken from him, including his freedom, and he takes little notice of these losses and harms.

In extreme cases, masses become capable of committing atrocities, all the while believing they are performing an almost sacral duty for the greater good. As Gustave Le Bon, author of the 1895 classic work, The Crowd: A Study of the Popular Mind, pointed out: if those who are awake try to wake up those who are sleepwalking, they will initially meet with little success; however, they must continue to try, peacefully and nonviolently, to prevent the worst outcomes. Any violence will be used as an excuse for the aggressors to increase their persecution and repression. So it is important to continue to speak the truth and exercise nonviolent resistance.

In addition to the mass formation theory, the insights of Stanford Professor Rene Girard, one of the 20th Century’s greatest thinkers, on mimetic contagion and the scapegoating mechanism are helpful to understand this phenomenon. In many ways, this complements the mass formation account. Girard saw that we imitate not only one another’s behaviors, but one another’s desires. We end up wanting the same thing(s), e.g., “I need to be first in line for the vaccine, which will let me get my life back.”

This can lead to mimetic rivalry and increase social tension and conflict. The mechanism that societies use to resolve this conflict is scapegoating. The social tension (amplified during lockdowns and with the fear-based propaganda) is attributed to a person or class of person, with the proposal that if we can only rid ourselves of the [fill in the blank “unclean” member(s) of society] the social tension will resolve.

The banishment or destruction of the scapegoat (in this case, the unvaccinated) falsely promises to return society to a harmonious state and diffuse the threat of violent conflict. While scapegoating does relieve social tensions a bit, this is always only temporary. Mimetic rivalry continues, social tensions once again build, and another scapegoat must be identified (e.g., now the enemy is those who spread alleged disinformation). The cycle continues.

As an interesting side note, Girard argued that the crucifixion of Christ unveiled this scapegoating mechanism and simultaneously removed its power, because it revealed that the scapegoat was an innocent victim—thereby robbing the scapegoating mechanism of its temporary power. The innocence of the scapegoated victim, the terminal phase of mimetic contagion, is a lesson we still have not learned.


Republished from the author’s Substack
Aaron Kheriaty, former Professor of Psychiatry at the UCI School of Medicine and Director, Medical Ethics at UCI Health, is a Senior Scholar of the Brownstone Institute.
 

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Are you sure about that?
United States is 'out of the pandemic phase,' Fauci says


The United States is finally "out of the pandemic phase," the country's top infectious disease expert said, as cases and hospitalizations are notably down and mask mandates are all but extinct.

“We are certainly right now in this country out of the pandemic phase," Anthony Fauci, President Joe Biden's chief medical adviser, said Tuesday.

Fauci said the United States was no longer seeing "tens and tens and tens of thousands of hospitalizations and thousands of deaths. We are at a low level right now."

The coronavirus will not be eradicated, Fauci said, but can be handled if its level of spread is kept "very low" and people are "intermittently" vaccinated, though he said he did not know how frequently.

Awww... isn't that precious? The malignant dwarf is trying to negotiate.
 

thompson

Certa Bonum Certamen
Yet another bleeping LIAR



BUSTED: How a COVID Frontline Doctor Was Exposed as a Total Fraud


Matt Vespa
Posted: Apr 27, 2022 2:30 PM

Lady, you're a lying sack. Of all times to pull a con, this isn't it, especially in this profession. We all have supported our doctors and nurses who dealt with the original COVID strain and Delta variant. No doubt hospitals were filling up, though it was never on the verge of collapse—a liberal media scare point that was peddled some 9,000 times. Hospital system collapse never happened. There were shortages of personal protection equipment at the outset of the pandemic. Yet, our medical workers pulled through, and now the pandemic is over.

Some on the left in the mask cult can't let it go, but this is done. By this November, when the GOP retakes control across the country, it will truly be over. Now, it doesn't negate that our medical professionals are heroes. They should have been hailed as such but were then cast aside when a significant number of them refused to get the COVID vaccine. The media trampled over them.

Granted, my head was already spinning with this group by the summer of 2020. At the start of the lockdowns, the medical expert community said "stay inside to stop the spread" to avoid overwhelming our hospitals. That made sense. Then, the George Floyd incident caused Minneapolis and the rest of urban America to blow up. Black Lives Matter was holding protests everywhere, and it was supported by these people. Racism is also a pandemic—that was the line used to justify these mass protests. If you're protesting, the virus can't infect you. This was when "expert opinion" began to depreciate fast.

View: https://twitter.com/guypbenson/status/1519279726216548352?s=20&t=PmMICXDDm17ygPfxYoUhcg


I say all of this because some frontline COVID doctor who claimed to be overworked has just been exposed as a remote school pediatrician working nine-to-five and living a cushy lifestyle. Her Instagram turned out to be her undoing. Substack writer Sarah Beth Burwick uncovered the ruse first (via NY Post):

A New York City pediatrician spent the COVID-19 pandemic complaining online about her grueling 12-hour days in full PPE on the frontlines — only to be revealed as a school doctor with a plum 9-to-5 job, according to an explosive report.
Dr. Risa Hoshino had emerged as one of the preeminent physician influencers at the height of the pandemic, created a reputation for herself online as an expert in treating children with COVID-19 and long COVID symptoms, according to Substack blogger Sarah Beth Burwick.

But according to the report, Hoshino has been misrepresenting her job and exaggerating about working long hours in the hospital and saving coronavirus-stricken children.

Hoshino has a $170,000-a-year gig as a New York City public school pediatrician, with most of her work being done remotely, according to Burwick, who describes herself as a lawyer mom from Los Angeles.

While Hoshino reportedly often posed up in personal protection equipment and scrubs, complained about being overworked and disrespected by her patients, and used her public platform to promote mask-wearing and vaccinations, her Instagram page painted a very different picture.

On Hoshino’s IG account, the raven-haired physician was reportedly seen in bikini shots looking carefree on the beach – a far cry from the worn-out COVID doctor persona that she cultivated on Twitter.

Other images reportedly showed the beaming doctor having maskless drinks with friends, even as she continued beating the drum about the importance of face coverings on Twitter.
To no one's surprise, Dr. Hoshino has gone quiet on her social media activity. Accounts have either been made private or been deleted outright, according to the NY Post. She worked remotely throughout 2020 and claimed to be some COVID hero. What a sick puppy. Also, claiming to be on the frontlines while posting photos of you pounding margaritas on the beach? This game was never going to last.
 

Heliobas Disciple

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View: https://www.youtube.com/watch?v=c15m3yhlIxk
Denmark suspends vaccinations
17 min 26 sec
Apr 28, 2022
Dr. John Campbell

Denmark is ahead of the strategy, as usual. China latest news, not good at all. Denmark https://www.sst.dk/en/english/corona-... Population, 5.9 million Cases, + 1,484 Reinfections, 128 Hospitalised, 733 ICU, 13 Ventilated, 4 Deaths, 4 Over 12, 2 doses, 89% Over 18, boosted, 76% Denmark February 1st First country to remove all pandemic related domestic restrictions (Virus was no longer considered a critical threat) Tyra Grove Krause, director of infection preparedness, SSI Let the new wave run through the population With omicron, it is impossible to stop the spread of infection, even with severe restrictions https://www.telegraph.co.uk/world-new... First country to suspend Covid-19 vaccination programme From May 15th May resume the programme after the summer Danish Health Authority Virus under control High levels of vaccination Drop in the number of new infections Stabilising hospitalisation rates Bolette Soborg, Chief physician We plan to reopen the vaccination programme in the autumn. This will be preceded by a thorough professional assessment of who and when to vaccinate and with which vaccines China https://www.telegraph.co.uk/business/... Dr Yanzhong Huang, Council on Foreign Relations They’re not even considering co-existence with the virus as an option right now Dr Liang Wannian, head of expert panel huge disaster if China relaxed restrictions zero-Covid policy insurance for the 1.4 billion people Background scandals 2018, Changchun Changsheng, violated standards in 250,000 doses of vaccine for diphtheria, tetanus, whooping cough Hong Kong data Two doses of Sinovac, 72% effective against severe or fatal Covid-19 for over 60s Three doses, 98% One month Chinese outbreak, 31,000 to 250,000 deaths. Professor Steve Tsang, Chatham House China’s low death demonstrate clear superiority Zero-Covid is Xi's policy Xi does not make mistakes and cannot be seen to make mistakes It cannot be changed unless Xi says otherwise
 

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Foreign research finds Pfizer, Moderna COVID vaccines don't reduce all-cause mortality
Vaccine experts worry U.S. policy is headed toward annual COVID booster recommendation without data. Dozens ask FDA to consider more than short-lived antibody response in COVID vaccine trials.
By Greg Piper
Updated: April 27, 2022 - 11:12pm

The mRNA COVID-19 vaccines made by Pfizer and Moderna showed no reduction in all-cause mortality in randomized controlled trials (RCTs), according to a new paper by researchers at primarily Danish institutions.

"Based on the RCTs with the longest possible follow-up," mRNA vaccines only protected against "fatal" COVID, while adenovirus-vector vaccines made with older technology, including Johnson & Johnson's, "were associated with lower overall mortality and lower non-accident, non-COVID-19 mortality," they wrote.

The research adds to existing questions about the evidentiary basis for vaccine and booster mandates on tens of millions of Americans.

CDC Director Rochelle Walensky justified the agency's about-face on masks for vaccinated people in July by citing "similarly high SARS-CoV-2 viral loads in vaccinated and unvaccinated people" during the Delta variant wave.
Vaccine experts, including the FDA's former chief scientist Luciana Borio and current adviser Paul Offit, recently told Stat News they were worried U.S. policy was headed for an annual booster recommendation without data to justify it.

Dozens, including Borio, signed an open letter to top FDA officials last week asking them to recommend "T-cell assessment in COVID-19 vaccine clinical trials" in addition to antibody response, which is often short-lived and has underperformed against Delta and Omicron variants. Pfizer CEO Albert Bourla has admitted its vaccine hit a brick wall against Omicron.

As a preprint hosted by The Lancet but not necessarily submitted to that medical journal, the Danish paper has not undergone formal peer review. The CDC also publishes much COVID-related research without peer review in its own Morbidity and Mortality Weekly Report.

Former Harvard Medical School professor Martin Kulldorff told Just the News that he and two others, in the U.S. and Europe, had reviewed the Danish paper. Stanford University medical professor Jay Bhattacharya, Kulldorff's Great Barrington Declaration coauthor, confirmed he was the other U.S. reviewer.

"Given this pattern of evidence it makes sense to recommend the adenovector vaccines in most cases over the mRNA vaccines, and to ask the mRNA vaccine manufacturers to provide randomized evidence of mortality reduction against an adenovector vaccine," Bhattacharya wrote in an email.

Citing the "ample evidence" of "broad heterologous effects on the immune system" from COVID vaccines, the paper set out to study "completely unexpected effects on overall mortality" from COVID vaccines that are "different from what could be anticipated based on the protection against the vaccine-targeted disease."

The researchers identified three RCTs on mRNA vaccines with 74,000 adults and six on adenovirus-vector vaccines with 122,000 that included mortality data 3-4 months after vaccination.

They examined mortality risk instead of rate because "follow-up time was not reported in a consistent manner" and obtained clarifying data from RCT authors, including whether deaths were caused by COVID, cardiovascular disease, accidents or other causes.

Sixty-one vaccinated people died compared to 60 placebos in the mRNA RCTs, for an overall risk reduction (RR) of 1.03, a statistically insignificant difference. The paper said the analysis had "low power to detect differences in effect between" the Pfizer and Moderna vaccines.

Sixteen people who received the adenovirus-vector vaccines (J&J, AstraZeneca and Russia's Sputnik) died, compared to 30 in the control group, for a highly significant overall RR of 0.37. Individually, the RRs were 0.19 for J&J and 0.50 for AstraZeneca, but Sputnik had too few deaths to confidently discern any difference.

Corresponding author Peter Aaby told Just the News Wednesday he couldn't respond the same day to a request for comment about the paper's professional reception.

Pfizer and Moderna didn't answer queries to respond to the research. Neither did the CDC or FDA when asked why they hadn't funded or sought research to determine whether mRNA COVID vaccines actually save lives, continuing a pattern of getting upstaged by COVID research from abroad.

Kulldorff said the paper was the first COVID vaccine study to answer "the right question with the right data" in an essay for the Brownstone Institute, where he and Bhattacharya are senior scholars.

The researchers did a "brilliant job extracting as much information as possible from the industry-sponsored RCTs," which were prematurely cut short due to emergency use authorization and recruited people too young to determine whether the vaccines reduced mortality, he said.

The mRNA vaccines reduced COVID deaths but increased them for cardiovascular deaths, though "neither was statistically significant," while the other vaccines showed "statistically significant decreases in both Covid and cardiovascular deaths, unlikely to be due to chance," according to Kulldorff.

"If Pfizer and Moderna want to continue to sell these vaccines, we should demand that they conduct a proper randomized clinical trial that proves that the vaccines reduce mortality," he said.

Stanford Med student Santiago Sanchez critiqued the paper in a tweet thread Saturday that denigrated "the GBD gang," referring to Kulldorff, Bhattacharya and the Brownstone Institute.

The "overlapping confidence intervals" (CIs) in the mRNA RCTs don't mean the results are statistically insignificant, he said. The CIs in the adenovirus group substantially crossed 1 for every vaccine but J&J, whose trial data "likely almost entirely" explains that group's overall mortality reduction, and J&J also had a much shorter followup period than mRNA vaccines.

Shown the Sanchez thread, Bhattacharya disputed the student's claim that "no conclusion can be drawn about overall mortality" from these data.

The adenovirus but not mRNA vaccines "had a statistically significant all-cause mortality benefit," he wrote in an email. Even though "we'd need a larger trial" to conclude the latter increases all-cause mortality, "the balance of evidence points to recommending the adenovirus vaccines."

Regarding the disparate followup time period flagged by Sanchez, Bhattaharya said extending the mRNA trials "would not 'by chance' lead to a null finding" if they really did reduce all-cause mortality. "The same incorrect reasoning could be applied to covid mortality."
 

Heliobas Disciple

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Fauci: U.S. is 'certainly' out of pandemic stage of COVID-19
Fauci noted that many Americans may have to receive vaccines every year in order to keep case numbers low.
By Sophie Mann
Updated: April 27, 2022 - 10:03am

Dr. Anthony Fauci, the country's top infectious disease expert, says the United States is "certainly" past the pandemic stage of fighting the coronavirus, though he acknowledges it continues in other countries around the world.

"We are certainly right now in this country out of the pandemic phase," he told PBS NewsHour host Judy Woodruff on Tuesday. "We don't have 900,000 new infections a day and tens and tens and tens of thousands of hospitalizations and thousands of deaths. We are at a low level right now. So, if you're saying, are we out of the pandemic phase in this country, we are."

Fauci, also President Biden's chief medical adviser, also said the U.S. was "not going to eradicate this virus" entirely and that the government should continue a practice of "intermittently vaccinat(ing) people."

Many Americans, he said, may have to get vaccinated annually for an unclear period of time in an effort to reduce the number of infections.

"That might be every year, that might be longer, in order to keep that level low. But, right now, we are not in the pandemic phase in this country," he said.
 

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EMPHASIS IS IN THE ARTICLE (not added by me)


Fauci Admits "Pandemic Phase" Of COVID Is Over
by Tyler Durden
Wednesday, Apr 27, 2022 - 05:05 PM

We are certainly right now in this country out of the pandemic phase," White House Chief Medical Adviser Dr. Anthony Fauci remarked during an interview with PBS Newshour.
"Namely, we don't have 900,000 new infections a day and tens and tens and tens of thousands of hospitalizations and thousands of deaths. We are at a low level right now."
“So, if you’re saying, are we out of the pandemic phase in this country, we are,” he added.​

Is this Biden-and-Fauci's "Mission Accomplished" moment?

But it's not over for the rest of the world...

"Pandemic means a widespread, throughout the world, infection that spreads rapidly among people," Fauci said.
"So, if you look at the global situation, there's no doubt this pandemic is still ongoing."

Earlier this month, Fauci also acknowledged that COVID would never be “eradicated” and that “each individual is going to have to make their calculation of the amount of risk that they want to take.”

The best hope is to maintain the coronavirus at low levels of transmission and pursue intermittent vaccinations, Fauci said.

Fauci's 'brave' call comes just days after The CDC announced that because so many people in the U.S. have now caught omicron and other strains of the coronavirus, nearly 60% of the population - and almost 75% of children 11 and younger - now have antibodies to it in their blood.

There's just one small problem... no one told The White House...

Psaki: "COVID isn't over, and the pandemic isn't over." pic.twitter.com/95hopEF0Gm
— The Post Millennial (@TPostMillennial) April 27, 2022

While Fauci and other technocrats may be loosening the chains in the short term, others have indicated that the push for new restrictions will return before winter, and given the 'outbreak' that appears to be ripping through Washington elites, nothing would surprise us less than attempts to reinstate restrictions - because they all worked so well last time and every time - for your own safety!
 

Heliobas Disciple

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Mask Mandates Make Comeback to US College Campuses
By Bill Pan
Updated: April 24, 2022

Two months after the federal government eased mask recommendations for most Americans, some colleges and universities have reinstated mask mandates, along with other measures, citing surges in COVID-19 cases on their campuses.

Several prominent institutions—including American University and Georgetown University in Washington, D.C.; Columbia University in New York; Johns Hopkins University in Maryland; and Rice University in Texas, to name a few—have brought back indoor mask requirements that were phased out not too long ago.

Many of these schools already have vaccine and booster mandates. For example, Columbia required all students and employees to submit proof of their booster vaccination before March, boasting an overall 99.9 percent compliance rate for the campus community. Yet it now demands that students wear surgical masks in classrooms because of an uptick of COVID-19 cases on campus and elsewhere in New York City.

“Based on the current situation and in an abundance of caution, we will require wearing of non-cloth masks in classrooms,” the Ivy League school announced on April 10. In a more recent update, the university said the requirement wouldn’t go away any time soon, despite an overwhelmingly high level of vaccination among the campus population.

“We anticipate making no changes in our current campus COVID-19 guidance, unless New York City puts in place measures that we would be required to follow,” Columbia officials said on April 22, noting a “gradual increase in COVID-19 cases” in the city.

Rice also requires all eligible students and employees to get booster shots. In mid-March, the Houston-based university lifted its mask mandate for vaccinated individuals, only to reverse the policy after less than a month because of a sudden rise in COVID-19 cases.

“There’s been a significant rise in the number of positive cases reported in our community—about 145,” the university said in an April 10 statement. Specifically, Rice demanded that everyone in a classroom wear a mask regardless of their vaccination status, except for instructors while lecturing, since 90 percent of those new cases have occurred among undergraduate students. Large events also have been canceled. Students can continue to eat in dining halls, but at half of the designated capacity.

According to a COVID-19 tracker on Rice’s website, the university has recorded 31 positive tests for the week following Easter. There’s also been a noticeable downward trajectory since April 10, but the restrictions remain in place.

Meanwhile, in Philadelphia, health officials and the mayor raised the city’s COVID-19 alert level on April 18, requiring citizens to wear face coverings when out in public. That has prompted a number of schools, including the University of Pennsylvania, Temple, St. Joseph’s, La Salle, Drexel, and Thomas Jefferson universities, to require students and staff to mask up while in school buildings.

All of these Philadelphia schools went mask-optional again just three days later, when the city announced that it not only has reversed the decision to reimpose the mask mandate, but also ditched the COVID-19 alert system that triggered it.

“The infection rate is going down, hospitalizations are going down, and, frankly, the ruling in Florida confused a lot of stuff. SEPTA is doing what they did and confused a lot of stuff,” said Philadelphia Mayor Jim Kenney.

Kenney was referring to a U.S. district judge in Florida who struck down a federal rule requiring face coverings for planes and other forms of public transportation, as well as the decision by SEPTA, Pennsylvania’s regional transit authority, to lift the requirement that travelers must wear masks on its buses and trains.

Florida’s universities were among the earliest in the nation to drop their mask mandates. South Florida University has been mask-optional since August 2021, while the University of Florida said it simply doesn’t have the authority to force people to mask up on campus.

“The university does not currently have the authority to take the actions you recommend,” University of Florida President Kent Fuchs wrote in response to the Alachua County Commission, which had asked the school to adhere to a public health emergency declaration that mandated masks indoors.
 

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Asthma Drug Montelukast (Singulair) Can Block Crucial COVID Protein, Reducing Viral Replication
By Indian Institute of Science (IISc)
April 27, 2022

Montelukast is a drug used in the maintenance treatment of asthma that is marketed under the trade name Singulair and others. In general, it is less favored for this application than inhaled corticosteroids. It is ineffective in treating acute asthma attacks. Other applications include allergic rhinitis and long-lasting hives. It is a second-line therapy for allergic rhinitis.

Targeting Nsp1 with montelukast (Singulair) helps prevent shutdown of host protein synthesis. Credit: Mohammad Afsar
An oral medication used to treat asthma and allergies can bind to and block a crucial protein produced by the SARS-CoV-2 virus, and reduce viral replication in human immune cells, according to a new study by researchers at the Indian Institute of Science (IISc).

Approved by the US Food and Drug Administration (FDA), the drug, called montelukast, has been around for more than 20 years and is typically prescribed to reduce inflammation caused by conditions like asthma, hives, and hay fever. In the United States, montelukast is sold under the brand name Singulair.

In the study published recently in the journal eLife, the researchers show that the drug binds strongly to one end (‘C-terminal’) of a SARS-CoV-2 protein called Nsp1, which is one of the first viral proteins unleashed inside the human cells.

This protein can bind to ribosomes – the protein-making machinery – inside our immune cells and shut down the synthesis of vital proteins required by the immune system, thereby weakening it. Targeting Nsp1 could therefore reduce the damage inflicted by the virus.

“The mutation rate in this protein, especially the C-terminal region, is very low compared to the rest of the viral proteins,” explains Tanweer Hussain, Assistant Professor in the Department of Molecular Reproduction, Development and Genetics (MRDG), IISc, and senior author of the study. Since Nsp1 is likely to remain largely unchanged in any variants of the virus that emerge, drugs targeting this region are expected to work against all such variants, he adds.

Hussain and his team first used computational modeling to screen more than 1,600 FDA-approved drugs in order to find the ones that bound strongly to Nsp1. From these, they were able to shortlist a dozen drugs including montelukast and saquinavir, an anti-HIV drug. “The molecular dynamic simulations generate a lot of data, in the range of terabytes, and help to figure out the stability of the drug-bound protein molecule. To analyze these and identify which drugs may work inside the cell was a challenge,” says Mohammad Afsar, former Project Scientist at MRDG, currently a postdoc at the University of Texas at Austin, and first author of the study.

Working with the group of Sandeep Eswarappa, Associate Professor in the Department of Biochemistry, Hussain’s team then cultured human cells in the lab that specifically produced Nsp1, treated them with montelukast and saquinavir separately, and found that only montelukast was able to rescue the inhibition of protein synthesis by Nsp1.

“There are two aspects [to consider]: one is affinity and the other is stability,” explains Afsar. This means that the drug needs to not only bind to the viral protein strongly, but also stay bound for a sufficiently long time to prevent the protein from affecting the host cell, he adds. “The anti-HIV drug (saquinavir) showed good affinity, but not good stability.” Montelukast, on the other hand, was found to bind strongly and stably to Nsp1, allowing the host cells to resume normal protein synthesis.

Hussain’s lab then tested the effect of the drug on live viruses, in the Bio-Safety Level 3 (BSL-3) facility at the Centre for Infectious Disease Research (CIDR), IISc, in collaboration with Shashank Tripathi, Assistant Professor at CIDR, and his team. They found that the drug was able to reduce viral numbers in infected cells in the culture.

“Clinicians have tried using the drug … and there are reports that said that montelukast reduced hospitalization in COVID-19 patients,” says Hussain, adding that the exact mechanisms by which it works still need to be fully understood. His team plans to work with chemists to see if they can modify the structure of the drug to make it more potent against SARS-CoV-2. They also plan to continue hunting for similar drugs with strong antiviral activity.

Reference: “Drug targeting Nsp1-ribosomal complex shows antiviral activity against SARS-CoV-2” by Mohammad Afsar, Rohan Narayan, Md Noor Akhtar, Deepakash Das, Huma Rahil, Santhosh Kambaiah Nagaraj, Sandeep M Eswarappa, Shashank Tripathi and Tanweer Hussain, 24 March 2022, eLife.

DOI: 10.7554/eLife.74877
 

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Researchers Assess the Power of T-Cell Immune Response to COVID-19 BA.1 and BA.2 Omicron Variants
By National Research University Higher School of Economics
April 27, 2022

Researchers have demonstrated the efficiency of T-cell immune response against the Omicron variant of SARS-CoV-2. In approximately 90% of vaccinated Europeans, T-cell immunity was as effective against Omicron as with other COVID variants.

Scientists from HSE University and the RAS Institute of Bioorganic Chemistry have demonstrated the efficiency of T-cell immune response against the Omicron variant of SARS-CoV-2 (the virus that causes COVID-19). In approximately 90% of vaccinated Europeans, T-cell immunity was as effective against Omicron as with other variants. The results of the study were published today (April 27, 2022) in the journal PeerJ.

The Omicron variant of SARS-CoV-2 caused a new wave of the global COVID-19 pandemic. The new mutations help the virus spread more effectively and avoid antibodies, which is why those who have already had the disease or who have been vaccinated are getting infected more often. At the same time, recent data shows that the severity of the disease in vaccinated patients is significantly lower than in people who had not previously contracted the virus.

Peptide Binding COVID Variants

Peptides of the Wuhan basic variant and the Delta variant bind well with HLA-DRB1*03:01 (high orange column on the left), while Omicron BA.1 and BA.2 peptides are no longer recognized by this molecule. Credit: S.Nersisyan et al.

The researchers assume that this can be explained by several factors. First, the Omicron variant is slower at infecting the human cells; second, there is a hypothesis that a lighter course of the disease is related to effective action of T-cell immunity.

To confirm this assumption, a team of researchers from the HSE Faculty of Biology and Biotechnology and the RAS Institute of Bioorganic Chemistry (Stepan Nersisyan, Anton Zhiyanov, Alexey Galatenko, Maxim Shkurnikov, Maria Zakharova, Irina Ishina, Inna Kurbatskaia, Azad Mamedov, Alexander Gabibov, and Alexander Tonevitsky) studied the Omicron variant for mutations that help it avoid the T-cell immune response.

The development of T-cell response starts from the recognition of virus peptides (short fragments of proteins) with the molecules of the human major histocompatibility complex (HLA). The more peptides that are recognized, the faster and more efficient T-cell immunity is. Virus mutations can change such peptides, which is why they can stop being recognized by HLA molecules, and the T-cell response will be less effective.

T-CoV, a bioinformatics algorithm, demonstrated that the Omicron variant avoided none of the HLA molecule variants. But it detected several HLA molecule variants that started to become less effective at recognizing the Omicron’s S-protein. An outstanding discovery was the HLA-DRB1*03:01 variant of the molecule. The most important peptide of the virus managed to avoid it. Interestingly, both types of Omicron, BA.1 and BA.2 (also known as ‘Stealth’), evaded immune response recognition, though this was achieved by completely different mutations.

The bioinformatics calculations were verified experimentally in a laboratory. The researchers proved that there is no binding between Omicron peptides and HLA-DRB1*03:01 molecule, which was expressed in vitro.

The researchers emphasize that the initial peptide from the Wuhan basic variant, as well as Delta peptide, are recognized effectively by this molecule.

The authors emphasize that the detected HLA-DRB1*03:01 variant is present in a big share of the global population: for example, in 8.9% of Europeans.

‘The population diversity of HLA molecules, as well as the specificity of their work do not let the virus avoid the T-cell immune response. But the virus has managed to hide its S-protein from one of the HLA molecules. Importantly, most of COVID-19 vaccines (Sputnik V, Pfizer, Moderna, AstraZeneca and some others) carry specifically this virus protein. This means that people with the variant HLA-DRB1*03:01 (who make up 9% of Europe’s population, for example) vaccinated by S-protein may suffer from a more severe course of the disease caused by the Omicron variant,’ said Alexander Tonevitsky, Dean of the HSE Faculty of Biology and Biotechnology.

Reference: “Alterations in SARS-CoV-2 Omicron and Delta peptides presentation by HLA molecules” by Stepan Nersisyan, Anton Zhiyanov, Maria Zakharova, Irina Ishina, Inna Kurbatskaia, Azad Mamedov, Alexei Galatenko, Maxim Shkurnikov?, Alexander Gabibov and Alexander Tonevitsky, 27 April 2022, PeerJ.

DOI: 10.7717/peerj.13354
 

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Children's mental health during pandemic influenced by adult vaccination rates and socioeconomic factors
by Weill Cornell Medical College
April 27, 2022

Adult vaccination rates and social determinants of health—or the social and economic conditions in which families live and work—have played an important role in children's mental health during the pandemic, according to a new study led by Weill Cornell Medicine investigators.

The study, published April 27 in JAMA Psychiatry, found that stress surrounding the pandemic in the United States declined in children after the vaccinations were rolled out for adults in December 2020.

"Children who are living in states with higher vaccination rates may be less worried about the future of this pandemic," said lead author Dr. Yunyu Xiao, assistant professor of population health sciences at Weill Cornell Medicine. "Getting vaccinated may also affect the mental health of parents and the home environment that kids are living in."

Social determinants of health that influenced children's mental health during the pandemic include food insecurity, unemployment, disrupted access to health care, and having parents who were essential workers. "Many of these structural and social issues existed before the pandemic but were further exacerbated by it," Dr. Xiao said.

Dr. Xiao and her colleagues, Dr. John J. Mann of Columbia University, Dr. Paul Yip of the University of Hong Kong and Dr. Jyotishman Pathak of Weill Cornell Medicine, assessed data from 8,493 children in the Adolescent Brain Cognitive Development (ABCD) study, a long-term analysis of brain development in children funded by the National Institutes of Health with 21 research sites across the United States. This study also included survey data about the mental and social impact of the COVID-19 pandemic. In addition, the researchers evaluated geocoded COVID-19 data describing the local environment—including COVID-19 prevalence and social distancing metrics—for each study participant. They also cross-referenced vaccination eligibility data, as well as full vaccination rates for adults across 17 states.

They discovered that stress, sadness, and COVID-related worry decreased significantly after the adult vaccination rollout. Moreover, children living in states with later vaccination eligibility dates for adults or fewer fully vaccinated adults experienced greater COVID-related worry and stress.

Groups of children that reported high rates of stress were older, female, Hispanic, had parents who were separated, experienced interruptions to healthcare, lived in economically deprived neighborhoods or in areas with more full-time, working-class adults who were unable to social distance; that is, essential workers. Children who were Asian, Black, or multi-racial also reported higher rates of COVID-related worry than white children.

A variety of local, statewide, and federal policies can help to alleviate stress in children, including those that seek to vaccinate the adults in their lives, Dr. Xiao said. In addition, policies that target food insecurity and offer nutrition assistance, extend unemployment insurance and moratoria on housing evictions, expand healthcare coverage, and support essential workers would also be beneficial. The development and expansion of broadband services so that more communities have access to telehealth services is another avenue that should be explored. "Structural level changes are needed to prepare for the next public health emergency," Dr. Xiao said.

Dr. Xiao and the study team plan to investigate additional social determinants of health, including the pandemic preparedness of schools and the pre-pandemic mental health of children, and how they have influenced the overall well-being of children.

"We also want to better understand how various policies that have been implemented are affecting children's mental health," she said. "This could ultimately help policymakers know what resources they should invest in."
 

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Notice the article doesn't say what the Ad.26.COV2.S vaccine is. I had to google it - it's the J&J vaccine. why not just say so? :shr:

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


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Risk for Guillain-Barré syndrome up after Ad.26.COV2.S vaccination
April 27, 2022

The incidence of Guillain-Barré syndrome (GBS) is increased after Ad.26.COV2.S vaccination, but incidence is not increased after mRNA vaccination, according to a study published online April 26 in JAMA Network Open.

Kayla E. Hanson, M.P.H., from the Marshfield Clinic Research Institute in Wisconsin, and colleagues used data from the Vaccine Safety Datalink to describe the incidence of GBS following COVID-19 vaccination. Data were included for 10,158,003 participants who were aged 12 years or older.

From Dec. 13, 2020, through Nov. 13, 2021, 15,120,073 doses of COVID-19 vaccine were administered to 7,894,989 individuals, including 483,053 Ad.26.COV2.S doses, 8,806,595 BNT162b2 doses, and 5,830,425 mRNA-1273 doses. The researchers confirmed 11 cases of GBS after Ad.26.COV2.S vaccination. The unadjusted incidence rate of GBS was 32.4 per 100,000 person-years in the one to 21 days after Ad.26.COV2.S, which was significantly higher than the background rate; the adjusted rate ratio was 6.03 in the one to 21 versus 22 to 42 days following Ad.26.COV2.S vaccination. There were 36 confirmed cases of GBS after mRNA vaccines, for an unadjusted incidence rate of 1.3 per 100,000 in the one to 21 days after vaccination. The adjusted rate ratio was 0.56 in the one to 21 versus 22 to 42 days after vaccination. The adjusted rate ratio was 20.56 in a head-to-head comparison of Ad.26.COV2.S versus mRNA vaccines.

"In this interim analysis of surveillance data of COVID-19 vaccines, findings were consistent with an elevated risk of GBS after primary Ad.26.COV2.S vaccination," the authors write.

Several authors disclosed financial ties to the pharmaceutical industry, including receipt of grants from manufacturers of COVID-19 vaccines; one author disclosed ties to Arnold Ventures.
 

Heliobas Disciple

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New study shows fewer people die from COVID-19 in better vaccinated communities
by British Medical Journal
April 27, 2022

A large US study published by The BMJ today finds that fewer people die from COVID-19 in better vaccinated communities.

The findings, based on data across 2,558 counties in 48 US states, show that counties with high vaccine coverage had a more than 80% reduction in death rates compared with largely unvaccinated counties.

This large benefit complements the growing body of evidence indicating individual level benefits of COVID-19 vaccination. A linked editorial also proposes that encouraging people to keep up to date with vaccination saves lives.

As of 11 April 2022, more than 11 billion COVID-19 vaccine doses have been administered globally and the World Health Organization's target is to vaccinate 70% of the world's population by mid-2022.

Yet while previous vaccine studies have shown benefits at the individual level, the wider population level impact of scaling up COVID-19 vaccination remains largely unknown.

To address this, researchers at the US Centers for Disease Control and Prevention (CDC) set out to estimate how increasing county coverage of vaccines affected population level mortality and incidence of COVID-19.

Their findings are based on more than 30 million cases of COVID-19 and over 400,000 deaths linked to COVID-19 across 2558 counties, which were reported during the second year of the pandemic, between December 2020 and December 2021.

They measured effectiveness by comparing reported COVID-19 incidence and mortality rates in counties with very low (0-9%), low (10-39%), medium (40-69%), and high (70% or more) vaccination coverage—defined as the percentage of adults (aged 18 and over) who had received at least one dose of a COVID-19 vaccine.

After taking account of potentially influential factors, the researchers found that increased vaccination coverage in counties was associated with reduced levels of COVID-19 related mortality and cases.

For example, during the first half of 2021, when the alpha variant of coronavirus was dominant, the COVID-19 mortality rate was reduced by 60%, 75%, and 81% in counties with low, medium, and high vaccination coverage, respectively, compared with counties that had very low coverage.

The corresponding figures for the reduction in cases were 57%, 70%, and 80%.

Similar reductions in mortality were also seen during the second half of 2021 when the delta variant became dominant in the US, although with smaller effects on case levels.

This is an observational study, so can't establish cause and the researchers say several limitations should be considered when interpreting these data. For example, additional markers of severe disease, such as hospital admissions, were not explored and they did not control for factors such as rules on wearing a face mask masking and physical distancing at the time, which may have affected their results.

Nevertheless, they point out that results were similar after further sensitivity analyses, suggesting that they withstand scrutiny. And they say: "Future research may benefit from evaluating macroeconomic effects of improving population health, such as changes in employment rates and gross domestic product resulting from reopening society."

This study adds to the evidence that vaccination can prevent infection and illness on a large scale, writes Professor Christopher Dye at the University of Oxford in a linked editorial.

"The findings of this study also make clear that many more lives could have been saved, and will be saved, by encouraging people to keep up to date with vaccination in the face of waning immunity and new coronavirus variants and by achieving even higher population coverage," he adds.

"How many lives is a matter for others to explore. Meanwhile, this new study is another confidence booster for COVID-19 vaccines," he concludes.
 

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Wastewater can reveal how many of us have gotten COVID-19
by Susie Allen, Yale University
April 27, 2022

Since the early weeks of the COVID-19 pandemic in the United States, a group of Yale researchers has diligently tracked the virus via a useful but decidedly unglamorous source: sewage.

Daily measurements from the New Haven wastewater treatment facility have yielded a series of important insights about the pandemic's course. In one study, a group of Yale researchers including Yale SOM's Edward H. Kaplan, a professor of operations research, public health, and engineering, and Jordan Peccia, professor of chemical and environmental engineering, demonstrated that the concentration of COVID-19 RNA per milliliter of sewage sludge rises and falls with the rate of infection seen in testing and hospitalization data. In another, they found that testing wastewater can provide an early warning sign of a worsening outbreak, three to five days before hospitalizations begin to surge.

Now they've uncovered yet another secret in the sludge. In their latest paper, Kaplan, Peccia, and Yale student coauthors Alessandro Zulli and Marcela Sanchez use wastewater data to calculate the cumulative COVID-19 incidence rate in New Haven and present a formula that would allow other municipalities to do the same. Their results suggest that nearly a third of people in the New Haven area had been infected by May 2021—a finding that is consistent with three other independent statistical estimates, but notably larger than the 12% figure derived from official case counts.

To develop their estimate, Kaplan and Peccia needed just one reliable measure of how many people had been infected against which to calibrate their wastewater measurements. They were fortunate to have data from the Centers for Disease Control, which conducted antibody blood testing in Connecticut in the summer of 2020. That CDC testing, which took place before the arrival of vaccines, told the researchers how many people had been infected up to that point. After matching the CDC's estimate with the concentration of RNA in wastewater at the same time, they could extrapolate forward to May 2021.

Any city could, in theory, do the same, whether using CDC data from the area or antibody tests from another source. "The principle is what's important," Kaplan explains. With frequent sewage data and one accurate point-in-time estimate of infections, the same basic approach can work anywhere.

Knowing how many people have been infected with COVID-19 over time "is important to knowing what our actual immunity to SARS-CoV-2 could be," Peccia explains—but getting a good grasp on the cumulative incidence rate has proved challenging. (The CDC antibody tests from 2020 were helpful but not nationally representative and quickly fell out of date.)

Official case counts, which are derived from testing, reflect inconsistencies in testing across the U.S. Early in the pandemic, tests were scarce; more recently, the widespread use of at-home tests means that not every positive result is being reported to public health authorities as a new case of COVID-19. Trying to reverse engineer the number from other signals, such as hospitalizations, is equally tricky: some variants have put more people in the hospital than others.

But where tests and other measures fail, toilets succeed. People who contract COVID-19 go to the bathroom whether or not they get tested, making wastewater one of the few direct, population-level sources of information about the pandemic's ebb and flow. "How many infections are happening? That's the hidden thing that you want to see," Kaplan says. "We believe the wastewater signal is giving us the very best view of that."

In New Haven, the incidence rate derived from sewage suggests "there's a lot of immunity out there," Peccia says. "We're not all as vaccinated as we should be and not as boosted as we should be, but there's a lot of people that have been infected. If you just go back and you look at [case counts], you'll really underestimate that."

Kaplan and Peccia are quick to point out that wastewater monitoring, for all its merits, is no substitute for testing. After all, "you can't do contact tracing off of wastewater," Kaplan says. Tests help individuals know whether to isolate and allow public health officials to link cases to vaccination status, for instance. But testing programs are also very expensive, and as the pandemic stretches on, "we're going to need to augment them in some way."

Wastewater monitoring offers a powerful and economical complement to a conventional COVID-19 testing program. In addition to calculating cumulative incidence rates, wastewater data makes it possible for officials to spot emerging outbreaks. Kaplan cites the example of Norwich, Connecticut, which used wastewater data to identify a cluster of cases and intervene before it spread further.

Kaplan and Peccia also see potential in sewage-based monitoring for diseases beyond COVID-19. They're in the early stages of studying influenza in New Haven; wastewater has previously been used to track polio in the developing world. The work they and others have been doing, Peccia says, "lays the groundwork for many, many other types of viruses."
 

Heliobas Disciple

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as vaccine failure becomes more and more proven, it's time to pivot to "nothing to see here"
fauci claims we are now "out of the pandemic phase"
el gao malo
16 hr ago

in his 12,343rd interview of the pandemic, flip flop fauci comes to spin yet another yarn. this time, just for variety’s sake, he actually begins with something that might be true, at least in part.



but, being tony, he rapidly forays into falsehood and grandiose claims of having saved the day.

predominantly, he hypes the role of vaccines and plays up the temporary nature of natural immunity. this appears to be a part of a suddenly unified edifice of unfounded claims that “vaccinated immunity outperforms natural/recovered immunity.”

it’s suddenly popping up everywhere.



color me cynical, but this has, over the last 2 years, been an excellent predictor of problems about to emerge into the collective consciousness.

this got me interested because these claims are, of course, total bunk and yet another example of “fact checking as captured talking point pushing”.

the evidence is overwhelming that natural immunity is stronger, more sterilizing, and longer lasting than covid vaccination. brownstone has collected over 150 studies on this topic HERE.

it is manifestly clear that not only are the vaxxed and boosted getting more covid than the unvaccinated:



but that this trend is getting worse over time as variants undergo evolution driven by leaky vaccines that have antigenically fixated the purportedly inoculated.


this is likely driving the opposite of herd immunity. it’s driving herd antigenic fixation and perpetual vulnerability.
many states are starting to try to adulterate and hide the data on outcomes here.

“In an announcement Tuesday, the Department of Health and Human Services said it had redefined COVID-19 hospitalization to include only patients being treated with remdesivir or dexamethasone, drugs used for hospitalized patients with moderate to severe illness. Those hospitalized with milder symptoms or primarily for another cause are no longer included — even if they continue to take up a hospital bed because they are too ill to be discharged.”

i suspect that this is because those who are still doing apples to apples comps look like this in the over 70’s hospitalization figures despite 95%+ vaxx rates.

this is out of season and unexpected. something is wrong.

(note that these are not the same scale)



and it’s pretty clear what that something is: the vaccines are becoming the problem.

issues with vaccines preventing/attenuating the acquisition of long term, sterilizing immunity even after having had actual covid have been known for some time and we’ve seen that variant specific boosters did nothing to broaden immunity or make it more specific.


at the end of this trial, certain internet felines were heard to ask:
testing the effects of adaptive immune learning from exposure to live pathogen is a really obvious next step in an experimental series like this and one the researchers were well set up to undertake.
i wonder why they didn’t…?

well, while one can never be sure when guessing at the motivations of others, we may now have a bit more reason to suspect it was “because they did not want to have to release the results” because it sure looks like they played out just as one would predict. and that is incredibly damning for vaccines.

THIS study is devastating. (and the lead author, dean follmann, is from the NIAID, fauci’s fiefdom)
the key finding is here:



in simple layman’s terms, this is showing you serious suppression of immune system training. mRNA vaccines do not train your immune system to recognize the nucleocapsid of SARSCOV. they cannot. they do not contain it. they contain instructions to teach your cells to express proteins on their surfaces that look like those created by cells infected with covid19 and to then elicit (and intensify) and immune response. this is a narrow, intense form of immune training.

it is also why, many have posited, these vaccines have proven so unable to provide sterilizing immunity. because this is an after effect. it’s akin to training your night watchman to recognize a burning building, but not an arsonist. until the fire gets lit, he won’t react, even if the arsonist is still standing right next to it. he’s never seen one. he does not know what an arsonist is.

exposure to live virus should teach him. the result of this learning is the ability and propensity to produce N antibodies against the nucleocapsid of the virus itself. now you WILL attack arsonists as soon as you see them.

93% of untreated who got the virus acquired this ability.

but only 40% of those who took the moderna vaccine and were then exposed to live virus did.

nearly 6 in 10 (57%) of those vaccinated who would have been expected to generate these antibodies did not.

welcome to OAS/antigenic fixation, population: probably you.

this gets more complex and considerably more concerning as the N response appears exposure intensity related and varies widely by intensity of exposure.

at low exposures, the likelihood of manifesting is 6-8 to 1 in favor of placebo.



note that this is pre-unblinding data from the actual moderna phase 3 trial. it is not new data, just a new analysis/publication. (it was all also done in old variants. there is strong reason to expect current result would be even worse for vaccines)

so this was known or at least knowable back before the FDA has made any approvals. the fact that it was either missed or ignored/not published is astonishing. that’s a staggering lapse and i honestly struggle to imagine a valid and non-nefarious reason for this that could not be construed as full blown gross incompetence.

i am all but totally sure we’re going to see this same issue in the pfizer data that the FDA was so desperate to delay the release of.

i struggle to imagine pfizer missing this, moderna missing this, and the FDA missing this. if that happened, then some very pointy questions about how broken our approval process is beg to be asked. because everything here is pointing more and more toward: the vaccines are going to be a serious, long term preventer of herd immunity. this is an astonishing outcome from the agencies and experts that literally just changed the very definition of herd immunity to exclude natural immunity and include only vaccines.

Image

so, yes, expect a stunning pivot in the US. this is well past “inconvenient truth” and inching toward “we’re going down in history as the worst villains in the history of public health.”

expect to see heaven and earth moved to stop that from emerging.

but i doubt the charade can last. signs are becoming too blatant and the effects over months and years will be too clear.
also, others, who are not so conflicted and prone to cronyistic dissembling and are looking into it.

little discussed in the US, the danes just suspended their covid vaccination campaign. (many in scandinavia having already discontinued mRNA jabs for the young)

perhaps i’m being overly optimistic and reading more into this than is warranted, but this “thorough assessment” they reference piqued my interest.

Image
i wonder if the folks that gutted masks with their DANMASK study might be about to perform a similar service for vaccines?

for while bill the bard might speak of something rotten in denmark, it does not appear to be their public health agencies.
and they sure have lots of data to look at.

i wonder what they’ll find?
 

Heliobas Disciple

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Three new papers everyone should know about
These three papers provide compelling evidence that the vaccines should be avoided and are unethical to mandate.
Steve Kirsch
9 hr ago

Here’s a recent video everyone (including public policy makers in Australia) should watch for just 60 seconds (the link starts 9:15 into the video).

View: https://youtu.be/a8kdH2Xgf-k?t=556
Mark Steyn | Thursday 21st April
59 minutes
Streamed live on Apr 21, 2022

Mark Steyn makes the point that it’s “either official information so you can say it, or it’s disinformation and you’ll lose your Facebook account”

He goes on to say that the official UK government data clearly shows that your third shot significantly increases your risk of infection, hospitalization, and death. He says (start watching at 13:50) that if you are triple vaccinated, you die at three times the rate of people who aren’t triple vaccinated.

You can find the transcript of Mark’s remarks here.

Some people pointed out that the data is age confounded because Mark assumed that the numbers who are triple vaccinated equaled the numbers who are less than triple vaccinated for all age groups. This is not true for the elderly for example. But my article takes all of that into account and finds that even when you compute the rates for each age range, the data isn’t favorable for the vaccine. It’s probably why the UK government stopped reporting the numbers so you wouldn’t be able to figure it out anymore.

It’s also important to note it isn’t just the UK numbers that are troubling. The numbers from Walgreens in the US aren’t supportive either, not even for the elderly which is the most vulnerable group. It shows that the third dose wears off and leaves you much worse off than the unvaccinated (more than twice as likely to be infected).



You have to be dumber than a doornail to mandate this.

Three recent papers everyone should be aware of.

Here are three recent papers that everyone should be aware of and their conclusions.

1. The vaccine hasn’t saved any lives. Zero.
I wrote this article in November: No scientific evidence of all-cause mortality benefit.​
But now there is a Danish preprint in the Lancet that analyzed clinical trial data from 9 trials. The paper supports what I pointed out almost a year ago on May 25, 2021 in TrialSiteNews: there is no all-cause mortality benefit from the mRNA vaccines.​
In short, why would we mandate a vaccine (with lots of disabling side effects) that doesn’t save any lives? Nobody wants to answer that question on camera.​
2. The vaccines damage our immune system.
A paper by Stephanie Seneff and Peter McCullough entitled, “Innate immune suppression by SARS-CoV-2 mRNA vaccinations: The role of G-quadruplexes, exosomes, and MicroRNAs” shows that the vaccines impair our immune system, likely until we die (which is now more likely after the jab).​
The paper is one of the mechanisms that explains tweets like this one which I see all the time:​
3. The vaccines impair our ability to resist future variants of the virus. The more we vaccinate, the more vulnerable we become.
This paper is extremely troubling: Anti-nucleocapsid antibodies following SARS-CoV-2 infection in the blinded phase of the mRNA-1273 Covid-19 vaccine efficacy clinical trial. It points out that the more times people are vaccinated, the less likely they are to develop broad-based immunity when they get the actual virus. What this means is the more vaccines you get, the less likely you are to develop full immunity from the virus when you get it (which you will since the vaccines are going to make that more likely).​
Igor’s newsletter has a great writeup of the paper. Here is the most important image from his article:​
In plain English, you are more than 13X less likely to develop full natural immunity to a breakthrough infection after your initial two jabs.​
Here’s the thing. Moderna knew this over a year ago, but they didn’t think it was worth warning anyone about. Now they’ve admitted it but not issued any kind of press release or public warning about it. And of course the mainstream media is not going to ever cover this at all. But there is the paper, in black and white, for everyone to see. Including all the mainstream docs.​
But this is the really important part: this is a paper with multiple authors from both the NIH and Moderna so nobody can say it is “misinformation.”

Summary

The COVID vaccines are bad news. They always have been. But now the papers are being published in the scientific literature that make all our earlier warnings about the dangers of these vaccines impossible for any sane person to ignore.

At a bare minimum, we need to stop mandating these vaccines (and masks) worldwide and every honest member of the mainstream medical community (yeah, both of them) should be calling for stopping all the mandates.

Will this new science make a difference? No, not one bit. Why? Because the CDC says the vaccines are safe and effective and only a small handful of health officials (like Florida’s Joe Ladapo) are willing to challenge the narrative.

Science doesn’t matter to politicians and public health officials. It’s all about following the CDC and government narratives, not the data.
 
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Heliobas Disciple

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Tennessee Makes Ivermectin Available Without Prescription
By Michelle Edwards
April 27, 2022

Tennessee Governor Bill Lee signed a bill on Apr. 22, 2022, allowing Ivermectin to be dispensed without a prescription. The new law states, “a pharmacist, in good faith, may provide Ivermectin to a patient who is eighteen (18) years of age or older pursuant to a valid collaborative pharmacy practice agreement containing a non-patient-specific prescriptive order and standardized procedures developed and executed by one (1) or more authorized prescribers.”

Introduced by Sen. Frank Niceley (R-Strawberry Plains) on Jan. 31, Senate Bill 2188 was co-sponsored by Sen. Rusty Crowe (R-Johnson City). The amended version of the bill signed by Gov. Lee will create a standard procedure for pharmacists to easily dispense Ivermectin to patients while protecting a pharmacist or doctor from being held liable for doing so.

Enacted by adding a new section to Tennessee Code Annotated, Title 63, Chapter 10, Part 2, the law states that “a pharmacist or prescriber acting in good faith and with reasonable care involved in the provision of Ivermectin pursuant to this section is immune from disciplinary or adverse administrative actions under this title for acts or omissions during the provision of Ivermectin.” The law further states:

“A pharmacist or prescriber involved in the provision of Ivermectin pursuant to this section is immune from civil liability in the absence of gross negligence or willful misconduct for actions authorized by this section.”

The state’s board of pharmacy is tasked with adopting rules to establish standard procedures for the provision of Ivermectin by pharmacists, including providing patients with a screening risk assessment tool. They will also offer a standardized fact sheet that includes the indications and contraindications for using Ivermectin, the appropriate method for using the drug, and the importance of medical follow-up, among other information deemed relevant by the board.

IMG_8032.png

Screenshot / c19ivermectin.com

The Republican-backed bill passed the Senate in a vote of 23-6 and passed the House on a 66-20 party-line vote, with bill sponsor Rep. Susan Lynn (R-Mt. Juliet) stating it is a safe and effective alternative to the experimental COVID-19 “vaccines.” Lynn commented that the amended bill, which does not require pharmacists to dispense Ivermectin, “would allow Tennesseans to have a solution for early at-home care in the event they get a virus such as COVID.” Disgruntled Nashville Democrat Rep. Bo Mitchell dismissed the drug’s well-established safety and effectiveness, asking Lynn:

“So I just heard you admit there you want to remove any liability from the pharmacists for giving, handing this out. Why would we want to do that if this was such a great way to treat these conditions?”

Lynn pointed out that the pharmacist “is not the prescriber” and would simply be consulting with the patient or family member seeking Ivermectin, adding, “They’re making up their minds to seek this very, very safe, historically safe medication that works well on viruses.”

While Sens. Niceley and Crowe were instrumental in introducing the bill making Ivermectin available in the Volunteer State, Dr. Lynn Fynn, an expert in the early treatment of COVID-19, also played a crucial role in the bill becoming law. On Apr. 25, Dr. Fynn shared the news of Tennessee’s accomplishment, stating on her Telegram channel:

“Proud of my team! Because Global Covid Summit and FLCCC testified at the TN State Legislature so effectively, Ivermectin is now Over The Counter! No prescription and no consult needed! This is unprecedented as in the past, only the FDA was able to determine this; however, TN got it done!”

DR. LYNN FYNN
5 min 10 sec


Screenshot / Federation of State Medical Boards

Despite the National Institute of Health’s (NIH) and Dr. Anthony Fauci’s refusal to recommend Ivermectin, Tennessee joins at least 30 states that have bills that would either restrict medical boards’ authority to discipline clinicians who prescribe Ivermectin or allow its off-label use for treating COVID-19, or both. After all, many experts recommend the drug for treating COVID-19, which is supported by numerous studies.

One such study published in PubMed by The American Journal of Therapeutics asserts that repurposed medicines like Ivermectin may have a valuable role against the SARS-CoV-2 virus. With antiviral and anti-inflammatory properties, the drug has now been tested in multiple clinical trials. Inspired by the prior literature review of Dr. Pierre Kory, the study concluded:

“Moderate-certainty evidence finds that large reductions in COVID-19 deaths are possible using Ivermectin. Using Ivermectin early in the clinical course may reduce numbers progressing to severe disease. The apparent safety and low cost suggest that Ivermectin is likely to have a significant impact on the SARS-CoV-2 pandemic globally.”

In addition to the state’s victory with Ivermectin, Tennessee has another significant COVID-related bill that has made its way to the governor’s desk. HB 1871 – SB 1982 “prohibits any private business, governmental entity, local education agency, or school from adopting or enforcing a rule, policy, procedure, or practice which treats individuals with natural immunity from COVID-19 that has been verified by documentation differently than those who have received a vaccination for COVID-19.” The bill was transmitted to Gov. Lee for his action on Apr. 19, 2022.

The Story Of Ivermectin And COVID-19
24 min 33 sec
 

Heliobas Disciple

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Moderna Asks FDA to Authorize COVID Vaccines for Kids Under 6, Changes Efficacy Claims to Meet Guidelines
Moderna today asked the U.S. Food and Drug Administration to authorize its COVID-19 vaccine for children under age 6. The company claimed its trials for the 6-month to 2-year age group showed the vaccine was 51% effective — only 1% above the requirement — after last month stating the product was only 43.7% effective.
By Megan Redshaw
04/28/22

Moderna today asked the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for its COVID-19 mRNA-1273 vaccine for children age 6 months to 6 years.

The company conducted separate trials for two versions of the vaccine, one for infants and toddlers age 6 months to 2 years, and one for children age 2 years to 6 years.

“We believe mRNA-1273 will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19 and will be especially welcomed by parents and caregivers,” Stéphane Bancel, CEO of Moderna said in a press release.

The company claimed data showed “a robust neutralizing antibody response” and “a favorable safety profile.”

Yet, Moderna’s KidCOVE study cited in today’s press release shows Moderna’s COVID-19 vaccine failed to meet the FDA’s minimum efficacy requirements for EUA in the 2- to under-6 age group, and barely surpassed the agency’s 50% efficacy requirement in the 6-month to 2-year age group after the vaccine maker changed its analysis of the study to meet the threshold.

In the younger age group, Moderna said today, the effectiveness of its vaccine was 51%. In the older age group, vaccine efficacy was only 37% — substantially lower than the FDA’s requirement.

These are different efficacy numbers than those the company reported last month.

In a March 23 press release, Moderna said its vaccine in the 6-month to 2-year age group was only 43.7% effective. In the older age group, the company said its vaccine was 37.5% effective.

The New York Times on Tuesday said Moderna’s COVID-19 vaccine “proved disappointing” because it was only 40% effective, and a top official with Moderna said she expected a booster to be necessary.

To explain the increase in efficacy to 51%, Moderna in today’s press release:

“The previously announced results included a supportive preliminary efficacy analysis on cases mostly collected during the Omicron wave, including home testing for COVID-19.

“When the analysis is limited only to cases confirmed positive for SARS-CoV-2 by central lab RT-PCR, vaccine efficacy remained significant at 51% (95% CI: 21-69) for 6 months to <2 years and 37% (95% CI: 13-54) for 2 to <6 years.”

Moderna said it still needs to complete its EUA filing by sending final datasets to the FDA, which the company said will not happen until next week.

Dr. Madhava Setty told The Defender Moderna is not providing the data needed to calculate the risk-benefit of its COVID-19 vaccine.

“They’re proud of the immune response but the FDA has already concluded in its advisory committee meeting on April 6, that immune response means nothing,” Setty said. “We need actual outcomes.”

Setty, a board-certified anesthesiologist and senior science editor for The Defender, explained:

“In order for parents to understand risk vs. benefit for their child, they need to know exactly how many children got COVID-19 in Moderna’s study. This is the only way to calculate how many children need to get jabbed to prevent a single case.

“By offering us only vaccine efficacy numbers, Moderna and CNN are implying that there is no associated risk for their child, which we know is untrue.”

Setty noted that 51% effectiveness barely meets the FDA’s minimum efficacy under EUA and children were followed for only 28 days.

New York data show vaccine effectiveness against SARS-CoV-2 in the 5 to 11 age group plummets within seven weeks to 12%,” Setty said.

“Here, we’re looking only at the first four weeks. Although data from New York were in a different age group using a different mRNA vaccine, the effectiveness was remarkably similar after four weeks. Why wouldn’t we expect that the same thing is going to happen?”

According to CNN, the most common reactions reported during the study were pain at the injection site and fever. There were no cases of heart inflammation or myocarditis, according to Moderna.

Setty said:

“With only 2,500 children included in the youngest age group and the rate of myocarditis at 1 in 2,700 in a higher at-risk age group, according to a recent Hong Kong study, a trial this small is not going to pick up myocarditis. Saying there were no cases of myocarditis is hardly reassuring. The study is not powered to pick it up.”

According to ClinicalTrials.gov, the results of Moderna’s study have not been posted and the study is not scheduled to be completed until Nov. 12, 2023.

FDA requires 50% efficacy in preventing or decreasing severe disease for EUA

According to the FDA, for a COVID-19 vaccine to receive EUA, it must be at least 50% effective at preventing or decreasing the severity of the disease.

Guidelines for COVID-19 vaccines were released during a June 30, 2020 briefing with the Senate Committee on Health, Education, Labor and Pensions, during which senators sought assurances from former FDA Commissioner Stephen Hahn, Dr. Anthony Fauci and other top health officials that the expedited speed of development wouldn’t compromise the integrity of the final product.

According to Moderna, its KidCOVE study is a “randomized, observer-blind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of two doses of mRNA-1273 given to healthy children 28 days apart.”

The study population was divided into three age groups (6 to <12 years, 2 to <6 years, and 6 months to <2 years). In the study, efficacy could be evaluated only if enough cases accrued.

Approximately 6,700 participants 6 months to under 6 years old were enrolled in the study.

In its March 23 press release, Moderna said using the Phase 3 COVE study COVID-19 definition, vaccine efficacy in children 6 months to 2 years was 43.7% and vaccine efficacy was 37.5% in the 2 years to under 6 years age group. The company defined “statistically significant” as a lower bound on the 95% confidence interval, which is greater than 0.

“The majority of cases were mild, and no severe COVID-19 disease was observed in either age group,” the company added. “The absence of any severe disease, hospitalization or death in the study precludes the assessment of vaccine efficacy against these endpoints.”

In an email to The Defender, Dr. Meryl Nass, an internist and member of the Children’s Health Defense scientific advisory committee, said the FDA told manufacturers it needed 50% efficacy with a lower bound of 30% to issue COVID-19 vaccines under EUA.

Yet, Moderna produced no evidence its vaccine prevents severe disease, hospitalization or death from COVID-19.

Nass explained:

“The efficacy of this vaccine was under 50% for both age groups and their lower bound is 0, well below the 30% specified by FDA, and indicating a reasonable chance the vaccine may provide no benefit at all.

“There were no cases of severe disease, hospitalization or death from COVID-19 in the 6,700 children studied from 6 months through 6 years. Since these are the only endpoints (dreaded COVID-19 effects) that everyone wants to prevent, there is no evidence whatsoever that the Moderna vaccine prevents them.”

Nass said there is “no need to vaccinate small children with an experimental vaccine that has been shown to prevent only the equivalent of a cold” and the FDA cannot justify issuing an EUA or license for the Moderna shot for children 6 and under.

Nass said:

“The vaccine fails to meet the standards FDA published, there is no evidence it prevents severe disease and its safety is a mystery.

“They did not provide any reasonable justification for what they did — for doubling the sample size or extending the trial — nor did they say how many weeks or months after vaccination they got this result.

“How many kids actually got sick in the control group versus the vaccinated group? If they were trying to convince us this data should have been provided.”

“Will FDA con parents into thinking they are giving their children durable COVID-19 protection by issuing an EUA and permitting broad use of Moderna’s vaccine in the youngest children?” Nass asked.

“We continue to ignore the ‘E’ in ‘EUA,’” Setty said. “Despite it being deployed on thousands of children, this therapy did not prevent death. It didn’t prevent hospitalization. It didn’t prevent severe disease. It modestly prevented the sniffles.
Where is the emergency?”

Moderna making last-ditch effort to get jab approved, pediatrician says

According to the most recent data from the Centers for Disease Control and Prevention, out of 2,311,870 children under 4 who had COVID-19, 475 deaths were reported, accounting for 0.1% of all COVID-19 deaths.

Dr. Michelle Perro, pediatrician and co-author of “What’s Making Our Children Sick?” told The Defender this may be “Moderna’s last-ditch effort to get their COVID jab approved for EUA for children 6 years younger, avoiding indemnification,” yet there are “obvious flaws in this last desperate push.”

Perro explained:

“Firstly, there is no emergency. Secondly, and more importantly, children do not have morbidity or mortality from COVID-19. As more and more people have become cognizant of the fact that their children were subjected to an unknown, dangerous gene therapy, the resistance to this failed experiment grows.

“The literature is shedding light on the children now with chronic cardiac disorders, sequelae from clotting issues and bizarre neurologic symptoms — an incomplete list — who were sacrificed.

“The only issue now facing practitioners caring for children is how to help those injured by the genetic experiment and hope that the damage will not lead to long-term health consequences.”

No COVID-19 vaccine has been authorized for children younger than 5 in the U.S. and a timeline for potential authorization is not yet clear.

As The Defender reported, the House Select Subcommittee on Coronavirus Crisis on Tuesday asked the FDA for a status update on COVID-19 vaccines for children under 5.

In a letter to FDA Commissioner Dr. Robert Califf requesting a staff briefing, committee members said “millions of young children still remain unprotected because no vaccine has yet been authorized” for this age group.

A top FDA official on Tuesday told The New York Times the agency had not cleared a COVID-19 vaccine for the youngest age group because Pfizer and Moderna had not finished their applications for authorization.

The agency said last week it was considering holding off on reviewing Moderna’s request to authorize its COVID-19 vaccine for children under 5 until it has data from Pfizer and BioNTech on their vaccine for children, pushing the earliest possible authorization of a vaccine from May to June.
 

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Novavax Says New Flu-COVID Vaccine ‘Safe and Effective,’ But FDA Hasn’t Yet Authorized COVID-Only Version
Novavax on Wednesday announced that early data on its combination vaccine targeting COVID-19 and influenza showed the vaccine produced a strong immune response. The U.S. Food and Drug Administration has yet to grant the Maryland-based company’s request for Emergency Use Authorization for its COVID-only vaccine.
By David Charbonneau, Ph.D.
04/21/22

Vaccine maker Novavax on Wednesday announced that early data on its combination vaccine targeting COVID-19 and influenza showed the vaccine produced a strong immune response.

Chief Medical Officer Filip Dubovsky, during a call with reporters, said the Maryland-based company’s early phase clinical trial found that up to 25 micrograms of the COVID formulation combined with up to 35 micrograms of the flu formulation triggered a promising level of protective antibodies in the Novavax COVID-Influenza Combination Vaccine.

The shot would combine a seasonal booster for COVID with a seasonal flu shot.

“What we demonstrated in this study is we were able to get the immune responses really comparable to what the individual vaccines did prior to combination,” Dubovsky said.

Participants in the Phase 1 trial had a median age of 59 and all previously had received COVID vaccines.

Novavax plans to move forward with a Phase 2 trial this year to confirm the appropriate dosing levels, and plans to launch a Phase 3 trial on efficacy during the 2023 flu season at the earliest, Dubovsky said.

“Combination vaccines are an attractive public health intervention,” Dubovsky said. “You are hitting two life-threatening diseases in one medical contact, giving a single vaccination.”

Novavax’s COVID vaccine uses different technology than the Pfizer and Moderna shots, which rely on messenger RNA to turn human cells into factories that produce copies of the virus spike protein, inducing an immune response that fights COVID.

The spike is the part of the virus that latches onto and invades human cells.

Novavax’s shots, in contrast, synthesize the virus spike outside the human body. The genetic code for the spike is put into a baculovirus that infects insect cells, which then produce copies of the spike that are purified and extracted.

The spike copy is then injected into people to induce an immune response against the virus.

The vaccine also uses a novel adjuvant that contains a purified extract from the bark of a tree in South America, to induce a broader immune response.

The most common side effects of the Novavax combination vaccine were injection site pain, fatigue and headaches, Dubovsky said.

The company said the preliminary trial results found that the combination vaccine formulations induced immune responses in participants comparable to reference stand-alone influenza and stand-alone COVID-19 vaccine formulations (for H1N1, H3N2, B-Victoria HA and SARS-CoV-2 antigens).

According to Dr. Meryl Nass, internist and member of Children’s Health Defense scientific advisory committee, experts acknowledged during the April 6 meeting of the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting that immune responses, or neutralizing antibody titers, were inadequate to assess the immune response for COVID.

“The committee said future COVID vaccines would need to be authorized or licensed using clinical trial data, not antibody titers,” Nass said.

Novavax said clinical modeling results also showed a combined formulation has the potential to reduce total antigen amount by up to 50% overall, optimizing production and delivery, and reducing side effects.

“We continue to evaluate the dynamic public health landscape and believe there may be a need for recurrent boosters to fight both COVID-19 and seasonal influenza,” said Dr. Gregory M. Glenn, president of research and development at Novavax.

“We’re encouraged by these data and the potential path forward for a combination COVID-19-influenza vaccine as well as stand-alone vaccines for influenza and COVID-19.”

Dubovsky expressed confidence the new vaccine’s recombinant protein-based nanoparticle technology would allow the combo shot to be easily “tweaked” to address emerging coronavirus variants.

Is FDA slow-walking Novavax authorization in U.S.?

The World Health Organization in December 2021 approved Novavax’s COVID vaccine (not the new COVID-flu combination vaccine) for use in the European Union, but the FDA has yet to grant Emergency Use Authorization (EUA) of the product in the U.S.

Novavax’s Glenn today told attendees at the World Vaccine Congress the company is still optimistic about obtaining the EUA.

In a statement later in the day, the company said:

“We continue to have a productive dialogue with the FDA as they review data and we answer inquiries related to clinical and manufacturing data as expected. We look forward to scheduling our VRBPAC meeting in the near future as indicated by the FDA.”

At a Wednesday meeting of the Centers for Disease Control and Prevention’s (CDC) vaccine advisory committee, an FDA official indicated the agency was still awaiting manufacturing data from Novavax.

But an FDA spokesperson later said it was nothing more than the usual back-and-forth as part of the regulatory process.

An FDA spokesperson said:

“While the FDA cannot predict how long its evaluation of the data and information will take, the agency will review the EUA request as expeditiously as possible using its thorough and science-based approach.

“The agency plans to schedule a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss the EUA request with the FDA’s panel of outside scientific and medical experts.”

The company published its clinical data in the New England Journal of Medicine soon after filing its EUA application on Jan. 31, but still has not received a date for its FDA advisory committee meeting.

Nass said similar to trials for other COVID vaccines, the Novavax trial followed participants for only 70 days post-“full vaccination” status — not long enough to identify the waning efficacy and determine how well the vaccine really works over 6 to 12 months and more.

“The bottom line is that with yet another brief-duration trial, we can’t say anything about the long-term safety or efficacy, which are the only measures that really matter,” Nass said.

By comparison, the other three vaccines available in the U.S. were authorized prior to publication of their clinical data.
Also, the vaccine applications of Pfizer and Moderna in late November 2020 were authorized by the FDA in just over three weeks.

“It’s been far too long since Novavax has asked for authorization and I think the FDA has been slow-walking it,” said Lawrence Gostin, professor of global health law at Georgetown University.

Another vaccine option is important for the U.S., Gostin said.

“The FDA should authorize it and it should be another vaccine in the toolbox for the United States and the world,” he said.
In an interview with CBS affiliate WUSA9 just days after filing for emergency use, a Novavax official said unlike Moderna and Pfizer’s mRNA vaccines, many people are holding out for Novavax’s protein-based shot, which is very similar to many childhood immunizations.

“We think that our vaccine can be an important option in making people feel more comfortable and confident in getting their vaccination,” said Silvia Taylor with Novavax Global Corporate Affairs.

Clinical trials have shown Novavax to be 90% effective against COVID infection. If approved, those 18 years and older would be eligible for the shot.

“It may not be that there will be a very large uptake of Novavax, but there’s a certain segment of the population that really wants to use a much more traditional vaccine and not a messenger RNA vaccine,” said Gostin.

In January, Dr. Anthony Fauci seemed to dismiss Novavax’s potential to jump-start a nationwide vaccination effort largely stalled since last October.

“It just seems rather unusual that people are waiting for something else when you have vaccines that have been given to 9 billion people,” Fauci told Yahoo Finance. (The global population is estimated to be only about 8 billion people.)

“I’m not sure what people are waiting for when you say they’re waiting for something else,” he said.

CDC Director Dr. Rochelle Walensky was more optimistic, noting that Novavax’s “approval could help address [vaccine] hesitancy.”

Japan authorizes Novavax COVID vaccine

Meanwhile, Japan’s health ministry on Tuesday joined a list of more than 40 countries that have approved Novavax’s COVID vaccine, announcing the purchase of 150 million doses.

Japan in recent days reported a resurgence of the fast-spreading omicron BA.2 variant.

The ministry approval came the day after its expert panel endorsed use of Novavax’s protein vaccine, which is designed with vaccine technology similar to that used in vaccines for the flu and hepatitis B.

Health Minister Shigeyuki Goto told reporters the Novavax product adds variety to the choices available and could appeal to those who are hesitant to use COVID vaccines such as Pfizer’s and Moderna’s, which are designed with newer technologies.

Shots are expected to be available in Japan as soon as early May.

In March, the country lifted all COVID restrictions as infections slowed significantly, but experts noted signs of a resurgence in a number of prefectures during a season of traveling and parties marking graduation and the start of the academic and business year.

The government is trying to expand businesses and put the pandemic-hit economy back on track. Japan slowly eased the border controls following sharp criticisms for its longtime restrictions on non-resident foreign students, scholars and business people, but Prime Minister Fumio Kishida said Japan is not considering restarting inbound tourism anytime soon.
 

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Fauci Walks Back Coronavirus Comments, Says Pandemic Not Over in U.S.
Fauci had said that ‘we are certainly, right now, in this country, out of the pandemic phase.’
By Cecelia Smith-Schoenwalder
April 28, 2022, at 12:17 p.m.

Leading infectious disease expert Anthony Fauci this week walked back his comments that the U.S. is “out of the pandemic phase.”

“I want to clarify one thing,” Dr. Anthony Fauci told NPR on Wednesday. “I probably should have said the acute component of the pandemic phase, and I understand how that can lead to some misinterpretation.”

On Tuesday, Fauci told PBS NewsHour that "we are certainly, right now, in this country, out of the pandemic phase.”

"Namely, we don't have 900,000 new infections a day and tens and tens and tens of thousands of hospitalizations and thousands of deaths. We are at a low level right now. So, if you're saying, are we out of the pandemic phase in this country? We are," he said.

White House press secretary Jen Psaki also attempted to clarify Fauci’s comments on Wednesday.

“What Dr. Fauci was saying is that we are in a different phase of this pandemic, and that's absolutely true,” Psaki said. She added that “we also know COVID isn't over and the pandemic isn't over.”

The comments come as the Biden administration grapples with increasing coronavirus cases and hospitalizations during a time when many Americans are unwilling to reimplement mitigation measures like mask-wearing.

Fauci has been a lightning rod for criticism from Republicans and others who have opposed masking and vaccine mandates and questioned changing coronavirus guidance.

And the issue is growing closer to the White House, with Vice President Kamala Harris testing positive for the coronavirus this week.

The White House, however, defended its COVID-19 protocols. But risk concerns did prompt Fauci to back out of the White House Correspondents’ Dinner this weekend while Biden will no longer attend the dinner portion of the event.
 

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Moderna Asks FDA To Authorize Covid Vaccine For Children Under 6
by Tyler Durden
Thursday, Apr 28, 2022 - 05:40 PM

Moderna on Thursday became the first Covid-19 vaccine manufacturer to ask the Food and Drug Administration (FDA) to approve its jab for children under 6, less than six months after the agency delayed approval for adolescents as young as 12-years-old over the risk of dangerous heart inflammation in younger patients.

The development comes after the company announced positive results in late March for a phase 2/3 study for children aged 6 months to under 6 years - which found that the vaccine had "lower efficacy" against the Omicron strain.

"Using the Phase 3 COVE study COVID-19 definition, vaccine efficacy in children 6 months to 2 years was 43.7% and vaccine efficacy was 37.5% in the 2 to under 6 years age group."

And while the New York Times says that "Parents of the roughly 18 million youngest Americans" have been "waiting for months for pediatric doses," a CDC study revealed that throughout the entire pandemic up until January 31, 2022, there were just 2,562 children up the age of four years-old who were hospitalized with Covid-19, and just 16 deaths (2 of them from Omicron).

So Moderna wants approval for a jab with efficacy as low a 37.5%, for a demographic which has a 0.000142% hospitalization rate and generally mild (to no) symptoms without vaccination.

Moderna’s clinical trial data showed that the antibody response of the youngest children compared favorably with that of adults ages 18 to 25, meeting the trial’s primary criterion for success. Although the trial was not big enough to measure vaccine effectiveness, Moderna said Thursday the vaccine appeared to be 51 percent effective against symptomatic infection among those younger than 2, and 37 percent effective among those 2 to 5. -NYT

Moderna's chief medical officer, Dr. Paul Burton, said that the Omicron variant accounted for 80% of cases in the study group, which explains the low efficacy rate.

For now, Moderna's vaccine has only been cleared for adults - and the company has also requested authorization of its Covid vaccine for those aged 6-11 and 12-17, which the company will submit data for in around two weeks.
The FDA's head of vaccine regulation, Dr. Peter Marks, hinted at a Tuesday Senate oversight hearing that the agency may consider Moderna's applications for all children as a whole.

Moderna and Pfizer-BioNTech have both been developing doses for the youngest children since last year. Moderna is proposing a two-dose regimen for children from 6 months to 5 years old, using one-fourth the strength of an adult dose. Pfizer and BioNTech are working on a three-dose regimen for those 6 months to 4 years old, at one-tenth the strength of the adult dose. Pfizer has not yet submitted a request for F.D.A. authorization, but is expected to do so soon. -NYT

Last week, White House adviser Dr. Anthony Fauci suggested that the agency wants to review data for Moderna and Pfizer simultaneously in order to directly compare the two.

Regulators aren't expected to act on Moderna's application before June, while federal officials will ask the agency's outside advisory panel of experts to review the data before authorizing any vaccine for the least vulnerable.
 

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Whistleblowers: CDC, FDA "Altered" Covid Guidance And Suppressed Findings Amid Political Pressure
by Tyler Durden
Thursday, Apr 28, 2022 - 07:00 PM

Instead of 'following the science,' the CDC and FDA 'altered' Covid guidance and 'suppressed' findings while under political pressure, accoridng to a 37-page report from the Government Accountability Office (GAO), a watchdog group which spoke with two former CDC directors, four former FDA directors and 17 employees who were involved with the US pandemic response.

As the Daily Mail reports, "They unearthed allegations of 'political interference' in scientific reports, raising fears that research was tampered with," and that "neither agency had a system in place for reporting allegations of political interference. It also said they had failed to train staff how to spot and report this."

The report defined 'political' interference as that which seeks to 'undermine impartiality... and professional judgement.' They set up an anonymous whistleblower hotline for 60 days which employees could call to report instances, and which received 'a few calls.'

A few respondents from CDC and FDA stated they felt that the potential political interference they observed resulted in the alteration or suppression of scientific findings. Some of these respondents believed that this potential political interference may have resulted in the politically motivated alteration of public health guidance or delayed publication of COVID-19-related scientific findings. -GAO

The whistleblowers say they didn't speak out earlier out of fear of retaliation - and didn't know how to report issues to higher-ups.

More from the report;

Through semi-structured interviews and a confidential hotline, employees at CDC, FDA, and NIH told GAO they observed incidents that they perceived to be political interference but did not report them for various reasons. These reasons included fearing retaliation, being unsure how to report issues, and believing agency leaders were already aware.
A footnote reveals that emails made public last April between Trump officials and CDC employees suggested that the agency had bent to pressure over a study in its weekly morbidity reports (MMWR).

In one 2020 email, former Trump scientific adviser Paul Alexander appeared to be celebrating getting the top line in one of its reports changed - writing "Small victory, but a victory nonetheless yippee!!!"

Meanwhile, the FDA was also accused of 'grossly misrepresenting' the effectiveness of blood plasma transfusions according to another GAO footnote which cited a New York Times article. The report slams the Trump administration for touting a '35% efficacy', when in fact plasma transfusions actually provided little benefit to Covid-19 patients.

On Tuesday, Biden's top Covid adviser, Dr. Anthony Fauci, declared that the US is now 'out of the pandemic phase' of the disease...

...
however he quickly walked that back the statement - telling AP that the US is in a "different moment" but that the pandemic isn't over yet.

"After a brutal winter surge, "we’ve now decelerated and transitioned into more of a controlled phase," he said. "By no means does that mean the pandemic is over."

Why the 'clarification' Anthony?

The GAO report made seven recommendations to the four agencies it investigated for 'political interference,' according to the Mail, which included establishing systems for whistleblowers to report potential interference, as well as training staff how to identify and respond to it.

Read the GAO report below:
 

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CDC and FDA 'altered' Covid guidance and even 'suppressed' findings while under political pressure, bombshell report suggests: Whistle-blower employees say they feared 'retaliation' if they spoke up
  • Federal investigators interviewed top-level directors and managers at agencies
  • They also opened a hotline for employees to report 'political interference'
  • Government Accountability Office uncovered widespread allegations of this
  • They raised fears that Covid guidance may have been 'altered or suppressed'
  • GAO warned none of the agencies had systems in place for reporting allegations
  • Said they had failed to train staff in how to report and spot political interference
  • Follows allegations White House waged a war on science early in the pandemic
By Luke Andrews Health Reporter For Dailymail.Com
Published: 13:29 EDT, 27 April 2022 | Updated: 18:53 EDT, 27 April 2022

CDC and FDA officials 'altered' Covid guidance and even 'suppressed' findings related to the virus due to political pressure, a bombshell report suggests.

Investigators from the watchdog Government Accountability Office (GAO) spoke to more than a dozen directors and managers who worked at the agencies behind the country's pandemic guidance.

They unearthed allegations of 'political interference' in scientific reports, raising fears that research was tampered with.
In its 37-page report, the GAO warned that neither agency had a system in place for reporting allegations of political interference. It also said they had failed to train staff how to spot and report this.

Whistleblowers said they did not speak up at the time for fear of retaliation, because they were unsure how to report the issues or believed leaders were already aware.

This is just the latest in a growing patchwork of reports suggesting politicians influenced 'scientific' papers during the pandemic for their own ends.

On Tuesday, the Biden administration's top medical adviser Dr Anthony Fauci declared the U.S. is now 'out of the pandemic phase' of Covid, citing low cases and hospitalizations.

But health experts were quick to question the claim — buried at the end of an interview with PBS' NewsHour — suggesting he may have bungled his words and should only have said the nation was in a phase of 'low hospitalizations'.

In the early phase the White House was accused of waging a war on science, with then-president Donald Trump repeatedly pushing for Centers for Disease Control and Prevention (CDC) reports to be amended to support his views, as shown in emails made public by congressional investigators last April.

'A few respondents from CDC and [Food and Drug Administration] FDA stated they felt that the potential political interference they observed resulted in the alteration or suppression of scientific findings,' GAO investigators wrote in the report.

'Some of these respondents believed that this potential political interference may have resulted in the politically motivated alteration of public health guidance or delayed publication of Covid-related scientific findings.'

The GAO report published last week looked into the two agencies, alongside the National Institutes of Health (NIH) — America's top research institution— and the Office of the Assistant Secretary for Preparedness and Response (ASPR) — in charge of natural disaster response.

All are part of the Department of Health and Human Services (HHS), which in February was branded as at 'high risk' for fraud, mismanagement and abuse by the GAO in a separate report.

In the latest report, they defined 'political interference' as political influences seeking to 'undermine impartiality... and professional judgement'.

Investigators said they also set up an anonymous hotline for two months to allow employees to report instances, which received 'a few calls'.

No specific cases of altering advice were revealed for confidentiality reasons.

But the GAO mentioned in a footnote emails made public by congressional investigators last April that were sent between Trump officials and employees at the CDC.

They suggested the agency had bowed to political pressure over a study in its Morbidity and Mortality Weekly Reports (MMWR) — a notice that documents current trends in U.S. health.

Former scientific advisor to the then-president Paul Alexander wrote in an email from 2020 that he had succeeded in getting the top line in one of its reports changed. He wrote: 'Small victory, but a victory nonetheless yippee!!!'

In the first year of the pandemic the FDA was also accused of 'grossly misrepresenting' the effectiveness of a blood plasma transfusion for hospitalized Covid patients, in a New York Times article that was also footnoted by the GAO.
Its press release thundered that the treatment was 35 percent effective against death, a figure which Trump branded 'tremendous'.

But scientists were taken aback by the figure, which was not mentioned in the official authorization letter or in the 17-page memo written by its scientist. It was also not in the analysis conducted by the Mayo clinic that was frequently cited.
Recently it has emerged that these transfusions actually provided little benefit to patients infected with Covid, and they are now no longer routinely offered by hospitals.

A state health official also alleged he had been reassigned after refusing to invest federal money in hydroxychloroquine, Stat News reported, which was previously touted by Trump as a possible Covid treatment.

Dr Fauci's comments yesterday were quickly blasted by other health officials, however, with Dr Louise Ivers, a global health expert at Harvard University, retorting 'there is a pandemic'.

The top medical adviser has doubled down on his personal policy of mask wearing and general isolation in spite of his comments yesterday.

He declined an invitation to the prestigious White House Correspondents Association Dinner this Saturday 'because of my individual assessment of my personal risk'.

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The GAO report made seven recommendations to the four agencies it investigated for 'political interference'.
These included the agencies setting up a system for reporting potential interference, and training staff to notice and respond to it.

For the report they spoke to two former CDC directors, and four former FDA directors, as well as 17 employees.

The GAO pointed out it had not looked into the allegations to confirm whether political interference had led to changes to the science.

The HHS said in response: 'It is important to differentiate scientifically trained political officials engaging in the legitimate conduct, management, communication and use of science from political officials inappropriately breaching scientific integrity because of political motivations.'

They also 'concurred' with 'the recommendations that [HHS] should ensure that procedures for reporting and addressing potential political interference in scientific decision-making are developed and documented.'

It agreed that employees should be 'trained on how to report allegations of inappropriate political interference in scientific decision-making'.

It follows a report from the GAO in February which branded the HHS — that all four agencies sit under — as 'high risk'.
They warned of a 'lack of leadership and preparedness' in the department for dealing with either Covid or the zika virus outbreak, alongside natural disasters such as hurricanes and wild fires.

The HHS is at risk of financial waste, fraud, abuse, mismanagement and other major shortcomings at times when it is required, they said.

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

U.S. Health Department at 'high risk' of fraud and mismanagement, report

The U.S. Department of Health and Human Services is at 'high risk' of fraud and mismanagement, a report published in February suggests.

The Government Accountability Office (GAO) — which carried out the investigation — also said it was exposed to financial waste and abuse.

They pointed to a lack of leadership at the agency during the Covid pandemic, Zika outbreak and when natural disasters like hurricanes and forest fires sweep the U.S.

The Department is also responsible for the CDC and FDA which 'altered' findings during the pandemic due to political pressure, another report released this month suggests.

It is based on interviews with top-ranking officials at the agencies.
 
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