By Michael Nevradakis, Ph.D. | The Defender | May 18, 2022
An 80,000-page cache of Pfizer-BioNTech COVID-19 vaccine documents released by the U.S. Food and Drug Administration (FDA) sheds light on Pfizer’s extensive vaccine trials in Argentina, including the unusually large size of the trials and the story of a trial participant whose vaccine reaction was “disappeared.”
The case of Augusto Roux in Argentina suggests that in at least one instance, a trial participant whose symptoms were determined to be connected to the COVID-19 vaccine was later listed, in official records, as having experienced adverse events that were not related to the vaccination.
Vaccine trials in Argentina also appear to have glossed over adverse events suffered by other trial participants, and the potential connection between the adverse events and the vaccine.
The FDA on May 2 released the latest cache of documents, which pertain to the Emergency Use Authorization of Pfizer’s vaccine, as part of a court-ordered disclosure schedule stemming from an expedited Freedom of Information Act request filed in August 2021.
As previously reported by The Defender, the documents included Case Report Forms from Pfizer COVID vaccine trials in the U.S., and the “third interim report” from BioNTech’s trials conducted in Germany, both of which listed adverse events sustained by participants in the U.S. and German trials.
Many of these adverse events were indicated as being “unrelated” to the vaccines — even in instances where the patients were healthy or otherwise had no prior medical history related to the injuries they sustained.
Story of ‘disappeared patient’ goes public
Several bloggers and online investigators called into question various aspects of the Argentine vaccine trials, pointing out the number of participants in the Argentine trials dwarfed that of other, typically smaller trials at other locations in different countries.
They also pointed out the large number of participants appeared to have been recruited to the trial in a remarkably short time, and questioned the connections between one of the key figures of the Argentine trial to vaccine manufacturers, Big Pharma and the Bill & Melinda Gates Foundation.
The large number of trial participants in Argentina may be related to the fact that the trial appears to have been held simultaneously in 26 hospitals.
The large number of participants is revealed in another of the documents released this month, where on page 2,245, the list of randomized participants at trial site 1231 begins, while on page 4,329, the list of participants at trial site 4444 begins.
Site 1231 refers to the main trial site location and 4444 (page 24) most likely refers to the disparate hospitals participating in the trial outside the main location.
Commenting on the revelation, blogger David Healy wrote:
“About 5,800 volunteers were enrolled, half getting the active vaccine. This is almost 4 times more than the next largest centre in this trial.
“Amazingly 467 doctors were almost instantly signed up and trained as assistant investigators in the study.”
In all, 4,501 patients participated in the Argentine trials, representing 10% of all Pfizer trial participants worldwide.
Complete information about adverse events during this extensive trial in Argentina does not appear to have been released as of this writing.
However, Roux’s experience has since become public.
Roux, often referred to as the “disappeared” patient, volunteered for the trial (volunteer number 12312982) and received his first dose of the Pfizer vaccine on Aug. 21, 2020.
According to Healy, Roux “felt pain and swelling in his arm right after the injection. Later that day he had nausea, difficulty swallowing, and felt hungover.”
After a series of symptoms, Roux — during a clinical trial visit on Aug. 23, 2020 — was classified as experiencing a “toxicity grade 1 adverse effect.”
He nevertheless received his second dose on Sept. 9, 2020.
According to Healy:
“On the way home by taxi, he started feeling unwell. At 19:30, he was short of breath, had a burning pain in his chest and was extremely fatigued. He lay on his bed and fell asleep. He woke up at 21:00 with nausea and fever (38-39 C) and was unable to get out of bed due to the fatigue.
“Over the next two days, he reports a high fever (41 C) and feeling delirious.
“On September 11, he was able to get out of bed and go to the bathroom when he observed his urine to be dark (like Coca-Cola). He felt as if his heart expanded, had a sudden lack of breath and fell unconscious on the floor for approximately 3 hours.
“Once he recovered, he felt tired, was uncomfortable, had a high heart rate on minor movement, was dizzy when changing posture. He had a chest pain which radiated to his left arm and back.”
On Sept. 12, 2020, Roux was admitted to the Hospital Alemán, where he stayed for two days. It was initially believed he had COVID-19, but he tested negative for the virus. His symptoms also were found to not correspond with viral pneumonia.
After a series of X-rays, CT scans and urine tests, Roux was discharged Sept. 14, 2020, after being diagnosed with an adverse reaction — specifically, an unequivocal pericardial effusion — to the coronavirus vaccine (high probability), according to his discharge summary.
Doctor who altered Roux’s record had ties to Gates, NIH, Big Pharma
However, on Sept. 17, Dr. Fernando Polack, Pfizer’s lead investigator for the Argentine trials according to a Pfizer document released in December 2021, reported in Roux’s record that his “hospitalization was not related to the vaccine.”
Even after Roux’s discharge, his health difficulties continued. As reported by Healy:
“On November 13 [2020], he had negative IgG and IgM SARS COV-2 (QML technique), which is unusual post vaccine.
“On February 24, 2021, a liver scan showed a minor degree of abnormality. In March 2021 and February 2022, his liver enzymes remained abnormal.”
Ultimately, Roux lost 14 kilograms (30.8 pounds) in a period of three to four months, and continued to suffer from fever and bouts of breathlessness for several months afterward.
Polack, who reported Roux’s hospitalization as unrelated to the vaccination, is known for his close ties with various vaccine manufacturers, pharmaceutical companies and the Bill & Melinda Gates Foundation.
For instance, he is listed as the lead author in a Dec. 31, 2020, New England Journal of Medicine (NEJM) article on the purported efficacy of the Pfizer COVID-19 vaccine.
According to Healy, Polack also appears to be the founder of iTRIALS, a trial site management company, and another organization located at the same physical headquarters, the Fundación INFANT.
Healy wrote:
“When COVID struck Argentina, [Polack] and his Fundación became involved in a trial of immune plasma, taken from patients who had recovered from COVID, given to patients who had recently acquired the disease.
“In May 2020 he speculated that this would make COVID like an ordinary cold, and the Gates Foundation would offer financial support. He used high-profile press conferences to disseminate his exciting message.”
The conclusion of the study published in the NEJM following the plasma study reads:
“Funded by the Bill and Melinda Gates Foundation and the Fundación INFANT Pandemic Fund; Dirección de Sangre y Medicina Transfusional del Ministerio de Salud number, PAEPCC19, Plataforma de Registro Informatizado de Investigaciones en Salud number, 1421, and ClinicalTrials.gov number, NCT04479163.”
According to Healy, “[a] subsequent systematic review and meta-analysis failed to confirm these findings, noting ‘very serious imprecision concerns.’”
Healy pointed out that Polack, in his NEJM disclosure statement, did not indicate any conflict of interest or financial interest in the COVID-19 vaccine trials in Argentina, but:
“Polack reported grants from Novavax and personal fees from Janssen, Bavarian Nordic A/S, Pfizer, Sanofi, Regeneron, Merck, Medimmune, Vir Bio[technology], Ark Bio, Daiichi Sankyo outside the submitted work.
“At least eight of these companies are engaged in RSV vaccine research in babies and pregnant women. Fernando has mentioned a combined RSV, flu and COVID vaccine.”
And, in relation to Polack’s relationship with the Bill & Melinda Gates Foundation, Healy reported:
“[Polack] also doesn’t mention his extensive financial involvement with the Bill & Melinda Gates Foundation. This organization supports industry vaccine trials including Covid and RSV. Fernando is heavily involved through his Gates-sponsored Fundación INFANT in Buenos Aires in RSV trials and research.
“Gates sunk $82,553,834 into Novavax’s RSV vaccine ResVax which was shown to be ineffective in clinical trials in pregnant women.”
Polack’s own bio from a 2017 medical conference states “[h]is work is funded by the Bill & Melinda Gates Foundation, the National Institutes of Health [NIH], the Thrasher Research Fund, the Optimus Foundation and other international organizations.”
That same year, Polack testified at an FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, where he “acknowledged having financial interests in or professional relationships with some of the affected firms identified for this meeting, namely Janssen [producer of the Johnson & Johnson COVID vaccine], Novavax, and Bavarian Nordic.”
According to Dr. Joseph Mercola, Polack “also happens to be a consultant for the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC),” and “a current adjunct professor at Vanderbilt University in Tennessee.”
Michael Nevradakis, Ph.D., is an independent journalist and researcher based in Athens, Greece.
The Daily Sceptic | May 20, 2022
Governments concerned about Covid misinformation should start with their own lies and distortions, Indiana’s Attorney General has told the U.S. Government. In a submission to the U.S. Surgeon General, who had requested information on the impact of online health misinformation during the pandemic in the United States, Todd Rokita joined with leading scientists Dr. Jay Bhattacharya and Dr. Martin Kulldorff to set out nine examples of disinformation propagated by the CDC and other health organisations that have “shattered the public’s trust in science and public health and will take decades to repair”. Read their full submission below.
May 2nd 2022
Agency: Department of Health and Human Services, Office of the Surgeon General
Action: Request for Information (RFI)
Subject: Impact of Health Misinformation in the Digital Information Environment in the United States Throughout the COVID-19 Pandemic
Response: COVID-19 Misinformation from Official Sources During the Pandemic
Submitting parties: Todd Rokita, Indiana Attorney General; Dr. Jay Bhattacharya, Professor at Stanford University School of Medicine; and Dr. Kulldorff, Senior Research Fellow at the Brownstone Institute and former Professor at Harvard University School of Medicine.
The Office of the Surgeon General requested information on the prevalence of health misinformation during the COVID-19 pandemic and the impact of such misinformation on the U.S. public health system in order to be better prepared to respond to a future public health crisis.
We agree that misinformation has been a major problem during the pandemic. The spread of inaccurate scientific information has made it difficult for the public to make the right decisions to protect themselves, their families, and their communities from COVID-19 and the collateral public health damage arising from the pandemic countermeasures. As such, the disinformation has led to great harm in the lives and livelihoods of Americans. We submit the following examples of disinformation from the CDC and other health organisations that have shattered the public’s trust in science and public health and will take decades to repair.
#1 Overcounting COVID-19: The official CDC numbers for COVID-19 deaths and hospitalisations are inaccurate. The official tallies include many people who have died with rather than from COVID-19. CDC has not distinguished deaths where COVID-19 was the primary cause of death, where COVID-19 was a contributing cause of death, or where the death was entirely unrelated to COVID-19, but they incidentally tested positive.
There are three reasons for this problem. (i) The counting of COVID-19 cases and deaths is unlike the way that public health counts the incidence and mortality caused by other diseases; physicians have been advised to fill out death certificates to privilege COVID-19 as a proximal cause, even when the medical facts suggest otherwise. (ii) The population-wide testing to identify asymptomatic individuals infected with the SARS-CoV-2 virus is unprecedented in human history. (iii) Although it would have been easy, CDC has not conducted random national surveys of medical charts to determine what proportion of reported COVID-19 deaths were truly due to COVID-19. Ex-post audits of death certificates and medical records in Santa Clara County and Alameda County, California, for instance, found that in around 25% of death certificates in which COVID-19 was labelled as the primary cause of death, other causes of death were more likely. The peer-reviewed literature confirms that COVID-19 is overcounted in other developed countries. Ex post audits of death certificates should be conducted to establish an accurate death count from COVID-19.
#2 Questioning Natural Immunity: There has been consistent questioning and denying of natural immunity after COVID-19 recovery. Using seriously flawed studies, CDC falsely claimed that natural immunity is worse than vaccine acquired immunity. In October 2020, the CDC director published a “memorandum” in the Lancet, questioning natural immunity. Most critically, by mandating vaccination for people who have recovered from COVID-19, the Government, corporations, and universities de facto deny natural immunity.
For scientists, this has been the most surprising disinformation. We have known about natural immunity since the Athenian Plague in 430 BC; other coronaviruses generate natural immunity; and throughout the pandemic, we knew that the COVID-19 recovered have good natural immunity if and when they get exposed the next time. That is, six months after the start of the pandemic, we had epidemiological evidence that natural immunity lasts at least six months; a year into the pandemic, we knew that natural immunity lasted at least one year, and so on.
#3 COVID-19 Vaccines Prevent Transmission: The CDC director and other health officials falsely claimed that the COVID-19 vaccine prevents the transmission of COVID-19 to others. This was also the rationale for vaccine mandates and passports – to prevent the spread of the virus to others. At the time, we did not know, and it turned out to be wrong. When the COVID-19 vaccines were approved for emergency use, the manufacturers presented randomised controlled trials (RCTs) that showed that the vaccines reduced symptomatic disease. The trials were not designed to determine whether they could also limit transmission or prevent death, even though they could have been designed to do so. As it turned out, vaccinated individuals spread the disease to others. While it was unfortunate that the RCTs were not designed to answer the disease transmission question, it is irresponsible for public health officials to claim that they did when the RCTs did not even attempt to answer that question.
#4 School Closures Were Effective and Costless: In the United States, most schools were closed for in-person teaching for some time, and many schools were closed for over a year. This decision was based on false claims that it would protect children, teachers and the community at large. Already in the early summer of 2020, we knew this was false. Sweden was the only major Western country to keep schools open throughout spring 2020 without masks, social distancing, or testing. Among these 1.8 million children ages one to 15, there were zero COVID-19 deaths, only a few hospitalisations, and teachers did not have a higher COVID-19 risk than the average of other professions.
Moreover, while older people living with a working-age adult had a higher COVID-19 risk, there was no evidence that also living with a child increased that risk further. In a July 2020 New England Journal of Medicine article evaluating school closures, they did not mention the Swedish data and evidence, which is like evaluating a new drug without including data from the placebo comparison group. Despite clear evidence on the safety of keeping schools open, misinformation led to many schools being closed for over one year.
#5 Everyone is equally at risk of hospitalisation and death from COVID-19 infection: Though public health messaging has blunted this fact, there is more than a thousand-fold difference in the risk of hospitalisation and death for the old relative to the young. Though the risk of death is high for the old and some other vulnerable populations with severe chronic illness, the risk posed to children from COVID-19 infection is on par with the risk posed by a bad influenza season. Surveys indicate, however, that both old and young overestimate the risk of death from COVID-19 infection. This misperception about risk is harmful because it leads to demand for policies – such as school closures and lockdowns – that were themselves harmful.
#6 There was no reasonable policy alternative to lockdowns: Even from the beginning of the pandemic, the sharp age-gradient in the risk of severe disease on COVID-19 infection has provided an alternative to the lockdown-focused policies that many U.S. states adopted – focused protection of the aged and otherwise vulnerable. In October 2020, along with Prof. Sunetra Gupta of Oxford University, we wrote the Great Barrington Declaration – a public petition that proposed heightened measures to protect the vulnerable and a return to near-normal life for the less vulnerable (including the opening of schools). Tens of thousands of doctors and scientists signed the Declaration in opposition to lockdowns. In the Declaration itself and in supporting documents, we offered many concrete policy suggestions for better protecting the vulnerable, including reduced staff rotations in nursing homes, free home delivery of groceries and other essentials offered to older people living in the community, paid sabbatical leave or alternative work arrangements for older workers, and many other policy options. We also invited the public health community to join in thinking creatively about other ideas to protect the vulnerable. As subsequent research has confirmed, it was clear even at the time that lockdowns could not protect the vulnerable (nearly 80% of COVID-19 deaths have occurred among the elderly in the U.S.). Meanwhile, countries like Sweden, which did not implement lockdowns, have had near-zero overall excess death over the last two years of the pandemic. Lockdowns are an aberration– a sharp deviation from traditional public health management of respiratory epidemics – and a catastrophic failure of public health policy.
#7 Mask mandates are effective in reducing the spread of viral infectious diseases: Contrary to assertions by some public health officials, mask mandates have not been effective in protecting most populations against COVID-19 risk. The SARS-CoV-2 virus spreads by aerosolisation. Unlike larger viral droplets, which are pulled by gravity to the ground shortly after emission, aerosols are tiny particles that can persist in the air for extended periods. Aerosols escape through gaps of poorly fitted masks, greatly reducing their ability to stop disease spread. Cloth masks, in particular, cannot stop aerosols, and even well-fitted N95 masks have diminished capacity to stop viral transmission when they become moist from breathing. It is thus unsurprising that the highest quality evidence available – randomised trials – conducted both before and during the pandemic find that masks are ineffective at stopping the spread of respiratory viruses in most settings when worn by untrained people.
#8 Mass testing of asymptomatic individuals and contact tracing of positive cases is effective in reducing disease spread: Mass testing of asymptomatic individuals with contact tracing and quarantining of people who test positive has failed to substantively slow the progress of the epidemic and has imposed great costs on people who were quarantined even though they posed no risk of infecting others. Three facts are crucial to understanding why this policy has failed. First, even close contacts of someone who tests positive for the SARS-Cov-2 virus are unlikely to pass the disease on. In a large meta-analysis of household contacts of asymptomatic positive cases, only 3% of people living in the same home got sick. Second, the PCR test that has been used to identify asymptomatic infections often returns a positive result for people who have dead viral fragments, are not infectious, and pose no risk of infecting others. And third, the contact tracing system becomes overwhelmed whenever cases start to rise, leading to long delays in contacting new cases. At precisely the moment when contact tracing might be needed, it cannot do its job. At the same time, quarantining people is costly – for workers without adequate sick leave, absenteeism due to contact tracing means pay cuts, lost opportunities and perhaps even an inability to feed families. For children, it means more skipped lessons and missed opportunities for academic and social growth at school, with long-run negative consequences for their future prospects. In the U.K., an official government review determined that its 37 billion pound investment in contact tracing was a waste of resources. The same is undoubtedly true in the United States.
#9 The eradication of COVID-19 is a feasible goal: Throughout the pandemic, from “two weeks to flatten the curve” and onwards, the suppression of the spread of COVID-19 has been an explicit policy goal. Implicitly, public health leaders have made the suppression of COVID-19 spread to near-zero levels the endpoint of the pandemic. However, SARS-CoV-2 has none of the characteristics of a disease that can be eradicated. First, we have no technology to reduce the spread of the disease or meaningfully alter disease dynamics. Lockdowns and social restrictions fail because only people who can afford to work from home without losing their job can comply over long periods. While we have vaccines that can help prevent hospitalisation or death resulting from COVID-19 infection, the vaccines wane in efficacy against COVID-19 infection and cannot stop transmission. Second, there are many animal hosts for SARS-CoV-2 and evidence of transmission between mammals and humans. One USDA study in late 2021 found that nearly 80% of white-tailed deer in the U.S. had evidence of COVID-19 antibodies. Dogs, cats, bats, mink and many other mammals can get COVID-19. So even if the disease were eradicated among humans, zoonotic transmission would guarantee that it would come back. Finally, eradication takes a global commitment from every country – an impossible goal since COVID-19 eradication is far from the most pressing public health problem for many developing countries.
eugyppius – May 18, 2022
As we saw a few weeks ago, Bill Gates is subtly annoyed at our SARS-2 mRNA vaccines. They have to be kept cold, which makes them third-world unfriendly. They’re not very good at inducing mucosal immunity, which makes them bad at stopping infection. They require trained needle-wielding “vaccinators”*, which is an extra step that limits uptake. What would please this unelected omnipresent merchant of nuclear-grade charitable benevolence the most, is a nasal spray vaccine, like they had in the movie Contagion. Gates really liked that film. They just snorted the vaccine, and then the virus went away.
Why can’t we have vaccines like they have in the movies, Gates wants to know? Well, perhaps we can.
Two weeks after Gates made his wishes known, a curious guest essay appeared in the New York Times : The Answer to Stopping the Coronavirus May be Up Your Nose. The vaccines are great, says essay author and Yale immunobiologist Akiko Iwasaki. Only, nasal spray vaccines would be even better. Our current vaccines are bad at inducing mucosal immunity. Also, the “barrier … for a needle shot” is probably higher than the barrier for inhaling things.
Iwasaki envisions “potentially over the counter” vaccines that everyone can snort “every four to six months.” She’s also co-author of a preprint, which shows that if you get mRNA-immunised mice to inhale recombinant unadjuvanted spike protein, their mucosal immunity improves. Not for nothing, this is the same approach envisioned by the EcoHealth Alliance lunatics in their infamous PREEMPT grant proposal. There, they fantasised about “develop[ing] recombinant chimeric spike-proteins from known SARSr-CoVs … to boost immune memory in adult bats” and then spraying these proteins into caves for the bats to inhale (p.4).
It’s nice to know that the research program that set off the whole pandemic will now circle back to provide remedies against the pandemic that it caused. This is fine. This is Science.
* To my great delight, Gates actually uses this term.
The Naked Emperor’s Newsletter | May 19, 2022
Judges in Germany’s top court clearly haven’t looked at the data produced in multiple countries, showing the vaccinated being more likely to catch coronavirus.
In a press release today, the court announced that a case, challenging the obligation to provide evidence of vaccination, had been unsuccessful. The complainants said that the mandates violated their fundamental rights.
Whilst the initial vaccine mandate for all adults was rejected earlier in the year, it was still implemented for healthcare workers in March. This meant that all healthcare workers had to provide proof of full vaccination, recovery from COVID-19 or a small number of medical exemptions. If employees did not provide proof, the health department was to be notified immediately and the individual banned from entering the workplace.
One of the reasons for the case being unsuccessful, given in the judgment, was that interference with the right to physical integrity is constitutionally justified. Basically, the protection of vulnerable people is more important than an individual’s fundamental right.
The judgement admits that COVID-19 is mild for most people but can be fatal for the elderly and vulnerable who also don’t respond well to vaccination. They say that at the time the law was passed, a clear scientific majority assumed that vaccinated and recovered people were less likely to become infected and therefore transmit the virus. It was also assumed that vaccinated people were less infectious and for a shorter amount of time. According to the judgement, expert third parties largely agree that vaccine effectiveness will continue to exist, albeit at a reduced level.
Comically, the judgement states that there is no justification for compulsory vaccination enforced by the state but instead the decision should be down to the individual – they can choose to either give up their previous job or consent to the impairment of their physical integrity. Why thank you, Master, for providing me with two terrible choices. But, every cloud and all that, I suppose it is better than being pinned down and vaccinated. Well, until you can’t pay your rent or buy food for your children and have to steal a cardboard box to sleep on in the street.
Fortunately, the judges concluded that it is ok to breach an individual’s fundamental rights because serious side effects or serious consequences induced by the administration of the vaccine are very rare. And, in any case, they are continuously monitoring and evaluating them. They say that the very low probability of serious consequences of vaccination contrasts with the significantly higher probability of damage to vulnerable people.
They conclude, that the further development of the pandemic, after the law was passed, has not changed anything. Nor have any new developments or better insights.
So there you have it. An individual’s rights can be overhauled if a majority of experts conclude you are a danger to a small group of people. Whilst I can understand and appreciate the need to protect the elderly and vulnerable, this shouldn’t be used as a pretext to remove people’s basic rights.
The majority of health care workers want to protect the elderly and vulnerable, that’s why they do the jobs they do. If they are ill or test positive, they aren’t going to deliberately go and infect someone who is likely to die from Covid – they aren’t pyschos (unlike some of the individual’s making these laws).
Furthermore, the science clearly doesn’t back up what they are saying. You are more likely to catch Covid if you are vaccinated and your viral load is similar, if not the same. There may be evidence showing that you are not as infectious for as long but there also may be evidence showing you can have Covid but aren’t testing positive.
Health Minister Karl Lauterbach welcomed the ruling saying that “the state is obliged to protect vulnerable groups”. He is now off for a meeting with other G7 ministers, despite being in contact with the US health secretary, a day before testing positive for Covid. Rules for thee, not for me.
Clearly, the battle to retain one’s basic rights is still not over in many parts of the world. And if it isn’t completely squashed now, you can be sure it will return everywhere with a vengeance, come the winter.
By Megan Redshaw | The Defender | May 17, 2022
The U.S. Food and Drug Administration (FDA) today authorized a booster dose of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11, without convening its vaccine advisory panel of independent experts to discuss Pfizer’s data on 5- to 11-year-olds — and based on a study subset of only 67 children, CNBC reported.
The FDA granted Emergency Use Authorization (EUA) for the boosters despite data showing higher infection rates among fully vaccinated children in the 5 to 11 age group compared to unvaccinated children, no studies testing the efficacy of the vaccine against the current dominant BA.2 COVID-19 variant and two new studies showing that for vaccinated people who get Omicron, the infection provides better protection against future infections than a second booster dose.
The vaccine advisory panel for the Centers for Disease Control and Prevention (CDC) is scheduled to meet Thursday. The agency and its director, Dr. Rochelle Walensky, are expected to sign off on the boosters, The Washington Post reported.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said data increasingly show protection provided by two shots wanes over time, but the agency determined a third shot could help boost protection for children in the 5 to 11 age group and the “benefits outweigh the risks.”
The FDA authorized the third shot after analyzing data from an ongoing Pfizer clinical trial in which a small subset of only 67 children in the age group had higher antibody levels one month after receiving a booster dose.
As The Defender reported, antibody levels alone are not indicative of immune protection. When it comes to COVID-19, T cell and natural killer cell responses are the crucial part of immune protection.
Pfizer has not published its actual data, precluding experts from conducting this analysis.
The authorized booster dose, the same strength as the first two doses, generated neutralizing antibodies to Omicron and the ancestral Wuhan version of the virus, according to The New York Times.
The FDA said it did not identify any new safety concerns and found the children in the trial experienced the same mild side effects other people do after receiving a booster.
However, a subset of only 67 children is not large enough to detect potential adverse events like myocarditis, and it is unknown how rapidly any protection provided wanes because trial participants were not followed beyond a 28-day period.
About 8.1 million, or 28%, of children ages 5 to 11, received their primary series of two COVID-19 vaccine doses as of May 11, according to data from the American Academy of Pediatrics.
Those children will now be eligible for a third dose five months after their second dose based on data obtained from the 67 children who were followed for only one month.
COVID cases higher in vaccinated children aged 5 to 11, CDC data show
According to the latest CDC data, since February, higher COVID-19 case rates were recorded among fully vaccinated children compared to unvaccinated children in the 5 to 11 age group.
The CDC on Feb. 12 reported a weekly case rate of 250.02 per 10,000 population in fully vaccinated children ages 5 to 11, compared to 245.82 for unvaccinated children in the same age group.
The trend continued through the third week of March, which is the latest week of available data.
“Several factors likely affect crude case rates by vaccination and booster dose status, making interpretation of recent trends difficult,” CDC spokesperson Jasmine Reed told The Epoch Times in an email.
“Limitations include higher prevalence of previous infection among the unvaccinated and unboosted groups, difficulty in accounting for time since vaccination and waning protection, and possible differences in testing practices (such as at-home tests) and prevention behaviors by age and vaccination status,” Reed said. “These limitations appear to have less impact on the death rates presented here.”
According to CDC data, the gap between fully vaccinated and unvaccinated individuals in all age groups has grown increasingly smaller, with the death rate showing the same trend for people over age 50.
For people under age 50, death rates are almost identical between the vaccinated and unvaccinated since the beginning of the vaccine rollout.
Data show COVID-19 vaccines have a “negligible effect” on people, said Dr. Peter McCullough, a prominent cardiologist and epidemiologist.
“With these results in hand, it is clear the vaccines are having a negligible effect in populations,” McCullough told The Epoch Times in an email.
“Given the overall poor safety profile and lack of any assurances on long-term safety, Americans should be cautious in considering additional injections of these products.”
Having COVID may be more effective than getting a booster, studies show
Two new studies show, for people who are vaccinated against COVID-19, getting a breakthrough Omicron infection may provide better protection than receiving a second booster, Fortune reported.
One study conducted by German biotechnology company BioNTech SE assessed vaccinated individuals who had breakthrough COVID-19 infection associated with the Omicron variant.
BioNTech found these individuals had a better B-cell response than individuals who had received a booster but had not been infected.
According to MD Anderson Center, B cells are a type of white blood cell that create antibodies that bind to pathogens or foreign substances and neutralize them. B cells bind to a virus and prevent it from entering a normal cell causing infection. They also recruit other cells to help destroy infected cells.
A second study by the University of Washington and Vir Biotechnology investigated the immune responses of various groups based on vaccination and infection status.
The study analyzed blood samples of individuals who had been vaccinated and then caught the Delta or Omicron variants and compared them with those who had COVID-19 first and were then vaccinated, those who had been vaccinated but were not previously infected and those who were infected but had never received a COVID-19 vaccine.
The study found vaccinated individuals with breakthrough Omicron infection produced antibodies that formed a strong defense against other variants of the virus. Unvaccinated people who caught Omicron did not have a similarly robust immune response.
Efficacy of Pfizer’s COVID vaccine wanes rapidly
A study published May 13 in the Journal of the American Medical Association (JAMA) found protection from Pfizer’s COVID-19 vaccine turned negatively effective among children and adolescents five months after receiving a second dose — meaning recipients were more likely to get COVID-19 five months after being vaccinated.
Vaccine effectiveness “was no longer significantly different from 0 during month 3 after the second dose,” the researchers wrote. They also found protection against hospitalization waned significantly over time.
In adolescents, the authors said, efficacy increased again with boosters.
Most non-randomized studies attempting to determine vaccine efficacy (VE) had “common flaws,” including no accounting for baseline prior COVID-19 infection, no reporting for those who received a booster within a six-month time window and no adjudication of hospitalization or death due to COVID-19 or other conditions, McCullough told The Epoch Times.
“As a result, most studies of COVID-19 VE have biases towards overestimating any clinical benefit of vaccination,” McCullough said.
As The Defender reported on May 13, a different study published in JAMA showed second and third doses of Pfizer’s COVID-19 vaccine provided protection against the Omicron variant for only a few weeks.
“Our study found a rapid decline in Omicron-specific serum neutralizing antibody titers only a few weeks after the second and third doses of [the Pfizer-BioNTech] BNT162b2,” the authors wrote.
A preprint study released in February showed Pfizer’s two-dose regimen of its COVID-19 vaccine for children was only 12% effective against Omicron in children ages 9 to 11, and the effectiveness of the vaccine “declined rapidly” for children 5 to 11.
Researchers at the New York State Department of Health and the University at Albany School of Public Health examined the effectiveness of the vaccine in children 5 to 11 and adolescents 12 to 17 from Dec. 13, 2021, to Jan. 30, 2022, and determined the effectiveness of Pfizer’s COVID-19 vaccine declined rapidly for children, particularly those 5-11 years.
According to a Danish study of 128 people who had received two or three doses of Pfizer’s COVID-19 vaccine, levels of Omicron-specific “neutralizing” antibodies decline rapidly after a second and third dose of Pfizer’s shot.
Compared to original and Delta variants, researchers found the proportion of Omicron-specific antibodies detected in participants’ blood dropped “rapidly” from 76% four weeks after the second dose to 53% at weeks 8 to 10 and 19% at weeks 12 to 14.
After the third shot, neutralizing antibodies against Omicron fell 5.4-fold between week 3 and week 8.
Last month, Moderna requested EUA for its COVID-19 vaccine for children aged 6 months to 6 years. Pfizer plans to seek EUA for a three-dose regimen for the same age group.
The FDA’s top vaccine official told a congressional committee on May 6 COVID-19 vaccines for children under 6 will not have to meet the agency’s 50% efficacy threshold required to obtain EUA.
Megan Redshaw is a staff attorney for Children’s Health Defense and a reporter for The Defender.
© 2022 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.
By Kate Dunlop | TCW Defending Freedom | May 18, 2022
ARE you getting used to the Great Reset? How are you liking the New World Order built on globalist diktat, infection, mass poisoning by inoculation, inaccessible healthcare, inflation, draconian policing, shortages, uncontrolled migration, fear, more fear, and war…
You’ll doubtless be prepared for what’s coming next. It’s not a secret – Bill Gates and his World Health Organisation cohorts have already told us. The next viral releases – Hantavirus, Nipah virus, Marburg, whatever – are all primed and ready to go, together with monkeypox and avian bird flu. All come packaged with their own ‘off the shelf treatments’ from Big Pharma, all guaranteed to be equally as effective as the Covid jabs.
Supply chain problems are already here and will worsen, depending on whatever the next emergency is, and the UK is as well prepared for them as it is for shortages of fuel, gas, and electricity – which is to say not at all.
Now we are being told that a major food crisis is inevitable. Speaking at a Nato conference in Brussels on March 25th of this year, Joe Biden said: ‘Regarding food shortages – yes, we did talk about shortages, and they’re going to be real.’ He’s a man of his word.
Previously the blame was put on ‘climate change’, Brexit, shortages of foreign hands to pick and harvest crops, not enough lorry drivers, lockdowns, the ‘management’ of Covid, and the mass culling of chickens due to bird flu.
Now the war in Ukraine and sanctions against Russia are delivering shortages of gas, oil, and wheat. Russia and Ukraine together are the largest exporters of wheat and other grains in the world and Russia the largest exporter of oil and gas. Their impact on global logistics and food supply is immense.
At the same time, food production and processing facilities in the US seem to be spontaneously combusting. Since August last year, more than 16 such plants have been damaged by fire.
In September, a meat processor in Nebraska lost five per cent of the country’s beef supply. In March this year, a frozen food plant in Arkansas and a potato processing site in Maine both burned down. Last month, two planes crashed into two food plants, causing massive destruction – one at a General Mills facility in Georgia and another at a potato processing unit in Idaho.
Florida is having its worst orange crop in 70 years, with 90 per cent of trees affected by ‘citrus greening,’ a disease spread by the invasive Asian citrus psyllid bug, which was first found in China, then India and Saudi Arabia. Today, every citrus grove is infected. The impact on farmers already suffering from Covid restrictions is disastrous.
Russia and Belarus are two of the biggest global exporters of fertiliser and fertiliser-related products, accounting for 10 billion dollars activity per annum. The war and the sanctions have damaged the fertiliser market, with prices hitting all-time highs in March.
China’s draconian ‘Zero Covid’ approach and its export ban on fertiliser since last summer has added to farmers’ woes and hit food production costs.
Now it’s baby formula milk, with shortages across the US since February this year. CBS News reports that some 40 per cent of top-selling formula products were ‘out of stock’ at the end of April, according to an analysis from Datasembly.
The Wall Street Journal suggests two reasons for the shortages. It says supply chain issues caused by the Covid-19 pandemic worsened after Abbott Labs, a major formula manufacturer, voluntarily recalled some products and closed a plant in Michigan. Then there was a Food and Drug Administration investigation into complaints related to four infants who were hospitalised, two of whom died.
The White House reaction last week was woeful, with the tone-deaf press secretary Jen Psaki saying the government is ‘doing its best’ and that manufacturers are working at full capacity. In a national health emergency she went on to hint that some mothers are hoarding formula.
But, as with everything in the Magic Kingdom of Biden, things are not what they seem. The legacy media are slow to show locked cabinets in Walmart and empty shelves in other stores, though news that the government is transporting supplies of baby formula to border migrants is beginning to leak, as Tucker Carlson reports.
Eric Boehm, writing in Reason, confirms that although some of the shortages stem from the closure of the Abbott plant, there were already longstanding market problems. A closer look at US trade and regulatory policies shows that government is primarily responsible for the shortages.
According to the New York Times, ‘baby formula is one of the most tightly regulated food products in the US, with the Food and Drug Administration dictating the nutrients and vitamins, and setting strict rules about how formula is produced, packaged, and labelled’.
The US formula market was valued at 3,653 million dollars in 2019 and projected to reach 5,811 million dollars by 2027. The Covid-19 pandemic brought an upsurge in demand due to panic buying on the back of shortage fears.
Rising numbers of American parents are sourcing ‘unapproved’ European formula, even though it attracts an 18 per cent tariff quota. Some are desperate for supply, but others choose European brands because they offer options such as goat’s milk or milk from pasture-raised cows, which are ‘rare or non-existent in an FDA-regulated form in the US’.
Others consider EU products to be of higher quality due to stricter content regulations, including important levels of DHA (an omega-3 fatty acid), which are not required in the US. Almost no American baby formula would meet EU standards and many parents worry about adulteration.
Americans pay well over the odds for European formula, with one website selling product from Germany at 26 dollars for a 400-gram box, about four times the price of the top US formulas.
In April 2021, US Customs and Border Protection agents in Philadelphia seized 588 cases of formula worth around 30,000 dollars. The formula was said to have violated the FDA’s ‘import safety regulations.’ According to Twitter chatter, the FDA issued a fake recall of European formulas in 2021 and has regularly seized legal personal-use shipments.
Plain old natural disaster coupled with bureaucratic interference is not what is going on here. The US baby formula shortage is neither due to incompetence nor maladministration – it is an attack on the most vulnerable in society; part of a deliberate policy to keep chaos bubbling at peak in the service of the Great Reset.
We know what is going on. In 1974, Henry Kissinger said: ‘Who controls the food supply controls the people; who controls the energy can control whole continents; who controls money can control the world.’
By Toby Green | UnHerd | May 9, 2022
It’s not easy being a regular multi-billionaire. Bill Gates used to be the simple guy-in-the-mansion next door, worried about virus outbreaks and global warming. Then, during the pandemic he became the point at which all conspiracy theories met.
Ever since March 2020, the memes have spread. Was Gates a mass murderer with a global depopulation agenda? Was he a “biofascist” seeking control over the world’s population through vaccine passports and microchips?
It didn’t stop there. Was the Covid-19 pandemic actually “plandemic”? Did the Microsoft founder and his acolytes create it through funding “gain of function” research in a biosecurity lab in Wuhan? Was it all war-gamed at Event 201 in October 2019?
Bill Gates has not much enjoyed being the focus of these stories for the past 18 months. He just wants to help out. He wants to solve problems so badly, he tells us early on in How To Prevent the Next Pandemic, that in February 2020, he flew from Seattle to South Africa to participate in a charity tennis match, no doubt on one of his four personal jets.
It was in South Africa that he first began to join the Covid-19 dots. The tech entrepreneur delivers the story with characteristic flair: “A couple of days after returning from South Africa, I sent an email about scheduling something for the coming Friday night: ‘We could try and do a dinner with the people involved with coronavirus work to touch base.’” Gates is happy, “everyone was nice enough to say yes — despite the timing and their busy schedules”. His work on the pandemic begins.
Now Gates is tired of all the conspiracies. He asks his critics to judge him by his actions. And the best way to do so is by reading the book: does Gates have anything sensible to say about the best way to combat future pathogenic outbreaks?
His model for the future is built on what he feels has worked over the past two years: isolate contacts, close borders, lockdown as quickly as possible, then remove restrictions slowly and cautiously. He cites Dr Anthony Fauci, who Gates says he spoke to once a month during the pandemic: “Not only should you appear to overreact at first, as Tony Fauci said, but you also have to be careful about relaxing all NPIs [non-pharmaceutical interventions] too soon.” Meanwhile, you should invest enormous sums in boosting global public health systems, vaccine production in poor and rich countries, and fund a Global Pandemic Emergency Response Unit to monitor potential outbreaks. The aim, says Gates, is to vaccinate the entire world — twice if necessary — within six months while lockdown measures restrict the spread of the new pathogen.
It all sounds so reasonable, doesn’t it? Or it might do to those who haven’t seen the footage of Shanghai’s lockdown circulating on social media, to those who can work online in relative comfort, or indeed to billionaires with comfortable gardens and libraries in which to while away those six months. With the Gates model, a little translation is in order.
The massive investment required to make this vision happen is a good starting point. Where will it come from? Gates is a well-known philanthropist, and makes much of the more than US$2 billion which the Bill and Melinda Gates Foundation have ploughed into fighting Covid-19. Yet this is a small amount compared to the US$6 billion that the US government has invested in the Moderna vaccine alone. As Gates points out, “Most of the world’s greatest talent for translating research into commercial products is in the private sector… It’s the government’s role to invest in the basic research that leads to major innovations, adopt policies that let new ideas flourish.”
Translation: taxpayers invest in developing products through government agencies, and private companies and their shareholders reap the profits. How does this work in practice? Gates does not give what we might call full disclosure. He offers the example of the antiviral Molnupiravir which “Merck and its partners developed”. It was authorised to great fanfare as a Covid treatment in November 2021.
Yet Merck did not develop this drug. It was initially developed as a veterinary drug for horses at Emory University, with a US$19 million grant from Fauci’s NIAID and funding from other sectors of the US government. Molnupiravir costs US$17.74 per dose to manufacture, according to an estimate from researchers at Harvard and King’s College London, but is being retailed to the US government for US$712 per course — a profit of 4,000%.
Another example of Gates’s eye for detail is his discussion of Remdesivir, which was approved as “Standard of Care” for Covid in the US by the Federal Drug Agency. Again, like Molnupiravir, much of the funding and institutional support for the drug originally came from the US government. Remdesivir was the baby of the drug company Gilead.
Gates describes how one study showed that “it may have a major impact in patients who aren’t yet sick enough to be in the hospital”. But other details are ignored. He doesn’t tell us that in an earlier, peer-reviewed study from China, published in the Lancet in May 2020, “Remdesivir was not associated with statistically significant clinical benefits”, and that the trial was “stopped early because of adverse events in 18 (12%) patients versus four (5%) patients who stopped placebo early”. All the same, the profits were good: while the drug cost Gilead just US$10 per dose to manufacture, it was being retailed to US taxpayers at US$3,120.
Maybe Gates knows nothing about the Lancet study. Perhaps he doesn’t know that in both of these cases, public investment has funded enormous private profits — and that in the case of one of the drugs, there’s little evidence that this was to any benefit. He’s just a software engineer after all.
For Gates, technology really does provide all the answers, as it certainly has in his own life. He believes humanity belongs online: “once people learn the digital approach, they generally stick to it”. Post-Covid, he envisages a world of flexible working, in which regular guys like him with large mansions and decent living space can languidly choose between going into the office on Wednesdays or Thursdays. The problem with Gates’s digital utopia — full of virtual spaces where 3D avatars attend business meetings — is that I suspect many of us will not want to live in it.
Gates tries to show in this book that he gets it, while at the same time demonstrating on every page that he just doesn’t. As he draws up his elaborate plans for global governance, Gates writes that he does so knowing that he hasn’t been elected. He tells us he wouldn’t want to be anyway (after all, we can surmise, if he were elected, he might be accountable).
Gracefully, Gates understands that people are angry at the huge increases in wealth disparities during the pandemic, and pledges to return his profits to “make the world a fairer place”. He recognises that poor people across the world have suffered, and are far less able to deal with lockdowns, and even acknowledges that harsh measures might not be a good idea for some of them… And yet he recently went on record as saying that “if every country does what Australia did, then you wouldn’t be calling it a pandemic”. We can, in fact, judge him by his actions, and his words: he says one thing, and funds and promotes others.
Looking forward, the outlook is bleak. Preventing pandemics in Gates-World means shutting down immediately at the “next major outbreak” — a favourite, and alarming turn of phrase. Future semi-permanent global lockdowns are baked-in as the new normal, something I warned of in the conclusion to my book The Covid Consensus. As Gates notes, the WHO have identified 1,500 new pathogens in the past 50 years, and thus the “next major outbreak” surely cannot be far off. In the past 20 years, pre-Covid, there were already three of note (SARS — 2003; Avian Flu — 2005; Swine Flu — 2009). In each case enormous fatalities were falsely predicted, and would surely have led to six month shutdowns in the Gates model.
Gates-World is one where citizens make sacrifices for his model to work. And it’s also one where class is totally ignored. Does Gates know what it was like for Angolan children to be forced to stay at home for seven months in 2020? He admits that internet connections need to be improved to make digital schooling possible — but does he understand that no IT in the world can help children of sex workers in Mumbai slums with their homework? Can he comprehend what it is like to be incarcerated in a flat with small children for months on end in New York, Shanghai or London?
Gates wants to be respected, and understood. His world is one of innovative scientists having dinner with one another. They solve the world’s problems by the pool, or near the barbecue. It’s what he likes doing best, because “I’ve had some of the best conversations of my working life with a fork in my hand and a napkin in my lap” (p4). He wants to fund more and more work leading to experiences like this, and meanwhile turn the rest of human society into a digital avatar of itself.
No doubt he means well. But you don’t need to indulge the conspiracy theories to realise that the road to hell is paved with good intentions.
Toby Green is a Professor of History at King’s College, London.
Steve Kirsch | May 14, 2022
Ever wonder why so many flights are delayed or canceled? A lot of it is due to injuries caused by the vaccine mandates.
Today, there are many pilots who are vaccine injured and not saying anything, endangering the public.
Here’s what happened to one vaccine injured pilot who now has to retire because he’s unable to fly anymore.
He speaks freely, right after being released from the hospital.
And no, the CEO of American Airlines, working just 10 minutes away didn’t call or come visit him. That’s the way they treat “family” at American Airlines.
Other articles about the vaccine and pilots
I wonder if the vaccine is causing all these incidents. I’m told they are safe and effective. But that’s not what the data says.
THREE KILLED, AS PLANE CRASHES INTO MEXICAN SUPERMARKET
PLANE CRASHES ONTO A STREET IN SAN DIEGO
PILOT SUFFERS MID-AIR HEART ATTACK
CO-PILOT LANDS PLANE AFTER PILOT HAS HEART ATTACK:
TRAFFIC CONTROL HELPS PASSENGER LAND PLANE, AFTER PILOT HAS HEART ATTACK
A little trip down memory lane
el gato malo – bad cattitude – may 16, 2022
My goodness, these “conspiracy theorists” certainly do have vivid imaginations, don’t they?
i mean, that would be terribly divisive, counter to rights, and directly antagonistic to people who just want bodily autonomy. can you even imagine public officials doing something like that?
pretty far fetched…
or health bodies using disease to engage in surveillance?
or governments seeking to do the same and mitigate privacy altogether?
i mean, that’s just silly!
what next, some wild eyed claims that they want universal digital ID?
that they have been quietly rolling out the standards for
and making international and inescapable?
i mean, what will these prolific conspiracy boffins think up next, some sort of state run digital currencies to link to this new ID and surveillance state?
i mean, who would even suggest something like that?
and anyhow, what’s the worst that could happen?
i mean, they told us this is all benign, right?
and it’s not like they ever lied to us before! (or if they did, i’m sure it was for our own good…)
and it’s not like they are seeking to give this power to deeply compromised and captured transnational agencies with no accountability whatsoever and grant them authority over citizens who had no say in the matter…
so let’s all take a breath. i’m sure you’re just overwrought and imagining things.
there are no conspiracies.
no one is out to get you, least of all some shadowy davos cabal.
and come on, if they were really trying to do this to you, i’m sure they would not just come right out and tell you in some sort of james bond villain megalomaniacal monologue.
i mean, this is real life. no one actually does that…
and hey, i’m sure they’ll probably manage to keep those first 2 promises.
watch out for that third one though.
i have some real doubts about it it…
or go to
Aletho News Archives – Video-Images
By Lisa Pease | Consortium News | September 16, 2013
More than a half century ago, just after midnight on Sept. 18, 1961, the plane carrying UN Secretary-General Dag Hammarskjöld and 15 others went down in a plane crash over Northern Rhodesia (now Zambia). All 16 died, but the facts of the crash were provocatively mysterious. … continue
Aletho News If Americans Knew No Tricks Zone
Aletho News 