FDA Caught Creating and Using Unreliable and Inconsistent Data to Create An Illusion of COVID-19 Vaccine Efficacy as They Attempt to Justify Approval for Use in Infants and Toddlers

They want the COVID-19 vaccine approval for children so bad, Peter Marks himself and his cronies published the very study he has to use to evaluate for approval.

Urgent Action Item Below.

As promised, the FDA has ginned up a report that ostensibly will be used to try to justify “approval” (whatever they mean by that now) of COVID-19 vaccines for infants and toddlers (children < 5 years old). Here’s the report for your reference.

This report comes after a torrent of massive reports from Moderna and Pfizer that claim to review studies of the safety and efficacy of COVID-19 vaccines in children. It is not hard to see what shenanigans the FDA has been up to to try to bolster a vaccine that fewer and fewer adults want. It’s more of the same: exaggerate the apparent risk of the virus and minimizing the perception of risk. In other words, lies.

1. There is no evidence of clinical urgency. Infants and toddlers (and children in general) do not get COVID-19; they do not (yet) die from COVID-19. All that can change when antibody dependent enhancement kicks in for the vaccinated. FDA’s own reports cites 1,086 deaths “from COVID-19” and 10,700,000 “cases” of COVID-19 in children aged 0-17. There have been 832 days since April 1, 2020 when diagnoses started for COVID-19. For the entire population of children in the US (73,000,000), the risk of COVID-19 infection since the onset of COVID is 10,700,000/73,000,000 = 0.14657. The risk of a child dying if they have a diagnosis is 1,086/10,700,00 or 1086/10700000 = 0.00010149532. The risk of any child dying of COVID-19 over this time period is 1,086/73000000 = 0.00001487671. The per-day risk is on the order of 1.78806611e-8 (0.000000001788). There is no real unmet clinical need and the FDA needs to go back to college to understand how to use RT-PCR correctly. Children do not get COVID-19, and they do not die.

2. Inconsistent use of the idea “vaccinated”. This has been the pattern from the very first study. FDA, CDC, Moderna, Pfizer, and others pull out whatever definition of “vaccinated” they want. Examples: “Vaccinated” is defined in the original trials as people who received both doses and who did not develop COVID-19 before two weeks passed after the second exposure to the vaccine. In fact, that means that people who developed COVID-19 due to disease enhancement were dropped from the study calculations. First, this is the first time people were dropped from a vaccine trial for getting infected with the pathogen targeted by the vaccine up to 13 or 14 days after being vaccinated. Second, it’s actually five entire weeks - one month and one week - 44 days - after the first exposure. ALL of the vaccine efficacy being cited by FDA is suspect. Moderna’s and Pfizer’s vaccines never achieved >90% true vaccine efficacy; the best estimate is more like 75%.

3. Inconsistent use of the idea “vaccine efficacy”. Over the time period since the first COVID-19 vaccine trials, various definitions of “vaccine efficacy” have been used. Decreased transmission. Reduction in infection rates. Reduced hospitalization. Presence of neutralizing antibodies. Presence of antibodies. All are used and cited in FDA’s report whenever convenient, all in an ad-hoc manner. It’s more than irritating. It’s moving the goal post and represents reckless (and ineffective) attempts to manipulate public perception. This practice continues in the reports and studies that are cited by FDA. I do not trust the efficacy data FDA cites in their report (why would we given Point 1?).

   Further evidence of the futility of the evidence used to claim efficacy comes from Moderna’s Sponsor Briefing report to the FDA:

   “3.3 Regulatory Considerations for Clinical Development of COVID-19 Vaccines in Children

   Effectiveness

   Regulatory precedent with other preventive vaccines provides a basis for inference of vaccine effectiveness in pediatric populations based on immunobridging to a young adult population in which clinical disease endpoint vaccine efficacy has been demonstrated for the same prototype vaccine. The immune marker(s) used for immunobridging do not need to be scientifically established to predict protection but should be clinically relevant to the disease. Based on available data in humans and animal models, FDA considers neutralizing antibody titers (a functional measure of the vaccine immune response against SARS-CoV-2) to be clinically relevant for immunobridging to infer effectiveness of COVID-19 vaccines in pediatric age groups. Because no specific neutralizing antibody titer has been established to predict protection against COVID-19, two immunogenicity endpoints (GMT and SRR) are considered appropriate for comparing the range of neutralizing antibody responses elicited by the vaccine in pediatric versus young adult populations.

   Also embedded in this piece of work is the fact that FDA does not need evidence of long-term immunity; they are settling for something called “immunobridging” - guessing at the efficacy of a vaccine in one clinical population from measurements made from other clinical populaton.

   They also are making people dependent on vaccines… expecting patients to have antibodies from one vaccine to the next. This makes no sense immunologically. We don’t need continuously high antibody levels against any pathogen. We have memory B-cells and T-cells. In accepting this paradigm, FDA is completely off its rocker and will cause immune exhaustion with constant vaccinations every 3-4 months.

4. Incomplete consideration of the scientific data (Barnstable County, Israel, Ontario). We know that months after vaccination, those who are vaccinated are at higher risk of infection and now of hospitalizations. Data actually show negative vaccine efficacy in children (per Jeremy Hammond). See: “Evidence for Negative COVID-19 Vaccine Effectiveness in Children”. From that article:

   “vaccine effectiveness (VE) in children becomes(sic) negative within several months since receipt of the second dose.

   Researchers from the New York State Department of Health published a study on the preprint server medRxiv on February 28 noting that the evidence for vaccine effectiveness in children, particularly those aged five to eleven, was “limited”. So, they aimed to provide data to inform policymaking.

   “During Omicraon variant predominance,” the authors concluded, “VE against infection declined rapidly” for young children in the state of New York, “with low protection by one month following full-vaccination.”

   Comparing COVID-19 cases during January between unvaccinated and vaccinated children, they estimated initial vaccine effectiveness for children aged twelve to seventeen to be 76 percent, but this dropped to below 50 percent after just five weeks since receipt of the second dose.

   Moreover, for young children (aged five to eleven), they observed a drop from 65 percent to just 12 percent after only one month.

   Thereafter, their estimate indicated significantly negative effectiveness for this age group, as shown in Figure 2 of their paper: by 35 to 41 days, VE reached negative 10 percent, and by 42 to 48 days, it reached negative 41 percent.

   

   Jeremy goes on to report (correctly) that the authors of the article misinterpreted their own data. History will remember Jeremy as a reporter with great integrity.

5. Moderna and Pfizer reports fail to study long-term risks. Like I said, more of the same shenanigans. In this report, for example, Moderna offers data on myocarditis only up to Day 28 after the vaccine. Why Day 28? Why not “since the vaccine has been administered” to more accurately reflect the real-world clinical situation? They also state that myocarditis in a large concern in people infected with SARS-CoV-2 - but the comparison is to the uninfected, not the vaccinated, and we know that the spike protein is the cause (syncytia among heart muscles caused by the spike protein). The spike protein, of course, is the basis of their mRNA vaccines.

6. Incestuous COIs/Unjustified Influence by Regulators. Peter Marks is charged with setting the decisions at FDA whether to consider vaccines for specific populations. Why the hell is he involved in a study conducted to bolster the vaccines he is going to have to decide upon? See “Benefit-risk assessment of COVID-19 vaccine, mRNA (Comirnaty) for age 16–29 years”. That “study” is also guilty of all of the same loose logic as above; it is noteworthy that the study assumes as “worst case scenario” of zero deaths from myocarditis following COVID-19 vaccination (Credit: Toby Rogers, who wrote this to me:

   “I'm reading the Moderna "Sponsor Briefing Document" and they built their benefit-risk assessment off of Funk et al. (2022). So I looked up Funk and it's a recent paper by six staffers at the FDA including Peter Marks, Richard Forshee, and Hong Yang (who wrote the dreadful benefit-risk assessment for kids 5 to 11 back in October). Quite literally in their "worst-case scenario" they predict 0 deaths from myocarditis in the vaccine group. It's a stunning work of fiction.”

7. I’m on an email thread with Steve Kirsch (he considers me part of his “debate team”. Last week, Steve challenged Peter Marks to a debate:

   “Hi Peter,

   You are right about the vaccine uptake problem. According to independent survey we just commissioned, only 33% of Americans opted to go further than the first 2 doses.

   You were quoted in that CNN article:

   "We do have a problem with vaccine uptake that is very serious in the United States and anything we can do to get people more comfortable to be able to accept these potentially life-saving medical products is something that we feel we are compelled to do," said Dr. Peter Marks, director of the Center for Biologics Evaluation and Research.

   Isn’t it time for you to end the misinformation problem by debating us in a public forum?

   My colleagues and I look forward to hearing from you.

   The only way to end the misinformation is to debate the top misinformation spreaders. You will never win by trying to censor us.

   We would be HAPPY to debate to you to end the misinformation problem. As you can see from this slide deck, all the evidence we’ve been able to find shows there was clinical trial fraud and that the vaccines are very dangerous. We would love to know how we got it wrong

   I look forward to hearing from you.

   -steve

   To my knowledge, Marks has not replied. I replied to Steve and the entire email thread, including Marks, though:

   “Steve,

   History is going to remember one person on this email thread in a manner in which I would not ever care to be seen associating with.

   I would therefore decline to participate in such a debate.

   Sincerely,

   James Lyons-Weiler, PhD

I could continue and debate dozens more points in the report dump by the FDA. I don’t have to. Marks himself provides evidence of being way off-target immunologically and lying about the “need” for COVID-19 vaccines for children.

Here’s an old video of Prevaricating Peter lying about the need for “high antibody titres” for immunity, and that children’s immune response is “not enough for some of these variants” (no data on that, just words):

The comments in that video have not aged well. Call your Senator and Congressional Reps and demand that Peter Marks resign. Email them this article. Marks and the FDA are NOT basing their considerations on independent fact, science and logic. He and his cronies are either incompetent or working for the industry. Either way, he and his cronies have to go.