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Editor’s Note: Advisors to the U.S. Food and Drug Administration on Wednesday recommended the agency grant Emergency Use Authorization of the Pfizer and Moderna COVID-19 vaccines for children under 5 years old, despite questions about safety and efficacy, and whether children, who are at low risk of serous illness from the virus, need the vaccines.
Here are a few things members of the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) saw and heard before they voted to recommend approval anyway:
1. They proceeded for recommendation of approval based on a guess that three doses will correct negative efficacy.
Pfizer has a serious problem: Its two-dose data reflected the reality I’ve been reporting about (and predicted) since the Israeli and Barnstable County data came out: the confidence interval for their estimate of the number of cases prevented by three doses of their vaccine points, if anything, to negative efficacy (-369.1 to 99.6).
The confidence interval crosses zero. The problem is not just that the result is based on a ridiculously small number of data points. See Point 2.
2. The problem also is that this result confirms (validates) the result of the two-dose vaccine. Their measure of vaccine efficacy was only 14.5% seven days after the second dose the confidence intervals crossed zero, so they were not statistically significant.
3. They relied on proxy outcome measures (neutralizing antibodies). Neutralizing antibodies sound good, but they are the wrong antibodies (the Wuhan-1 virus is extinct). Look at the antibody response to Omicron (Pfizer):
I predict the entire vaccination program is going to drive COVID-19 numbers up across the board routinely and on a regular, ongoing basis due to antibody-dependent enhancement, as predicted by Dr. Fantini’s analysis.
4. Given these three points alone, FDA might just as well be staring at a blank sheet of paper and rubberstamp the approval.
Look at the confidence interest after Dose 2 and Dose 3.
5. No one raised the issue of failure to meet FDA’s required 50% efficacy.
Moderna and Pfizer’s own endpoint data fall short of the 50% mark. Pfizer decreased its dose and this seems to have decreased the reported adverse events. But we’ll get to the real problem with adverse events shortly.
6. Their numbers are ridiculously small. Pfizer showed an estimate of 80.3% vaccine efficacy is based on – get this – 7 cases in the placebo group and 3 in the vaccine group.
Notice the emblazoned 80% — as if that data point has any basis in reality.
7. They are ignoring the risk of altered neurodevelopment. The Moderna vaccine especially had high numbers of high fevers (>104°). Many studies exist that show that high fever following vaccination is associated with autism, especially if the kids are given acetaminophen.
8. Moderna presented antibody data against the reference strain (Wuhan-1). But We don’t only care about how good a vaccine is at generating antibodies. Moderna knows this. VRBPAC knows this. Now you know this, too.
9. Inconsistent case definition. Moderna ran only PCR tests if patients in the vaccinated group had two symptoms.
In other words, they made up their own clinical designation of “COVID-19.” Under CDC’s case definition (which is also not correct), Moderna’s data show that in kids 2 to 5, “vaccine efficacy” was 36.8% but under Moderna’s new definition, 46.4%.
Moderna also used antigen tests, making any measure of efficacy incomparable to other studies.
10. Risk of hospitalization cited out of context.
One committee member compared the risk of a child dying from COVID-19 to a person being struck by lightning (see my calculations here).
They showed the Omicron hospitalization rate “surge.”
Yet it’s much lower than that for influenza, per CDC:
11. They may have broken the rules of engagement for open meetings
Any reasonable person would expect that public open meetings held by organizations such as VRBPAC would know and follow administrative rules for open meetings.
How is it then that only VPBPAC members managed to ask questions and voice their opinions on how necessary (or not) COVID-19 vaccination in children might be AFTER the votes were made to approve the vaccine for children under 5?
Dr. Meryl Nass was denied an opportunity to speak in the public comment period, yet the same pro-vaccine mother was able to speak two days in a row. Thus, the public may have been denied the opportunity to contribute their comments.
This is being looked at by lawyers. If it is true the FDA broke the rules of open meetings, then any ethical judge would rule this vote to recommend is null and void ab initio.
Originally published on James Lyons-Weiler’s Popular Rationalism Substack page.
