On Sunday night, the FDA released its risk benefit assessment of Pfizer’s Emergency Use Authorization (EUA) application to inject mRNA into kids 6 months to four years years old. This application will be voted on at the June 15meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). I read the document cover-to-cover this morning. Here are my observations.
I. Bad study design leads to unusable results
FDA/Pfizer claim that this is a study of 4,526 participants 6 months through 4 years old. This is of course a lie. Like Moderna, Pfizer found ways to whittle down the number of participants to force the “data” to fit a pre-determined fictional narrative. We’ll return to this in a moment.
Pfizer has a unique problem — and this may be one reason why it has taken them so long to get to the application stage… Apparently Pfizer thought that this clinical trial in kids was going to work, so they unblinded it on September 28, 2021 and they started vaccinating the placebo group (to destroy the control and eliminate any long term safety data) on November 3, 2021 (seep. 23). Then in early December the data showed that the trial had failed. Whoops! So Pfizer had to scramble to enroll even more kids (643 more by my estimation) in the attempt to save the clinical trial with a third dose.
The results then become a complete muddle because Pfizer has to refer to the blinded period (before September 28, 2021), the unblinded and crossover period (after September 28), and then the post “protocol amendment 6 period” (February 1 to the “data-cutoff” of April 29, 2022).
When it suits their needs (in the press) Pfizer points to the larger sample size. When they are trying to hide bad data (immunogenicity) they just use a tiny slice of the total sample. This is dishonest and unethical and makes this study functionally useless for making decisions.
II. The immunogenicity section is preposterous
Pfizer took blood samples from just 82 children ages 6-23 months and 143 children ages 2 to 4 years old. That is less than 5% of the total sample that FDA/Pfizer bragged about at the start of the document and in the press. Pfizer calls this the “immunogenicity population.” No explanation is given for how they selected the less than 5% of participants who would be included in this subsample. There is no bloodwork from the placebo group — so this study is not an RCT.
The blood samples were taken one month post Dose 3 and measured for antibodies against the original ancestral strain of SARS-CoV-2. Of course antibodies are highest one month after dose 3 — that does not tell us anything about health. As I pointed out yesterday, the VRBPAC concluded at the April 6, 2022 meeting that there there are no known “correlates of protection” that one can use to predict who will be immune to SARS-CoV-2.
As Eric Rubin, Harvard Professor and editor of the NEJM states, “We know what kind of antibody response can be generated, we just don’t know if it works.” You don’t have to take my word for it, it’s all on video:
The antibodies in the kids’ blood samples were then compared against the antibody levels in 170 people age 16 to 25 years in a prior Pfizer clinical trial. Once again no explanation is given for how those 170 people were chosen out of the thousands in the adult trial and why the others were excluded.
Because the antibody levels are similar, FDA/Pfizer declare ‘Voilà it will somehow stop Covid-19 in the future, even though it did not in the clinical trial, and even though the VRBPAC admit that one cannot use antibody levels for this purpose.’
It’s sad that we even have to point out the inanity of this whole process but here we are.
III. The efficacy data is a hot mess
Having convinced no one of the utility of the mRNA shot by appealing to antibodies, Pfizer/FDA switched to…
Continue reading the full story [icon name=”arrow-right” prefix=”fas”] The Pfizer clinical trial in kids 6 months to 4 years old is an embarrassment