The FDA Expanded Pfizer Vaccine EUA based on a Failed Trial

The FDA Expanded Pfizer Vaccine EUA based on a Failed Trial

Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.

The EUA expansion1  for Pfizer BNT162b2 vaccine for kids aged 12–15 was done after it failed (as I will show below) its pro-forma clinical trial2.

Abysmal Safety

Only 1,131 kids received at least one injection of the experimental vaccine. Most of them experienced side effects. Within a few days after the second shot, 66% of the kids developed fatigue, 65% developed headaches, 42% developed chills, and so on. The first shot was tolerated only slightly better. Symptoms varied from mild to severe. More than half of the kids had to resort to painkillers or antipyretics after the second injection. Given such frequency and severity of adverse effects, the sponsor had to either stop the trial because of safety, or to significantly increase its size to exclude high likelihood of death. At the trial size, if the risk of immediate death were 1 per 1,000, the trial had only a 32% probability of missing it. We are lucky that this is not the case. 

From 1, Table 17. Frequency of Solicited Systemic Adverse Events Within 7 Days After Each Dose, by Maximum Severity, Participants 12 Through 15 

Event BNT162b2 Dose 1, N=1127 n (%) BNT162b2Dose 2, N=1097n (%)
Fatigue, any 677 (60.1) 726 (66.2)
Fatigue moderate or severe399 (35.4) 494 (45.1)
Headache, any623 (55.3) 708 (64.5)
Headache moderate or severe 262 (23.3) 406 (37.0)
Chills 311 (27.6) 455 (41.5)
Chills moderate or severe116 (10.2) 234 (21.3)
Fever (≥38.0°C) 114 (10.1) 215 (19.6)
Muscle Pain 272 (24.1) 355 (32.4)
Muscle Pain moderate or severe147 (13.1) 203 (18.5)
Joints Pain109 (  9.7) 173 (15.8)
Joints Pain moderate or severe  43 (  3.8)   82 (  7.5)

Efficacy was not Shown

The media heralded 100% efficacy in COVID-19 prevention because 16 kids (1.5%) in the placebo group had putatively developed COVID-19 within 2 months after the second shot, while no kids in the experimental group had. The study reported no severe cases in the placebo group. At closer look at the definition of a case and the conduct of the trial, very mild disease or even a positive test associated with non-specific symptoms were counted as cases.

“For the primary efficacy endpoint, the case definition for a confirmed COVID-19 case was the presence of at least one of the following symptoms and a positive SARS-CoV-2 NAAT within 4 days of the symptomatic period: • Fever; • New or increased cough; • New or increased shortness of breath; • Chills; • New or increased muscle pain; • New loss of taste or smell; • Sore throat; • Diarrhea; • Vomiting.”

Add to this that the trial was in winter and the researchers solicited answers about COVID-19 symptoms, encouraging kids to keep e-diaries. Thus, a kid getting a sore throat or fever for any reason and a positive PCR test within four days of each other was counted as a case. Solicitation leads for excessive reporting of symptoms. We do not know how many of the “cases” would be more correctly classified as asymptomatic infection if not for symptoms solicitation. Also, only 1.5% of the placebo group has got adverse symptoms, compared with at least 90% in the vaccinated group. Where is efficacy?

Further, “The efficacy analysis for the 12-to-15-year-old cohort was planned as a descriptive analysis because the number of cases that would occur in the age subgroups was unknown.” Thus, this trial was a fiction from the beginning—an excuse for the HHS to start injecting 12-year-olds.

The conclusion: the COVID-19 vaccine FAILED in both safety and efficacy for 12–15-year-olds.

Possible Errors in the Trial

There are indications of other errors in the study. With the rate of treatment adverse effects close to 100%, maintaining placebo blinding was very unlikely. If a kid comes home after an injection with an unusual fatigue and headache, what parent would believe he had received placebo?  

An interesting detail is that, within the first 2 months after the 2nd shot, 1.5% of the placebo group had a COVID-19 case, but only 0.3% had it within the next 2+ months. This is not necessarily an indication of foul play. It is another demonstration of uselessness of COVID-19 vaccination for kids.

The way in which PCR testing was used in the trial raises additional questions. COVID-19 PCR tests are notorious for their inaccuracy and ease of manipulation, including by selecting the amplification cycles number. The Supplemental Appendix2 says: 

“The central laboratory NAAT [nucleic acid amplification test] result was used for the case definition. If no result was available from the central laboratory, a local NAAT result could be used if it was obtained using either the Cepheid Xpert Xpress SARS-CoV-2, Roche cobas SARS-CoV-2 real-time RT-PCR test, or the Abbott Molecular/RealTime SARS-CoV-2 assay.”

This sounds like an open door for cherry-picking testing facilities on case-by-case basis.

Legal Aspects

Now this study is used to coerce and/or trick kids and young adults into getting vaccinated against COVID-19. Luckily, we have a legal recourse. Government-sponsored medical procedures require informed consent of the patients – see In re Cincinnati Radiation Litigation, 874 F. Supp. 796 – Dist. Court, SD Ohio 1995. Otherwise, they violate the due process clauses of the XIV and V Amendments. Deceit (including denying futility of COVID-19 vaccines for 12–15-year-olds, denying effectiveness of ivermectin for COVID-19 treatment and prophylaxis, or failure to disclose the risk of future ADE) and coercion (including blocking access to ivermectin and hydroxychloroquine) invalidate the apparent consent. For minors, consent of the parents is also mandatory. Medical procedures that involve no more than trivial risk might be an exception, but COVID-19 vaccines are certainly not such a case.

The vaccination of the young people is not just government-sponsored, but almost entirely conducted by the government. The government cannot bypass the Constitution by relying on the opinion of the FDA, which is itself a government agency. Truth matters.

The cherry on top of the cake: government officials carry personal responsibility for their actions in violation of this principle. They cannot assert qualified immunity.


1. FDA re-Amendment. Pfizer-BioNTech COVID-19 Vaccine EUA Amendment Review Memorandum 05262021. Published online May 10, 2021.

2. Robert W.  Frenck J, Klein NP, Kitchin N, et al. Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. New England Journal of Medicine. Published online May 27, 2021. doi:10.1056/NEJMoa2107456


  1. BTW, the trial was conducted on kids with “no evidence of previous SARS-CoV-2 infection” (i.e., not immune). The vaccination is expected to have stronger impact and worse adverse effects in the kids that already had SARS-COV-2 infection and immunity.