Report on the FDA’s Failure Regarding Approval of the Comirnaty mRNA Vaccine for Children Aged 6 Months to <5 Years

Zuzana Krátká, Jaroslav Janošek, Tomáš Fürst

On June 15, 2022, the FDA panel of experts approved Pfizer’s Comirnaty vaccine for emergency use in children aged 6 months to <5 years. It did so despite the evidence of the ineffectiveness of the Pfizer childhood vaccine demonstrated directly in the submitted report of the clinical trial and despite the lack of data on the safety of the vaccine. The quality of the evidence and the conclusions reached are beyond reason, and we consider it important to draw the attention of politicians, professionals, and the general public to this decision by the US regulatory authorities to prevent repeating this on the EU level.

The evidence base for Pfizer’s vaccine approval is available here.

The FDA meeting can be viewed here.

A total of approximately 4,500 participants were enrolled in the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) clinical trial for children aged 6 months to 5 years originally planned for two doses of the vaccine. However, the final conclusions presented in the executive summary of the 60-page document are based only on the results of the subgroup that was vaccinated with three doses and then followed for more than one week (758 in the vaccine group and 348 in the placebo group). The efficacy of the vaccine was assessed from the perspectives of the:
• total covid cases (positive test, not a symptomatic disease),
• the incidence of „severe“ covid disease (which was defined as an increase in heart and respiratory rates in children),
• the number of hospital admissions detected in the vaccine group and the control group,
• immunobridging, i.e. the ability of the vaccine to induce the production of antibodies against the virus causing COVID-19

The study was randomized, double-blind, and placebo-controlled. Vaccination involved the administration of three doses of the vaccine at 3 μg/dose. The second dose was administered after 3 weeks, and the third dose was administered after a minimum of 8 weeks.

The most important raw data on vaccine effectiveness against infection are presented in Tables 19 and 20.
In the group of children aged 6-23 months, 1,178 children were vaccinated with the first dose of vaccine, and 598 children with the first dose of placebo. Between the first and second dose, 13 children vaccinated with the active vaccine and 5 children vaccinated with placebo were positively tested for covid. Thus, the vaccination efficacy between the first and second dose amounted to a
negative 30 % (with a very wide confidence interval containing zero, which meansthat neither a protective nor a negative effect of the vaccine can be confirmed). Between the second and third doses, there were 83 infections in the treatment arm and 51 in the placebo arm. This implies an efficacy of around 15%, again with a confidence interval containing zero. After the third dose, the
evaluable population of which was only 277 children in the active arm and 139 children in the placebo arm (discussing only children 6-23 months of age who had been vaccinated with the third dose for more than 7 days), there were almost no infections – 1 child in the active arm and 2 children in the placebo arm became infected, leading to a calculation of the vaccine efficacy of 76%, with confidence intervals from minus 370% to almost 100%.
In the group of children aged 2-5 years, 1,835 children were vaccinated with the first dose of the vaccine, and 915 children with the first dose of placebo. Between the first and the second dose, 21 children vaccinated with the active substance and 8 children vaccinated with placebo became ill with covid. Thus, the vaccination effectiveness between the first and second dose again came turned out to be about minus 30 per cent, very similar to that of younger children. Between the second and third dose, there were 104 infections in the active arm and 79 in the placebo arm, giving an efficacy of around 30 %. After the third dose, which was, again, received by only a part of the original study population, 2 children in the active arm and 5 children in the placebo arm became ill. In this case, the alleged efficacy result was 82 per cent – which is, however, negated by the wide confidence interval ranging from minus 8 % to 98 %.
Only the results after three doses were included in the executive summary. In effect, a total of 97% of the SARS-CoV-2 coronavirus cases were not included in the summary presented to the FDA panel. Even so, the two figures „proving“ the vaccine’s effectiveness, i.e. 75% in younger children and 82% in older children – are statistically indistinguishable from zero.

There were 12 children in the study who had two episodes of covid during the study. Eleven of them were vaccinated with the active agent, only one with placebo.

For the purposes of the study, „severe covid“ was defined as a condition with an increased heart rate or increased respiratory rate. In a group of 2-4-years-old children, 6 „severe“ cases were found in the vaccine group, while only 1 child with severe covid occurred in the placebo group.
Another peculiarity is the evaluation of vaccine effectiveness based on immunobridging; in this case, the protective effect was inferred from the neutralization titres and protective effects these titres had in the age group of 16-25 years, whose immune systems work quite differently from young
children). The point to be made here is that we constantly hear from experts and government officials that antibody levels cannot be used to determine whether or not a given individual is protected from COVID-19 because it is not known what level of antibodies has a protective effect. Apparently, however, the same was considered sufficient for emergency approval of a vaccine for very young children, who (if they have no other chronic diseases) are at minimal risk from covid. It is also worth noting that the effectiveness of the antibodies elicited by the vaccine has been demonstrated against the original Wuhan strain of the virus, from which the vaccine was constructed (and thus has the highest efficacy against it); however, this strain has been absent from the population for a year and a half. After testing the efficacy of antibodies against the omicron strain in several dozen samples, the study authors found that their efficacy was several times lower than against the Wu-Han strain (Table 18).

To summarize again what the clinical study showed:

  1. No statistically significant reduction in the incidence of covid in children vaccinated with the active agent compared to children vaccinated with placebo was proved in any of the studied subgroups.
  2. The incidence of „severe“ covid was higher in the group of vaccinated children.
  3. Multiple covid illnesses were more common in vaccinated individuals

As COVID-19 poses little risk to children under five years of age and serious harm or even death only occurs in very rare cases in this age group while long-term effects of the novel mRNA vaccination could not have been established yet. For this reason, we sincerely hope that EMA will not repeat the error made by FDA and will, after a thorough analysis of the Pfizer study, reject the request for conditional authorization of the vaccine for this age category.