Re: Upcoming VRBPAC Meeting on Amending the EUA for the Pfizer-BioNTech COVID-19 mRNA Vaccine for Administration to Children 6 Months to 4 Years of Age

1
February 11, 2022
VIA ELECTRONIC SUBMISSION AND EMAIL
FDA-2022-N-0082
vrbpac@fda.hhs.gov
cbervrbpac@fda.hhs.gov
Members of Vaccines and Related Biological Products Advisory Committee
Food and Drug Administration
Re: Upcoming VRBPAC Meeting on Amending the EUA for the Pfizer-BioNTech
COVID-19 mRNA Vaccine for Administration to Children 6 Months to 4 Years of
Age

VIII. Conclusion
Healthy children ages 6 months to 4 years in the United States are at effectively zero risk
of dying from COVID-19. Even assuming that the vaccine is 100% effective against the Omicron
variant and that no healthy child has natural immunity, the risk-benefit analysis would still not
favor vaccination due to the threat of, even if nothing more, myo/pericarditis in young healthy
children, of which the long-term cardiovascular sequelae are unknown. For instance, as of January
28, 2022, there have been 39 deaths, 551 cases of myocarditis, and 186 cases of

pericarditis
involving children between 6 and 17 years of age reported to VAERS after BNT162b2 vaccination.
While association is not causation, we do know that healthy children do not spontaneously develop
symptomatic heart inflammation. If the rate of heart inflammation alone in 6-month to 4-year-
olds post-vaccination is higher than even 1 life-threatening case per million healthy children, then
amending the EUA to include this age group is unscientific.
Accurate quantification of myo/pericarditis rates in children ages 6 months to 4 years in
Pfizer’s clinical trial is virtually impossible because it would require enrolling many fold more
children than are currently enrolled. Consequently, regulatory agencies will have to rely on
inaccurate post-marketing data to quantify the rate of heart inflammation. Taking such a risk is
illogical given that the rate of healthy children dying from COVID-19 is hard to quantify and, in
any case, infinitesimally low.
Setting aside the low death rates, the unknown risk of myo/pericarditis, and the failing
vaccine efficacy against Omicron, the primary reason VRBPAC should not amend the EUA is
because two 3mcg doses of BNT162b2 did not stimulate a sufficient adaptive immune
response in children between 2- and 4-years-of-age. Currently, immunogenicity data for the
third 3mcg dose 60 days after the second dose will not be submitted to the FDA “until the first half
of 2022.”49 If VRBPAC decides to amend the EUA for two doses and it is later revealed that the
third dose still does not stimulate an appropriate immune response, then the FDA will have to
backtrack its decision, losing even more credibility in the process.
49 https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-update-ongoing-

ICAN therefore requests that VRBPAC adhere to science and logic by declining to
recommend Pfizer’s COVID-19 vaccine for healthy 6-month to 4-year-old children.
Please consider your upcoming decision carefully.
Sincerely,
Aaron Siri, Esq
Elizabeth A. Brehm, Esq
Matthew Menendez, Ph.D.