One Oct 29, 2021, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the experimental messenger RNA (mRNA) Pfizer/BioNTech COVID-19 biologic BNT162b2 for children five to 11 years old. The FDA’s decision, which is based on a clinical trial earlier this year involving 2,268 kindergartners and elementary school-aged kids and an ongoing trial involving more than 4,600 participants, comes two weeks after the Biden administration outlined plans to begin administering the biologic to children in this age range against COVID.1 2 3
FDA Uses Modeling to Predict If Giving Pfizer COVID Shots to Young Children is Worth the Potential Risks
In a press release, the FDA stated:
The FDA has determined this Pfizer vaccine has met the criteria for emergency use authorization. Based on the totality of scientific evidence available, the known and potential benefits of the Pfizer/BioNTech COVID-19 vaccine in individuals down to five years of age outweigh the known and potential risks.1 2
The FDA noted that the potential risks include “increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following vaccination with Pfizer/BioNTech COVID-19 Vaccine, particularly following the second dose, and with the observed risk highest in males 12 through 17 years of age.”2 According to the FDA, the agency legally responsible for licensing drugs and biological products distributed in the U.S., it has…
conducted its own benefit-risk assessment using modeling to predict how many symptomatic COVID-19 cases, hospitalizations, intensive care unit (ICU) admissions and deaths from COVID-19 the vaccine in children five through 11 years of age would prevent versus the number of potential myocarditis cases, hospitalizations, ICU admissions and deaths that the vaccine might cause.2
The FDA’s model “predicts that, overall, the benefits of the vaccine would outweigh its risks in children five through 11 years of age.”2
The Pfizer/BioNTech COVID shot for children aged five to 11 years old would be administered in two doses 21 days apart, which is the same regimen used for those 12 years and older. The dosage, however, would be two-thirds smaller—10 μg (micrograms) rather than the 30 μg given to older children and adults.1 2 3
CDC Committee Gives Unanimous Approval to Give Pfizer COVID Shots to Children 5 to 11 Years Old
The FDA’s EUA approval was followed on Nov. 2 by a unanimous recommendation (14-0 vote) by the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) to administer Pfizer/BioNTech COVID biologic to all children five to 11 years of age—a total of about 28 million children in the United States. The recommendation was endorsed later that day by CDC director Rochelle Walensky, MD.4 5 6 7
According to Jeff Zients, the White House Coronavirus Response Coordinator, the program to give children five to 11 years old the Pfizer/BioNTech biologic will begin in earnest this week. “Parents will be able to schedule appointments at convenient sites they know and trust to get their kids vaccinated. And the number of sites will continue to increase throughout the month as more vaccine sites open their doors and administer vaccine, “Zients said.5 6
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1 Barrabi T. FDA approves Pfizer vaccine for emergency use in children aged 5 to 11. Fox Business Oct. 29, 2021.
2 Press release. FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age. U.S. Food and Drug Administration Oct 29, 2021.
3 TVR Staff. White House Reveals Plans to Give COVID Shots to All 5 to 11 Year Old Children. The Vaccine Reaction Oct. 25, 2021.
4 Associated Press. CDC gives final approval for Pfizer’s COVID shot for kids 5-11. MarketWatch Nov. 2,2 021.
5 Branswell H. CDC advisers endorse Pfizer’s Covid-19 vaccine for kids 5-11. STAT Nov. 2, 2021.
6 McKenna J. ACIP Recommends Pfizer-BioNTech Covid-19 Vax for Kids Ages 5-11. Physician’s Weekly Nov. 3, 2021.
7 Press release. CDC Recommends Pediatric COVID-19 Vaccine for Children 5 to 11 Years. U.S. Centers for Disease Control and Prevention Nov. 2, 2021.