On June 1, 2022, Pfizer and BioNTech submitted an application to the U.S. Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) to distribute their messenger RNA (mRNA) BNT162b2 (also known as “Comirnaty”) COVID-19 biologic for children as young as six months to five years old. The application is for a three-dose regimen, with each dose containing three micrograms (µg) of the product.1 2
In a public statement, the FDA said:
We recognize parents are anxious to have their young children vaccinated against COVID-19 and while the FDA cannot predict how long its evaluation of the data and information will take, we will review any EUA request we receive as quickly as possible using a science-based approach.1
The data provided by Pfizer and BioNTech to the FDA for BNT162b2 use in children six months to five years old was taken from a Phase 2/3 trial involving 1,678 children. Preliminary results determined the reduced dose biologic to have an estimated efficacy of 80.3 percent at preventing COVID disease after three doses.1 2
The Pfizer/BioNTech data on the reduced dose biologic for infants and young children is “preliminary,” and it has not been peer-reviewed or published in a medical journal.2
The EUA application by Pfizer/BioNTech follows a similar EUA application made by ModernaTX, Inc. on Apr. 28 to distribute its mRNA-1273 (“Spikevax”) COVID biologic for children six months to four years of age. Unlike BNT162b2, Moderna’s product calls for two 25-µg doses.1 3 4
Moderna’s chief medical officer, Paul Burton, MD, told The Associated Press that he believes the two doses of mRNA-1273 will “safely protect” babies, toddlers and preschoolers.4 He added:
I think it is likely that over time they will need additional doses. But we’re working on that.4
FDA Decision on Pfizer and Moderna EUA Requests Expected Within Weeks
An advisory panel for the FDA, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), which consists of members appointed by the FDA Commissioner, plans to meet on June 15 to review both EUA requests. Based on comments by White House COVID response coordinator Ashish Jha, MD on June 2, it appears likely that favorable recommendations will be made by VRBPAC, followed by FDA staff approval of the EUA requests, followed by universal use recommendations by the U.S. Centers for Disease Control and Prevention (CDC).5 6
“We expect an FDA decision shortly after the [VRBPAC meeting], and we look forward to the process playing out,” Dr. Jha said. “We’ll move from planning to execution.”5
The director of the FDA’s Center for Biologics Evaluation and Research (CBER), Peter Marks, MD, said the FDA will “move quickly” to make a decision on the EUA requests “without sacrificing our standards.”4
Federal Government Ready to Move Forward With Vaccinating Young Children Against COVID
Dr. Jha noted that the Biden administration would initially make 10 millions doses of the Pfizer/BioNTech and Moderna/NIAID) COVID shots available to states, pharmacies and community health clinics and that state governments could begin placing orders on June 3, but that the doses would only begin to be delivered after approval by the FDA.5 6
Dr. Jha stressed that his intention was not to “prejudge the outcome of the process,” but that the administration was “hard at work planning all sorts of scenarios based on whatever the outcome is.”7
According to the Dr. Jha:
We’re going to ship doses out as fast as possible. We’re going to make sure that supply is always meeting demand. And we’re going to do everything we can to make it easy for providers and parents alike to get their kids vaccinated.5
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Click here to view References:
1 Kekatos M. FDA accepts Pfizer application for COVID vaccine in kids under 5, clearing way for June timeline. ABC News June 1, 2022.
2 Pfizer asks FDA to authorize Covid-19 vaccine for youngest kids. CNN June 1, 2022.
3 Accesswire. Moderna Files for Authorization of Its COVID-19 Vaccine in Young Children Six Months to Under Six Years of Age. Moderna Apr. 28, 2022.
4 Neergaard L. Moderna asks for FDA approval of vaccine for young children. PBS Apr. 28, 2022.
5 Howell T. White House COVID-19 coordinator: Vaccination of children under 5 could begin mid-June. The Washington Times June 2, 2022.
6 Kimball S. White House expects Covid vaccinations for children under age 5 to begin as early as June 21. CNBC June 2, 2022.
7 Stolberg SG. If cleared, Covid shots for children under 5 could be available as soon as June 21, a White House official says. The New York Times June 2, 2022.