U.S. drug regulators signaled on April 29 that they may authorize COVID-19 vaccines for young children in June.
The Food and Drug Administration (FDA) said it plans to convene its expert advisory panel, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), to consider updates to the Moderna and Pfizer emergency use authorizations (EUAs).
The FDA is holding the dates of June 8, 21, and 22 for the meetings.
A spokesperson for the agency told The Epoch Times in an email that normal FDA procedures are, for decisions in which VRBPAC are consulted, the FDA typically waits until after hearing from the panel before greenlighting or rejecting the applications.
After consulting the committee, the FDA has in the past cleared vaccines within days.
No children under 5 can currently get a COVID-19 vaccine, frustrating some parents and healthcare professionals despite the low risk COVID-19 presents to many kids.
“The data that we saw made us realize that we needed to see data from a third dose, as in the ongoing trial, in order to make the determination that we could proceed with doing an authorization,” Marks told reporters on a call at the time.
Dr. Scott Gottlieb, a former FDA commissioner, who sits on Pfizer’s board, later said the delay stemmed from the low number of COVID-19 cases among both arms in the trial.
Seemingly responding to Dr. Anthony Fauci, the chief White House medical adviser, who recently indicated regulators might wait to look at the Pfizer and Moderna vaccines together with an aim of producing less confusion among parents, the FDA said it “understands the urgency to authorize a vaccine for age groups who are not currently eligible for vaccination and will work diligently to complete our evaluation of the data.”
“Should any of the submissions be completed in a timely manner and the data support a clear path forward following our evaluation, the FDA will act quickly,” the agency said.