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).
Moderna announced Thursday it submitted an EUA for children aged 6 months to 5 years old; Pfizer is still waiting on clinical trial data after its two-shot primary regimen failed to trigger an adequate immune response in children from 6 months to 4 years of age.
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.
“We would anticipate June authorizations for one or more of the pediatric vaccinations,” provided the data is sufficient, Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, told the Washington Post.
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.
On the other hand, Moderna’s trial produced substandard effectiveness, prompting multiple experts to say the results do not warrant authorization.
The FDA was poised to meet with VRBPAC on Pfizer’s vaccine for young kids in February, but abruptly canceled the meeting days before it was scheduled.
“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.
Children are much less likely to experience any symptoms from COVID-19 and to experience severe illness after contracting the disease, which is caused by the CCP (Chinese Communist Party) virus.
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.
From The Epoch Times
