Dr. Vinay Prasad heads the Food and Drug Administration’s Center for Biologics Evaluation and Research.
The Food and Drug Administration’s top vaccine official has overruled agency reviewers on three decisions involving COVID-19 vaccines, including the recent approval of Moderna’s shot for some young children, according to documents released by the FDA.
Dr. Vinay Prasad, the agency’s chief medical officer and head of its Center for Biologics Evaluation and Research, said in a memorandum dated July 9 and uploaded to the FDA’s website on July 11 that his analysis of Moderna’s Spikevax reached a different conclusion than that of agency reviewers.
“The review team has done a commendable job in summarizing and analyzing the submission to date. Nevertheless, I feel differently about certain aspects of their conclusions and instead reach the conclusion described below,” Prasad wrote.
He said there was sufficient evidence to approve Spikevax for children at least 6 months old who have one or more conditions the government says put them at higher risk of severe COVID-19 outcomes, but not for all children, as Moderna had sought.
There is not a “substantial certainty of a net clinical benefit (benefits outweigh harms) to vaccinating healthy children,” Prasad wrote. But that certainty exists for children with risk factors, he added.
It’s not clear whether FDA reviewers aligned completely with Moderna or advised an approval that differed from both Moderna and Prasad.
The FDA did not respond to a request for comment.
A spokesperson for the Department of Health and Human Services, the FDA’s parent agency, previously told The Epoch Times in an email that “healthy children infected with COVID-19 have consistently shown strong resilience and face an extremely low risk of serious illness or harm” and “for these children, the risks of the COVID-19 vaccine may outweigh the potential benefits.”
The spokesperson also said that the narrow approval was issued “following a targeted review of the vaccine’s data, focused specifically on protecting children at highest risk.”
