Dr. Vinay Prasad, the U.S. Food and Drug
Administration’s
top vaccine official, has overruled agency staff reviewers on three separate decisions regarding COVID-19 vaccine approvals, according to newly released FDA documents.
In a July 9 memo made public by the FDA on July 11, Prasad—chief medical officer and head of the FDA’s Center for Biologics Evaluation and Research—disagreed with internal reviewers over Moderna’s request to authorize its Spikevax vaccine for all young children. Instead, he approved the vaccine only for children 6 months and older who have one or more health conditions that put them at increased risk of severe COVID-19.
While praising the review team’s work, Prasad wrote: “I feel differently about certain aspects of their conclusions.” He explained there wasn’t “substantial certainty of a net clinical benefit” to vaccinating healthy children, but found sufficient evidence to justify use in at-risk pediatric populations.
It remains unclear whether all reviewers fully
supported
Moderna’s broader request.
Disagreements Acknowledged
In a July 16 FDA video, Prasad acknowledged some internal disagreement: “There may be other reviewers who agree with me a little bit more… I deeply respect the reviewers who disagree with me. And I think this is okay to sometimes, in incredibly contentious topics, have small
disagreements
.”
The Department of Health and Human Services noted in an earlier email to
The Epoch Times
that “healthy children infected with COVID-19 have consistently shown strong resilience” and that “the risks of the COVID-19 vaccine may outweigh the potential benefits” for this group. The agency said the narrow approval followed a targeted review focused on high-risk children.
Mixed Reactions
Moderna CEO Stéphane Bancel expressed support for the FDA’s decision, saying that vaccination “can be an important tool” to protect vulnerable children from severe outcomes. He thanked the FDA for its “diligent scientific review.”
However, not all experts were convinced. Dr. Jeremy Faust, a Harvard Medical School assistant professor, criticized Prasad for allegedly ignoring Moderna’s 2024
pediatric
trial, which found that vaccinated children produced antibodies and had lower infection rates than those who received a placebo. Faust said the memo lacked detailed analysis and failed to clearly outline where Prasad disagreed with staff scientists.
In his memo, Prasad noted that COVID-19 hospitalization and death rates in children have significantly declined and that Moderna has not demonstrated in randomized controlled trials that its vaccine reduces severe outcomes in children.
Broader Pattern of Intervention
Prasad has also overruled agency reviewers on two other major COVID-19 vaccine decisions this year:
-
Moderna’s mNEXSPIKE Vaccine
: In May, FDAreviewers
supported making this next-generation vaccine available to everyone aged 12 and older. Prasad restricted approval to people 65 and older, or those 12 to 64 with at least one risk factor.
-
Novavax’s Nuvaxovid
: In a May 16 memo, Prasad again overrode staff recommendations and limited approval to the same high-risk groups.
FDA Commissioner Dr. Marty Makary, who has supported Prasad’s stricter approach, told
The Epoch Times
that the limited approvals were intended to encourage
manufacturers
to run new clinical trials targeting healthy populations before seeking broader use.
A Shift in FDA Standards
Before joining the FDA earlier this year, Prasad had publicly criticized the agency’s leadership for overriding internal experts on past approvals, including a controversial gene therapy linked to patient deaths. Now at the helm of key vaccine decisions, he appears to be applying a more conservative, evidence-demanding approach—particularly regarding pediatric and low-risk populations.
The FDA has not responded to media requests for comment.
