The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. (Madalina Vasiliu/The Epoch Times)
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."
“COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions,” Moderna CEO Stéphane Bancel said in a statement. “Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization. We appreciate the FDA’s diligent scientific review and approval of Spikevax for pediatric populations at increased risk for COVID-19 disease.”
Dr. Vinay Prasad, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, in an undated photograph. FDA via The Epoch Times
Dr. Jeremy Faust, a professor at Harvard Medical School and a frequent critic of the Trump administration, said on his blog that Prasad ignored data from a Moderna trial that tested its vaccine in children and was completed in 2024.
Prasad, in a separate letter to Moderna about the limited approval, cited the trial, which found that children who received the vaccine produced antibodies against COVID-19 and were less likely to contract COVID-19 than placebo recipients.
"The memo also attempts to justify why leadership ignored its own scientists’ recommendations in various ways. Lacking, however, are any comprehensive analyses of the data, including explicit delineations of where Dr. Prasad believes FDA’s rank-and-file scientists got things wrong," Faust wrote.
Prasad said in his memo that COVID-19 hospitalizations and deaths are low in children and are down from higher levels during the COVID-19 pandemic. He also wrote that Moderna has never shown that COVID-19 vaccines reduce severe COVID-19, hospitalization, or death in children in a randomized, controlled trial.
Prasad and FDA Commissioner Dr. Marty Makary said in May that the FDA would not approve COVID-19 vaccines for Americans who are under 65 and don't have a risk factor unless manufacturers show the vaccines impact clinical endpoints, such as symptomatic COVID-19.
Makary told The Epoch Times this week that the approval of Spikevax, another COVID-19 vaccine from Moderna, and Novavax’s COVID-19 vaccine for individuals with at least one risk factor and all persons age 65 and older was granted to give officials leverage to compel manufacturers to run new clinical trials testing updated versions of the vaccines in healthy individuals.
After the FDA in May approved mNEXSPIKE, Moderna's next-generation COVID-19 vaccine, the agency released documents showing reviewers believed the evidence supported making it available to all individuals aged at least 12, but Prasad overruled them and determined the shot should only be approved for the elderly and people aged 12 to 64 with at least one of the risk factors.
A third memo, dated May 16, outlined how Prasad overruled reviewers on Novavax's application for a license for its COVID-19 vaccine. The FDA ultimately approved Nuvaxovid for the same populations as mNEXSPIKE.
Before joining the FDA this year, Prasad criticized how FDA officials overruled staffers on approval decisions, including the approval of a gene therapy for muscular dystrophy that has since been linked to several deaths.
