FDA Vaccine Chief Limits COVID Shots for Most \ Newslooks \ Washington DC \ Mary Sidiqi \ Evening Edition \ Dr. Vinay Prasad, the FDA’s new vaccine chief under Health Secretary Robert F. Kennedy Jr., has restricted COVID-19 vaccine approvals despite FDA scientists recommending broader access. The decision affects Moderna and Novavax shots, now limited to high-risk groups. Internal memos show growing tension inside the agency over vaccine policy.
Quick Looks
- Dr. Vinay Prasad limited Moderna, Novavax vaccine approvals
- FDA scientists recommended broader access for ages 12+
- Decision restricts shots to seniors and high-risk individuals
- Prasad cites declining COVID severity and vaccine side effects
- Documents reveal internal disagreements within FDA
- Prasad appointed by RFK Jr., known for vaccine skepticism
- Moderna ordered to study myocarditis risk post-approval
- FDA warns of rare heart inflammation risk in mRNA shots
Deep Look
In a controversial decision that diverges sharply from standard FDA protocol, Dr. Vinay Prasad—the newly appointed vaccine chief under Health Secretary Robert F. Kennedy Jr.—has overruled agency scientists and restricted the use of two major COVID-19 vaccines. Internal documents released Wednesday reveal that Prasad personally intervened to limit approvals of updated COVID shots from Moderna and Novavax, ignoring recommendations to authorize the vaccines for general use in individuals 12 and older.
According to internal memos from the Food and Drug Administration (FDA), Prasad chose instead to approve the vaccines only for people considered at high risk from COVID-19: seniors, children under 2, and those with underlying medical conditions such as asthma or obesity. The restriction marks a significant shift in U.S. vaccine strategy as COVID cases and hospitalizations continue to mount.
“We’ve seen a decline in COVID-related deaths and hospitalizations, and must reevaluate vaccine risk versus benefit,” Prasad wrote in a five-page override memo. “Even rare vaccination-related harms both known and unknown now have a higher chance of outweighing potential benefits.”
This decision contradicts the analysis of FDA review teams, which had supported broader access. The internal staff reviews concluded that both Moderna’s updated mNexspike shot and Novavax’s Nuvaxovid protein-based vaccine offered a favorable risk-benefit ratio for the general public aged 12 and older. Moderna’s updated vaccine uses a lower dose version of its original mRNA-based formula, while Novavax’s shot remains the only protein-based COVID vaccine on the U.S. market.
FDA staff cited data from large clinical trials, including one involving over 30,000 adults, supporting the safety and efficacy of the vaccines. Nonetheless, Prasad chose to apply stricter limitations, raising concerns among public health experts about increased politicization of the vaccine approval process.
Prasad’s background has made him a divisive figure. A former cancer researcher and medical commentator, he rose to prominence during the pandemic by questioning lockdowns, vaccine mandates, and the widespread use of boosters for healthy adults. He was appointed in May to lead the FDA’s vaccine division following the resignation of Dr. Peter Marks, who reportedly clashed with RFK Jr. over vaccine policy.
Since his arrival, Prasad has worked closely with FDA Commissioner Mark Makary to overhaul vaccine guidance. The new policy restricts future COVID vaccine approvals primarily to those at elevated risk. That framework now informs decisions like the limited approval granted to Moderna and Novavax.
Prasad’s decision comes amid ongoing scrutiny of rare side effects associated with COVID vaccines—particularly myocarditis, an inflammation of the heart muscle. The FDA recently updated warning labels on Moderna and Pfizer shots to include information about this risk, especially in young males. Prasad’s memo emphasized lingering questions about myocarditis frequency, and as part of Moderna’s conditional approval, the FDA has ordered the company to conduct additional post-market studies.
Andrew Nixon, a spokesperson for the Department of Health, defended the move, stating that Prasad has “raised serious concerns” about vaccine side effects. “We will not ignore these risks and will ensure that the gold standard of science is used for any decisions,” Nixon said in a statement.
Outside experts have countered that myocarditis cases linked to mRNA vaccines tend to be mild and resolve quickly, often less severe than myocarditis triggered by COVID-19 itself. They argue that restricting access could create unnecessary risk for the general population by reducing vaccination rates.
Dr. Prasad’s override is highly unusual in FDA practice. Senior officials rarely intervene in individual vaccine approvals, typically deferring to career scientists who evaluate trial data and public health trends. While legally allowed to overrule lower-level reviewers, such moves are considered extreme and are generally reserved for clear-cut safety concerns or legal barriers—not differences in interpretation.
Prasad’s appointment under RFK Jr.—a longtime critic of childhood vaccine schedules and pharmaceutical industry influence—has already prompted concern among public health experts who fear a rollback of evidence-based vaccine policy. Kennedy, a 2024 presidential candidate, has historically cast doubt on the safety and necessity of routine immunizations, including those for COVID-19.
COVID-19 continues to pose a significant public health challenge. According to the Centers for Disease Control and Prevention (CDC), between 32,000 and 51,000 Americans have died from COVID since last fall, with more than 250,000 hospitalizations. Children under 2 and adults over 65 remain the most vulnerable.
While Prasad argues that the vaccine landscape must evolve with the virus, critics worry that limiting access to vaccines could leave large portions of the population unprotected, especially as new variants emerge.
The FDA’s decision to restrict the Moderna and Novavax shots—both of which received full agency approval in May after extensive review—could have broader consequences. It sets a precedent for future vaccine decisions and may influence uptake among Americans already uncertain about COVID-19 boosters.
The New York Times was first to report the release of the internal memos, shedding light on growing internal friction within the FDA over vaccine direction.
Whether the new strategy will boost public confidence or further polarize vaccine discourse remains to be seen. But with Prasad at the helm of vaccine policy, the FDA appears poised for a more conservative, risk-focused approach to COVID-19 vaccination moving forward.
FDA Vaccine Chief
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