Vinay Prasad Details New Approach to COVID-19 Vaccine Approvals in Recent FDA Memos

Vinay Prasad, now director of the FDA’s Center for Biologics Evaluation and Research, has adopted a stricter and more evidence-focused approach to COVID-19 vaccine approvals, especially for children134.

In recent memos, Prasad overruled FDA staff, recommending that Moderna's Spikevax vaccine be approved for children only if they have at least one underlying condition increasing their risk for severe COVID-19, rather than for all children as previously proposed3.

Prasad argued that Moderna has not demonstrated through randomized studies a clear benefit for preventing severe COVID-19, hospitalization, ICU stays, or death in healthy children, partly because such outcomes are extremely rare in this group134.

He also noted that much of the evidence provided by Moderna was generated in an epidemiological landscape very different from the current situation, as the virus has evolved and population immunity is greater13.

Prasad expressed concerns about the potential for long-term harms from mRNA products that may not yet be apparent, although he acknowledged that billions of doses have been administered safely so far1.

Prasad’s approach has led to multiple overrulings of FDA staff recommendations and reflects a broader FDA trend of reassessing pediatric COVID-19 vaccine policies, including the possible withdrawal of emergency use authorization for other pediatric vaccines135.

He emphasized the FDA mandate to only approve products when there is substantial certainty that benefits outweigh risks, and promoted further randomized trials as the path for vaccine companies to demonstrate value in low-risk populations4.

These regulatory changes are occurring alongside shifts in advisory panels and increased scrutiny of COVID-19 vaccine evidence at the federal level1.

Sources:

1. https://www.biopharmadive.com/news/vinay-prasad-fda-moderna-covid-vaccine-review-children/753183/

3. https://www.biospace.com/fda/vinay-prasad-overruled-reviewers-on-modernas-covid-19-shot-for-kids

4. https://www.youtube.com/watch?v=jtudwT6zZwc

5. https://www.raps.org/news-and-articles/news-articles/2025/8/this-week-prasads-back-fda-considers-covid-authori