Moderna Inc. (MRNA) took a hit Monday, alongside other vaccine makers, after news broke that the FDA's Center for Biologics Evaluation and Research Center Director Vinay Prasad is pushing for stricter vaccine approval standards. His rationale? Claims linking vaccines to child deaths that have experts raising serious red flags.
What's Behind the Controversy
According to a memo obtained by NBC News, Prasad told FDA staff that an internal review identified at least 10 child deaths "after and because of receiving" the Covid vaccine, pulling from reports in the Vaccine Adverse Event Reporting System (VAERS) spanning 2021 to 2024. Here's the thing: the memo didn't include ages, medical histories, or documentation, and it hasn't been published in any peer-reviewed journal.
The scientific community isn't buying it. Experts quickly pointed out that VAERS submissions are unverified by design and often contain inaccurate or incomplete information. Multiple scientists criticized the memo for misusing the database and called its conclusions irresponsible. Former FDA vaccine chief Peter Marks went further, describing the document as "a troubling mixture of misrepresentation and lies" and suggesting the agency is reclassifying older reports.
Proposed Changes and Pushback
The memo didn't stop at criticism. It used ideological language to attack past agency decisions and vaccine requirements, arguing that regulation "may have harmed more children than we saved." Prasad also instructed staff who disagree with his conclusions to resign—a rather blunt approach to internal dissent.
On the policy front, he proposed significant changes to vaccine evaluation, including reassessing annual flu shots and requiring pneumonia vaccine makers to demonstrate actual reductions in pneumonia cases rather than just showing improved antibody levels.
The timing is notable: the memo surfaced just before next week's CDC vaccine advisory committee meeting on the childhood vaccine schedule. Meanwhile, extensive research cited in the NBC News report continues to show that Covid vaccines are safe for children and protect against severe illness, with large studies demonstrating lower infection and hospitalization risks among vaccinated kids.
Market Impact: Moderna stock was trading 5.93% lower at $24.44 at the time of reporting.
