FDA Refuses Moderna Flu Shot Review Sparks Outrage
The Food and Drug Administration (FDA) has refused to review Moderna’s experimental flu shot, mRNA-1010, citing issues with the study design despite previous agency approval. Moderna stated the FDA did not identify any safety or efficacy concerns and plans to meet with the agency to discuss a path forward. This decision, which contrasts with prior feedback, occurs amidst broader shifts in U.S. vaccine regulation influenced by prominent vaccine skeptic Robert F. Kennedy Jr. and the return of FDA vaccine regulator Vinay Prasad, who has advocated for tighter vaccine rules. Despite this setback, Moderna’s stock saw a slight dip, but the company expects approval for its flu shot by late 2026 or late 2027, pending international reviews.
John Q. Hosedrinker