Trump official overruled FDA scientists to reject Moderna’s flu shot

During the Trump administration, Vinay Prasad, the leading vaccine official at the Food and Drug Administration (FDA), reportedly made the unilateral decision to halt the review of Moderna's mRNA flu vaccine. This move came despite the backing of agency scientists who were prepared to evaluate the vaccine, as reported by Stat News and The Wall Street Journal. Sources within the FDA indicated that a team of experienced scientists had been ready to proceed with the review. Notably, David Kaslow, a senior official responsible for vaccine assessments, reportedly submitted a memo opposing Prasad's decision. This memo provided a thorough rationale for why the review should advance, emphasizing the potential benefits of the vaccine. In a meeting held in early January, FDA scientists shared their concerns with Prasad, who has been known for his controversial views, including anti-vaccine sentiments. They expressed that blocking the review was not the correct course of action. It is important to note that Prasad's refusal was not due to any issues with the Moderna mRNA vaccine itself, but rather centered around the licensed vaccine used as a comparator in a Phase 3 clinical trial involving nearly 41,000 adults aged 50 and older. The FDA had previously reviewed Moderna's trial plans multiple times without raising any objections. Although Moderna recognized that FDA scientists had recommended using a different vaccine comparator for older participants eligible for a high-dose flu shot, they maintained that the agency had deemed their trial design "acceptable."