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

Source: Ars Technica

Moderna’s trial adjustments

Moderna largely stuck with its plan to use a standard dose for all participants, but it altered the protocol after receiving feedback. Specifically, the company added a comparison of a high‑dose vaccine for some older participants and provided the FDA with an additional analysis.

FDA review and Prasad’s actions

According to sources cited by The Journal, FDA official Prasad told FDA staff that he wants to send more refusal letters that appear to blindside drug developers. Review staff pushed back, noting that such moves break with the agency’s practices and could expose the FDA to lawsuits. Prasad reportedly dismissed concerns over possible litigation.

Trump‑appointed FDA Commissioner Marty Makary seemed similarly unconcerned, suggesting on Fox News that Moderna’s trial may be “unethical.”

Potential path forward for Moderna

A senior FDA official told Stat that the door might not be entirely closed for Moderna’s flu vaccine. The official suggested the company could discard the data for participants aged 65 and older and focus on the 50‑to‑65 age group, where there is “a little more equipoise.” The review team could then consider that cohort.

Industry impact

The Journal notes that Moderna is at least the ninth company to receive a surprise rejection from Prasad and his team. This unpredictability is raising fears about the industry’s ability to secure investments and innovate.

Concerns about Prasad

Prasad, a blood‑cancer specialist with no expertise or experience in vaccine regulation, is facing internal problems at the agency. His management style has created an environment “rife with mistrust and paranoia,” according to Stat. Several complaints have been filed against him, including allegations of sexual harassment, retaliation against subordinates, and verbally berating staff.