Trump Official Overrides FDA Scientists to Reject Moderna’s Flu Vaccine

The recent developments regarding Moderna’s flu vaccine have raised significant concerns among drug developers and industry experts. The U.S. Food and Drug Administration (FDA) faced criticism for its unexpected rejection of Moderna’s vaccine proposal, primarily led by the FDA’s Director, Dr. Prasad.

Moderna’s Vaccine Proposal and Feedback

Moderna initially planned to use a standard dose for all participants during its vaccine trials. However, they adjusted their strategy in response to FDA feedback. The company included a high-dose vaccine comparison for older participants and submitted an additional analysis to the FDA.

FDA’s Rejection and Industry Reaction

Despite these efforts, Dr. Prasad’s team decided to reject the proposal. Sources indicated that Prasad expressed a desire to issue more rejection letters that could disrupt pharmaceutical developers. FDA review staff raised concerns about this approach, noting it deviates from traditional practices and could lead to legal challenges.

• Dr. Prasad’s management style has created a climate of mistrust within the FDA.
• Multiple complaints have been filed against him, including allegations of harassment and retaliation.
• This rejection marks at least the ninth instance where Prasad’s team blindsided a pharmaceutical company.

Implications for Vaccine Development

The unpredictability surrounding FDA decisions is fostering anxiety about the future of vaccine innovation. Dr. Marty Makary, former FDA Commissioner, suggested that Moderna’s trial may have ethical issues, further complicating the situation.

Possible Paths Forward for Moderna

Despite the current setback, a senior FDA official hinted that options remain open for Moderna. They suggested that the data for participants aged 65 and older could be disregarded. If Moderna were to submit a revised proposal focusing on participants aged 50 to 65, it could lead to a reconsideration.

This situation emphasizes the challenges faced by the pharmaceutical industry in navigating FDA regulations and gaining necessary investments for future developments. The potential for continued innovation remains uncertain amid rising tensions within the agency.