FDA Official Prasad Faces Allegations Amid Moderna Vaccine Dispute

Vinay Prasad, head of the FDA's biologics division, is accused of misconduct as he rejects Moderna's influenza vaccine application.

Published on Feb. 12, 2026

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Vinay Prasad, the director of the FDA's Center for Biologics Evaluation and Research, is facing internal complaints of sexual harassment, retaliation, and verbally berating staff, according to reports. This controversy comes as Prasad has faced pushback from FDA staff over his decision to reject Moderna's application for its influenza vaccine candidate mRNA-1010, overruling his own review team.

Why it matters

Prasad's personal conduct issues raise questions about leadership and culture within the FDA, an agency tasked with overseeing the safety and efficacy of new medical products. The dispute with Moderna also highlights tensions between FDA leadership and staff over the review process for new vaccines.

The details

Prasad, who previously worked at the University of California, San Francisco, has been commuting from the San Francisco Bay Area to the FDA's Maryland offices at a cost of $65,000 per year to taxpayers. He is accused of sexual harassment, retaliation against subordinates, and verbally berating staff, according to unnamed sources. Internally, Prasad overruled FDA staff who argued that Moderna's influenza vaccine application should be reviewed, rather than issuing a refusal-to-file letter. The review team had already been assembled, and some staffers pushed back against Prasad's criticism of Moderna's trial design.

  • In January 2026, FDA staff argued against Prasad's plan to block Moderna's application in a meeting.
  • In August 2025, a few months after Prasad joined the FDA, Moderna met with the agency and provided additional data as requested by CBER staff.
  • In September 2024, Moderna launched a Phase 3 study for mRNA-1010 without objections from the FDA.

The players

Vinay Prasad

The director of the FDA's Center for Biologics Evaluation and Research, who is facing internal complaints of misconduct and has overruled his staff's recommendations on Moderna's influenza vaccine application.

Moderna

A pharmaceutical company that submitted an application for its influenza vaccine candidate mRNA-1010, which the FDA under Prasad's leadership has rejected.

David Kaslow

The director of the Office of Vaccines Research and Review within CBER, who wrote an internal memo arguing against Prasad's decision to reject Moderna's application.

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What they’re saying

“It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed on with CBER prior to starting.”

— Stéphane Bancel, CEO, Moderna (Moderna press release)

“There was a 'a diverse set of conclusions among the review team' looking at Moderna's application.”

— Andrew Nixon, Spokesperson, Health and Human Services (Fierce Biotech)

What’s next

Moderna will share its fourth quarter and full-year 2025 earnings on Friday, where analysts will likely seek details on the company's plans for mRNA-1010 and the combination influenza/COVID-19 vaccine mRNA-1083, which could be impacted by the setback with mRNA-1010.

The takeaway

The controversy surrounding Vinay Prasad's leadership of the FDA's biologics division highlights the need for strong oversight and accountability within the agency, especially as it navigates high-stakes decisions on new vaccine approvals. The dispute with Moderna also underscores the tensions that can arise between agency leadership and staff over the review process for innovative medical products.