FDA’s Prasad Navigates Controversy and Strife Amid Moderna Dispute
The controversy surrounding Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), intensifies amid turbulent relations with Moderna. His recent decision to refuse review of Moderna’s flu vaccine candidate, mRNA-1010, has drawn significant internal backlash, with multiple complaints lodged against him.
Internal Complaints and Conduct Issues
Prasad is facing allegations of serious misconduct, including:
- Sexual harassment
- Retaliation against employees
- Verbal abuse of staff
A report by The Wall Street Journal cites multiple sources familiar with the situation, highlighting a troubling atmosphere within the agency.
Dispute Over Moderna’s Application
As part of the ongoing tensions, Prasad’s decision to issue a refusal-to-file (RTF) letter to Moderna has sparked frustration among FDA staff. A review team was prepared to evaluate the application prior to Prasad’s intervention, prompting concerns regarding his leadership style.
Meeting Insights and Staff Reactions
During a January meeting, FDA personnel expressed their disagreement with Prasad’s claim that the study design did not meet the best-available standards. David Kaslow, director of the Office of Vaccines Research and Review, argued against the RTF decision in an internal memo.
Health and Human Services spokesperson Andrew Nixon emphasized that the review team had diverse opinions concerning Moderna’s submission.
Moderna’s Response
Moderna has publicly criticized the RTF, stressing that the design of its trial was pre-approved by CBER officials before Prasad’s leadership began in May 2025. CEO Stéphane Bancel remarked that it shouldn’t be contentious to perform a thorough review of the submission.
Impact on Future Developments
As Moderna prepares to release its earnings report for the fourth quarter and full year of 2025, the repercussions of the RTF on its future vaccine projects are under scrutiny. Analysts are keen to learn about both mRNA-1010 and the combination flu/COVID-19 vaccine, mRNA-1083.
The controversy surrounding Prasad and the implications of his decisions may significantly impact both Moderna’s product development and the FDA’s reputation in vaccine evaluations.
