FDA Reverses Course, Will Review Moderna’s mRNA Flu Vaccine Application
After initially refusing to review Moderna’s application for its new mRNA-based influenza vaccine, the U.S. Food and Drug Administration (FDA) has reversed its decision and will now proceed with a review. The shift comes after Moderna proposed a revised regulatory approach for its investigational seasonal influenza vaccine candidate, mRNA-1010.
Initial Rejection and Subsequent Reversal
The FDA’s Center for Biologics Evaluation and Research (CBER) initially rejected the application, citing concerns that the Phase 3 study was not “adequate and well-controlled.” Specifically, the FDA questioned the use of a standard-dose flu shot in the comparator arm of the trial for participants aged 65 and older, suggesting a high-dose seasonal flu vaccine would have been more appropriate. Center for Infectious Disease Research and Policy reported on the initial rejection and subsequent reversal.
Revised Regulatory Pathway
Moderna is now seeking full FDA approval for adults aged 50 to 64 and accelerated approval for those 65 and older. The accelerated approval pathway for older adults will be contingent upon a post-marketing requirement to conduct an additional study in this age group. The FDA has set a review deadline of August 5, 2026. CIDRAP News details this revised approach.
Industry Reaction and Concerns
The initial rejection of Moderna’s application caused significant disruption within the vaccine market, leading to job cuts and research curtailments at Moderna and potentially other vaccine manufacturers, anticipating further challenges under the current administration. CIDRAP News highlighted the impact on the industry.
Leadership and Policy Shifts
The reversal in the FDA’s decision comes amid broader policy shifts regarding mRNA vaccines. The FDA, under the leadership of Health and Human Services Secretary Robert F. Kennedy Jr., reduced mRNA contract funding by $500 million as of last August. Kennedy has a long-standing history of opposing mRNA vaccines, including those developed during Operation Warp Speed. CIDRAP News provides context on the political landscape.
Expert Perspectives
Experts in the field have expressed both relief and caution. Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, emphasized the need for consistent policy and protocol for vaccine developers. Robert H. Hopkins Jr., MD, medical director of the National Foundation for Infectious Diseases, expressed hope that the reversal signals a positive shift in the agency’s approach to new vaccine applications. CIDRAP News includes quotes from both experts.
Looking Ahead
Pending FDA approval, Moderna aims to make its flu vaccine available later this year, offering a new option for influenza protection, particularly for seniors. The availability of a rapidly adaptable mRNA-based flu vaccine could represent a significant advancement in public health efforts to combat influenza.