WASHINGTON — The Food and Drug Administration (FDA) will now review Moderna’s application for a new influenza vaccine, the company announced Wednesday, reversing an earlier decision that sparked criticism from the biotechnology industry and prompted questions about the agency’s internal processes.
Earlier this month, the FDA informed Moderna it would not review the submission for the vaccine, intended for adults aged 50 and older, citing concerns regarding the design of a clinical trial. This decision, first reported by STAT News, triggered a public dispute and accusations that senior FDA official Vinay Prasad had overruled the recommendations of career scientists within the agency’s vaccine center.
The FDA will now pursue two review pathways for the Moderna vaccine. For adults aged 50 to 64, the agency will conduct a standard review. For those over 65, the vaccine will be considered for accelerated approval, contingent upon the completion of a post-marketing study to further evaluate its effectiveness and safety, according to Moderna.
The agency has set a goal of completing the review process by August 5, according to Moderna. The reversal comes after what the company described as a resolution of the public dispute with the FDA. The New York Times reported that the initial decision to halt the review was unusual and raised concerns about potential political interference in the agency’s scientific evaluations.
Moderna’s proposed vaccine utilizes mRNA technology, the same platform used in its widely administered COVID-19 vaccine. The company is seeking to expand its portfolio beyond COVID-19 vaccines and address the ongoing public health necessitate for more effective influenza prevention. The FDA’s initial reluctance to review the data had raised concerns among industry observers about the agency’s willingness to embrace innovative vaccine technologies.
The FDA did not immediately respond to requests for further comment on the decision. The agency’s change in course follows reports that Prasad, a medical officer within the FDA, had previously questioned the scientific rigor of Moderna’s clinical trial design. The details of the dispute centered on the methodology used to assess the vaccine’s efficacy in older adults, a population particularly vulnerable to severe influenza complications.
The New York Post reported that the FDA’s reversal was a significant win for Moderna and a signal that the agency is willing to reconsider its position in light of mounting pressure from the scientific community and industry stakeholders. The agency’s decision to pursue accelerated approval for the vaccine in older adults suggests a willingness to expedite access to potentially beneficial treatments, whereas still ensuring adequate safety monitoring through post-marketing studies.
