FDA Rejects Moderna’s mRNA Flu Vaccine Application
In a recent announcement, Moderna revealed that the FDA’s Center for Biologics Evaluation and Research (CBER) will not initiate a review of its investigational mRNA flu vaccine application. This decision has drawn attention due to the lack of specific safety or efficacy concerns cited by the FDA.
FDA’s Decision Explained
Andrew Nixon, a spokesperson for the Department of Health and Human Services, clarified the context of the FDA’s rejection. He indicated that the application was denied because Moderna did not adhere to clear guidance issued by the FDA earlier in 2024. This guidance required the company to test its vaccine against a flu vaccine recommended by the CDC to properly compare safety and efficacy.
- FDA demanded a clinical trial for comparison with CDC recommended flu vaccine.
- Participants aged 65 and over faced heightened risks due to the substandard care provided.
Moderna’s Response
Moderna contended that the reasons for not filing their application do not align with existing FDA regulations and guidelines. According to sources, CBER Director Vinayak Prasad made this decision, reportedly overruling reviews from FDA staff members.
When approached for comments, FDA officials did not respond regarding this decision. However, one senior official suggested that Moderna could resubmit their data, provided they approach the situation with humility.
Background on the Clinical Trial
Moderna stated that the FDA had initially reviewed and approved their trial design before the study commenced, which took place approximately 18 months ago. The company emphasized the necessity of clear and transparent regulations to foster long-term investments beneficial to the public.
This recent development raises questions about FDA’s decision-making process and the implications for future mRNA vaccine research. As the situation evolves, both companies and health authorities will need to communicate effectively to navigate the complexities of vaccine development.
