FDA Rejects Moderna’s New mRNA Flu Vaccine Application, Company Reports
The U.S. Food and Drug Administration (FDA) has rejected Moderna’s application for a novel flu vaccine utilizing mRNA technology. This development, announced on Tuesday, highlights increased scrutiny by the FDA, particularly under Health Secretary Robert F. Kennedy Jr., who has openly criticized mRNA vaccines.
FDA’s Refusal-to-File Letter
Moderna received a “refusal-to-file” letter from the FDA, which raised concerns over the methodology of a clinical trial involving 40,000 participants. This trial compared the new flu vaccine with an existing standard flu shot, revealing that the new vaccine was somewhat more effective for adults aged 50 and older.
Concerns Over Clinical Trial Methodology
In the refusal letter, Dr. Vinay Prasad, the FDA’s vaccine director, noted that the agency deemed the trial inadequate. The FDA indicated that the trial did not compare the new vaccine against “the best-available standard of care in the United States” at the time of the study.
- Moderna was advised to use a specific flu vaccine for seniors.
- The FDA allowed the trial to proceed but later questioned its design.
- Moderna claims to have shared additional data from a separate trial with the FDA.
Industry Impact and Future Plans
Moderna’s CEO, Stephane Bancel, stated that the FDA did not express any safety or efficacy concerns regarding the product. Following the rejection, Moderna has sought an urgent meeting with the FDA to address the situation. The company has also submitted its application for approval of the vaccine in Europe, Canada, and Australia.
Funding Implications and Regulatory Changes
Under Secretary Kennedy’s direction, the U.S. has also canceled $500 million in funding for mRNA vaccine development. Over the past year, the administration has rolled back guidelines surrounding COVID-19 vaccinations and has expanded warnings associated with the leading mRNA COVID vaccines.
| Key Developments | Impact |
|---|---|
| FDA’s rejection of Moderna’s flu vaccine application | Setback for Moderna and mRNA technology’s future in influenza vaccines |
| Cancellation of $500 million in mRNA funding | Reduced support for future vaccine innovations |
The FDA has historically permitted vaccine manufacturers to swiftly adapt flu vaccinations based on emerging strains. However, recent internal communications suggest a shift in policy, causing concern among previous FDA commissioners regarding this new direction.
As the landscape of vaccine technology evolves, the implications of this rejection could impact not only Moderna’s future endeavors but also the broader field of mRNA vaccine research.
