Summary
The U.S. Food and Drug Administration (FDA) has declined to review Moderna's application for a flu vaccine, citing inadequate data and comparison standards. Moderna disagrees with the FDA's assessment and plans to address the issues and resubmit the application. The vaccine is currently under review in other countries, with possible approvals expected in late 2026 or early 2027.
Key Facts
- The FDA refused to review Moderna’s flu vaccine application due to insufficient data.
- The FDA questioned Moderna's rationale for comparing its vaccine to a standard flu dose.
- Moderna's CEO stated there were no safety or effectiveness concerns with the vaccine.
- Experts highlighted the importance of FDA guidance for companies to improve their applications.
- Moderna's mRNA-1010 vaccine reportedly has a 26.6% higher efficacy than a similar approved vaccine.
- The flu and COVID combination vaccine application was previously withdrawn by Moderna for more data.
- The vaccine is under review in the EU, Canada, and Australia, with approvals expected around late 2026 or early 2027.
