FDA REVERSES SURPRISE REJECTION OF MODERNA'S MRNA FLU VACCINE

Summary from the TLDR newsletter

The FDA has now agreed to review Moderna's mRNA flu vaccine after the company held a formal meeting with the FDA and proposed a change to the regulatory pathways used in the application. Moderna hopes to make its vaccine available this year, pending FDA approval. The reason for initially refusing to review the application was based on the established flu vaccine Moderna used for comparison in its Phase 3 trial, which the FDA said did not reflect the best-available standard of care, but the agency ultimately signed off on the trial design. Moderna has agreed to add a comparison of high-dose vaccines to some older participants and provide the FDA with additional analysis.