FDA reverses course; agrees to review Moderna flu vaccine 

The FDA has agreed to review Moderna’s investigational flu vaccine for potential approval, about a week after telling the drugmaker it would not consider the application.

On Feb. 10, the agency notified the drugmaker that it would not review its application for an mRNA-based flu vaccine, citing issues with the design of a phase 3 study. Federal regulators did not raise specific safety or efficacy concerns. 

After receiving the letter, Moderna requested a Type A meeting with the FDA and proposed a revised regulatory strategy. On Feb. 18, the company said the agency agreed to move forward with its review following those discussions.

Under the updated approach, Moderna is seeking traditional approval for adults ages 50 to 64 and accelerated approval for adults 65 and older. The company also agreed to conduct an additional post-marketing study in the 65-and-older population if the vaccine is approved.

“We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” Stéphane Bancel, Moderna’s CEO, said in a news release. “Pending FDA approval, we look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against flu.”

The FDA plans to make a decision on whether to approve the vaccine by Aug. 5, Moderna said. The drugmaker’s flu vaccine candidate is also under review in Europe, Canada and Australia.

The federal government has increased scrutiny of mRNA technology in recent months. HHS Secretary Robert F. Kennedy Jr. has repeatedly questioned the safety and efficacy of mRNA-based vaccines, despite broad scientific consensus supporting their safety and effectiveness.

In August, HHS canceled nearly $500 million in federal contracts tied to mRNA vaccine development, terminating 22 projects funded through the Biomedical Advanced Research and Development Authority and stating that no new mRNA vaccine initiatives would be approved.

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