FDA agrees to review Moderna’s mRNA flu vaccine application in a reversal

Moderna

said on Wednesday the Food and Drug Administration has agreed to review its experimental mRNA flu shot, reversing the agency’s earlier decision to refuse to accept the application in a move that stunned Wall Street and the medical community.

The announcement clears a path forward for the vaccine, which is key to Moderna’s experimental combination Covid-flu jab and the company’s goal of breaking even by 2028. The FDA is slated to make a decision on the flu shot on Aug. 5, which will allow Moderna to make the vaccine available for the upcoming influenza season.

“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,” said Moderna CEO Stéphane Bancel in a release.

Shares of the biotech company rose more than 6% on Wednesday.