FDA Decides to Review Moderna’s Flu Shot in Surprise Reversal

The US Food and Drug Administration will review a Moderna Inc. flu shot made with mRNA technology, reversing a previous decision that shocked Wall Street and spurred a public spat between the company and its regulator.

The two sides agreed to move forward with a traditional review of the company’s shot for adults aged 50 to 64, and consider an accelerated approval for those aged 65 and older, the company said in a statement on Wednesday. The revised regulatory approach takes into account the agency’s criticisms that Moderna’s clinical trial wasn’t rigorous enough among the oldest patients when it refused to look at the application earlier.