FDA Agrees to Review Moderna’s Flu Shot in Surprise Reversal (1)

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 ...