STAT+: FDA refuses to review Moderna’s influenza vaccine

The Food and Drug Administration refused to review Moderna’s application for a new influenza vaccine, the company said Tuesday, a surprise decision that could  raise concerns about the agency’s posture toward drug companies and the Trump administration’s policies on vaccines.

Moderna, revealing the rejection, took the unusual step of releasing the letter that it had received from Vinay Prasad, who heads FDA’s biologics division, and issued a strongly worded statement from its CEO, Stephane Bancel, saying the decision “does not further our shared goal of enhancing America’s leadership in developing innovative medicines.”

At the heart of the dispute is what existing influenza vaccine Moderna should have used as a control when testing the efficacy of its new shot, which utilizes the same mRNA technology the company’s used in its Covid-19 vaccine 

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