FDA refuses to review Moderna’s flu vaccine application

Helen Branswell covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Follow her on Mastodon and Bluesky. You can reach Helen on Signal at hbranswell.01.

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 it had received from Vinay Prasad, who heads the FDA’s biologics division. They also issued a strongly worded statement from its CEO Stephane Bancel, who said 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 used in its Covid-19 vaccine.