FDA refuses to review Moderna’s flu vaccine application

Helen Branswell covers points broadly associated to infectious ailments, together with outbreaks, preparedness, analysis, and vaccine growth. Observe her on Mastodon and Bluesky. You may attain Helen on Sign at hbranswell.01.

The Meals and Drug Administration refused to overview Moderna’s utility for a brand new influenza vaccine, the corporate mentioned Tuesday, a shock choice that would  elevate considerations in regards to the company’s posture towards drug corporations and the Trump administration’s insurance policies on vaccines.

Moderna, revealing the rejection, took the weird step of releasing the letter it had obtained from Vinay Prasad, who heads the FDA’s biologics division. In addition they issued a strongly worded assertion from its CEO Stephane Bancel, who mentioned the choice “doesn’t additional our shared objective of enhancing America’s management in creating revolutionary medicines.”

On the coronary heart of the dispute is what current influenza vaccine Moderna ought to have used as a management when testing the efficacy of its new shot, which makes use of the identical mRNA know-how the corporate utilized in its Covid-19 vaccine.