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. It also issued a strongly worded statement from its CEO Stéphane 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.
This article is exclusive to STAT+ subscribers
Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+.
Already have an account? Log in
