FDA will consider Moderna's mRNA flu vaccine after all

Moderna said the FDA will consider whether to approve its new mRNA flu vaccine after the agency resolved a public dispute that had previously blocked the company’s application, according to an Associated Press report.

The change came Wednesday, about a week after Moderna disclosed that the agency’s vaccine chief had been refusing to review the product. The announcement followed a rare public back-and-forth between the company and the FDA over what data the agency said was needed to move forward.

In its initial interaction, the FDA issued a rare “refusal to file” letter, the AP reported, faulting the study design for not including another flu shot brand that is specifically recommended for people 65 and older. The letter’s criticism was associated in the report with FDA vaccine director Dr. Vinay Prasad.

Moderna publicly objected to that characterization of the trial, saying the FDA had recommended the approach and then ultimately agreed to the study’s design. Moderna also said it provided additional comparison data from a separate trial that used a high-dose shot for older people, and it said the FDA did not identify safety concerns.

Despite the earlier block, Moderna said Wednesday it is pursuing a compromise route: full approval for the vaccine’s use in adults 50 to 64, and accelerated approval for adults 65 and older, along with an additional study after the shot is on the market.

The FDA is targeting an Aug. 5 decision on the application, and Moderna said it hopes to have the vaccine available later this year. The company has also applied for approval in Europe, Canada and Australia, the AP reported.

The dispute also drew attention to what the AP described as heightened scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr., particularly those using mRNA technology. The story said FDA officials working under Kennedy have, in the past year, rolled back recommendations around COVID-19 shots, added extra warnings to two leading mRNA COVID vaccines, and removed critics from an FDA advisory panel.

In response to questions about the process, the AP reported that HHS spokesman Andrew Nixon said the FDA would maintain its high standards “during review and potential licensure stages as it does with all products.”

Related prior coverage includes an earlier report on Moderna’s statement that the FDA would not consider its mRNA flu vaccine application. MSI previously reported that Moderna said the FDA would not consider its application.