FDA agrees to review Moderna’s updated mRNA flu vaccine proposal after earlier rejection

(ABC36 NEWS NOW) — The U.S. Food and Drug Administration says it will move forward with a review of a new mRNA-based flu vaccine developed by Moderna, following changes to the company’s original application.

Earlier this month, the FDA declined to accept Moderna’s first submission, citing concerns about how the vaccine had been tested. Moderna said at the time that regulators did not raise issues related to the vaccine’s safety or effectiveness.

After meeting with federal regulators, the company submitted a revised approval strategy that focuses on specific age groups.

Under the updated plan, Moderna is seeking full approval of the flu vaccine for adults ages 50 to 64. The company is also asking for accelerated approval for adults 65 and older, along with a requirement to complete an additional follow-up study.

The FDA’s review marks another step in the development of mRNA technology beyond COVID-19 vaccines, as researchers explore new ways to prevent seasonal influenza.