Moderna has confirmed that the U.S. Food and Drug Administration (FDA) has agreed to reassess its influenza vaccine application after initially declining to review it, following modifications made by the company. The announcement of this reversal was made on Wednesday, just one week after the unexpected decision by the FDA to not review Moderna’s experimental flu vaccine application.
According to Moderna, the FDA has now accepted the company’s revised approach, with plans to pursue full approval for the vaccine for adults aged 50 to 64, and accelerated approval for those aged 65 and above. Additionally, the company disclosed that a post-marketing study will be conducted in older adults.
The mRNA technology utilized in Moderna’s flu vaccine, similar to most COVID-19 vaccines, has been lauded for its role in saving numerous lives. This technology shift reflects a change in health policy under U.S. Health Secretary Robert F. Kennedy Jr., who has a history of opposing vaccines, particularly mRNA vaccines.
Moderna’s CEO, Stéphane Bancel, expressed optimism pending FDA approval, aiming to introduce the flu vaccine later this year to provide seniors in America with a new defense against the flu. The FDA is anticipated to reach a decision on the vaccine candidate by August 5.
In January 2026, Health Canada announced its acceptance of Moderna’s mRNA influenza vaccine for review, with an expected decision within the standard 300-day review timeline post-acceptance. Moderna has also sought approval for its vaccine in Europe and Australia.
