The FDA has reversed its stance and agreed to review Moderna’s mRNA influenza vaccine after earlier rejecting the submission for review, marking a notable shift in regulatory handling.

HHS spokesperson Andrew Nixon said the FDA’s decision reflects maintained high standards and a revised regulatory approach following discussions with Moderna that led to an amended application.

Moderna stated it updated its application, prompting renewed FDA consideration and the acceptance of an amended submission.

This development is breaking news and may evolve, set against a broader backdrop of vaccine science and policy during this period.

The vaccine relies on messenger RNA technology, which has faced political criticism from some figures, though public health experts broadly deem mRNA vaccines safe.

As with other mRNA vaccines, the flu shot mirrors the technology used in COVID-19 vaccines and aligns with ongoing shifts in U.S. health policy under the current Health Secretary.

The reversal comes amid debate over a potential policy shift and concerns about vaccination rates and regulatory changes under the current administration.

Moderna’s CEO Stéphane Bancel said the company aims to make the flu vaccine available later this year, offering seniors a new protective option.

Context notes that mRNA development surged during the prior administration but has seen reduced activity recently, affecting the vaccine industry.

Moderna’s updated vaccine is pursuing full approval for adults 50 to 64 and accelerated approval for adults 65 and older, with a post-marketing study mandated for older adults.

Experts emphasize the importance of fair assessment of new vaccines and the potential benefits of mRNA vaccines to respond quickly to variants.

The FDA’s plan includes targeted approvals by age, alongside a post-marketing commitment to monitor safety in older populations.