• The FDA will review Moderna's revised application for a mRNA-based flu vaccine.
• Initial rejection sparked industry concerns about vaccine policy changes under the Trump administration.
• Moderna's new shot targets adults aged 50-64 with accelerated approval for those aged 65 and older.
• The FDA's decision is due by August 5, aiming for vaccine availability later this year.
• Moderna agreed to conduct a post-marketing study after the vaccine is released.

The U.S. Food and Drug Administration (FDA) has reversed its previous decision and will review Moderna's application for a new mRNA-based flu vaccine, which was initially rejected due to concerns regarding the adequacy of Moderna's clinical trials. The FDA's reversal follows a constructive meeting between the agency and Moderna, allowing the revised application to proceed. The company now seeks full approval for adults aged 50 to 64 and accelerated approval for those aged 65 and older, according to Reuters and Channel News Asia.

The initial rejection had raised alarms among pharmaceutical stakeholders regarding significant changes in U.S. vaccine policy, particularly under the Trump administration. Health Secretary Robert F. Kennedy Jr., known for his skepticism towards vaccines, had previously overseen the cancellation of numerous federal contracts related to mRNA vaccines, intensifying concerns over the regulatory environment. Following a trial suggesting higher efficacy for Moderna's vaccine compared to standard flu shots, stakeholders expressed increased apprehension about the trajectory of vaccine approvals, as noted by CBS News and Al Jazeera.

Notably, the FDA's revised approach reflects an acknowledgment of the importance of enhancing immunization options for older adults, highlighting the urgency of accessible vaccinations amid public health challenges. In addition to the revised application, Moderna has agreed to conduct a post-marketing study focused on older populations. The FDA is anticipated to make a decision by August 5 on the application, with Moderna aiming for vaccine availability aimed at protecting seniors from seasonal flu, according to Reuters, Channel News Asia, CBS News, and Al Jazeera.