Moderna has confirmed that the Food and Drug Administration (FDA) will proceed with evaluating its new flu vaccine for older adults, marking a resolution to a recent public dispute that had stalled the application process. The announcement came on Wednesday, following a week of tension after Moderna revealed that the FDA's vaccine chief had initially refused to review the innovative shot.
Background of the Dispute
The conflict arose from a 40,000-person clinical trial, which demonstrated that Moderna's mRNA-based flu vaccine was more effective in adults aged 50 and older compared to a standard flu shot currently in use. In a rare "refusal to file" letter, Dr. Vinay Prasad, the FDA's vaccine director, criticised the trial for not including another brand specifically recommended for individuals aged 65 and older.
Moderna's Response and Compromise
Moderna publicly contested the FDA's stance, arguing that while the agency had suggested the inclusion of the additional brand, it had ultimately approved the study's design. The company also provided extra comparison data from a separate trial involving a high-dose shot for older adults and noted that no safety concerns were raised by the FDA.
In a compromise reached this week, Moderna is now seeking full approval for the vaccine's use in adults aged 50 to 64 and accelerated approval for those 65 and older, with plans for a follow-up study once the vaccine is on the market. Following this announcement, shares of Moderna Inc. surged by more than 5% in morning trading.
Regulatory Timeline and Global Applications
The FDA is targeting a decision on the application by August 5, and Moderna hopes to make the vaccine available later this year. Additionally, the company has submitted applications for approval in Europe, Canada, and Australia, expanding its global reach.
Broader Implications for Vaccine Scrutiny
This highly unusual public dispute highlights the FDA's increased scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr., particularly those utilising mRNA technology, which he has criticised both before and after assuming office. Over the past year, FDA officials have rolled back recommendations for COVID-19 shots, added extra warnings to leading mRNA-based COVID vaccines, and removed critics from an FDA advisory panel.
The resolution of this case may set a precedent for future vaccine approvals, especially as mRNA technology continues to evolve and face regulatory challenges.
