The U.S. Food and Drug Administration has made a significant reversal, agreeing to review Moderna's application for its influenza vaccine after initially rejecting it just a week prior. This decision came after Moderna submitted modifications to its proposal, leading to a more than 3% increase in the company's shares before market opening on Wednesday.
Revised Approval Strategy
Moderna announced that the FDA has accepted its revised approach, which seeks full approval for the vaccine in adults aged 50 to 64 and accelerated approval for those 65 and older. Additionally, the company will conduct a post-marketing study specifically focused on older adults to ensure safety and efficacy in this vulnerable population.
Policy Shift Under New Leadership
This development occurs amidst a notable shift in national health policy under U.S. Health Secretary Robert F. Kennedy Jr., a long-time anti-vaccine activist who has been particularly critical of mRNA vaccines. The mRNA technology, which is central to Moderna's and many other COVID-19 shots and has been credited with saving millions of lives, is now under renewed scrutiny and support in this evolving regulatory landscape.
FDA's Initial Defense and Moderna's Response
The FDA had previously defended its initial rejection, stating that Moderna should have administered a higher-strength vaccine to older patients in the control arm of its clinical trial. In response to the reversal, Moderna CEO Stéphane Bancel expressed optimism, saying, "Pending FDA approval, we look forward to making our flu vaccine available later this year so that America's seniors have access to a new option to protect themselves against flu."
The regulator is expected to reach a decision on the vaccine candidate by August 5, setting a timeline for potential availability. This move highlights the dynamic nature of vaccine approvals and the impact of regulatory changes on public health initiatives.
