The Food and Drug Administration has reversed its earlier decision and will now review Moderna’s application for the first mRNA-based flu vaccine, the company announced Wednesday (February 18).
The FDA had initially declined to consider the vaccine application earlier this month due to concerns over clinical trial design. The reversal comes after a Type A meeting between Moderna and the agency, where the company proposed a modified approach to approval.
Under the new agreement, the FDA will review the vaccine for adults aged 50-64 through the regular approval pathway, while considering it for adults 65 and older via accelerated approval with a requirement for additional post-marketing studies.
“We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” Moderna CEO Stéphane Bancel said in a statement.
The agency has set August 5 as its target date for completing the review, potentially making the vaccine available before the next flu season begins.
The reversal represents a significant development for Moderna, which has been working to expand the application of its mRNA technology beyond COVID-19 vaccines to other areas including influenza prevention.
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