FDA Poised to Review Moderna’s Groundbreaking Flu Vaccine Following Resolution of Public Dispute

WASHINGTON – The Food and Drug Administration (FDA) has decided to move forward with evaluating Moderna’s innovative flu vaccine, putting an end to a previous impasse that hindered the company’s application for this groundbreaking shot.

Moderna made this announcement on Wednesday, just days after disclosing that the FDA’s head of vaccine regulation had initially declined to assess the new vaccine, which leverages mRNA technology—a method recognized with a Nobel Prize.

The contention arose from a substantial clinical trial involving 40,000 participants, which suggested that Moderna’s vaccine was more effective in individuals aged 50 and above compared to traditional flu vaccines in use today. In a rare move, Dr. Vinay Prasad, the FDA’s vaccine director, issued a “refusal to file” letter, criticizing the trial for excluding another vaccine brand recommended specifically for those 65 and older.

In response, Moderna publicly disagreed with the FDA’s stance. The company argued that while the FDA had initially suggested an alternative trial design, it ultimately sanctioned the study as conducted. Additionally, Moderna provided supplementary data from a different trial that included a high-dose vaccine for older adults. Importantly, the FDA did not raise any safety issues.

On Wednesday, Moderna announced a compromise: it is seeking full approval for its vaccine for adults aged 50 to 64 and accelerated approval for those 65 and older, contingent upon further study once the vaccine is available to the public. Following this announcement, shares of Moderna Inc. surged over 5% during morning trading.

The FDA is targeting a decision on the application by Aug. 5, and Moderna said it hoped to make the vaccine available later this year. It also has applied for the vaccine’s approval in Europe, Canada and Australia.

The highly unusual public dispute was the latest sign of the FDA’s heightened scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr., particularly those using mRNA technology, which he has criticized before and after becoming the nation’s top health official.

In the past year, FDA officials working under Kennedy have rolled back recommendations around COVID-19 shots, added extra warnings to the two leading COVID vaccines — which are made with mRNA technology — and removed critics of the administration’s approach from an FDA advisory panel.

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