Moderna mRNA influenza vaccine regulatory process

FDA approves Moderna’s mRNA influenza vaccine

An FDA advisory panel voted unanimously that the vaccine's benefits outweighed its risks.

In June, an expert panel advising the FDA on vaccines voted unanimously that the benefits of the vaccine outweighed any risks.

Vinay Prasad left the FDA.

In early 2026, Vinay Prasad left the FDA at the end of April. At the time, Prasad served as the agency's head of biologics and had been involved in a regulatory dispute regarding Moderna's influenza vaccine application.

In February, Prasad issued a refusal-to-file notice to Moderna, stating the agency would not review the vaccine based on the available data package. His initial objection centered on Moderna's failure to use an adjuvanted or high-dose vaccine as a comparator for the older age group, an issue the FDA had reportedly raised with Moderna before the trial began. This decision was reversed one week after Moderna disclosed the FDA's decision and expressed its displeasure.

The FDA reversed its refusal-to-file decision one week after Moderna disclosed its displeasure.

In February, the FDA's head of biologics, Vinay Prasad, issued a refusal-to-file notice to Moderna, stating the agency would not review the influenza vaccine based on the available data package. The initial objection focused on Moderna's failure to use an adjuvanted or high-dose vaccine as a comparator in the older age group, despite notes that the FDA had raised this issue before the trial began.

One week after Moderna disclosed the decision and expressed its displeasure, the FDA reversed its position. This reversal occurred following a meeting that Moderna described as constructive.

The FDA's head of biologics issued a refusal-to-file notice to Moderna.

In February, the FDA’s head of biologics at the time, Vinay Prasad, issued a refusal-to-file notice to Moderna. The agency stated it would not review the vaccine based on the available data package provided.

The initial objection centered on the fact that Moderna had not used an adjuvanted or high-dose vaccine as a comparator in the older age group. Although the FDA had reportedly raised this issue with Moderna before the trial began, the decision to refuse the filing was reversed a week after Moderna disclosed the agency's decision and its own displeasure, following what the company described as a constructive meeting.