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News|HealthUS says that it will review Moderna flu vaccine it previously declinedThe pharmaceutical giant expressed optimism that its new flu shot would be available this year, after approval concerns.

## FDA Review of Moderna Flu Vaccine Application

JBy Jason FordFeb 19, 20261 min read

FDA Review of Moderna Flu Vaccine Application

The Food and Drug Administration (FDA) has agreed to review Moderna's revised application for a new flu vaccine. The application seeks full approval for use among individuals aged 50 to 64 and expedited approval for those over 65.

The FDA's decision to review the application marks a reversal from its previous position. On February 10, the agency had declined to review the initial application, a move that prompted concerns within the pharmaceutical industry regarding the reception of new vaccines under the current U.S. administration.

Moderna conducted a 40,000-person clinical trial focusing on adults aged 50 and older. The results indicated that the new vaccine was more effective than the standard flu shot. The FDA had initially suggested that the trial include a high-dose brand for comparison, which was not included.

The Food and Drug Administration (FDA) has agreed to review Moderna's revised application for a new flu vaccine.
Jason Ford · Thehackingpost

In response, Moderna has agreed to conduct an additional study post-approval. The FDA aims to decide on the revised application by Sat, Aug 5, 2023.

The flu vaccine employs mRNA technology. Recent policy shifts have affected funding and support for mRNA research, including the cancellation of federal grants and contracts.

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Based on reporting by Al Jazeera.

AI transparency. This article was produced with the assistance of artificial intelligence and published under human editorial oversight. AI systems can make mistakes. Read how we use AI (EU AI Act, Art. 50).
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