FDA Advisors Unanimously Back Moderna's mRNA Flu Vaccine After Internal Review Disagreements

🏥 Sağlık 📰 United States 🕐 5 saat önce
FDA Advisors Unanimously Back Moderna's mRNA Flu Vaccine After Internal Review Disagreements

Independent advisors for the Food and Drug Administration on Friday voted 9–0 in support of approving Moderna's seasonal mRNA flu vaccine, which a Trump appointee at the agency initially tried to block from even being reviewed. In an all-day meeting, members of the FDA's advisory committee—known as VRBPAC for Vaccines and Related Biological Products Advisory Committee—pored over data and presentations on the vaccine, which is dubbed mRNA-1010 and branded as mFlusiva. The pres

Independent advisors to the Food and Drug Administration (FDA) have unanimously recommended the approval of Moderna's mRNA seasonal flu vaccine, mRNA-1010 (branded as mFlusiva). The vote by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) was 9-0, following an all-day review of the vaccine's data. This recommendation comes despite initial attempts by a Trump appointee within the FDA to prevent the vaccine from being reviewed. Clinical trial data involving over 40,000 adults aged 50 and older indicated the mRNA vaccine was approximately 27% more effective than standard flu shots. A separate trial with nearly 3,000 individuals aged 65 and older showed it produced stronger immune responses compared to high-dose flu vaccines. The vaccine's safety profile was also deemed generally favorable by the committee.

The unanimous recommendation for Moderna's mRNA flu vaccine marks a significant step towards a new generation of influenza prevention, potentially offering enhanced protection, especially for older adults.

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