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Baker's Take· 2 sources

Moderna's mRNA flu vaccine clears key FDA advisory hurdle despite political interference

By

Mr Bagel

· 2d ago

An independent advisory panel to the U.S. Food and Drug Administration has unanimously endorsed Moderna's experimental mRNA-based seasonal flu vaccine, known as mRNA-1010, after a contentious review process that drew political scrutiny. The Vaccines and Related Biological Products Advisory Committee voted 9-0 to recommend approval, according to Statnews, marking a significant step forward for the first mRNA flu shot to reach this stage of regulatory review.

Moderna's mRNA flu vaccine clears key FDA advisory hurdle despite political interference

The endorsement came despite what Statnews described as the vaccine having "earlier this year became the subject of controversy." Hacker News reported that the controversy stemmed from a Trump appointee at the agency who "initially attempting to block the vaccine from even being reviewed." The committee's unanimous vote effectively overrode that internal opposition.

"FDA independent advisors voted 9-0 to recommend approval of Moderna's mRNA seasonal flu vaccine (mRNA-1010), despite a Trump appointee at the agency initially attempting to block the vaccine from even being reviewed."

Hacker News

Hacker News noted that the VRBPAC committee "reviewed data and presentations on the vaccine in an all-day meeting before reaching their unanimous decision." The panel's strong consensus suggests the clinical evidence met the rigorous standards expected for a new influenza vaccine platform.

The positive recommendation moves Moderna closer to bringing a second mRNA product to market, following its COVID-19 vaccine. If the FDA follows the advisory panel's guidance, mRNA-1010 could become the first mRNA-based flu vaccine authorized in the United States, potentially offering faster production and better strain matching than traditional egg-based flu shots.

The reporting

2 outlets covered this story. Each links to the original.