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Vrbpac

All articles tagged with #vrbpac

health2 months ago•5 min saved

Regulatory drama ends with unanimous FDA advisory vote for Moderna's mRNA flu vaccine

FDA advisors voted 9-0 to approve Moderna’s mRNA-1010 seasonal flu vaccine (mFlusiva) after a Trump-era official briefly blocked review; Phase 3 data show ~27% higher efficacy than standard flu vaccines in adults 50+, with strong immune responses in older adults and a generally favorable safety profile. A final FDA decision is due by August 5, and CDC/ACIP recommendations would follow for coverage, though ACIP is currently affected by an injunction tied to vaccine-administration policy.

via Ars Technica|

#fda #flu-vaccine #health

public-health5 months ago•6 min saved

FDA panel backs subclade K as centerpiece of fall flu shots

U.S. FDA vaccine advisers unanimously endorsed including the A(H3N2) subclade K in next fall’s flu vaccines, aligning with WHO guidance; final approval rests with FDA Commissioner Makary. Subclade K has become the dominant strain in the Northern Hemisphere, highlighting the annual, uncertain process of strain selection. The season saw limited vaccine effectiveness and a high pediatric burden, with falling vaccination rates since the pandemic, alongside tens of millions of illnesses and thousands of hospitalizations.

via CIDRAP|

#fda #flu #influenza