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Moderna's mRNA flu shot earns FDA approval after rollercoaster review

Moderna's mRNA flu shot earns FDA approval after rollercoaster review

Summary

The Food and Drug Administration (FDA) has approved Moderna’s mRNA flu vaccine called mRNA-1010 or mFLUSIVA for adults aged 50 and older. This is the first flu vaccine using mRNA technology to get FDA approval, following positive trial results and a unanimous advisory committee vote.

Key Facts

  • The FDA approved Moderna’s mRNA flu vaccine for adults 50+ after trials with about 44,000 people.
  • FDA advisors voted unanimously in June to approve the vaccine based on its safety and better effectiveness than existing flu shots.
  • The vaccine uses mRNA technology, which allows faster production compared to traditional flu vaccines that take 6-8 months to make in chicken eggs.
  • Moderna’s COVID-19 vaccine also uses the mRNA platform, which is known for easy updates and quick manufacturing.
  • The approval process faced challenges, including opposition from Health Secretary Robert F. Kennedy Jr., who is against vaccines and mRNA technology.
  • A Trump appointee at the FDA initially refused to review the vaccine but was removed from the agency after controversy.
  • The CDC advisory panel that guides vaccine recommendations is not currently functioning due to legal challenges involving appointments made by Kennedy.
  • Without CDC panel guidance, doctors might be unsure about how to use the new vaccine in the upcoming flu season.
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