US FDA approves first mRNA flu shot from Moderna
The shot showed 26.6% better effectiveness than a licensed standard-dose flu vaccine in a late-stage trial of more than 40,000 adults.
- On Wednesday, the Food and Drug Administration approved the United States' first mRNA-based flu vaccine for adults 50 and older, Moderna announced, offering what Moderna CEO Stephane Bancel called an "important new option for America's seniors."
- The FDA initially declined to review the vaccine in February, citing inadequate trials despite conflicting internal feedback, but reversed course two weeks later and agreed to evaluate the shot.
- Clinical trials involving over 40,000 adults found the vaccine about 27% more effective than standard shots during the 2024–25 season; an independent Advisory Committee unanimously voted in June that benefits outweigh risks.
- Moderna expects the vaccine available this fall; however, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices has not met since March, potentially delaying formal recommendations.
- While an mRNA-based flu and Covid-19 vaccine was approved in Europe earlier this year, HHS Secretary Robert F. Kennedy Jr. canceled about $500 million in mRNA projects, claiming these vaccines fail to protect against infections.
19 Articles
19 Articles
The Food and Drug Administration (FDA) on Wednesday approved the first mRNA-based flu vaccine in the United States for adults 50 and older, Moderna announced. “Flu remains a significant public health challenge, and mFLUSIVA offers an important new option for older adults in the United States,” Moderna CEO Stephane Bancel said in a statement. “This approval also reflects the continued potential of our mRNA platform to help address important publi…
Moderna's mRNA Flu Shot Wins US Approval in FDA Turnaround
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