FDA panel considers a first-of-its-kind flu vaccine using mRNA technology

Live updates

1. 1h ago

   FDA Panel Backs Moderna mRNA Flu Vaccine Ahead of August Decision

   An FDA advisory committee voted 9-0 to recommend Moderna's mRNA-1010 vaccine for adults 50 and older. The company's stock rose to $79.80 by July 2, 2026. A final PDUFA decision is expected on August 5.

   What's confirmed:

   • An FDA advisory committee voted 9-0 in favor of Moderna's mRNA-1010 flu vaccine candidate.
   • The PDUFA decision for the vaccine is scheduled for August 5.
   • Moderna shares rose from $45.64 on June 2 to $79.80 by July 2, 2026.
   • The mRNA-1010 study consists of three parts: A, B, and C.

   Still unconfirmed:

   • The vaccine's benefits outweigh its risks for adults aged 50 and older.
   • Phase 3 data shows the shot is about 27% more effective than standard flu vaccines.
   confidence 90%
2. 5d ago

   FDA Panel Unanimously Backs Moderna mRNA Flu Vaccine

   An FDA advisory committee recommended the approval of Moderna's mFlusiva for adults aged 50 and older. The panel voted 9-0 that the vaccine's benefits outweigh its risks. Phase 3 data indicated the shot is about 27% more effective than standard flu vaccines.

   What's confirmed:

   • The FDA Vaccines and Related Biological Products Advisory Committee voted 9-0 to recommend mFlusiva for adults aged 50 and older.
   • The panel met and voted on June 18.
   • Late-stage trial data showed the vaccine is about 27% more effective than a standard flu vaccine.
   • mFlusiva uses messenger RNA technology.

   Still unconfirmed:

   • Moderna shares traded near a one-year high following the news.
   • Moderna shares rose 10.1% after the panel backing.
   confidence 100%
3. 9d ago

   Moderna Seeks FDA Approval for mRNA Flu Vaccine Before Fall

   Federal health advisers unanimously approved the benefit-risk profile of Moderna's mFlusiva on June 18. This is the first flu vaccine to use mRNA technology. Moderna wants to market the shot to individuals aged 50 and older.

   What's confirmed:

   • Federal health advisers unanimously approved the benefit-risk profile of mFlusiva on June 18.
   • mFlusiva is the first flu vaccine to use mRNA technology.
   • Moderna is seeking FDA approval to market the vaccine to people aged 50 and older.

   Still unconfirmed:

   • Moderna seeks approval of its new flu vaccine before the fall season.
   confidence 90%
4. 12d ago

   FDA Panel Backs Moderna mRNA Flu Vaccine for Adults 50 Plus

   Federal health advisers unanimously approved the benefit-risk profile of Moderna's mFlusiva on June 18. The shot is the first flu vaccine to use mRNA technology. Moderna is seeking FDA approval to market the vaccine to people aged 50 and older.

   What's confirmed:

   • Moderna is seeking FDA approval for mFlusiva as an option for people 50 and older.
   • A federal panel voted unanimously on June 18 to favor the benefit-risk profile of the vaccine.
   • mFlusiva is the first flu vaccine utilizing mRNA technology.
   confidence 100%
5. 13d ago

   FDA Advisory Panel Recommends Approval of Moderna mRNA Flu Vaccine

   Federal health advisers recommended the approval of Moderna's mFlusiva, the first flu vaccine utilizing mRNA technology. The panel voted unanimously in favor of the vaccine's benefit-risk profile on Thursday, June 18. This move brings the first-of-its-kind shot closer to the U.S. market.

   What's confirmed:

   • FDA health advisers recommended approval of Moderna's mRNA flu vaccine on Thursday, June 18.
   • The vaccine, named mFlusiva, uses the same mRNA technology employed to end the COVID-19 pandemic.
   • The FDA advisory committee provided unanimous votes in favor of the vaccine.
   • The panel voted in favor of the benefit-risk profile for the vaccine.

   Still unconfirmed:

   • Phase 3 trials showed 26.6% RVE versus standard dose and 47.9% versus healthcare outcomes.
   • The PDUFA date is August 5, 2026.
   • The vaccine expands the B cell response breadth in humans.
   confidence 95%