FDA advisors unanimously vote to approve Moderna’s mRNA after agency drama

Live updates

1. 26d ago

   FDA Panel Unanimously Backs Moderna mRNA Flu Vaccine mFlusiva

   FDA advisers voted 9-0 on June 18 to recommend the approval of Moderna's mRNA-based flu vaccine, mFlusiva, for adults 50 and older. Phase 3 data indicated the shot is about 27% more effective than standard flu vaccines. The FDA is expected to issue a final decision by August 5.

   What's confirmed:

   • The FDA Vaccines and Related Biological Products Advisory Committee voted 9-0 on June 18, 2026, to endorse mFlusiva.
   • The vaccine is intended for adults 50 and older.
   • Phase 3 data showed mFlusiva to be about 27% more effective than a standard flu vaccine.
   • A final FDA decision is expected by August 5.

   Still unconfirmed:

   • Moderna Inc. stocks traded up between 10.13 percent and 14.04 percent following the news.
   • Jefferies maintained a Hold rating on MRNA stock.
   confidence 95%
2. 31d ago

   FDA Advisory Panel Unanimously Backs Moderna mRNA Flu Vaccine

   The FDA Vaccines and Related Biological Products Advisory Committee voted 9-0 on June 18, 2026, to endorse Moderna's mFlusiva. The panel found that the benefits of the vaccine outweigh its risks for adults 50 and older. A final FDA decision is expected by August 5.

   What's confirmed:

   • The FDA Vaccines and Related Biological Products Advisory Committee voted 9-0 to endorse Moderna's mRNA-1010 influenza vaccine, also known as mFlusiva.
   • The panel voted on June 18, 2026, that the benefits of the vaccine outweigh its risks.
   • The vaccine is intended for adults 50 and older, with standard approval sought for ages 50-64 and accelerated approval for those 65 and older.
   • The FDA has a PDUFA date of August 5 for a final decision.

   Still unconfirmed:

   • ACIP turmoil and a legal fight could threaten a fall 2026 rollout.
   • The Trump administration previously decided to halt federal funding for future mRNA vaccine development.
   confidence 95%
3. 34d ago

   FDA Panel Unanimously Backs Moderna Flu Vaccine

   An FDA advisory committee voted 9-0 to recommend the approval of Moderna's mRNA-1010 influenza vaccine. The agency is expected to issue a final verdict by Aug. 5. This follows a brief period in February where the FDA refused to review the vaccine due to trial inadequacies.

   What's confirmed:

   • An FDA advisory panel voted 9-0 to recommend the approval of Moderna's mRNA-1010 vaccine.
   • The FDA is expected to reach a verdict by Aug. 5.

   Still unconfirmed:

   • The FDA briefly refused to review the vaccine in February citing trial inadequacies before reversing course.
   confidence 90%
4. 36d ago

   FDA Panel Recommends Moderna mRNA Flu Vaccine for Older Adults

   Federal health advisers recommended the approval of Moderna's mRNA-1010 influenza vaccine. The shot targets adults aged 50 and older. It utilizes the same mRNA technology used during the pandemic.

   What's confirmed:

   • An FDA advisory committee voted 9-0 to recommend Moderna's mRNA-1010 influenza vaccine for adults aged 50 and older.
   • The vaccine uses mRNA technology.
   confidence 100%
5. 37d ago

   FDA Advisory Panel Unanimously Backs Moderna mRNA Flu Vaccine

   An FDA advisory committee voted 9-0 to recommend Moderna's mRNA-1010 influenza vaccine for adults aged 50 and older. The decision follows a period of agency controversy. A final approval decision is expected by August 5.

   What's confirmed:

   • FDA advisors voted unanimously to recommend Moderna's mRNA influenza vaccine for adults 50 and older.
   • The advisory panel's vote was 9-0.
   • The investigational vaccine is identified as mRNA-1010.
   • An FDA approval decision is pending for August 5.

   Still unconfirmed:

   • Moderna's mRNA flu vaccine expands B cell response breadth in humans.
   • MRNA stock had its best week in over 4 years following the endorsement.
   confidence 100%