By Christy Santhosh and Mariam Sunny
June 16 (Reuters) – Staff of the U.S. Food and Drug Administration said on Tuesday that data demonstrating a strong immune response to Moderna’s flu shot may support effectiveness in adults 65 years and older.
Moderna’s shot, mFlusiva, also showed superior relative vaccine efficacy versus a standard-dose flu vaccine in adults 50 to 64 years old, they said in briefing documents published ahead of the regulator’s advisory meeting. The company’s shares rose 2% in morning trading.
The FDA’s advisory committee will convene on June 18 to vote on whether the benefits of mFlusiva outweigh the risks in adults 50 to 64 years old, and in adults 65 and older.
Jefferies analyst Andrew Tsai said the assessment looks favorable, and that he expects $750 million of U.S. flu and COVID-flu combo vaccine sales by 2030.
FDA staff noted that Moderna’s application for adults 65 and older mainly rests on immunogenicity data against a standard-dose vaccine rather than CDC-preferred high dose shots for older adults.
They also flagged other issues such as limited one-season data, and higher short-term side effects and the need for postmarket studies in adults 65 and older.
Still, former FDA chief scientist Jesse Goodman said the assessment seemed reasonable and that the data support approval of the vaccine in both age groups.
Moderna is seeking a traditional approval of mFlusiva for adults 50 to 64 years old, and an accelerated approval for adults 65 and older.
The FDA, under the leadership of former commissioner Marty Makary, had rejected Moderna’s flu vaccine application in February. Senior FDA officials had said Moderna put patients at risk by not giving the preferred higher-dose flu vaccine to patients 65 and over as the control arm in its clinical trial.
The FDA later accepted an amended application after Moderna agreed to run a post-approval study in adults 65 and older.
If approved, mFlusiva would be the first mRNA-based seasonal flu vaccine in the U.S., with a decision expected by August 5.
Moderna did not immediately respond to a Reuters request for comment.
(Reporting by Christy Santhosh, Mariam Sunny in Bengaluru, Michael Erman in New York; Editing by Shilpi Majumdar)
By Christy Santhosh and Mariam Sunny | Reuters | © Copyright Thomson Reuters 2026.
