Takeaways from flu vaccine AdCom

Research evidence excerpt

Takeaways from flu vaccine AdCom

Update

June 18, 2026 07:54 PM GMT

Morgan Stanley & Co. LLCMModerna Inc | North America Terence C Flynn, Ph.D.

Equity Analyst

Takeaways from flu vaccine Terence.Flynn@morganstanley.comChris Yu, J.D., Ph.D. +1 212 761-2230

Chris.L.Yu@morganstanley.com +1 212 761-2535

AdCom Connor M Massari

Connor.Massari@morganstanley.com +1 212 761-2417

MRNA is seeking full FDA approval of its mRNA flu vaccine mFlusiva (mRNA-

Alexander Yevdokimov, Ph.D.

1010) for adults 50 to 64 years of age, and accelerated approval for adults 65 Research Associate

and older, along with a post-marketing requirement to conduct an additional study Alexander.Yevdokimov@morganstanley.com +1 212 761-2167

Hailey Horowitz

in older adults. Ahead of the PDUFA date of Aug. 5, 2026, the FDA convened an Research Associate

advisory committee (AdCom) panel meeting to assess the risk/benefit of mFlusiva. Hailey.Horowitz@morganstanley.com +1 212 761-5264

Damien H Kerner

The AdCom voted "Yes" unanimously in favor of mFlusiva on the following two Research Associate

Damien.H.Kerner@morganstanley.com +1 212 761-3829

questions: (1) Do the benefits of mFlusiva outweigh its risks for the prevention of

Morgan Stanley India Company Private Limited+

influenza disease in adults 50 through 64 years of age? and (2) Do the benefits of

Saket Agarwal

mFlusiva outweigh its risks for the prevention of influenza disease in adults 65 years Research Associate

of age and older? Saket.Agarwal@morganstanley.com +91 22 6995-4012

The FDA's presentation highlighted a favorable profile for mFlusiva (mRNA- Moderna Inc (MRNA.O, MRNA US)

1010) and did not identify any major concerns on either efficacy or safety. Biotechnology | United States of America