Moderna's Mrna Flu Vaccine Receives FDA Approval

WHO:

CNN - Moderna, a drugmaker, received FDA approval for its mRNA-based flu vaccine.

CNN - Stephane Bancel, CEO of Moderna, commented on the approval.

CNN - The FDA's independent vaccine advisory panel consists of nine physicians and vaccine scientists.

WHAT:

CNN - The FDA approved the first mRNA-based flu vaccine for adults aged 50 and older.

CNN - The new vaccine, named mFLUSIVA, was found to be about 27% more effective than standard flu shots during the 2024–25 respiratory virus season.

CNN - The study for the vaccine enrolled over 40,000 adults aged 50 and older.

CNN - Side effects of the vaccine included injection-site reactions, fatigue, headache, muscle or joint pain, nausea or vomiting, and fever.

CNN - Moderna expects to have the vaccine available in the fall.

CNN - The FDA initially declined Moderna's request for review in February, citing inadequate trials.

WHERE:

CNN - The vaccine is intended for use in the United States.

WHEN:

CNN - The FDA's independent vaccine advisory panel voted in June to endorse the new Moderna vaccine.

CNN - The CDC’s Advisory Committee on Immunization Practices is scheduled to meet in October.

WHY:

CNN - The approval reflects the ongoing potential of mRNA technology to address public health challenges.

CNN - The FDA switched course on the review of the vaccine after initial reluctance due to conflicting feedback.

HOW:

CNN - Moderna's mRNA flu vaccine requires less time between strain selection and public circulation compared to traditional flu vaccines.

(UPDATED August 6, 2026 05:11 UTC)

Moderna has received FDA approval for its mRNA-based flu vaccine, named mFLUSIVA, which is specifically designed for adults aged 50 and older. The new vaccine has been shown to be about 27% more effective than standard flu shots during the 2024–25 respiratory virus season, and side effects may include injection-site reactions, fatigue, and headaches. Moderna anticipates making the vaccine available in the fall, following the FDA's endorsement by its independent vaccine advisory panel in June and a scheduled meeting of the CDC’s Advisory Committee on Immunization Practices in October.