Archive · 6 Aug 2026
FDA Approves Moderna's mFlusiva, World's First mRNA Flu Vaccine
A brand-new flu shot called mFlusiva has been approved in the United States.
It is the first flu vaccine in the world made with mRNA, which are special instructions that teach your body how to fight the flu.
Unlike regular flu shots made with eggs, this vaccine tells your own cells to make a tiny piece of the flu virus so your immune system can learn to protect you.
The shot is only for adults aged 50 and older.
Scientists tested it on more than 40,000 people and found it worked a bit better than a standard flu vaccine.
It also gave older adults a stronger immune response than another high-dose flu shot, though more studies are needed.
Flu viruses change every year, and mRNA vaccines can be updated much faster than traditional ones.
That could help scientists make better flu vaccines more quickly in the future.
For now, the shot is only available in the United States.
The US Food and Drug Administration (FDA) approved Moderna's mFlusiva, the world's first mRNA-based seasonal influenza vaccine, for adults aged 50 years and older.
The vaccine received traditional approval for adults aged 50-64 and accelerated approval for adults aged 65+, with additional confirmatory studies required in the older group.
A Phase 3 trial involving more than 40,000 adults aged 50+ found mFlusiva reduced laboratory-confirmed influenza cases by 26.6% compared with a standard licensed flu vaccine.
Moderna reported stronger immune responses than Sanofi's high-dose flu vaccine in older adults, though further studies are needed to confirm clinical benefit for those 65 and above.
The approval currently applies only to the United States and does not affect India's influenza vaccination programme, where availability depends on future regulatory approvals.
- Who
- The US Food and Drug Administration (FDA) approved Moderna's mRNA influenza vaccine mFlusiva for adults aged 50 years and older.
- What
- The FDA approved the world's first mRNA-based seasonal influenza vaccine, mFlusiva, with traditional approval for adults aged 50-64 and accelerated approval for adults aged 65+.
- When
- The specific approval date was not stated in the article.
- Where
- United States - the approval currently applies only to the US, which uses egg- and cell-based manufacturing for most traditional flu vaccines.
- Why
- To address frequently mutating influenza viruses, since mRNA technology can shorten vaccine production timelines and enable faster strain updates.
- Vaccine
- mFlusiva (mRNA-based seasonal influenza vaccine)
- Developer
- Moderna
- Regulatory body
- US Food and Drug Administration (FDA)
- Eligible population
- Adults aged 50 years and older
- Approval type
- Traditional for ages 50-64; accelerated for ages 65+ with required confirmatory studies
- Clinical trial
- Phase 3 trial with more than 40,000 adults aged 50+
- Effectiveness
- 26.6% reduction in laboratory-confirmed flu cases vs a standard licensed vaccine
- Global flu burden (WHO)
- 3-5 million severe cases and up to 650,000 respiratory deaths per year