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FDA approves Moderna's mRNA flu vaccine for adults 50+

Created at 6 Aug · 2:06 PM1 source↑ Market-relevant
IN SHORT

The FDA has approved Moderna's mFlusiva, the first flu vaccine utilizing mRNA technology, for adults aged 50 and older. The approval follows a dispute over the application and aims to provide a faster-to-manufacture option against evolving flu strains.

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Key Numbers

50minimum age for mFlusiva approval
27%reduction in flu cases vs routine vaccine
40,000people in study for ages 50-64

Who's Involved

Moderna
manufacturer of the new mRNA flu vaccine
Food and Drug Administration
approved the new flu vaccine
Robert F Kennedy Jr
health secretary overseeing the FDA

↳ Why This Matters

This approval marks a significant step in applying mRNA technology beyond COVID-19, potentially offering a faster and more adaptable approach to combating the annually evolving influenza virus, especially for vulnerable older populations.

Key facts

  • The FDA has approved Moderna's mFlusiva, the first flu vaccine using mRNA technology.
  • The vaccine is intended for adults aged 50 or older.
  • A study showed mFlusiva reduced flu cases by about 27% compared to another flu vaccine.
  • For individuals 65 and older, the vaccine received accelerated approval.
  • Temporary reactions were reported, including injection site pain, fever, headache, tiredness, and aches.

The U.S. Food and Drug Administration has approved Moderna's mFlusiva, the first flu vaccine to utilize mRNA technology, the same platform behind its successful COVID-19 vaccines. The shot is intended for adults aged 50 and older and is expected to be available soon at select retailers.

While multiple flu vaccine options exist, including those for individuals 65 and older, influenza remains a significant cause of death, particularly among older adults. The mRNA technology allows for faster manufacturing compared to traditional vaccines, which experts believe could be beneficial if the rapidly mutating flu virus requires sudden updates to vaccine doses.

Moderna stated that the FDA granted full approval for mFlusiva's use in individuals aged 50 to 64, based on a study of 40,000 participants that demonstrated a roughly 27% reduction in flu cases when compared to another commonly used flu vaccine. For those aged 65 and older, the FDA granted accelerated approval, contingent on a postmarketing study, based on data showing a strong immune response compared to an existing high-dose vaccine for seniors.

Moderna's data indicated no major safety concerns, though some temporary reactions such as injection site pain, fever, headache, tiredness, and aches were reported at a slightly higher rate than with current flu shots.

The FDA's decision followed an unusual public dispute earlier this year when a top FDA official initially blocked the application. The agency reversed its stance after Moderna publicly challenged the ruling, and an independent advisory panel unanimously recommended the vaccine's approval in June.

Frequently asked questions

mFlusiva is a new flu vaccine developed by Moderna that uses mRNA technology, similar to its COVID-19 vaccines.

The vaccine is approved for adults aged 50 and older.

In a study of adults aged 50-64, it reduced flu cases by about 27% compared to another routine flu vaccine. For those 65+, it generated a strong immune response.

Temporary reactions reported include injection site pain, fever, headache, tiredness, and aches, occurring slightly more often than with current flu shots.

What Happens Next

01Moderna expects some doses of mFlusiva to be available soon at select retailers.
02Moderna will conduct an additional postmarketing study for individuals aged 65 and older.

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Cadence

How It Developed

The FDA approved Moderna's mFlusiva, an mRNA flu vaccine for adults 50 and older.
Moderna expects some doses to be available soon at select retailers.
The vaccine reduced flu cases by about 27% compared with a routinely used flu vaccine brand in a study of 40,000 people.
For those 65 and older, the FDA granted accelerated approval pending a postmarketing study.
The vaccine caused temporary reactions like injection site pain, fever, headache, tiredness, and aches.
An FDA official initially blocked the application but the agency reversed course after Moderna challenged the ruling.
A panel of independent advisers unanimously recommended the vaccine's approval in June.

Sources

T1
The mRNA technology behind Moderna’s Covid vaccine reaches the fluThe Guardian

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