In February, FDA announced that it would not review Moderna’s mRNA influenza vaccine; reversed its position about a week later; and now has agreed to take into consideration the unanimous recommendation of the agency’s independent advisory committee in making its final decision, which it intends to reach by early August.
The committee found the benefits of the “first-of-its-kind” flu vaccine to outweigh any risks for the intended age groups. The vaccine is unique in that it is made with the Nobel Prize-winning mRNA technology used in the COVID vaccines, and provides the benefit of being faster to manufacture than other types, enabling quick availability of a vaccine that closely matches a mutating flu strain.
With older adults being among the most vulnerable to serious effects or death from influenza, Moderna is seeking full approval for ages 50 to 64, and authorization for use in adults 65 and older while it conducts additional testing. Both were approved by the panel. The authorization is being requested for these age groups because it showed a stronger protective immune response than a high-dose flu vaccine currently recommended for that age group. If approved, Moderna’s next step will be to include 400,000 people 65 and older in the study, with half given the mRNA vaccine and the rest given one of today’s senior-approved shots, then repeat the study for two flu seasons. Moderna’s data showed no major safety issues beyond some injection-site pain, fever, headache, tiredness and aches typical of mRNA and other vaccines – which are actually signs that “your immune system is responding.”
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COVID Risk Matrix (as of June 1, 2026)
Influenza
Public Health News
- A new kind of flu vaccine moved a step closer to the U.S. market last week as federal health advisers recommended approval of the first flu vaccine made with mRNA technology. After having previously announced that it would not review the vaccine, despite late-stage trials showing it was safe and effective, the agency is now considering the advisory committee’s recommendation to make a final decision by early August.
- The US CDC has issued a travel alert for Manitoba over hepatitis A outbreak. It is a Level 1 alert, the lowest of the agency’s four-tier travel system related to health risks. It advises practicing usual precautions for safety and hygiene, without the need for extreme or emergency measures. Since April 2025, there have been more than 700 cases and 4 deaths, primarily among people experiencing homelessness.
- Another norovirus outbreak has occurred among hikers, with this one affecting campers hiking on the Appalachian Trail in Virginia at Shenandoah National Park; multiple cases have been reported. Because the virus spreads easily, the Park Service is urging visitors and hikers to take precautions to protect themselves and others.
- Demonstrating the widespread transmissibility of Avian flu, the first case of HPAI in Australia has been reported in a bird that washed up on a beach, and there may be more suspect cases. HPAI has now been detected in all 7 continents. Investigation of the possible source of the route for this illness is underway.
- A study of 13,000 VA patients related to the past season’s respiratory illnesses has found that the flu was much more likely to lead to hospitalization than COVID last winter. Last year’s flu strain was especially virulent.
