FDA panel considers a first-of-its-kind flu vaccine using mRNA technology

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FDA panel considers a first-of-its-kind flu vaccine using mRNA technology

2026-06-18 19:10 Last Updated At：19:20

WASHINGTON (AP) — U.S. health advisers are debating a new kind of flu vaccine Thursday, the first made with the same mRNA technology that was key to ending the COVID-19 pandemic.

Moderna is seeking Food and Drug Administration approval of its new shot, dubbed mFlusiva, as an option for people 50 and older. The FDA advisory committee meeting is a step toward a final decision ahead of the winter flu season.

Tens of thousands of Americans die from influenza every year, and older adults are among the most vulnerable. There are various types of flu vaccines already available in the U.S., including three specifically recommended for people 65 and older. But vaccines made with the Nobel Prize-winning mRNA technology are faster to manufacture than other types — something experts say might help if the shape-shifting flu virus mutates in a way that requires suddenly brewing new doses to match.

In a study of 40,000 people age 50 and older, Moderna’s mRNA vaccine reduced flu cases by about 27% compared to those given another routinely used vaccine brand. Ahead of the meeting, FDA published a favorable review of that data and reported no safety concerns.

Moderna is seeking full approval for the vaccine’s use in the 50- to 64-year-old population — along with authorization for use in those 65 and older while it conducts additional testing.

Earlier this year, Moderna’s data was at the center of a highly unusual public dispute as a then-top FDA official blocked the company’s application for its first-of-its-kind shot.

The embattled vaccine chief at the time, Dr. Vinay Prasad, said the company should have compared its shot to a high-dose flu vaccine recommended for seniors rather than a standard-dose brand. It was a sign of FDA’s heightened vaccine scrutiny under Health Secretary Robert F. Kennedy Jr.

Moderna challenged that decision, noting that FDA staff had approved that main study’s design and citing a separate, smaller study comparing the mRNA shot with a high-dose vaccine for seniors. Days after the spat, the FDA accepted Moderna’s application.

The expert panel also will assess that smaller study, which found Moderna’s shot generated flu-fighting antibodies similarly to a high-dose senior shot. The FDA’s initial review noted the new vaccine lacks data on very frail older adults and those with weak immune systems.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

Pentagon chief lashes out at NATO allies and announces a review of US forces in Europe

BRUSSELS (AP) — U.S. Defense Secretary Pete Hegseth lashed out at NATO allies on Thursday, announcing a six-month Pentagon review of American forces in Europe whose outcome will depend on how fast the Europeans take responsibility for their own security.

“This will be a real review. It will be designed to ensure that NATO is moving fast and irreversibly toward Europe leading, stepping up to take primary responsibility for the defense of Europe,” he told his NATO counterparts in Brussels.

Hegseth lambasted European allies for failing to provide U.S. forces access to bases in Europe to launch attacks on Iran, calling it “shameful.”

“These allies, they put America’s sons and daughters, our sons and daughters, at risk by denying them the predictable access, basing and overflight that never should have been in question at all,” he said.

Taking the microphone at the top of the meeting, Hegseth also railed against migration and gender equality policies in Europe, in remarks reminiscent to those of Vice President JD Vance in February last year that angered many Europeans.

“Instead of tanks and fighters and air defenses, the focus has been on gender equity and climate change and defense austerity. Europe’s borders flew wide open, welfare states expanded, defense budgets cratered. Along with Europe’s belief in itself and its civilization,” Hegseth said.

Hegseth's comments largely mischaracterized European policies today. On defense, European allies and Canada have launched an unprecedented effort to boost defense spending and expand their armed forces. NATO Secretary-General Mark Rutte noted on Thursday that they spent $90 billion more on defense last year, a 20% increase over 2024. And while Europe accepted large numbers of migrants and asylum seekers more than a decade ago, most countries have tightened their borders since.

The Trump administration now wants a reboot of the 32-nation organization to turn it into a “NATO 3.0” capable of deterring any threat, Hegseth said.

Hegseth's remarks came a few weeks after the United States told its allies that it would no longer supply certain warships and aircraft if one of them comes under attack. European allies and Canada are trying to work out how to plug the gaps.

NATO’s supreme allied commander, an American, is working on backup plans to defend Europe after the U.S. signaled on June 3 that it would no longer supply an aircraft carrier and support ships, aerial refueling planes and dozens of fighter jets, among other military assets, in a crisis.

The Trump administration insists that it needs to be able to plan for two simultaneous conflicts and wants more military resources at hand should a conflict break out with China in the Indo-Pacific region.

Under NATO’s collective security guarantee – Article 5 of its founding treaty – the 32 allies pledge that an attack on one of them will be considered an attack on all. It does not oblige them to provide military support, although many likely would.

In essence, the United States is scaling back how it might help should an ally trigger Article 5. The U.S. has by far NATO’s biggest armed forces. It does not intend to withdraw its nuclear weapons in Europe, which are key to NATO’s deterrence.

To underscore that point, NATO’s Nuclear Planning Group issued its first statement in 19 years after it had assembled at Thursday’s meeting.

In the statement, it “recalled that the strategic nuclear forces of the Alliance remain the supreme guarantee of Allied security and underpin NATO’s extended deterrence architecture.”

The ministers “agreed to continue enhancing NATO’s nuclear deterrence mission by modernizing NATO’s nuclear capabilities, strengthening its nuclear planning capacity, and adapting to achieve its security interests.”