FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed, Oct. 14, 2015. (AP Photo/Andrew Harnik, File)
Food and Drug Administration commissioner Martin Markary speaks during an event in the Roosevelt Room at the White House, Monday, May 12, 2025, in Washington. (AP Photo/Mark Schiefelbein)
President Donald Trump, left, and Health and Human Services Secretary Robert F. Kennedy Jr. attend a Make America Healthy Again (MAHA) Commission Event in the East Room of the White House, Thursday, May 22, 2025, in Washington. (AP Photo/Jacquelyn Martin)
The U.S. approved a new COVID-19 vaccine made by Moderna late Friday but with limits on who can use it — not a replacement for the company’s existing shot, but a second option.
The new vaccine, mNexspike, is a step toward next-generation coronavirus vaccines. It's made in a way that allows for a lower dose — a fifth of the dose of its current COVID-19 vaccine, Spikevax — by refining its immune target.
The approval “adds an important new tool to help protect people at high risk of severe disease from COVID-19,†Stephane Bancel, Moderna’s CEO, said in a statement Saturday.
The Food and Drug Administration approved the new vaccine for use in all adults 65 and older, and for people age 12 to 64 who have a least one health condition that puts them at increased risk from the coronavirus.
That’s the same limit that the FDA set in licensing another COVID-19 vaccine option from competitor .
Those restrictions are a departure from how the U.S. has handled COVID-19 vaccines until now, reflecting from and other Trump officials.
Moderna’s existing vaccine doesn’t face those limits and has long been used for anyone ages 6 months and older. The company said it expected to offer both options this fall.
The FDA’s approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna’s existing vaccine. It found the new vaccine was safe and was at least as effective — and more by some measures — than the original shot, the company said.
The news came just days after the Trump administration for Moderna to develop a vaccine against potential pandemic flu viruses, including the H5N1 bird flu, despite promising early study results.
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