The U.S. approved a new COVID-19 vaccine made by Moderna late Friday but on who can use it 鈥� not a replacement for the company鈥檚 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 鈥� a fifth of the dose of its current COVID-19 vaccine, Spikevax 鈥� by refining its immune target.
The approval 鈥渁dds an important new tool to help protect people at high risk of severe disease from COVID-19,鈥� Stephane Bancel, Moderna鈥檚 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鈥檚 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鈥檚 existing vaccine doesn鈥檛 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鈥檚 approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna鈥檚 existing vaccine. It found the new vaccine was safe and was at least as effective 鈥� and more by some measures 鈥� 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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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute鈥檚 Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
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