FDA approves Moderna's new lower-dose COVID-19 vaccine
The U.S. approved a new COVID-19 vaccine made by Moderna late Friday but with limits on who can use it. It's not a replacement for the company鈥檚 existing shot, but a second option.
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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 aged 12 to 64 who have at least one health condition that puts them at increased risk from the coronavirus.
That is the same limit that the FDA set in licensing another COVID-19 vaccine option from competitor Novavax.
Those restrictions are a departure from how the U.S. has handled COVID-19 vaccines until now, reflecting skepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other Trump officials.
Moderna鈥檚 existing vaccine does not face those limits and has long been used for anyone ages 6 months and older. The company said it expects to offer both options this fall.
The FDA鈥檚 approval was based on a study of 11,400 people ages 12 and older that compared the new low-dose vaccine with Moderna鈥檚 existing vaccine. It found that 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 canceled funding 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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