FDA approves Moderna's new lower-dose COVID-19 vaccine
[June 02, 2025]
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 Novavax.
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 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’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 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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