FDA approves Moderna's new lower-dose Covid -19 vaccine
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.
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Washington, 31 May
The US 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.
Those restrictions
are a departure from how the US 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 cancelled 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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