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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.

PTI

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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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