The U.S. accepted a brand new COVID-19 vaccine made by Moderna late Friday however with limits on who can use it — not a alternative for the corporate’s current shot, however a second choice.
The brand new vaccine, mNexspike, is a step towards next-generation coronavirus vaccines. It is made in a means that enables for a decrease dose — a fifth of the dose of its present COVID-19 vaccine, Spikevax — by refining its immune goal.
The approval “provides an necessary new instrument to assist shield folks at excessive danger of extreme illness from COVID-19,” Stephane Bancel, Moderna’s CEO, mentioned in an announcement Saturday.
The Meals and Drug Administration accepted the brand new vaccine to be used in all adults 65 and older, and for folks age 12 to 64 who’ve a least one well being situation that places them at elevated danger from the coronavirus.
That’s the identical restrict that the FDA set in licensing one other COVID-19 vaccine choice from competitor Novavax.
These restrictions are a departure from how the U.S. has dealt with COVID-19 vaccines till now, reflecting skepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and different Trump officers.
Moderna’s current vaccine doesn’t face these limits and has lengthy been used for anybody ages 6 months and older. The corporate mentioned it anticipated to supply each choices this fall.
The FDA’s approval was based mostly on a examine of 11,400 folks age 12 and older that in contrast the brand new low-dose vaccine with Moderna’s current vaccine. It discovered the brand new vaccine was protected and was not less than as efficient — and extra by some measures — than the unique shot, the corporate mentioned.
The information got here simply days after the Trump administration canceled funding for Moderna to develop a vaccine in opposition to potential pandemic flu viruses, together with the H5N1 chicken flu, regardless of promising early examine outcomes.
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The Related Press Well being and Science Division receives assist from the Howard Hughes Medical Institute’s Science and Academic Media Group and the Robert Wooden Johnson Basis. The AP is solely accountable for all content material.
