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Moderna's new COVID-19 vaccine mNexspike approved by FDA, but there's a limit on who can use it
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.
It offers an alternative to the mRNA-based technology used in the most common COVID vaccines and has been used under emergency authorization since 2022. The new FDA decision grants its full ...
The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans, a move that may limit ...
such as developing COVID. That's a major change from the current approach, which recommends and approves the vaccines for almost everyone based on the more easily obtained immune system studies.
By Stephanie Brown HealthDay ReporterTUESDAY, June 3, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has ...
The FDA approved Moderna’s lower-dose COVID-19 vaccine, but only for individuals aged 65 years or older and people aged 12 to ...
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