Covid-19, FDA and vaccines
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CAMBRIDGE, MA / ACCESS Newswire / May 23, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2025-2026 formula,
The FDA picked the LP.8.1 Covid strain for the fall vaccines, fueling concerns that the shots may be limited to only the most at-risk Americans this fall.
The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded warning labels with more information about the risk of a rare heart condition after vaccination.
FDA leaders say the agency will require more clinical trials to show the benefits of annual COVID shots for healthy adults.
The U.S. Food and Drug Administration on Tuesday said it plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under age 65, effectively limiting them to older adults and those at risk of developing severe illness.
3don MSN
The FDA announced a policy shift for COVID-19 vaccine approvals to focus on Americans considered high-risk of contracting the virus, and those older than age 65.