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FDA requires Covid vaccine makers to expand warning about risk of rare heart inflammation
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.
Moderna Files FDA Application for the LP.8.1 Targeting COVID-19 Vaccine
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,
FDA Warns of Heart Risk With Pfizer, Moderna COVID Vaccines
The updated warnings highlight a rare risk of heart inflammation in teen boys and young men, CBS News reported. The warning applies to males ages 16 to 25 and is based on new data from FDA safety monitoring and a 2023 study. This includes both Pfizer's Comirnaty and Moderna's Spikevax vaccines.
With vaccine approval process set to change, FDA advisers leave wiggle room in annual Covid-19 shot recommendations
A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make a broad recommendation about which lineage of the coronavirus should be included in this year’s Covid-19 vaccines,
Who can get updated COVID vaccines this fall? FDA will OK for high-risk groups, calls for new clinical trials
The Food and Drug Administration says it has decided to continue approving COVID-19 vaccine updates for seniors and others at higher risk of severe disease, but will require vaccine makers to conduct major new clinical trials before approving them for wider use.
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FDA panel debates COVID vaccine recipe as questions swirl about fall shots
Government vaccine advisers are meeting to decide if the recipe for COVID-19 vaccines needs updating for this fall and winter
Moderna files application for updated COVID vaccine
Moderna said on Friday it had filed a marketing application for an updated COVID vaccine to the U.S. Food and Drug Administration.
FDA expands COVID vaccine warning about heart side effect risk for young males
The FDA is requiring COVID vaccine makers Pfizer and Moderna to update their warnings about the possible risk of myocarditis and pericarditis.
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FDA gives Covid vaccine manufacturers instructions for next fall’s shot
The notice came shortly after an advisory panel meeting at which members debated the pros and cons of asking manufacturers to update their vaccines.
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FDA Panel Recommends Monovalent COVID Vaccine for Next Season
An FDA advisory committee unanimously recommended Thursday that the next COVID vaccine should be a monovalent one in the JN.1 lineage, although members disagreed slightly about which specific strain should be included.
Joe Rogan Shares Bonkers Conspiracy About COVID Vaccine
Right-wing podcaster Joe Rogan thinks “Pfizer alone” may have killed off more people than World War I, World War II, and Vietnam. Rogan said “a conservative range of 470,000 to 600,000” Americans may have died as a result of Pfizer’s COVID-19 mRNA vaccine.
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