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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.

U.S. News & World Report · 1d

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.

CBS News on MSN · 2d

FDA expands COVID vaccine warning about possible side effect

The Food and Drug Administration is telling Pfizer and Moderna to expand the warning labels on their COVID-19 vaccines about the risk of a possible heart injury side effect linked to the mRNA shots, primarily in teen boys and young men,

6hon MSN

What we know about the safety, efficacy of mRNA vaccines amid recent scrutiny

Infectious disease experts say mRNA vaccines have been studied for decades, they are safe and effective, and were instrumental in saving lives during the COVID pandemic.

1don MSN

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 ...

Pfizer scientist claimed COVID vax results being delayed until after 2020 election ‘wasn’t a coincidence’: House GOP panel

The House Judiciary Committee revealed Thursday that Pfizer’s former Global Head of Vaccines Research and Development, Dr.

F.D.A. Poised to Restrict Access to Covid Vaccines

Agency leaders said there was evidence to justify approval only for older people and those with medical conditions. Many ...

3don MSN

Covid vaccine rollout for healthy kids and adults likely delayed by new FDA rule

The rollout of updated Covid vaccines for healthy children and adults this fall is likely to be delayed after the FDA said it ...

CIDRAP4d

Data show slight increase in menstrual length after COVID vaccines

Overall, women who received a COVID vaccine had a 19% greater risk of increase in menstrual cycle length as compared to ...

Asianet Newsable on MSN4d

Novavax Wins FDA Approval For COVID-19 Vaccine: Retail Calls For Buyback And Bigger Moves

The pharma company secured FDA clearance to manufacture and distribute its COVID-19 vaccine Nuvaxovid for adults and at-risk ...

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