FDA Just Approved a New Covid Vaccine
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The FDA is requiring COVID vaccine makers Pfizer and Moderna to update their warnings about the possible risk of myocarditis and pericarditis.
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.
In another sign of growing scrutiny over Covid-19 vaccines, the Food and Drug Administration has asked the two makers of mRNA vaccines to widen the age range of boys and young men that their labels say are at risk for a rare side effect causing heart inflammation.
According to the CDC, cases of myocarditis and pericarditis are rare with the vaccines and, in most cases, resolve within a few days of dosing. None of the companies involved have commented on the change in the warning text.
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Newspoint on MSNFDA Issues New Warning: Covid Vaccines May Pose Heart Risks, Labels to Include Myocarditis AlertAs Covid-19 cases begin to rise again in several parts of the world, concerns regarding vaccine side effects have re-emerged. In a significant move, the U.S. Food and Drug Administration (FDA) has now directed major pharmaceutical companies like Pfizer and Moderna to include a mandatory warning on their Covid-19 vaccine labels,
The FDA has told vaccine manufacturers to expand the warning labels on their COVID-19 shots with more information about the risk for rare heart conditions following vaccination.
The FDA plans to limit access to certain high-risk groups and also told Pfizer and Moderna to update their warning labels about heart inflammation.
The U.S. 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 ...
Senior Biden Food and Drug Administration (FDA) officials spent weeks casting doubt on reports of cardiac risks associated with the