U.S. FDA requires Covid vaccine makers to expand warning about risk of rare heart inflammation

FDA requires Covid vaccine makers to expand warning about risk of rare heart inflammation | CNN 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. Jen Christensen CNN

...

The vaccines’ previous labels warned about the risk of a heart condition called myocarditis, inflammation of the heart muscle, and pericarditis, inflammation of the lining outside the heart, which the US Centers for Disease Control and Prevention website says is rare but possible after vaccination. The new labels will expand that warning to certain age groups.

Research has consistently shown that the mRNA Covid-19 vaccines are safe and effective, and millions of people have gotten them without serious incident. Some studies have found that Covid-19 infection itself carries a higher risk of myocarditis or pericarditis than the vaccine does.

...

...