FDA Reviews If Moderna's COVID-19 Shot Is Associated With Higher Heart Inflammation Risk - Moderna (NASDAQ:MRNA), Pfizer (NYSE:PFE), BioNTech (NASDAQ:BNTX)

The U.S. health officials are reviewing reports that Moderna Inc's MRNA COVID-19 vaccine may be linked to a higher risk of a rare heart condition, Washington Post reported, citing people familiar with the matter.
The investigation involves the FDA and the Centers for Disease Control and Prevention, focusing on Canadian data suggesting the Moderna vaccine may be associated with a higher risk of heart inflammation than the Pfizer Inc PFE - BioNTech SE BNTX vaccine, especially for males below the age of 30.
The authorities are also scrutinizing data to determine whether there is evidence of an increased risk from Moderna in the U.S. population.
Related content: Benzinga's Full FDA Calendar.
"While we won't comment on internal meetings, we can say that FDA is absolutely committed to reviewing data as it becomes available to us," the FDA said.
The possible review comes just two days after U.S. health officials said that COVID-19 vaccine booster doses would be available to Americans from September 20.
The benefit of mRNA shots in preventing COVID-19 continues to outweigh the risks, regulators in the U.S. and the EU, and the World Health Organization, have said.
There might be a 2.5 times higher incidence of myocarditis in those who get the Moderna vaccine compared with Pfizer's vaccine, the Post quoted a source as saying.
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