FDA Reviews If Moderna's COVID-19 Shot Is Associated With Higher Heart Inflammation Risk

  • 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 PFEBioNTech 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.
  • Photo by Spencer Davis from Pixabay
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