FDA Revises Pfizer, Moderna COVID-19 Vaccine Sheets With Rare Heart Inflammation Warning

  • The FDA on Friday added a warning to patient and provider fact sheets for the Pfizer Inc PFE and Moderna Inc MRNA COVID-19 vaccines to indicate a rare risk of heart inflammation.
  • The fact sheets were revised for each vaccine to warn about myocarditis and pericarditis after the second dose and with the onset of symptoms within a few days after receiving the shot.
  • Myocarditis is the inflammation of the heart muscle, and pericarditis is the inflammation of the tissue surrounding the heart.
  • The FDA update follows a review and discussion by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices meeting on Wednesday. 
  • According to presentation slides from the CDC meeting, more than 1,200 cases of myocarditis or pericarditis cases have been reported, mostly in people 30 and under who received the shots.
  • Price Action: PFE shares are up 0.06% at $39, and MRNA shares are up 1.96% at $224.23 during the market session on the last check Monday.
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Posted In: BiotechNewsHealth CareFDAGeneralBriefsCOVID-19 Vaccine
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