FDA ADDS A WARNING TO COVID-19 VACCINES ABOUT RISK OF HEART INFLAMMATION
The US Food and Drug Administration added a warning about the risk of myocarditis and pericarditis to fact sheets for Moderna and Pfizer-BioNTech Covid-19 vaccines, CNN reported.
The warning notes that reports of adverse events following vaccination -- particularly after the second dose -- suggest increased risks of both types of heart inflammation.
Today, the FDA is announcing revisions to the patient and provider fact sheets for the Moderna and Pfizer-BioNTech COVID-19 vaccines regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination. For each vaccine, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) has been revised to include a warning about myocarditis and pericarditis and the Fact Sheet for Recipients and Caregivers has been revised to include information about myocarditis and pericarditis. This update follows an extensive review of information and the discussion by CDC’s Advisory Committee on Immunization Practices meeting on Wednesday. The data presented at this meeting reinforced the FDA’s decision to revise the fact sheets and further informed the specific revisions. The warning in the Fact Sheets for Healthcare Providers Administering Vaccines notes that reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly following the second dose and with onset of symptoms within a few days after vaccination. Additionally, the Fact Sheets for Recipients and Caregivers for these vaccines note that vaccine recipients should seek medical attention right away if they have chest pain, shortness of breath, or feelings of having a fast-beating, fluttering, or pounding heart after vaccination. The FDA and CDC are monitoring the reports, collecting more information, and will follow-up to assess longer-term outcomes over several months."
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CDC has confirmed about 300 of those cases, many of them among young men and adolescents. But patients are recovering quickly, Dr. Matthew Oster, a pediatric cardiologist, told the advisers, CNN reports. Almost all the cases resolved with little treatment and patients recovered quickly. The advisers said that the benefits of vaccination outweigh the risks.