FDA has announced revisions for Moderna and Pfizer-BioNTech COVID-19 vaccines regarding the increased risks of myocarditis and pericarditis

Today (June 25, 2021), 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.

source: FDA

Fact Sheet for Healthcare Providers Administering Vaccine

Fact Sheet for Healthcare Providers Administering Vaccine

Myocarditis and Pericarditis
Reports of adverse events following use of the Pfizer-BioNTech COVID-19 Vaccine
under EUA suggest increased risks of myocarditis and pericarditis, particularly
following the second dose. Typically, onset of symptoms has been within a few days
following receipt of the Pfizer-BioNTech COVID-19 Vaccine. Available data from
short-term follow-up suggest that most individuals have had resolution of symptoms,
but information is not yet available about potential long-term sequelae. The decision
to administer the Pfizer-BioNTech COVID-19 Vaccine to an individual with a history
of myocarditis or pericarditis should take into account the individual’s clinical
circumstances. The CDC has published clinical considerations relevant to
myocarditis and pericarditis associated with administration of the Pfizer-BioNTech
COVID-19 Vaccine

(https://www.cdc.gov/vaccines/covid-19/clinicalconsiderations/myocarditis.html).

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