Maine Medicine Weekly Update - June 19 - June 26 (Plain Text Version)
In this issue:
FDA to revise vaccine fact sheets on increased risk of myocarditis
FDA to revise vaccine fact sheets on increased risk of myocarditisThe FDA announced Friday they will revise the patient and provider fact sheets for the Moderna and Pfizer-BioNTech COVID-19 vaccines regarding the suggested increased risks of myocarditis and pericarditis following vaccination.
The FDA announced Friday they will revise 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.
The decision comes after the CDC Advisory Committee on Immunization Practices (ACIP) on Wednesday identified a “likely association” between the two mRNA vaccines and cases of myocarditis and pericarditis.
According to the FDA, the update follows an extensive review of information and the discussion by CDC’s Advisory Committee on Immunization Practices meeting on Wednesday.
· Reports describe the illness predominantly in males under 30 followingthe second dose of an mRNA vaccine, with most cases appearing to resolve themselves.
· More than 150 million people have received either the Pfizer or Moderna vaccine, making the 1,200-plus documented cases rare.
· 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.
· 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.