FDA adds heart inflammation warning to Pfizer, Moderna COVID-19 vaccines
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June 28, 2021 (LifeSiteNews) – The Food and Drug Administration (FDA) has added new warnings of heart inflammation risks to fact sheets for COVID-19 vaccines made by Pfizer-BioNTech and Moderna.
The warnings refer to myocarditis and pericarditis after a second dose of either vaccine, the FDA announced on Friday. Myocarditis is inflammation of the heart muscle, while pericarditis is inflammation of the lining around the heart. Symptoms, like shortness of breath or chest pain, typically occur within a few days of vaccination, the FDA said.
Fact sheets for both patients and healthcare providers have been updated, the agency said, adding that the change “follows an extensive review of information” and a meeting of the CDC’s vaccine safety committee last week.
The Advisory Committee on Immunization Practices of the CDC (ACIP) had convened on Wednesday and discussed a surge in heart inflammation cases following COVID-19 vaccination. Data presented at the meeting revealed that over 1,200 cases of myocarditis or pericarditis have been reported to U.S. health authorities after a dose of either Pfizer’s or Moderna’s shot.
The higher-than-expected cases included more than 800 among patients who had taken a second COVID-19 vaccine dose. The vast majority of cases involved males, and around 39% involved individuals under 30 years old, according to a presentation by Dr. Tom Shimabukuro, CDC deputy director of vaccine safety.
Public commenters at the ACIP meeting warned that heart inflammation cases, which were reported to the Vaccine Adverse Event Reporting System (VAERS), may be significantly undercounted. VAERS, a vaccine injury surveillance system run by the CDC and the FDA, has been criticized by experts for serious efficacy problems.
The CDC has determined that there is a “likely association” between heart inflammation and the Pfizer and Moderna vaccines. However CDC officials continue to insist that the benefits of the vaccines outweigh the now-acknowledged risks. The CDC and FDA have not recommended a pause on either the Pfizer or Moderna vaccine, as they did with the Johnson & Johnson COVID-19 vaccine earlier this year due to blood clot reports. Children and young adults have a less than 0.1% death rate from coronavirus.
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