The Food and Drug Administration (FDA) added a word of caution on Friday to the literature affixed on Moderna and Pfizer COVID vaccine shots, indicating the potential risk of heart inflammation. According to the FDA, for every vaccine, the fact sheets for healthcare providers have been modified to insert a warning, reporting incidents that suggest increased risks of pericarditis and myocarditis particularly after the second shot and with the onset of symptoms within a few days after inoculation.
As of June 11, over 1,200 cases of pericarditis or myocarditis have been reported to the US Vaccine Adverse Event Reporting System (VAERS) out of around 300 million mRNA vaccine shots administered. It appeared that the cases were notably higher in males and in the week following the second vaccine shot.
According to the Centers for Disease Control and Prevention (CDC), the findings do not alter the basic recommendation that all people 12 and older should be inoculated against the novel coronavirus. However, with vaccination rates slowing as the Delta variant becomes prevalent nationwide, the susceptibility may add to the concerns that vaccine skeptics already hold as reasons not to get vaccinated.
The most recent update follows an expansive review of data and the discussion by CDC's Advisory Committee on Immunization Practices meeting on Wednesday, reported The Edge Markets.
The CDC identified 309 hospitalizations from heart inflammation among individuals under the age of 30. Two hundred ninety-five of them have been discharged. Health regulators in many countries have been probing into cases of pericarditis and myocarditis after a dose of Moderna or Pfizer, vaccines that are based on the mRNA technology, reported Fox Business.
Meanwhile, Moderna and Pfizer did not immediately respond to requests for comment.
Dr. Mark Sawyer, an infectious disease specialist at San Diego's Rady Children's Hospital and pediatrics professor at the University of California San Diego, recently treated two of the eight boys under 15 years old who were brought to the hospital late after experiencing the painful inflammatory condition.
According to Sawyer, "Naturally it's concerning when you hear about inflammation in the heart, but I want to reassure people that it's really not fundamentally different from inflammation in your arm muscle when you got the vaccine. We don't think it has any long-term consequences, just like we don't think your arm muscle has any long-term consequences," reported NBC San Diego.
As explained by the experts, pericarditis is the inflammation of the membrane bordering the heart while myocarditis is underscored by inflammation of the heart muscle.
The condition is rare, with over 1,200 cases under probing as of June 11 among over 150 million people who have been inoculated with either the Moderna or Pfizer COVID-19 vaccine.
VAERS indicates there were 347 observed cases of heart inflammation in the week following the second vaccine shot in males from 12 to 24 years old.