By Megan Redshaw<\/p>\n
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The U.S. Food and Drug Administration (FDA) on June 25 added a warning to patient and provider fact sheets<\/a> for Pfizer<\/a> and Moderna<\/a> COVID vaccines indicating an increased risk of myocarditis and pericarditis following vaccination.<\/p>\n The warning notes<\/a> 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.<\/p>\n Myocarditis<\/a> is inflammation of the heart muscle that can lead to cardiac arrhythmia and death. According to researchers<\/a> at the National Organization for Rare Disorders, myocarditis can result from infections, but \u201cmore commonly the myocarditis is a result of the body\u2019s immune reaction to the initial heart damage.\u201d<\/p>\n Pericarditis<\/a> is often used interchangeably<\/a> with myocarditis and refers to inflammation of the pericardium, the thin sac surrounding the heart.<\/p>\n The FDA\u2019s update followed a review of information and discussion by the Centers for Disease Control and Prevention\u2019s (CDC) Advisory Committee on Immunization Practices (ACIP) meeting on June 23<\/a> where the committee acknowledged 1,200 cases of heart inflammation in 16- to 24-year-olds and said mRNA COVID vaccines should carry a warning statement.<\/p>\n \u201cThe data presented at this meeting reinforced the FDA\u2019s decision to revise the fact sheets and further informed the specific revisions,\u201d the FDA said in a statement.<\/a><\/p>\n Health officials said<\/a> the benefits of receiving a COVID vaccine still outweigh any risks. Physicians and other public commenters accused the CDC<\/a> during the meeting of exaggerating the risk to young people of COVID, and minimizing the risk of the vaccines.<\/p>\n Dr. Meryl Nass<\/a>, an internal medicine physician, pointed out several flaws in the data used during the ACIP\u2019s presentation:<\/p>\n \u201cAs of now, two major ways the rate of myocarditis were minimized [during the presentation] was to lump people from age 39 and down \u2014 even though the highest rates [of myocarditis] are in the youngest kids. This waters down the rate. The other method was to only include a very narrow window of time after vaccinations started in the 12-15 age group, thus omitting the vast majority of second doses, which is when about 75% or more of the myocarditis cases occur. Also, the genders were sometimes mixed. And rates in girls are much lower than boys.\u201d<\/p>\n During the CDC\u2019s presentation<\/a>, Dr. Megan Wallance stated the overall efficacy of Pfizer\u2019s COVID vaccine<\/a> in the 12 to 15 age group is 100% and Moderna\u2019s was comparable. Wallace then did a risk\/benefit analysis comparing myocarditis cases versus hospitalization rates for COVID in people between the ages of 12 and 29.<\/p>\n \u201cThe problem with her analysis is that now the myocarditis rate used is too low. But the risk from COVID<\/a> is magnified,\u201d Nass said.<\/p>\n