The Centers for Disease Control and Prevention announced Thursday that it would hold an emergency meeting of its advisers on June 18th. The purpose of the meeting will be to discuss rare but higher-than-expected reports of heart inflammation following the doses of Covid vaccinations (Pfizer and Moderna).
So far, 226 reports have been identified by the CDC that might meet the working case definition of pericarditis and myocarditis following the shots. The vast majority have recovered, but forty-one had ongoing symptoms, fifteen are still hospitalized, and three are in the intensive care unit. The reports represent just a small fraction of the nearly 130 million Americans who have been fully vaccinated.
“It’s a bit of an apples-to-oranges comparison because, again, these are preliminary reports. Not all these will turn out to be true myocarditis or pericarditis reports,” cautioned Dr. Tom Shimabukuro, a CDC vaccine safety official. Tom said their findings are mostly consistent with heart inflammation reports very rare that had been studied in Israel and earlier this year reported from the U.S. Department of Defense. According to him, CDC is working on more data and analysis on the reports ahead of the emergency meeting next week and also will analyze the risk of heart inflammation caused by Covid.
The new details about pericarditis and myocarditis emerged 1st in presentations to a panel of independent advisers for the Food and Drug Administration. These advisers are meeting on Thursday to discuss how the regulator should approach emergency use authorization for using Covid vaccines in young children. After earning an emergency use authorization for its vaccine for Covid in the U.S. as young as 12 months, Pfizer announced this week that it will now start a clinical trial of the vaccine at six months old and hope to submit the data by October. Moderna said Thursday it had requested the FDA’s permission for the use of its vaccine to adolescents.
Pfizer said they expect to finish clinical trials for children as young as two by September. FDA officials have previously said authorization for these vaccines will take time for these age groups mid to late fall at the earliest because they would need additional follow-up data needed for children after they receive the shots.
The CDC previously disclosed that reports of heart inflammation were primarily detected in teenage boys and young men following their second dose. There was a higher number of observed than expected cases in 16- to 24-year-olds.