The Centers for Disease Control and Prevention announced Thursday that it will convene an “emergency meeting” for its advisers on June 18 to discuss rare but higher-than-expected reports of heart inflammation after doses of the mRNA-based Pfizer and Modern COVID-19
So far, the CDC has identified 226 reports that may meet the agency’s “workflow definition” of myocarditis and pericarditis after the shots, the agency said Thursday. The vast majority have recovered, but 41 had ongoing symptoms, 15 are still hospitalized and 3 are in the intensive care unit.
The reports represent only a small fraction of the nearly 1
“It’s a bit of a comparison of apples to oranges because it’s again preliminary reports. Not all of these turn out to be true myocarditis or pericarditis reports,” warned Dr. Tom Shimabukuro, a CDC vaccine security officer.
Shimabukuro said their findings were mostly “consistent” with reports of rare cases of heart inflammation that had been investigated in Israel and reported by the U.S. Department of Defense earlier this year.
The CDC is working on more data and analysis of the reports before the emergency meeting with its own advisers next week, he said, and also planned to analyze the risk of heart inflammation by capturing COVID-19.
The new details on myocarditis and pericarditis first appeared in presentations to a panel of independent advisers to the Food and Drug Administration, who will meet on Thursday to discuss how the regulator should approach authorization for the use of COVID-19 vaccines in young children. .
After earning emergency use approval for his COVID-19 vaccine from Americanslast month, Pfizer announced this week that it had decided on doses for use in a clinical trial in children as young as 6 months and hoped to submit data by October. Moderna said Thursday that it had also asked the FDA for permission to give its mRNA vaccine to adolescents.
While Pfizer has said it expects to complete trials with children as young as 2 by September, FDA officials have previously warned that approval of vaccines for these age groups can take “mid to late fall” at the earliest, citing further follow-up up the data needed for children after receiving the shots.
“We recognize that some side effects, such as myocarditis or pericarditis as discussed earlier today, may be too rare to detect in a safety database of typical size for pre-licensed clinical trials,” says Dr. Doran Fink, a senior official in the FDA’s vaccine office.
The CDC previously revealed that reports of myocarditis were mostly detected in younger men and teenage boys after their second dose, and that there were a “higher number of observed than expected” cases in 16- to 24-year-olds. Last month, the CDC urged providers to “ask about previous COVID-19 vaccination” in patients with symptoms of heart inflammation.
“Benefits and risks to decide whether to issue an emergency use authorization for the use of a COVID-19 vaccine to healthy pediatric individuals should take this information into account and risk-benefit considerations are likely to be different, not only compared to those for adults, but they may also be different for younger versus older pediatric groups, “said Dr. Marion Gruber, director of the FDA’s vaccine office, at the meeting.