The Centers for Disease Control and Prevention announced Thursday that it will convene an “emergency meeting” of its advisers on June 18 to discuss rare but higher than expected reports of heart inflammation following doses of Pfizer and Moderna MRNA-based COVID-19.
So far, the CDC has identified 226 reports that could meet the agency’s “working case definition” for myocarditis and pericarditis in the aftermath of the shootings, the agency revealed Thursday. The vast majority have recovered, but 41 had persistent symptoms, 15 are still hospitalized and 3 are in intensive care.
Reports represent only a tiny fraction of the nearly 130 million Americans who have been fully immunized with doses of Pfizer or Moderna.
“It’s a bit of a comparison of apples to oranges because, again, these are preliminary reports. Not all of them will turn out to be true reports of myocarditis or pericarditis,” warned Dr Tom Shimabukuro, an official. vaccine safety from CDC.
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 US Department of Defense earlier this year.
The CDC is working on more data and analysis on the reports ahead of its own advisers’ emergency meeting next week, he said, and also plans to analyze the risk of heart inflammation posed by the capture of COVID-19.
The new details on myocarditis and pericarditis first emerged during presentations to a panel of independent advisers from the Food and Drug Administration, who meet on Thursday to discuss how the regulator should approach the authorization of emergency use for the use of COVID-19 vaccines in young children.
After obtaining emergency use authorization for its COVID-19 vaccine in AmericansLast month, Pfizer announced this week that it had decided on doses to use in a clinical trial in children as young as 6 months old and hoped to submit data by October. Moderna said Thursday that she also sought FDA clearance to give her mRNA vaccine to adolescents.
While Pfizer said they plan to complete trials for children as young as 2 by September, FDA officials have previously warned that vaccine clearance for these age groups may take more time – “mid to late fall” at the earliest – citing additional tracking. the data needed by children after receiving the injections.
“We recognize that some adverse reactions, for example myocarditis or pericarditis, as discussed earlier today, may be too rare to be detected in a safety database of typical size for pre-approval clinical trials,” said Dr. Doran Fink, a senior official with the FDA’s Office of Vaccines.
The CDC previously revealed that cases of heart inflammation were detected mostly in younger men and adolescents after their second dose, and that there was a “higher number of cases seen than expected” in those 16 to 16. 24 years. Last month, the CDC urged providers to “learn about pre-vaccination COVID-19” in patients with symptoms of heart inflammation.
“Risk-benefit considerations in determining whether to issue an emergency use authorization for the use of a COVID-19 vaccine in healthy children will need to take this information into account, and the risk considerations- benefits will likely be different, not only compared to those for adults, but they may also be different for the younger and older pediatric groups, ”said Dr. Marion Gruber, director of the FDA’s office of vaccines, during the presentation. meeting.