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 after doses of Pfizer and Moderna COVID mRNA-based -19
So far, the CDC has identified 226 reports that could meet the agency’s “definition” of myocarditis and pericarditis after the shootings, the agency revealed on Thursday. Most of them recovered, but 41 had ongoing symptoms, 15 were still hospitalized and 3 were in the intensive care unit.
The reports represent only a small fraction of the nearly 1
“This is a small comparison between apples and oranges, because again these are preliminary reports. Not all of them will be true reports of myocarditis or pericarditis,” warned Dr. Tom Shimabukuro, a CDC vaccine safety officer.
Shimabukuro said their findings were “compatible” mainly with reports of rare cases of heart inflammation that were investigated in Israel and reported by the US Department of Defense earlier this year.
The CDC is working on more data and analysis reports ahead of an emergency meeting of its own advisers next week, he said, and also plans to analyze the risk of heart inflammation caused by catching COVID-19.
The new details of myocarditis and pericarditis first appeared in presentations to a group of independent advisers to the Food and Drug Administration who are meeting on Thursday to discuss how the regulator should approach the emergency use permit for the use of COVID-19 vaccines in younger children.
After obtaining an emergency authorization for his vaccine COVID-19 in Americanslast month, Pfizer announced this week that it has decided on the doses to be used in a clinical trial in children under 6 months of age and hopes to provide data by October. Moderna said Thursday that she, too, has asked the FDA for permission to give her mRNA vaccine to adolescents.
While Pfizer said it expects trials of children under the age of 2 to be completed by September, FDA officials have previously warned that allowing vaccines for these age groups could take longer – “at the earliest” from mid to late fall. “, referring to the additional follow – up data needed for the children after receiving the photos.
“We recognize that some side effects, such as myocarditis or pericarditis, as discussed earlier today, may be too rare to be found in a typical safety database for pre-licensed clinical trials,” he said. Dr. Doran Fink, Senior FDA Vaccine Officer.
The CDC revealed earlier that reports of heart inflammation were found mostly in younger men and teenagers after their second dose, and that there were “more-than-expected” cases in 16- to 24-year-olds. Last month, the CDC called on providers to “ask about a previous vaccination against COVID-19” in patients with symptoms of heart inflammation.
“The risk-benefit considerations to determine whether to authorize the emergency use of COVID-19 vaccine in healthy pediatricians will need to take this information into account, and the risk-benefit considerations are likely to be different. only compared to adults, but they can also be different for younger than older pediatric groups, ”said Dr. Marion Gruber, director of the FDA’s Vaccine Service.