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The Centers for Disease Control and Prevention announced Thursday that it will hold an “emergency meeting” of its advisors on June 18 to discuss rare but higher-than-expected reports of heart inflammation after doses of Pfizer and our suppliers for COVID-19. Vaccines.
To date, the CDC has identified 226 reports that may meet the agency’s “working case definition” for post-injection myocarditis and pericarditis, the agency revealed Thursday. The vast majority have recovered, but 41 have had persistent symptoms, 15 are still hospitalized, and 3 are in the intensive care unit.
Reports represent only a small percentage of the approximately 130 million Americans who have been fully vaccinated with either Pfizer or Moderna doses.
“It’s kind of like comparing apples to oranges because again these are preliminary reports. It’s not going to turn out that all of these reports relate to myocarditis or pericarditis,” warned Dr. Tom Shimabukuro, CDC’s Vaccine Safety Officer.
Shimabukuro said their findings are mostly “consistent” with reports of rare cases of carditis studied in Israel that were reported from the US Department of Defense earlier this year.
He said the CDC is working on more data and analysis on the reports ahead of an emergency meeting of its advisors next week, and plans to analyze the risks of COVID-19-related carditis.
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New details about myocarditis and pericarditis first emerged in presentations before a panel of independent advisors to the Food and Drug Administration, who are meeting Thursday to discuss how the regulator will address emergency use authorization to use COVID-19 vaccines in younger children.
After receiving an emergency use authorization for a COVID-19 vaccine in Americans under 12 last month, Pfizer announced this week that it has decided which doses to use in a clinical trial in children as young as 6 months old and hopes to provide the data by October. Moderna said Thursday that it has also requested permission from the Food and Drug Administration to give the mRNA vaccine to teens.
While Pfizer said it expects to end trials for young children through September 2, FDA officials have previously warned that licensing vaccines for these age groups could take longer — “at least from mid to late fall,” citing additional follow-up — until data is needed. For children after receiving the shots.
“We are aware that some adverse reactions, for example myocarditis or pericarditis as discussed earlier today, may be very rare to be detected in a safety database of the typical size of pre-licensing clinical trials,” said Dr. Doran Fink, a senior official with FDA Vaccines Office.
The CDC previously revealed that reports of carditis were mostly detected in younger men and adolescents after the second dose, and that there were “more cases than expected” in people ages 16 to 24. Last month, the Centers for Disease Control and Prevention urged providers to “ask about prior COVID-19 vaccination” in patients with symptoms of carditis.
“Risk-benefit considerations to determine whether an emergency use authorization for the use of the COVID-19 vaccine will need to account for this information, and the risk-benefit consideration is likely to differ, not only compared to those of private individuals, and the risk-benefit consideration is likely to differ, not just compared to those of the private sector,” said Dr. The Food and Drug Administration at the meeting is adults, but they may also differ for younger versus older children.
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