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June 11, 2021 / 07:22 / CBS News
The Centers for Disease Control and Prevention announced Thursday that it is a “Emergency Meeting” from his advisors on June 18 to discuss rare but higher-than-expected reports of heart inflammation following doses of the mRNA-based Pfizer and Moderna COVID-19 vaccines.
So far, the CDC has identified 226 reports that may meet the agency’s “working definition” of myocarditis and pericarditis after the shots, the agency said. announced on Thursday. The vast majority have recovered, but 41 had persistent symptoms, 15 are still hospitalized and 3 are in intensive care.
The reports represent only a small part of the nearly 130 million Americans who have been fully vaccinated with doses of Pfizer or Moderna.
“It’s a bit of an apples-to-oranges comparison because again, these are preliminary reports. Not all of these will turn out to be true myocarditis or pericarditis reports,” warned Dr. Tom Shimabukuro, a CDC vaccine safety officer.
Shimabukuro said their findings were largely “consistent” with reports of rare cases of heart inflammation studied in Israel earlier this year and reported by the US Department of Defense earlier this year.
The CDC is working on more data and analysis of the reports ahead of its own advisers’ emergency meeting next week, he said, and also planned to reduce the risk of heart inflammation by catching heart disease. COVID-19.
The new details about myocarditis and pericarditis first emerged in presentations to a panel of independent advisors for the Food and Drug Administration, meeting Thursday to discuss how the regulator should approach emergency authorization for the use of COVID-19 vaccines in younger children.
After gaining emergency use authorization for its COVID-19 vaccine in Americans as young as 12 last month, Pfizer announced this week that it had decided to use doses in a clinical trial in children as young as 6 months old and hoped to submit data by October. Moderna said on Thursday that it also asked FDA approval to give its mRNA vaccine to adolescents.
While Pfizer has said it expects trials for children as young as 2 to be completed in September, FDA officials have warned before that authorizing vaccines for these age groups could take longer — “mid to late fall” at the earliest — citing the additional follow-up data needed for children after they receive the injections.
“We recognize that some adverse reactions, such as myocarditis or pericarditis, as discussed earlier today, may be too rare to detect in a typical pre-licensing clinical trial safety database,” said Dr. Doran Fink, a top official in the FDA’s vaccine agency.
the CDC previously revealed that reports of heart inflammation were most commonly detected in younger men and teenage boys after their second dose, and that there was a “higher number of observed than expected” cases in 16- to 24-year-olds. Last month, the CDC urged health care providers to “ask about prior COVID-19 vaccination” in patients with symptoms of heart inflammation.
“Risk-benefit considerations to determine whether an emergency authorization to use a COVID-19 vaccine should be issued to healthy pediatric individuals should take this information into account, and the risk-benefit tradeoff is likely to be different, not just 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 Agency, at the meeting.
First published on June 10, 2021 / 15:32
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CBS News reporter on public health and the pandemic.
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