Health
CDC plans “emergency meeting” on rare heart inflammation after COVID-19 vaccine
The Centers for Disease Control and Prevention announced on Thursday that it would hold a meeting. “Emergency meeting” On June 18, an advisor discussed a rare but higher-than-expected report of cardiac inflammation after administration of mRNA-based Pfizer and Moderna. COVID-19 (New Coronavirus Infection) vaccine.
To date, the CDC has identified 226 reports that may meet the “working case definition” of the post-shot myocarditis and pericarditis authorities. Disclosure on thursdayThe majority recovered, but 41 remained symptomatic, 15 were still hospitalized, and 3 were in the intensive care unit.
The report is Nearly 130 million Americans Those who have been completely vaccinated with either the Pfizer or Moderna vaccine.
“It’s like a comparison of apples and oranges. It’s also a preliminary report. Not all of these prove to be true myocarditis or pericarditis reports,” the CDC said. Vaccine safety official Dr. Tom Shimabukuro warned.
Shimabukuro said their findings were “in line” with reports of rare cases of heart inflammation that were studied in Israel and reported by the Pentagon earlier this year.
He said the CDC is working on analyzing more data and reports prior to an emergency meeting of his advisors next week, and also analyzes the risk of cardiac inflammation caused by capture. He said he was planning. COVID-19 (New Coronavirus Infection)..
New details on myocarditis and pericarditis were first revealed in a presentation to the academy. Panel of independent advisors The Food and Drug Administration (FDA), which meets Thursday, discusses how regulators should approach emergency use authorizations for the use of the COVID-19 vaccine in infants.
After obtaining an emergency use authorization for the COVID-19 vaccine in Americans 12 years old Last month, Pfizer announced this week that it would like to determine the dose to be used in clinical trials in 6-month-old children and submit the data. By octoberModerna said Thursday I also requested it FDA approval to administer mRNA vaccine to adolescents.
Pfizer said it plans to complete the trial for a two-year-old child by September, but FDA officials said Previously warned Vaccine approval for these age groups can take longer, which means that it can be “mid-autumn to late autumn” at the earliest.
“We find that some adverse reactions, such as myocarditis and pericarditis discussed today, are too rare to be detected in a typical size safety database of prelicensed clinical trials. We are aware of that, “says Dr. Doran Fink. FDA Vaccine Office.
CDC Previously disclosed Reports of cardiac inflammation were detected primarily in young men and teenage boys after the second dose. And what happened “More than expected” cases between the ages of 16 and 24. Last month, the CDC asked healthcare providers to “ask about previous COVID-19 vaccination” for patients with symptoms of heart inflammation.
“Risk-benefit considerations for deciding whether to issue an emergency use authorization to use the COVID-19 vaccine in healthy children should take this information into account. Adults as well as younger children’s groups And the elderly pediatric group can also be different, “said Dr. Marion Gruber, director of the FDA’s vaccine office, at the conference.
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