The Centers for Disease Control and Prevention will convene an advisor’s “emergency meeting” on Thursday, June 18, to discuss rare but higher-than-expected reports of cardiac inflammation after administration of mRNA-based Pfizer and Moderna COVID-19. I announced that.
So far, the CDC has identified 226 reports that may meet the authorities’ definition of working cases for post-fire myocarditis and pericarditis, authorities said Thursday. The majority recovered, but 41 had persistent symptoms, 15 were still hospitalized, and 3 were in the intensive care unit.
The report represents only a small proportion of approximately 130 million Americans who have been fully vaccinated with either Pfizer or Moderna doses.
“This is also a preliminary report, so it’s a comparison of apples and oranges,” said Dr. Tom Shimabukuro, a CDC vaccine safety officer. “Not all of these are reports of true myocarditis or pericarditis. No, “he 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 US Department of Defense earlier this year.
The CDC is working on more data and analysis of the report ahead of its advisor’s emergency meeting next week, and plans to analyze the risk of cardiac inflammation caused by catching COVID-19. He said he was.
New details on myocarditis and pericarditis were first revealed in a presentation to a panel of independent advisors to the Food and Drug Administration. They will meet on Thursday to discuss how regulators should work on an emergency use authorization to use the COVID-19 vaccine in infants.
After obtaining an emergency use authorization for the COVID-19 vaccine in AmericansLast month, Pfizer announced this week that it has decided on the dose to use in clinical trials in 6-month-old children and hopes to submit the data by October. Moderna said Thursday that it requested the FDA for permission to give the mRNA vaccine to adolescents.
Pfizer says it plans to complete trials in children up to the age of two by September, but FDA officials have previously provided additional follow-up to the approval of vaccines for these age groups. I quoted and warned that it could take longer. After the children receive the shot, we will upload the necessary data for the children.
“We are aware today that some side effects, such as myocarditis and pericarditis mentioned above, may be too infrequent to be detected in the general-sized safety database of prelicensed clinical trials. “Masu,” said the FDA’s vaccine office.
The CDC previously disclosed that reports of cardiac inflammation were detected primarily in young men and teenage boys after the second dose, with “more observed” cases between the ages of 16 and 24 years. did. Last month, the CDC urged 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 for the use of the COVID-19 vaccine in healthy children should take this information into account, and the risk-benefit considerations are It can be different not only for adults, but also for younger and older pediatric groups, “Dr. Marion Gruber, director of the FDA’s vaccine office, said at the conference.
CDC is planning an “emergency meeting” on rare heart inflammation after COVID-19 vaccination
Source link CDC is planning an “emergency meeting” on rare heart inflammation after COVID-19 vaccination