The Centers for Disease Control and Prevention announced Thursday that a meeting would be held. An “emergency meeting” of advisors on June 18 to discuss a rare report of heart inflammation. But higher than expected after Pfizer’s mRNA-based and Moderna COVID-19 doses.
So far, the CDC has identified 226 reports that may follow. The agency’s “working case definitions” on myocardial infarction and pericarditis after firing. The agency said Thursday. Most have recovered, but 41 have continued symptoms, 15 are still hospitalized and three are in the ICU.
Such reports are only a tiny fraction. of nearly 130 million Americans who have received the full dose of Pfizer or Moderna vaccine.
Dr. Tom Shimabukuro, CDC’s Vaccine Safety Officer, cautions, “Comparing apples to oranges is quite similar. Because this is a preliminary report. Not all of these will become true reports of myocardial infarction or pericarditis.”
Shimabukuro said their findings were largely “consistent” with the rare case reports 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 on reports ahead of its advisers’ emergency meeting next week, he said, and also plans to analyze the risk of heart inflammation caused by COVID-19 infection.
New details on myocarditis and pericarditis appear first in presentations to the Food and Drug Administration’s independent advisory panel. They are meeting on Thursday to discuss how regulators should approve the use of the COVID-19 vaccine. in case of emergency in young children
after being allowed to use the COVID-19 vaccine In an emergency in Americalast month Pfizer announced this week it had decided to use the dose in a clinical trial in six-month-old children and hopes to submit it by October. Moderna said Thursday it had asked for permission from the FDA to provide the mRNA vaccine to adolescents.
Pfizer, meanwhile, said they expect to complete the trial for children up to two years old by September. FDA officials had previously warned that approval of the vaccine for these age groups could take longer – “mid to late fall” at the earliest – citing additional follow-up – information needed for children after get shot
“We recognize that some adverse reactions, such as myocardial infarction or pericarditis, as discussed previously, It may not be too frequent to be detected in a normal-sized safety database for pre-licensing clinical trials,’ said Dr. Doran Fink, senior author at the National Institutes of Health. Vaccine Office of the FDA.
The CDC previously revealed that most reports of heart inflammation were detected in younger men and adolescent boys after the second dose. and the number of patients observed “The number observed was higher than expected” among 16 to 24 year olds. Last month, the CDC called on providers to “Ask about early COVID-19 vaccination” in patients with heart disease
“Considering the risks and benefits in considering whether to license the use of the COVID-19 vaccine. In an emergency in a healthy child? This information must also be taken into account. And the risk-benefit considerations tend to be different. Not only was it compared to that for adults, Dr. Marian Gruber, director of the FDA’s Vaccine Office, said at the meeting that adults, it could also be different among younger and older children.