June 11, 2021 –Swelling heart It appears to be a very rare side effect that primarily affects adolescents after COVID-19 vaccination, reported by CDC experts on Thursday. Myocarditis And Pericarditis Discovered through the government safety system.
Side effects appear to be more common in teenage boys and young men than in older people and women, and can occur in 16 cases for every 1 million people who receive a second dose, according to the CDC. Dr. Tom Shimabukuro, Deputy Director of Immunization Safety, said. An office that provided information about the incident to a panel of experts who advised the FDA: vaccine..
William Schaffner, MD, MD, an infectious disease expert at Vanderbilt University in Nashville, believes that certain features point to “rare but real” signals. First, the events are clustered and occur within a few days of vaccination. Second, they tend to be more common in men and younger people. Third, he states that the number of events exceeds the so-called “background rate”.
“I don’t think we’re that far yet. I haven’t tied the ribbon, but I think the data is heading in that direction,” he said.
The problem with myocarditis is vaccine Consideration by the Advisory Board on Biological Products and related bioproducts regarding the type and amount of data required to authorize the use of the vaccine against COVID in children.
Due to the low COVID hospitalization rate of children, the FDA has been for at least one year vaccine In clinical trials, the amount of data normally required for full approval instead of the two months currently required for an emergency use authorization. Some wondered if the risk of vaccination outweighed the benefits of this age group.
“I don’t really think this is a children’s emergency,” said Dr. Michael Krilla, a committee member who is the director of clinical innovation at the National Institutes of Health. However, Kurilla said he thought it might make sense to expand access programs for high-risk children.
Most of the young people who experienced myocarditis recovered quickly, but three needed intensive care and rehabilitation after the episode. Of the cases with known results, 81% have improved and 19% are still symptomatic.
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