FDA Meeting on Covid-19 Vaccine for Children – .

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FDA Meeting on Covid-19 Vaccine for Children – .


Myocarditis after Covid-19 vaccination is rare, but there are still studies needed to learn more about long-term outcomes, a State Centers for Disease Control and Prevention Covid-19 response official said on Tuesday. -United with U.S. Food and Drug Administration vaccine advisers.

The FDA’s Vaccines and Related Biologics Advisory Committee is meeting to determine whether to recommend the agency to authorize Pfizer’s Covid-19 vaccine for people aged 5 to 11.

Rare incidents of myocarditis – inflammation of the heart muscle – have already been linked to Pfizer’s Covid-19 vaccine.

Myocarditis is generally more common in young men, and this was also the case after vaccination against Covid-19, pediatric cardiologist Dr Matthew Oster told the panel; the theory is that it is linked to testosterone and hormone levels, which may explain why the risk peaks in adolescence and early adulthood. If this trend continues, Oster said, one would expect the risk to be lower for children aged 5 to 11, even after vaccination.

But presentations and outcomes for myocarditis may differ, Oster told FDA advisers, and it’s not clear how easily the types of myocarditis can be compared. “Classic” myocarditis, like that seen before Covid-19, is often linked to infections, but often a cause is not identified, and it can be serious. Myocarditis can also occur after Covid-19, or multisystem inflammatory syndrome in children, or MIS-C, a rare and serious complication of Covid-19 that affects children.

People who suffered from myocarditis after the Covid-19 vaccination tended to recover quickly, but data on potential long-term effects are limited, Oster said.

Of the 1,640 reports of potential myocarditis in people 29 years of age or younger in the CDC’s Vaccine Adverse Event Reporting System through October 6, 877 cases were investigated and responded to the decision of. myocarditis and 637 other cases were still under review, Oster said. Of the 877 confirmed cases, 829 resulted in hospitalization and 789 were discharged. Seventeen cases remain hospitalized, including five in intensive care.

“Not all myocarditis is the same. There may be similarities in presentation with some or in acute results with others, ”Oster said. “We really have to see what the long term results will be for these kids. So far, data for monitoring results is scarce but continuous monitoring is ongoing. “

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