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Benefits outweigh risks for Pfizer-BioNTech vaccine in children: FDA

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eMediNexus    24 October 2021

The U.S. Food and Drug Administration (FDA) experts have said that the benefits of administering the Pfizer-BioNTech COVID-19 vaccine to children ages 5 to 11 years clearly outweigh the risks of rare myocarditis cases.

Earlier on Friday, the companies had stated that their vaccine had an efficacy of 90.7% against the coronavirus in a clinical trial that included 5-11-year-olds. A panel of outside experts is scheduled to vote on Tuesday on whether to recommend that the FDA authorize the jab for the younger age group. If authorized by the FDA, it would be the first COVID vaccine for this age group and will likely be available in the United States early next month.

Pfizer has stated in its briefing documents that the rate of myocarditis in the age group will possibly be lower than that seen in vaccinated children ages 12 to 15 years, partly because a lower dose was given to younger children… (Reuters, October 23, 2021)

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