Source: Yonhap News
The U.S. Food and Drug Administration (FDA) has released an analysis of the “benefits outweighs the risks” of administering the Pfizer vaccine to children.
According to AP/Bloomberg, the FDA said in a report released on the 22nd local time that children aged 5 to 11 are given one-third of the adult dose of the Pfizer vaccine.
The FDA analyzed that the benefit of preventing death or hospitalization due to COVID-19 outweighs the risk of side effects such as myocarditis in most scenarios given under these conditions.
Whether or not to approve the emergency use of Pfizer’s vaccine for children 5-11 years old is expected to be finalized on the 26th after a decision by an advisory body outside the FDA is issued.
When an approval recommendation is issued, the Centers for Disease Control and Prevention (CDC) will select children to be vaccinated and vaccinate as early as next month, the Associated Press predicted.
Meanwhile, in the report, released four days before the advisory group’s decision, the FDA did not explicitly state that it should allow emergency approval of Pfizer vaccines for those age groups.
Earlier this morning, the FDA released data from a study on vaccinations for children aged 5 to 11 years submitted by Pfizer.
Pfizer explained that in a clinical trial conducted with 2,268 children aged 5 to 11 years old, Pfizer explained that the effect of preventing COVID-19 was calculated to be 90.7% as a result of receiving one-third of the adult dose.
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