FDA Advisory Board Recommends Approving Pfizer COVID-19 Vaccine for Children 5 to 11

dalek writes:

As expected, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended to amend the emergency use authorization for Comirnaty, Pfizer's COVID-19 vaccine, for use by children of ages 5 to 11. The vote was 17-0 with one committee member abstaining. The committee was concerned about the possible side effect of myocarditis in children and the lack of data about its frequency. However, the committee decided the benefits from vaccination outweighed possible safety risks. This is based on a clinical trial involving 2,268 children, of which two-thirds were given the vaccine while the other third was given a placebo. During the clinical trial, 16 children who received the placebo developed COVID-19 compared with three children who were vaccined and became symptomatic with COVID-19, which is an efficacy of 91% at preventing symptomatic COVID-19.

Some committee members expressed concern that the clinical trial was too small to properly quantify the risks of myocarditis, which is an inflammation of the heart. Children will receive two doses spaced three weeks apart, each containing 10 micrograms of mRNA, which is a third of the dosage given to adults. Here is the briefing document submitted to VRBPAC by Pfizer containing results of the clinical trials of Comirnaty in young children. The document specifically notes that myocarditis is associated with COVID-19 in children:

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