Pfizer says its vaccine is 90.7% effective against symptomatic COVID-19 in children ages 5 to 11

(CNN) — Pfizer assured that its vaccine is safe and 90.7% effective against symptomatic covid-19 in children 5 to 11 years old, in a new document published ahead of a key meeting of US Food and Drug Administration (FDA) vaccine advisers.

In the trial, which included about 2,000 children, there were three cases of Covid-19 in the group that received the vaccine and 16 cases in the placebo group. In the study, twice as many children received the vaccine as the placebo.

Pfizer/BioNTech requested authorization for emergency use of the FDA for a two-dose regimen of its 10-microgram dose for children 5 to 11 years of age. The two doses will be administered three weeks apart.

Last month, Pfizer released the details of a phase 2/3 trial that showed its COVID-19 vaccine was safe and produced a “strong” antibody response in children ages 5 to 11.

The trial included 2,268 participants between the ages of 5 and 11. Participants’ immune responses were measured by looking at the levels of neutralizing antibodies in their blood and comparing those levels with those of a control group of 16 to 25-year-old children given a two-dose regimen with the higher dose of 30 micrograms.

Pfizer said the levels compared well to those of older people who received the largest dose, demonstrating a “strong immune response in this group of children one month after the second dose.”

The FDA’s Advisory Commission on Vaccines and Related Biologics is scheduled to meet Oct. 26 to discuss whether to recommend licensing the vaccine for children ages 5 to 11.

If licensed, it would be the first COVID-19 vaccine for young children. The Pfizer / BioNTech vaccine is approved for individuals 16 years of age and older and has an emergency use authorization for individuals 12-15 years of age.

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