A COVID-19 vaccine for ages 5-11 won support Tuesday from a Food and Drug Administration advisory panel.
That sets the stage for the final steps in a process that could lead to the first pediatric vaccine becoming available as early as next week, according to national media reports.
On Tuesday, the FDA committee voted 17-0, with one abstention, to recommend emergency authorization for the Pfizer-BioNTech vaccines for the age group.
The recommendation is now before Acting FDA Commissioner Janet Woodcock. If she agrees with it, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization would review the vaccine at its meeting, scheduled for Nov. 2. The panel could decide whether to recommend the vaccine for all children or children with specific health risks.
If the CDC panel approves the vaccine, CDC Director Rochelle Walensky could give her final approval within hours.
The FDA advisory panel recommended Tuesday the vaccine be given as two doses consisting of 10 micrograms. Members said the shots should be given three weeks apart for ages 5-11.
Each dose would be a third of that given to teens and adults.
Pfizer submitted data to the FDA that the company said shows the vaccine is more than 90% effective against symptomatic disease for children in the 5-11 age group.
Pfizer’s data came from two studies, which involved 2,268 children ages 5-11. The youths either received two doses of the vaccine or two doses of a placebo, which is standard practice in clinical trials.
Of the children who got the vaccine, three tested positive for COVID-19, according to Pfizer. The company said among those in the placebo group, 16 tested positive for COVID after the second dose.
Last week the Biden administration announced it had a plan to administer the vaccine to 28 million American children. Under that plan, free vaccines would be available at doctors’ offices, children’s hospitals, pharmacies, and school- and community-based clinics.
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