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FDA Advisors Approve Emergency Use of Pfizer Vaccine in Children 5 to 11

Vote was nearly unanimous at 17 to 0, with one abstention; FDA expected to make a final ruling in a matter of days

By Physician’s Briefing Staff | October 26, 2021

A U.S. Food and Drug Administration advisory panel voted Tuesday to recommend emergency use of a smaller dose of the Pfizer COVID-19 vaccine for children aged 5 to 11 years, advancing plans to offer the shots to 28 million young children across the United States.

The vote was nearly unanimous at 17 to 0, with one abstention, and the FDA is expected to make a final ruling in a matter of days.

If approved by the FDA and then the U.S. Centers for Disease Control and Prevention, the Pfizer pediatric vaccine would involve a two-dose series of 10-mcg shots, about one-third of the dosage administered to adults and children aged 12 years or older. Two doses of the Pfizer vaccine are nearly 91 percent effective in preventing symptomatic illness in young children and bring no unexpected safety issues, according to a study posted Friday by the FDA.

The CDC vaccination advisors are now set to meet Nov. 2 to weigh in on the pediatric vaccine. Once they have spoken, CDC Director Rochelle Walensky, M.D., is expected to sign off on the panel's recommendation. After that comes the Biden administration plans to roll out the vaccine through pediatricians' offices, community clinics, and pharmacies, as they hope to reassure hesitant parents that the vaccine will protect their children from COVID-19.

The White House has decided that pediatric COVID-19 shots will be delivered in settings that parents know and trust, rather than mass vaccination sites. More than 25,000 pediatric and family doctor clinics will provide vaccinations to children, along with tens of thousands of pharmacies, children's hospitals, and community health centers, according to the White House plan.

"Our planning efforts mean that we will be ready to begin getting shots in arms in the days following a final CDC recommendation," a White House statement on the plan said. "These steps will be critical in ensuring that we are staying ahead of the virus by keeping kids and families safe, especially those at highest risk."


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