The Food and Drug Administration has approved Pfizer-BioNTech’s COVID-19 shot for children ages 5 to 11, paving the way for 28 million children to get vaccinated in the U.S.
The federal agency announced its approval on an emergency use basis on Friday. The Centers for Disease Control and Prevention’s vaccine advisory committee will next meet to review the FDA’s decision on Nov. 2-3. It’s expected to recommend it shortly after.
The FDA’s decision comes after an advisory panel for the agency decided unanimously that the vaccine’s benefits for children outweigh any potential risks.
“Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” said acting FDA Commissioner Janet Woodcock in a press release. “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.”
Pfizer’s vaccine had already been approved for children ages 12 to 15 on an emergency use basis, an approval that was made in May.
Pfizer has said that its smaller, pediatric-sized coronavirus vaccine is nearly 91% effective at preventing symptomatic infections in 5- to 11-year-olds. The most common side effects reported were fatigue, headache, muscle pain and chills, which are similar side effects documented in older children and adults.
Pfizer’s vaccine requires two doses that are administered three weeks apart. It then takes two weeks for full protection to kick in.
The White House has said that it has purchased enough doses, as well as smaller, child-sized needles, to vaccinate all of the nation’s 5- to 11-year-olds.
“The U.S. Department of Health and Human Services is working hand-in-hand with states to make this vaccine supply available in communities across the country as rapidly as possible,” the White House said last week.
This is a developing story. Please check back for updates.