Oct. 29, 2021 — The FDA has authorized Pfizer’s COVID-19 vaccine for children ages 5 to 11, which means vaccines could be available to school-aged children starting next week.
The move brings families with young children a step closer to resuming their normal activities, and it should help further slow transmission of the coronavirus in the U.S.
States have already placed their orders for initial doses of the vaccines. Friday’s FDA authorization triggers the shipment of millions of doses to pediatricians, family practice doctors, children’s hospitals, community health centers, and pharmacies.
Next, a panel of experts known as the Advisory Committee on Immunization Practices, or ACIP, will meet on Tuesday to vote on recommendations for use of the vaccine.
As soon as the CDC director signs off on those recommendations, children can get the shots, perhaps as early as next Wednesday.
Pfizer’s vaccine for children is 10 micrograms, or one-third of the dose given to teens and adults. Kids get two doses of the vaccine 3 weeks apart. In clinical trials, the most common side effects were pain at the injection site, fatigue, and headache. These side effects were mild and disappeared quickly. There were no serious adverse events detected in the studies, which included about 3,100 children. In one study, the vaccine was 90% effective at preventing COVID-19 infections with symptoms in younger children.
There are about 28 million children in the U.S. between the ages of 5 and 12.
“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Acting FDA Commissioner Janet Woodcock, MD, said in an FDA news 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,” she said.
Since the start of the pandemic, there have been at least 1.9 million cases of COVID-19 in children ages 5 through 11. At least one-third of the children who have been hospitalized for the infection have had no underlying medical conditions.
The FDA also approved a manufacturing change to the vaccine, which does not affect the safety profile of the shots, said Peter Marks, MD, who directs the FDA’s Center for Biologics Evaluation and Research.
The change makes the vaccine more stable at refrigerator temperatures for longer periods of time, Marks said.
“If I had a child in this age group, I would not hesitate, for a second, to give my child one of these vaccines,” Marks said.
Marks said the companies are still studying the use of the vaccines in even younger children and that COVID-19 vaccines were still a few months away for children under 5.