FDA/CDC

FDA authorizes Pfizer’s COVID-19 vaccine for kids


 

The Food and Drug Administration 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.

FDA icon

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 virus in the United States.

States have already placed their orders for initial doses of the vaccines. The Oct. 29 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 Nov. 2 to vote on recommendations for use of the vaccine.

As soon as the Centers for Disease Control and Prevention’s director signs off on those recommendations, children can get the shots, perhaps as early as Nov. 3.

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 United States 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.

A version of this article first appeared on WebMD.com.

Recommended Reading

FDA authorizes boosters for Moderna, J&J, allows mix-and-match
MDedge Pediatrics
The compass that points toward food
MDedge Pediatrics
CDC panel backs COVID-19 boosters for nearly all adults
MDedge Pediatrics
Unvaccinated people likely to catch COVID repeatedly
MDedge Pediatrics
Pandemic exacerbates primary care practices’ financial struggles
MDedge Pediatrics
FDA panel votes to approve Pfizer’s vaccine for children
MDedge Pediatrics
Ohio records more deaths than births for first time
MDedge Pediatrics
The devil in the (masking) details
MDedge Pediatrics
Chatbots can improve mental health in vulnerable populations
MDedge Pediatrics
CDC: Urgency remains to vaccinate children
MDedge Pediatrics