FDA authorizes Pfizer’s pediatric COVID-19 vaccine for emergency use

The FDA on Friday authorized the emergency use of the Pfizer-BioNTech pediatric COVID-19 vaccine for children aged 5 to 11 years.

The announcement came days after the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) supported the authorization with a 17-0 vote that said the benefits of the vaccine outweigh the risks.

“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 a press release announcing the authorization.

“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,” Woodcock said.

The regimen for children aged 5 to 11 years is two shots given 21 days apart — the same as in older age groups. However, the dose is smaller — two 10 µg shots instead of two 30 µg shots.

The vaccine was already fully approved for people aged 16 years or older and has been available under an emergency use authorization to children aged 12 to 15 years since May.

In a statement, the AAP said it was “encouraged” by the authorization.

“More than 6 million children have been infected with this virus since the beginning of the pandemic, and children have suffered in numerous other ways,” AAP President Lee Savio Beers, MD, said in a release. “This includes disruptions to their education, harms to their mental and emotional health, and greatly diminished access to critical medical services. Authorization of the vaccine for younger children is an important step in keeping them healthy and providing their families with peace of mind. The vaccine will make it safe for children to visit friends and family members, celebrate holiday gatherings, and to resume the normal childhood activities that they’ve missed during the pandemic.”

The CDC’s Advisory Committee on Immunization Practices will meet on Tuesday to make federal recommendations for the 5- to 11-year-old age group. The White House has already announced plans for a nationwide campaign to roll out and promote the vaccine, with plans to open vaccination centers in schools and community centers and to educate parents and the public.

A document prepared by the companies for the VRBPAC meeting reported that the vaccine’s efficacy against laboratory-confirmed symptomatic COVID-19 occurring at least 7 days after a second dose in children without evidence of a prior SARS-CoV-2 infection was 90.7% (two-sided 95% CI, 67.7%-98.3%), with no reported cases of severe COVID-19 or multisystem inflammatory syndrome in children.