The U.S. Food and Drug Administration on Friday approved an emergency use authorization of a lower dose of Pfizer’s COVID-19 vaccine for children aged 5 to 11, clearing another hurdle before those younger children may be able to receive the vaccine.
“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 Dr. Janet Woodcock said in a statement. “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.”
The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday overwhelmingly recommended the lower dose of the vaccine for those younger age groups.
Pfizer’s dose for those younger children are a third of what adults receive, the company said, and in clinical trials proved to be 90 percent effective at preventing symptomatic infection in those children.
The next step is for a Centers for Disease Control and Prevention advisory panel to meet Tuesday and debate whether to also recommend the vaccine for those aged 5 to 11.
If the CDC committee does approve the use, it will be up to CDC Director Rochelle Walensky to make the final decision. If she approves, vaccinations of those younger children could begin within days her her decision.
“More than 500 children have died during the course of this pandemic from COVID disease,” said Dr. David Kimberlin, co-director of UAB and Children’s of Alabama’s Division of Pediatric Infectious Diseases, speaking during a Wednesday briefing. “Right now for 5- through 11-year-olds, COVID is the eighth leading cause of death. This is something that, while parents may say ‘I think it is unlikely that this is going to happen to my child’ — you know, they’re right, it is unlikely, but it’s not impossible.”
Kimberlin said that although children have a high rate of survival of COVID-19, the potential long-term effects of COVID remain unclear, and getting those children vaccinated can prevent them from spreading the virus to others.