US authorizes Pfizer COVID-19 vaccine for children age 5 to 11 – regulator

Vials of the Comirnaty vaccine by Pfizer-BioNTech against COVID-19 are pictured on April 22, 2021, at the San Giovanni Addolorata Hospital in Rome. (Photo by Tiziana FABI / AFP)

Washington, United States — The United States on Friday authorized the Pfizer COVID vaccine for children aged five to 11 after a committee of experts this week found its benefits outweighed the risks.

“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization,” said acting Food and Drug Administration chief Janet Woodcock in a statement.

“Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy.”

The vaccine rollout should begin in earnest after the Centers for Disease Control and Prevention convenes a panel on Tuesday to further discuss clinical recommendations.

A clinical trial involving more than 2,000 participants was found to be more than 90 percent effective at preventing symptomatic disease.

The vaccine’s safety was also studied in more than 3,000 children, and no serious side effects have been detected in the ongoing study.

In this age group, the vaccine is given as two shots three weeks apart, dosed at 10 micrograms — a third of what is given to older age groups.

According to the CDC, there have been 8,300 COVID hospitalizations of children aged five-to-11 since the start of the pandemic, and 146 deaths.