FDA Authorizes Pfizer/BioNTech COVID-19 Shot for Children

The FDA on Friday granted an updated Emergency Use Authorization (EUA) for the Pfizer/BioNTech COVID-19 vaccine for use in children ages five to 11 years — following a thumbs up from the agency’s expert advisory panel earlier in the week.

But the vaccine can’t be given to young kids until the Centers for Disease Control and Prevention (CDC) makes recommendations for use following a meeting of its own advisory committee ― scheduled for tomorrow.

The news comes as a relief to many parents because ― according to the CDC ― COVID-19 cases in children age five to 11 account for 39 percent of all U.S. cases in people under 18 years old, with an estimated 8,300 cases in the five-to-11 age group having required hospitalization and, as of Oct. 17, 146 COVID-19-related deaths reported in kids age five to 11.

“As a mother and a physician, I know that parents, caregivers, school staff and children have been waiting for today’s authorization,” said Acting FDA Commissioner Janet Woodcock.

“Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Woodcock said, adding that the agency’s “comprehensive and rigorous evaluation … should help assure parents and guardians that this vaccine meets our high standards.”

The new EUA was supported by positive data from 4,700 children participating in a study in the U.S., Finland, Poland and Spain. Kids in the 264-person vaccine group were given a two-jab Pfizer-BioNTech COVID-19 regimen at a lower dosage. Their immune response was found to be comparable to 253 participants age 16 to 25 years given higher doses in a previous study.

The FDA also assessed phase 2/3 data from nearly 2,000 kids age five to 11, which showed that the vaccine was 90.7 percent effective at preventing infection one week after a second dose (DID, Oct. 27). ― Jason Scott