DURHAM, N.C. — A critical component to turning the tide against COVID-19 is opening the door for children to receive a vaccine.

What You Need To Know

• Pfizer and BioNTech applied for emergency FDA approval of vaccines for children ages 5-11
• If approved, the Pfizer and BioNTech vaccine would become the first in use for children in America under the age of 12
• Duke was a host site for pediatric clinical trials for the vaccine maker
• Data gathered from Duke’s child participants will be reviewed by FDA

On Thursday, company officials with Pfizer and BioNTech announced they asked the U.S. Food and Drug Administration to grant emergency authorization for children ages 5-11 to use their two-dose COVID-19 vaccine.

One of the sites for the vaccine maker’s clinical trials for a pediatric shot is Duke University. Dr. Emmanuel Walter is a pediatrician who captained Duke’s participation in the study.

“Data from children 5 to 11 years of age who received two doses of the Pfizer BioNTech vaccine, at a reduced 10 ug dose, showed the vaccine to be safe and led to an excellent immune response in children,” Walter said. Walter is also the director of the Duke Vaccine and Trials Unit. “The immune response in children was as good as that seen for participants in the study, which tested the higher 30 ug dose in persons 16 to 25 years of age.”

If approved, the Pfizer and BioNTech vaccine would become the first in use for children in America under the age of 12.

Walter said the levels of antibodies found in children who participated in the study are strong enough to protect them from serious illness, hospitalization and death due to the virus.

“Young kids have exposures too. They are in settings like day care, nursery school, preschool (and) play dates. They are not home and isolated by any means or just going to visit relatives,” Walter said. “I think children make up a significant part of the population. I think early on in the pandemic, I think we thought this was more of a disease that affected older adults and older adults with comorbidities.”

The delta variant of COVID-19 has shaken that thinking with a higher proportion of new infections seen in children. Trends tracked by the Centers for Disease Control and Prevention show a rise in hospitalizations for children younger than five since the summer. 

Walter said, “I think we were kind of lulled to sleep early in the pandemic that this wasn’t necessarily affecting young children or children. As things have moved along, we are realizing that yes, this virus does affect young children.”

An FDA advisory committee will meet on October 26 to discuss authorization. Walter believes approval could happen for this age group as soon as early November.