What is the hold up on COVID vaccines for kids under age 12?

FDA wants 4 to 6 months of follow-up data for younger children

Health officials continue looking into COVID vaccine for children under 12

It’s collision course that has parents worried -- kids heading back to school, COVID precautions being dropped and the delta variant surging.

While a vaccine would be welcomed by many families, the issue is time.

The Food and Drug Administration (FDA) wants four to six months of follow-up safety data for children under age 12. By comparison, two months of follow-up was required for the adult clinical trials.

Read: Michigan school districts reconsider mask mandate

Read: Metro Detroit infectious disease specialist supports universal mask wearing in school

“We are hopeful that we’ll have a safe and effective vaccine for younger children before the year is over,” said. Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention.

Pfizer said data for children ages 5 to 11 could come sometime in September. Depending on the findings, Pfizer could ask the FDA to authorize emergency use of the vaccine for that age group the same month. However, the FDA will then need time to review the data.

While younger children have much lower rates of serious illness, hospitalization and death, some have gotten seriously ill and died.

“We still don’t have the complete picture, as data in this age group are limited, but we do know that even children with mild cases of COVID may face serious long term effects,” Walensky said.

Experts said the best way to protect young children is to vaccinate the people around them.

“The ones who will also pay the price other than the unvaccinated adolescents are the little kids who depend on the adults and adolescents to get vaccinated in order to slower halt transmission,” said Dr. Peter Hotez with Baylor College of Medicine.



About the Author:

Dr. McGeorge can be seen on Local 4 News helping Metro Detroiters with health concerns when he isn't helping save lives in the emergency room at Henry Ford Hospital.