In anticipation of the U.S. Food and Drug Administration emergency use authorization for a COVID-19 vaccine for children ages 12 to 15, Norton Children’s has opened vaccine preregistration for children ages 12 and up on NortonChildrens.com. The Pfizer-BioNTech vaccine currently is in review with the U.S. Food and Drug Administration for possible emergency use authorization in ages 12 to 15. The vaccine currently is available for anyone age 16 or older. A decision by the FDA is expected in the coming days.

Parents or legal guardians who would like to pre-register their children for vaccination can sign-up at NortonChildrens.com. Once appointments open, anyone who signs up will receive an email for scheduling an appointment. Multiple Norton Children’s locations throughout Louisville Metro and surrounding counties will be giving vaccines. Parents or legal guardians of children 16 and older can sign up for a vaccine appointment at NortonChildrens.com.

A clinical trial of this vaccine in 2,260 children ages 12 to 15 found that of the 1,131 who received the actual vaccine, none were diagnosed with COVID-19. Eighteen cases of COVID-19 were seen in those who received a placebo shot. The same children who received the vaccine also developed a strong immune response. Side effects were similar to those seen in vaccine recipients ages 16 to 25 who participated in previous clinical trials. These include pain at the site of injection site, fatigue, headache, muscle pain, chills, joint pain, fever, and swelling and or redness at the site of the injection. These side effects usually last only 24 hours.

“The study results are promising, and we hope to see this younger age group eligible for the vaccine,” said Kristina A. Bryant, M.D., Norton Children’s Infectious Diseases, affiliated with the UofL School of Medicine. “Not only does it bring us another step closer to getting back to normal life, but this vaccine has been shown to be very safe for people ages 16 and up. The ability to vaccinate all teenagers in our community would be a huge step forward.”

“We hope to see the emergency use authorization granted, and we will be ready to begin vaccinations as soon as it is,” said Joseph M. Flynn, D.O., MPH, FACP, chief administrative officer, Norton Medical Group, and physician-in-chief, Norton Cancer Institute. “Norton Children’s has the expertise to ensure the vaccines are given safely and efficiently, and our teams are ready to take care of our community’s children, as we always have.”