Pending emergency approval from the U.S. Food and Drug Administration for a COVID-19 vaccine for children 12 to 15 years old, Norton Children’s has opened pre-registration for vaccines for children 12 and older on NortonChildrens.com. The Pfizer BioNTech vaccine is currently under review by the U.S. Food and Drug Administration for possible authorization for emergency use between the ages of 12 and 15. The vaccine is currently available to anyone aged 16 or older. A decision from the FDA is expected in the coming days.
Parents or legal guardians who wish to pre-register their children for vaccination can register at NortonChildrens.com. Once the appointments are open, everyone who signs up will receive an email to schedule an appointment. Multiple Norton Children’s locations in Louisville Metro and surrounding counties will provide vaccines. Parents or legal guardians of children 16 and older can sign up for a vaccination 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 injection. The same children who received the vaccine also developed a strong immune response. Side effects were similar to those seen in vaccine recipients aged 16 to 25 years old who participated in previous clinical studies. These include injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever and swelling and / or redness at the injection site. These side effects usually only last for 24 hours.
“The study results are promising and we hope that this younger age group will be eligible for the vaccine,” said Kristina A. Bryant, MD, Norton Children’s Infectious Diseases, of the UofL School of Medicine. “Not only does it take us one step closer to returning to normal life, but this vaccine has been shown to be very safe for people aged 16 and over. The ability to vaccinate all teenagers in our community would be a huge step forward. “
“We hope that emergency use approval is granted, and we will be ready to begin vaccinations as soon as it does,” said Joseph M. Flynn, DO, MPH, FACP, chief administrative officer, Norton Medical Group and doctor-in. Chief, Norton Cancer Institute. “Norton Children’s has the expertise to ensure the vaccines are delivered safely and efficiently, and our teams are ready to care for the children of our community, as we have always done.”