Pfizer-BioNTech COVID-19 Vaccine Now Available for Children Ages 5-11

PRESS RELEASE – Children ages 5 to 11 can now receive a safe and effective COVID-19 vaccine. The Food and Drug Administration has authorized a lower dose of the Pfizer-BioNTech COVID-19 vaccine for children in this age group, and the Centers for Disease Control and Prevention recommend all children 5–11 get the vaccine to protect against serious illness and help keep them healthy.

“Children are vulnerable to the COVID-19 virus just like everyone else,” said NCDHHS Secretary Mandy K. Cohen, M.D. “The authorization of the Pfizer-BioNTech vaccine provides a safe, tested way to protect them from serious illness and provide healthier, happier experiences in and outside of the classroom.”

During the most recent surge, pediatric cases of COVID-19 rose by about 240% in the United States, demonstrating a need to protect children from the disease. Results from clinical trials that began in March 2021 showed the Pfizer-BioNTech COVID-19 vaccine was safe and effective to protect children ages 5–11 from COVID-19.

There were no safety concerns or serious side effects noted in the clinical trials. Temporary side effects for kids 5–11 are similar to older kids and adults and may include a sore arm, headache and being tired or achy for a day or so.

More than 3,000 children ages 5–11 participated in the trials with volunteers from different races and ethnicities (77% white, 6% African American/Black, 8% Asian, 17% Hispanic/Latinx and 7% multiracial). This is comparable to the number included in many similar clinical trials with children.

Children are given two doses of the Pfizer vaccine. Each dose is one-third the amount given to people ages 12 and older. The dose for 5–11 year olds is different from the dose authorized for people ages 12 and older, and children in this age group should not receive the 12 and older dose.

The vaccine is effective and produced a similar immune response in children 5–11 as in older kids and adults ages 16–25. As with other routine vaccinations for children, the Pfizer-BioNTech COVID-19 vaccine underwent a thorough testing and review process by the FDA and an independent scientific committee to ensure it is safe and effective for children.

The Pfizer-BioNTech lower dose COVID-19 vaccine is currently the only one available for children between the ages of 5–11. Parents and guardians with questions about COVID-19 vaccines should talk with their child’s physician.

“Getting school-age kids vaccinated will help keep them safe to play sports, attend events, be with friends and do all of the other things kids love to do that they may currently be missing out on,” Secretary Cohen said. “I will be getting my daughters vaccinated this weekend. Don’t wait to vaccinate your kids, so they get back to safely being with family and friends, especially as we head into the holiday season.”

Everyone ages 5 and older can receive a free Pfizer-BioNTech COVID-19 vaccine, even if they don’t have health insurance and regardless of their immigration status.

North Carolina’s actions are based on recommendations from the CDC. Read the CDC’s full statement here.

For more information about how vaccines for children work and where you can find a vaccination appointment nearby, visit MySpot.nc.gov. The North Carolina Vaccine Help Center at 888-675-4567 can also help you make an appointment. It is open 7 a.m.–7 p.m. on weekdays and 8 a.m.–4 p.m. on weekends.