The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommends the use of the Pfizer-BioNTech COVID-19 vaccine for children 5 to 11 years of age.
The recommendation follows the Food and Drug Administration (FDA)’s Emergency Use Authorization of the vaccine for this pediatric population. On Tuesday, CDC Director Rochelle P. Walensky, MD, MPH endorsed the ACIP’s recommendation.
“We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine,” said Walensky. “As a mom, I encourage parents with questions to talk to their pediatrician, school nurse or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated.”
For children 5 to 11 years of age, the Pfizer-BioNTech COVID-19 vaccine is administered as a 2-dose series (10mcg each dose), separated by 3 weeks. Among clinical trial participants without evidence of prior SARS-CoV-2 infection, vaccine efficacy against symptomatic COVID-19 seven days after the second dose was reported to be 90.7% (95% CI, 67.4-98.3).
The most frequently reported adverse reactions were injection site pain, redness and swelling, fatigue, headache, muscle and/or joint pain, chills, fever, swollen lymph nodes, nausea, and decreased appetite. There were no reports of myocarditis or pericarditis observed in the study population.
Commenting on the recommendation, the American Academy of Pediatrics (AAP) President Lee Savio Beers, MD, FAAP, said: “We know from our experience with the Delta variant that this virus is unpredictable, and we cannot afford to be complacent. It is critical to use science and data to guide our decisions about the pandemic and school COVID-19 plans.”
The AAP continues to support universal mask-wearing in schools and now strongly recommends children 5 to 11 years old without contraindications receive the COVID-19 vaccine. The organization also supports vaccination in children with prior COVID-19 infection or disease in order to prevent a second infection and to lower the risk of severe illness and hospitalization.
Additional administration information for the Pfizer-BioNTech COVID-19 vaccine is available in the health care provider fact sheet.
The Pfizer-BioNTech COVID-19 vaccine designated for use in individuals 5 to 11 years old is supplied in a multiple dose vial with an orange cap and a label with an orange border. Distribution of the vaccine has already begun.
- CDC recommends pediatric COVID-19 vaccine for children 5 to 11 years. News release. November 2, 2021. https://www.cdc.gov/media/releases/2021/s1102-PediatricCOVID-19Vaccine.html.
- American Academy of Pediatrics applauds CDC advisory committee’s approval of safe, effective COVID-19 vaccine for children ages 5-11. News release. November 2, 2021. https://www.aap.org/en/news-room/news-releases/aap/2021/american-academy-of-pediatrics-applauds-cdc-approval-of-safe-effective-covid-19-vaccine-for-children-ages-5-11/.