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About 20 million U.S. children under 5 years old are eligible to receive a COVID-19 vaccine as early as next week following approval from the Centers for Disease Control and Prevention (CDC) Saturday afternoon.
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 12-0 to recommend Moderna COVID-19 vaccine for children ages 6 months through 5 years and Pfizer-BioNTech vaccine for children ages 6 months through 4 years.
Shortly afterward, CDC Director Rochelle P. Walensky, M.D., M.P.H., gave final approval for both vaccines, which were granted emergency use authorization from the Food and Drug Administration Friday.
The AAP released an updated policy statement Saturday recommending that all eligible infants, children and adolescents without contraindications get vaccinated.
“Pediatricians know the power of vaccines to protect infants, children, adolescents and entire communities against deadly and debilitating infectious diseases,” Yvonne “Bonnie” A. Maldonado, M.D., FAAP, chair of the AAP Committee on Infectious Diseases, said during the ACIP meeting. “We’ve successfully immunized millions of children and adolescents to protect them from COVID-19. Families with infants and toddlers need and deserve the same chance to protect their children against the virus.”
Vaccine administration
The Moderna vaccine will be available to children ages 6 months through 5 years as a primary series of two 25-microgram (µg) doses administered four to eight weeks apart. Children who are moderately or severely immunocompromised can receive three doses, each given four weeks apart.
The Pfizer-BioNTech vaccine will be available to children ages 6 months through 4 years as a primary series of three 3-µg doses. Dose 1 and dose 2 should be administered three to eight weeks apart, while the third dose should be given at least eight weeks after the second dose. Immunocompromised children should receive a second dose four weeks after the first dose, and dose 3 should be given at least four weeks after dose 2.
Among children, COVID-19 vaccine induces a broader neutralizing antibody response when compared with infection-induced immunity. In contrast with SARS-CoV-2 infection, children vaccinated with two doses demonstrated higher titers against alpha, beta, gamma, delta and omicron variants. Officials say the data show the importance of vaccinating children with prior infection to prevent both severe disease and future infections.
Vaccine rollout
Children should receive the age-appropriate vaccine formulation and follow the schedule based on their age on the day of vaccination, regardless of their size or weight. Children who move from the younger age group to an older age group during the primary series or between the primary series and receipt of the booster dose(s) should receive the vaccine dosage for the older age group for all subsequent doses.
The same mRNA vaccine product should be used for all primary series doses. In accordance with general best practices from ACIP, routine administration of all age-appropriate vaccines simultaneously is recommended for children for whom no specific contraindications exist at the time of the health care visit.
While some children over 5 years old were vaccinated at school and community clinics, experts said physicians are likely to be the leaders in vaccinating children under 5.
The Moderna vaccine for children ages 6 months through 5 years will ship with a magenta label, contains a new National Drug Code and does not require diluent.
The Pfizer-BioNTech vaccine will ship with a maroon cap, with a new National Drug Code and a different amount of diluent added (2.2 milliliters vs. 1.3 milliliters for doses given to children ages 5-11 years). While the vaccine label says “Age 2y to < 5y,” officials said the vaccine can be used in children as young as 6 months. The label also states the vaccine must be discarded six hours after dilution, but officials said the vaccine may be discarded 12 hours after dilution.
Both products come in cartons containing 10 vials that each have 10 doses (100 doses total) with a minimum order quantity of 100 doses per product. While providers may be hesitant to open new vials, officials said getting as many children vaccinated as possible is the priority, noting no opportunity should be missed.
“It’s extremely important that we get this vaccine now and there will be waste, we understand that, but it’s important to get shots in the arms and take advantage of every opportunity. Don’t feel guilty about having to open a vial to administer two doses or one dose,” said José R. Romero, M.D., FAAP, director of the CDC’s National Center for Immunization and Respiratory Diseases.
Clinical trials
Moderna’s clinical trial was conducted from December 2021 through February 2022 and involved 6,400 children. No deaths occurred among trial participants, and no cases of myocarditis/pericarditis or vaccine-associated anaphylaxis were reported.
Pfizer-BioNTech’s vaccine clinical trial included 3,000 children and was conducted from June 2021 through April 2022. Initially, it involved review of a two-dose series, but the company soon began studying a three-dose primary series.
No deaths were reported in any trial participants, and serious adverse events (SAEs) were rare overall. SAEs occurred in 1% of vaccine recipients and 1.5% of placebo receipts. No cases of myocarditis/pericarditis or vaccine-associated anaphylaxis were reported.
COVID-19 in children
Between March 1, 2020, and April 30, 2022, 269 children younger than 1 year and 134 children ages 1-4 years died as a result of COVID-19.
More than 2 million cases of COVID-19 have been reported among children ages 6 months through 4 years. Children in this age group are at risk of severe illness from COVID-19, and more than half of all hospitalized children ages 6 months through 4 years had no underlying conditions.
Resources
- CDC’s Pediatric COVID-19 Vaccination Operational Planning Guide
- AAP COVID vaccination resources
- CDC clinical considerations for administering COVID-19 vaccines
- Information from HealthyChildren.org: What Should Parents Know About the COVID Vaccine for Kids Under 5?
- CDC information on U.S. COVID-19 products
