Update 6/24/22: The CDC director has approved use of Moderna's COVID vaccine for children and adolescents ages 6-17 years. For the latest news on COVID-19, visit http://bit.ly/AAPNewsCOVID19.
A second COVID-19 vaccine for school-age children and adolescents moved closer to approval Thursday.
The Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) voted 15-0 in favor of Moderna’s vaccine for children ages 6-17 years, although advisers are concerned about confusing instructions for vaccinators. The recommendation now goes to the CDC director for final approval.
Among children ages 5-17 years, there have been more than 10 million COVID-19 cases, 45,000 hospitalizations and 600 deaths, according to the CDC. A vaccine from Pfizer-BioNTech already is available for these ages, but only 60% of those 12-17 years and 29% of those 5-11 years are fully vaccinated. The ACIP did not express a preference Thursday for one vaccine over another.
The AAP recommends all eligible children who do not have contraindications get vaccinated.
Vaccine administration
The Moderna vaccine for adolescents ages 12-17 is the same dose as for adults — two doses of 100 micrograms (µg) each. Children ages 6-11 years would get two 50-µg doses. While the standard time between doses is four weeks, the CDC recommends an interval of four to eight weeks between the doses for both age groups.
“Extending the interval between dose one and dose two of these mRNA COVID vaccines to eight weeks may further lower the myocarditis risk,” said Sara Oliver, M.D., M.S.P.H., who leads ACIP’s COVID-19 vaccines work group.
For children and adolescents ages 6-17 who are immunocompromised, the primary series is three doses with four weeks between doses one and two and at least four weeks between the second and third doses.
The vaccine vial for those ages 6-11 years has a dark blue cap and purple label border and is the same vial used for boosters in adults. While it is labeled “Booster doses only,” the CDC stressed it is the correct vial for children as well. The vial for ages 12 and older has a red cap and light blue label border. The Food and Drug Administration (FDA) has a chart showing the vial information at https://www.fda.gov/media/159306/download.
Multiple ACIP members expressed concern about confusion over the vials for multiple ages and relying on the color coding.
“Just recognize this does impact acceptability from a provider standpoint because there’s a lot of complexity to incorporate into a busy practice,” said ACIP Chair Grace M. Lee, M.D., M.P.H., associate chief medical officer for practice innovation at Lucile Packard Children’s Hospital.
Some also said instructions for children switching age groups mid-series were likely to be confusing. The CDC recommends choosing a vaccine product based on the child’s age on the day of vaccination regardless of size or weight.
Children and adolescents who begin a primary series with Moderna should receive a Moderna vaccine for the rest of the series, according to the CDC. It is not interchangeable with the Pfizer-BioNTech vaccine. The Moderna COVID vaccine can be co-administered with other vaccines.
Last week, the CDC approved Moderna’s COVID-19 vaccine for children under 6 years.
Clinical trials
More than 5,000 children and adolescents received the Moderna vaccine in clinical trials. Reactogenicity was similar to other age groups with fatigue and headache being most common.
There were no vaccine-related serious adverse events or cases of myocarditis. Myocarditis is more common after COVID-19 infection than after vaccination and the condition tends to be more severe after infection, according to the CDC. While rare, myocarditis does occur above baseline rates for some age groups after vaccination. Adolescent and young adult males have had the highest rates with the Pfizer-BioNTech vaccine, which is an mRNA vaccine like Moderna’s. There have been 635 confirmed cases among vaccine recipients ages 5-17 reported through the Vaccine Adverse Events Reporting System out of nearly 55 million doses administered to that age group.
In the trials, children ages 6-11 years and adolescents ages 12-17 years had similar antibody responses to young adults ages 18-25 years. Efficacy against symptomatic COVID infection was 76% for children and 89% for adolescents, according to a CDC analysis. However, case counts were small and confidence intervals were wide. Also, efficacy was not studied during the omicron period.
Thursday’s ACIP recommendation followed unanimous approval from the FDA’s vaccine committee. The FDA granted emergency use authorization last week.
Resources
- AAP COVID vaccination resources
- CDC clinical considerations for administering COVID-19 vaccines
- Information from the CDC on COVID-19 vaccination of children and teens
- AAP/Health and Human Services COVID vaccine toolkit
- Information from HealthyChildren.org on preparing children for a COVID-19 vaccine
