During the week of May 10, both the FDA and CDC have recommended the Pfizer-BioNTech vaccine for children aged 12-15.
In a Pfizer-BioNTech phase 3 trial of adolescents (age 12-15) without evidence of prior COVID-19 infection, data shows the vaccine had 100% efficacy and led to robust antibody responses. The trial enrolled 2,260 adolescents in the United States. 18 cases of COVID-19 were observed in the placebo group versus none in the vaccinated group. Vaccination elicited a strong antibody response in a subset of adolescents one month after the second dose.
Moderna is also conducting a trial in children 12 years and older.
PfizerBioNTech has begun testing its vaccine in children (from 6 months old to 11 years old) in late March.
Results are expected in the second half of 2021 and the company hopes to vaccinate children in early 2022.
Moderna is starting a study (KidsCove) to test the vaccine on children 6 months to less than 12 years old. Moderna plans to enroll approximately 6,750 pediatric participants in the U.S. and Canada in the two-part study.
Each child in Moderna’s study will receive two shots, 28 days apart. The study will have two parts.
Moderna developed its vaccine in collaboration with the National Institute of Allergy and Infectious Diseases. The company and the institute are also working together on the study, along with the federal Biomedical Advanced Research and Development Authority.
The AstraZeneca vaccine is not currently approved for children. They have currently paused their trial in children and teenagers, awaiting more data on the rare blood clots events in adult vaccine recipients.
What about reports of myocarditis following vaccination?
The Advisory Committee on Immunization Practices (ACIP) COVID-19 Vaccine Safety Technical (VaST) Work Group reviews post-authorization COVID-19 vaccine safety data on a weekly basis. The VaST session on May 17, 2021, reviewed reports on myocarditis (inflammation of the heart) following mRNA vaccines.
VaST concluded that there are relatively few reports of myocarditis to date and that these cases seem to occur:
Most cases appear to be mild, and follow-up of cases is ongoing.
Within CDC safety monitoring systems, rates of myocarditis reports in the window following COVID-19 vaccination have not differed from expected baseline rates. However, VaST members felt that information about reports of myocarditis should be communicated to providers.
CDC Pfizer-BioNTech Ages 12-15
Moderna KidsCove Study
NPR Moderna KidsCove Study
Reuter Pfizer Kids Study
Pfizer Adolescent Data
AstraZeneca Pediatric Trial Paused
CDC Myocarditis Update
Updated: May 27, 2021