Pfizer-BioNTech is approved for people 12 and older.
Moderna is approved for people 18 years and older.
Johnson & Johnson is approved for people 18 years and older.
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.
As part of a 144-participant Phase 1/II trial, they will test the safety of their two-shot vaccine at three different dosages – 10, 20 and 30 micrograms
They plan to later expand to a 4,500-participant late-stage trial in which they will test the safety, tolerability and immune response generated by the vaccine, likely by measuring antibody levels in the young subjects.
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.
In part 1, children aged 2 years to less than 12 may receive two doses of 50 or 100 micrograms each. Those under 2 years may receive two shots of 25, 50 or 100 micrograms. (One adult dose is 100 micrograms.) In each group, the first children inoculated will receive the lowest doses and will be monitored for reactions before later participants are given higher doses. Then, researchers will perform an interim analysis to determine which dose is safest and most likely to be protective for each age group.
In part 2 of the study will receive the doses selected by the analysis — or placebo shots consisting of salt water.
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.