Currently, the FDA has approved only one vaccine for use in children, as it expanded Pfizer's emergency use authorization to include people age 12 and older. Below are updates on how pediatric COVID-19 vaccine trials are going for the three drugmakers with vaccines that have earned the FDA's emergency use authorization.
Pfizer
On March 31, Pfizer said its COVID-19 vaccine was 100 percent effective in preventing COVID-19 among children ages 12 to 15 in clinical trials. One May 10, the FDA expanded the emergency use authorization for the vaccine to include children between the ages of 12 and 15.
The drugmaker is currently conducting trials for children between 6 months and 12 years old. It plans to enroll up to 4,500 children in the study, which will take place at more than 90 clinical sites in the U.S., Finland, Poland and Spain.
The trials will test a dose of 10 micrograms in children between ages 5 and 11, and 3 micrograms for children 6 months to 5 years old. The doses were determined based on the safety, tolerability and the immune response observed in 144 children during the drugmaker's phase 1 study.
Pfizer hopes to apply for FDA approval for its vaccine's use in children between ages 5 and 11 in September. Trial results for children between ages 2 and 5 could become available in October or November.
Moderna
On May 25, Moderna said its COVID-19 vaccine was 100 percent effective at preventing symptomatic COVID-19 in children ages 12 to 17 in clinical trials. On June 10, the drugmaker said it had requested the FDA expand the vaccine's emergency use authorization to include children ages 12 to 17.
The drugmaker is also testing the vaccine in trial participants between 6 months and 12 years old. Moderna said it aims to enroll about 6,750 children in the trial, which is taking place in the U.S. and Canada. The trial, announced March 16, is being conducted in collaboration with HHS and the National Institute of Allergy and Infectious Diseases.
Johnson & Johnson
On April 5, Johnson & Johnson said it had begun administering its COVID-19 vaccine to 12-17-year-old participants of its ongoing phase 2a clinical trial. The trial, which began in September, was designed to determine the vaccine's safety and efficacy for a one-dose regimen, as well as test potential vaccination schedules at one, two and three-month intervals for a two-dose regimen.