Pfizer will test its COVID-19 vaccine in a larger group of children between 6 months and 12 years old after choosing a lower dose than it administered in an earlier stage of the trial, The New York Times reported June 8.
The drugmaker 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.
Pfizer 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. These doses were determined based on the safety, tolerability and the immune response observed in 144 children during the drugmaker's phase 1 study.
The FDA on May 10 granted emergency use authorization for the vaccine's use in children between ages 12 and 15.
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, Kit Longley, the drugmaker's senior manager of science media relations, told the Times.