FILE PHOTO: A vial and syringe are seen in front of a displayed Pfizer logo in this illustration taken January 11, 2021. REUTERS/Dado Ruvic/Illustration
Pfizer Inc. and BioNTech SE’s Covid-19 vaccine will be tested in children under the age of 12 in a late-stage study of as many as 4,500 participants.
The vaccine partners announced plans on Tuesday to kick-start the trial of the shot within weeks. It will be conducted at more than 90 sites, spanning the U.S., Finland, Poland and Spain.
Based on findings from an early-stage trial that evaluated safety, tolerability and the immune response prompted by the vaccine, the companies selected new doses for children. Those ages 5 to 11 will receive a 10-microgram dose -- a third of the size given to those 12 years old and older. Children 6 months to 5 years old will be given 3 micrograms -- a tenth of the amount given to adolescents and adults.
On May 11, the two-shot messenger RNA vaccine was cleared for use in those 12 to 15 in the U.S., paving the way for the mass vaccination of middle- and high-school students. The trial of young teens, which enrolled more than 2,000 participants, found that the vaccine was 100% effective against symptomatic disease