March 31, 2021 – Pfizer and BioNTech have announced that trials of their COVID-19 vaccine showed its efficacy is 100% and it is well tolerated in children ages 12 to 15.
The companies plan to submit the data to the U.S. Food and Drug Administration (FDA) as soon as possible for expanded emergency use authorization of the two-dose vaccine.
In a Phase 3 trial of 2,260 participants ages 12 to 15 in the U.S., the vaccine elicited strong antibody responses one month after the second dose – exceeding those demonstrated in people ages 16 to 25 in previous trials, Pfizer reported.
Pfizer and BioNTech said that the side effects seen in the young teens were similar to those seen among 16 to 25-year-olds. Common side effects include pain at the injection site, fatigue and fever.
“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” said Albert Bourla, chairman and CEO, Pfizer. “We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year.”