Pfizer and BioNTech said their coronavirus vaccine has been 100% effective in a clinical trial of children ages 12 to 15, according to preliminary results.
In a news release Wednesday, the companies said the vaccine “demonstrated 100% efficacy and robust antibody responses” in a Phase 3 trial of 2,260 participants in that age group.
In the trial, 1,131 partipants were given the vaccine, and 1,129 participants received a placebo shot, the companies said. No COVID-19 cases occurred in the vaccinated group, while 18 occurred in the placebo group, according to the release.
The companies added that the vaccine “was well-tolerated, with side effects generally consistent with those observed in participants 16 to 25 years of age.”
“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,” Pfizer Chairman and CEO Albert Bourla said in a statement. “We plan to submit these data to [the U.S. Food and Drug Administration] 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.”
The FDA previously authorized the Pfizer-BioNTech vaccine for emergency use in people ages 16 and older. The vaccine was 95% effective in a Phase 3 clinical trial of more than 40,000 participants in that age group, the company announced late last year.
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