Pfizer trial shows 100% efficacy for ages 12-15
Tests of the Pfizer-BioNTech COVID-19 vaccine for ages 12-15 have showed 100% efficacy and robust antibody responses, the company announced on Wednesday. The trial of the vaccine showed a better response than the 16-25 year old age group which has been approved to receive the vaccine.
Pfizer will now submit the data to the U.S. Food and Drug Administration seeking to have the Emergency Use Authorization expanded for the 12-15 age group possible in time for the start of school in the fall. As of this time only ages 16 and older are eligible.
“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 Chief Executive Officer, 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.”
The trial enrolled 2,260 adolescents 12 to 15 years of age in the United States.
In the trial, 18 cases of COVID-19 were observed in the placebo group versus none in the vaccinated group.
Last week, Pfizer and BioNTech dosed the first healthy children in a global Phase 1/2/3 seamless study to further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in children 6 months to 11 years of age. The study is evaluating the safety, tolerability and immunogenicity of the PfizerBioNTech COVID-19 vaccine on a two-dose schedule (approximately 21 days apart) in three age groups: children aged 5 to 11 years, 2 to 5 years, and 6 months to 2 years. The 5 to 11 yearold cohort started dosing last week and the companies plan to initiate the 2 to 5 year-old cohort next week.