Pfizer Completes Phase 3 Coronavirus Vaccine Trial On Adolescents

CONNECTICUT — Pfizer announced Wednesday it has completed successful Phase 3 trials of its coronavirus vaccine on adolescents 12 to 15 years of age.

Pfizer and its German partner BioNTech plan to submit the results of the trial data to the U.S. Food & Drug Administration and European Marketing Association for approval to expand the vaccine's use in adolescents as quickly as possible. The Pfizer COVID-19 vaccine is the only one approved for people under the age of 18.

The vaccine demonstrated "100 percent efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old, and was well tolerated," according to a new release from Pfizer-BioNTech.

"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 of Pfizer.

The Pfizer chief said he hoped to vaccinate the new, younger age group before the start of the next school year.

"Any progress in creating a safe and effective vaccine for children is wonderful news," said Bethel Schools Superintendent Christine Carver.

The superintendent said she "had not heard anything from the state at this point about that age group."

All participants in the trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

The trial enrolled 2,260 children 12 to 15 years of age in the United States.

The Pfizer-BioNTech vaccine has not been approved or licensed by the FDA, but has been authorized for emergency use by the agency under an Emergency Use Authorization people 16 years of age and older.

Starting April 1, teens 16 and over are eligible to register on the Vaccine Administration Management System and seek out clinics offering the Pfizer vaccine. VAMS will show the public drive-thrus, community health centers, and pharmacies with Pfizer vaccine availability.

A separate study evaluating the safety, tolerability, and effectiveness of the Pfizer-BioNTech COVID-19 vaccine on younger patients is also underway. A 5 to 11-year-old cohort started dosing last week and the companies plan to initiate a 2 to 5-year-old cohort next week. Testing for a group aged 5 to 11 years is also in the works, according to a new release from the drug manufacturers.

Ugur Sahin, CEO and co-founder of BioNTech, said that adolescent studies suggest that children are particularly well protected by vaccination, which he called "very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 UK variant."