Pfizer announced Wednesday morning that its COVID-19 vaccine has demonstrated 100% efficacy in participants ages 12-15 — a finding that could soften the resistance of some of the remaining holdouts regarding kids returning to the classrooms.
The findings come from a recently completed Phase 3 trial of 2,260 adolescents. The results actually exceeded those reported in trial of vaccinated 16- to 25-year-old participants in an earlier analysis.
The pharmaceutical company, which has a strong presence in New Jersey, is urging the FDA to expand the emergency use authorization for the vaccine, CEO Albert Bourla said.
“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,” he said. “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.”
Pfizer and BioNTech are now increasing their studies. Last week, they announced they are in the process of trials on children ages 6 months to 11 years old.
The study is evaluating the safety, tolerability and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine on a two-dose schedule (approximately 21 days apart) in three age groups: children ages 5 to 11 years, 2 to 5 years, and 6 months to 2 years. The 5- to 11-year-old cohort started dosing last week and the companies plan to initiate the 2- to 5-year-old cohort next week.
Gov. Phil Murphy, state officials and numerous groups have been pushing for more schools to return to in-person learning. Murphy, in fact, has all but mandated the return for the fall. (Some districts, it should be noted, have done so this year to little detriment.)
Some teachers unions have resisted the idea, citing safety concerns.
The return to full-time in-school learning obviously would benefit the work world.
Ugur Sahin, co-founder and CEO of BioNTech, said the vaccination of adolescents would help spark a return to a life that has been taken away by the pandemic.
“Across the globe, we are longing for a normal life,” he said. “This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 U.K. variant.
“It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones.”