BioNTech-Pfizer says its vaccine showed 100 percent efficacy against the coronavirus in 12- to 15-year-olds, as it eyes approval for adolescents to get the shots before the next school year.
Phase 3 trials carried out on 2,260 adolescents in the United States “demonstrated 100 percent efficacy and robust antibody responses,” the companies says in a statement.
“We plan to submit these data to (US regulator) 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,” says Pfizer chief executive Albert Bourla.
Chief executive of German company BioNTech says the results showing high protection for teens were “very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 UK variant.”
The BioNTech/Pfizer shot is based on novel mRNA technology and was the first Covid-19 vaccine to be approved in the West late last year.
Both the United States and the European Union have approved its use for people aged 16 and above. Since then, it has been used in millions of adults in more than 65 countries.
A real world study involving 1.2 million people in Israel found it to be 94 percent effective.
BioNTech and Pfizer last week began studies of the shot on children, with the first group of 5- to 11-year-olds getting the vaccine.
A younger cohort of 2- to 5-year-olds are expected to get their first dose next week in the study, which will also cover children as young as six months old.