BERLIN, Germany — BioNTech-Pfizer said Wednesday that its vaccine showed 100 percent efficacy against the coronavirus in 12- to 15-year-olds, as the companies eye 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 said 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,” said Pfizer chief executive Albert Bourla.
The chief executive of German company BioNTech said 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.”
Senior Israeli Health Ministry officials were cited by the Kan public broadcaster as saying that once the move is approved by the FDA, there will be no problem approving it in Israel and quickly using the existing stock of Pfizer vaccines to start inoculating about 600,000 Israelis aged 12-15.
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 age 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% effective.
With the world scrambling to inoculate, BioNTech said Tuesday it was on track to manufacture 2.5 billion doses of its vaccine this year.
The higher output was driven by the recent launch of a new production site in the German city of Marburg, which is now one of the world’s largest mRNA vaccine manufacturing plants, it said.
The vaccine is also being produced at a Pfizer plant in Belgium and at three sites in the United States.
BioNTech said improved efficiency and new cooperation agreements with outside partners had also helped lift its vaccine target, as had the regulatory nod allowing vaccinators to extract six instead of just five doses from a single BioNTech/Pfizer vial.
BioNTech and Pfizer last week began studies of the vaccine on children, with the first group of 5- to 11-year-olds getting the vaccine.
A younger cohort of 2- to 5-year-olds is expected to get the first dose next week in the study, which will also cover children as young as six months old.