Pfizer and BioNTech have said their Covid-19 vaccine is safe and effective for children ages 12 to 15, and companies plan to push for emergency use authorization for this age group in the United States. and in Europe.
A Phase 3 trial has shown 100% efficacy in preventing symptomatic Covid-19 and ‘robust’ antibody responses exceeding those reported in vaccine trials involving people aged 16 to 25, said drug manufacturers.
The companies aim to get clearance in time for children to start getting vaccinated for the next school year, said Albert Bourla, chief executive of Pfizer.
“We share the urgency to extend the authorization of our vaccine for use in younger populations and are encouraged by the data from clinical trials,” he said in a statement Wednesday.
The clinical trial of 2,260 adolescents in the United States is the first to show how the jab would work on young school-aged children as authorities seek to attract students. back to classrooms as quickly as possible. The BioNTech / Pfizer vaccine is already authorized for people over the age of 16.
There were 18 cases of Covid-19 among the adolescents included in the trial who received placebo injections. None of those who received the vaccine were infected.
“The first results we have seen in studies of adolescents 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 UK variant B .1.1.7 ”, said Ugur Sahin, CEO and co-founder of BioNTech.
The side effects were consistent with those reported in a trial involving 16 to 25-year-olds, the companies said.
The two companies plan to submit their data to regulators at the U.S. Food and Drug Administration and the European Medicines Agency to apply for emergency clearance.
Pfizer and BioNTech began administering doses last week in their first trial in children aged 11 and under. The vaccine could eventually be tested on babies as young as six months old.