The Pfizer and BioNTech pharmaceutical partnership announced on Wednesday that their Covid-19 vaccine was safe, effective and produced robust antibody responses in 12-to 15-year old children, paving the way for them to seek US authorisation within the next few weeks and from regulators in other countries swiftly thereafter.
US company Pfizer and its German partner BioNTech hope that vaccinations of the latest group of people could begin before the next school year, Albert Bourla, Pfizer’s chairman and chief executive, said in a statement.
The announcement will lift hopes of getting millions more children safely back into classrooms after more than a year of their education being disrupted by the pandemic.
Pfizer’s vaccine is already authorized for use in people starting at age 16. The new study offers the first evidence of how the vaccine will also work in school-age adolescents.
The company is ramping up production and is already distributing its vaccine across the US and internationally at an accelerating rate.
In the latest trial, of 2,260 adolescents aged 12 to 15, there were 18 cases of Covid-19 in the group that got a placebo shot and none in the group that received the vaccine, resulting in 100% efficacy in preventing Covid-19, the companies said in a statement.
The vaccine was well tolerated, with side effects in line with those seen among those aged 16 to 25 in the adult trial.
The statement from the partnership did not list the side effects for the younger group, but the adult trial’s side effects generally were mild to moderate and included injection-site pain, headaches, fever and fatigue.
The companies also studied a subset of teens to measure the level of virus-neutralising antibodies a month after the second dose and found it was comparable to study participants aged 16 to 25 in the pivotal trial in adults.
Bourla said the company planned to seek emergency authorization from the US regulator, the Food and Drug Administration “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.”
Last week, the companies gave the first vaccine doses in a series of trials testing the vaccine in younger children, too.
The aim is to approve the vaccine for much younger children, including toddlers and babies, eventually vaccinating those as young as six months of age.