Pfizer Inc and BioNTech SE said on Wednesday their COVID-19 vaccine was safe and effective and produced robust antibody responses in 12- to 15-year olds, paving the way for them to seek U.S. emergency use authorization in weeks.
Pfizer hopes that vaccinations of the group could begin before the next school year, Albert Bourla, Pfizer's chairman and chief executive, said in a statement.
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.
In the 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 got 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. It 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.