Pfizer Inc and BioNTech SE on Wednesday informed that their Covid-19 vaccine was safe and effective and produced robust antibody responses in 12- to 15-year old, paving the way for them to seek U.S emergency use authorization in weeks.
Albert Bourla, Pfizer’s chairman and chief executive, said in a statement that Pfizer hopes that vaccinations of the group could begin before the next school year.
However, Pfizer‘s vaccine is already authorized for use in people starting at age 16 and according to a new study, it shows that the first evidence of how the vaccine will also work in school-age adolescents.
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.
The companies in a statement said that in the trial of 2,260 adolescents aged 12 to 15, there were about 18 Covid19 cases 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.
Bourla said the company planned to seek emergency authorization from the U.S. 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.”
The companies also studied a subset of teens to measure the level of virus-neutralizing antibodies a month after the second dose and found that it was comparable to the study of the participants aged 16 to 25 in the pivotal trial in adults.
The companies gave the first vaccine doses in a series of trials testing the vaccine in younger children, that will eventually go to those as young as 6 months of age.