31st March, 2021
Pfizer Inc and BioNTech SE will sooner seek U.S. emergency use authorisation to inoculate children aged between 12 and 15 with their COVID-19 vaccine.
This followed their announcement Wednesday their COVID-19 vaccine was safe and effective and produced robust antibody responses in the adolescents.
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 authorised 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.
The companies also studied a subset of teens to measure the level of virus-neutralizing 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 authorisation 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.”
Last week, 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.