Pfizer Inc and BioNTech SE announced on Wednesday their COVID-19 vaccine is safe and effective for 12- to 15-year olds. The company said the vaccine has produced robust antibody responses in children paving the way for them to seek US emergency use authorization in weeks.
Most COVID-19 vaccines being rolled out worldwide are for adults, who are at higher risk from the coronavirus. Pfizers vaccine is authorized for ages 16 and older. But vaccinating children of all ages will be critical to stopping the pandemic and helping schools, at least the upper grades, start to look a little more normal after months of disruption.
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.
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 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.”
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.
Children represent about 13% of COVID-19 cases documented in the US and while children are far less likely than adults to get seriously ill, at least 268 have died from COVID-19 in the US alone and more than 13,500 have been hospitalized, according to a tally by the American Academy of Pediatrics. Thats more than die from the flu in an average year. Additionally, a small number have developed a serious inflammatory condition linked to the coronavirus.