Pfizer and BioNTech on Wednesday said their COVID-19 vaccine was safe and effective and produced robust antibody responses in 12 to 15-year olds, setting the stage for them to seek approval in the United States and Europe within weeks -- and offering hope for a return to in-person schooling nationwide.
Their vaccine was authorized by U.S. regulators in late December for people aged 16 and older.
The new study offers the first evidence of how the vaccine will work in school-age adolescents - putting the two companies ahead of other western vaccine developers in the quest to protect children from the virus.
A trial by Moderna to test its COVID-19 vaccine in children aged six months to less than 12 years was launched this month, while Johnson & Johnson has yet to begin a planned trial.
AstraZeneca in December removed children from a mid-to-late stage trial of its COVID-19 vaccine in Britain.
The Pfizer/BioNTech trial was 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 in the earlier adult trial.
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.
Pfizer’s chief executive Albert Bourla said the company planned to seek emergency authorization from the U.S. Food and Drug Administration (quote) "in the coming weeks and to other regulators around the world.”
He added that he hopes to start vaccinating the younger age group before the start of the next school year.