Pfizer says the COVID-19 vaccine it has developed with Germany's BioNTech has shown 100% efficacy in preventing infection in 12-to-15-year-olds.
The vaccine rollout to American adults is now well underway, and vaccine developers have turned their attention to testing its safety and efficacy in children, with vaccinating the country's students seen as a crucial step in overcoming the pandemic.
On Wednesday, Pfizer announced that a trial of its two-dose vaccine among 2,260 children aged 12 to 15 "demonstrated 100% efficacy and robust antibody responses," based on results that are yet to be peer reviewed.
Of those in the trial, 1,131 received the Pfizer/BioNTech vaccine, with 1,129 receiving a placebo. Eighteen of those in the placebo group contracted COVID-19, with zero children in the vaccine group getting the virus.
The children who received the vaccine received two doses three weeks apart.
In a statement, Pfizer CEO Albert Bourla said the company now intends to submit the data to the FDA to amend its existing Emergency Use Authorization "with the hope of starting to vaccinate this age group before the start of the next school year."
Further tests are continuing in even younger children, with the first doses given in these tests last week.
The study will evaluate the "safety, tolerability, and immunogenicity" from the vaccine in three different age groups: 6 months to two years, two years to five years, and five years to 11 years.
A cohort of 5 to 11 year olds were the first to receive the vaccine, with the companies planning to start vaccinating the 2-5 cohort next week.
Most Minnesota schools had resumed in-person learning by the beginning of March, but the state has since seen a rise in COVID-19 rates, with health officials saying younger generations have been behind much of this recent spread.
The state has been urging parents and students to get tested for COVID-19 every two weeks amid the increasing incidence of more contagious variants of COVID-19.
“Across the globe, we are longing for a normal life," said Ugur Sahin, CEO of BioNTech. "This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 UK variant."