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The US authorizes Pfizer vaccine for children aged 12 to 15
The US Food and Drug Administration (FDA) announced on May 10 that it is broadening its emergency use authorization for the Pfizer-BioNTech coronavirus vaccine to include adolescents aged 12 to 15.
The approval was granted following an analysis of safety and efficacy data from a clinical trial.
Until now, the Pfizer-BioNTech vaccine has had emergency use authorization in the United States only for people aged 16 or older.
On March 31, Pfizer and BioNTech announced that their vaccine was safe and effective for adolescents. A clinical trial was held in the US involving 2,260 young people aged 12 to 15.
Adolescents were split into two groups. One group was given a placebo – and 18 people contracted COVID-19. There were zero cases among the group that received the vaccine.
Side effects reported among the vaccinated group largely corresponded to those developed in clinical trials for people aged 16 to 25.
Trials underway for younger children
Pfizer is also conducting clinical trials involving children aged 11 or younger, with plans to apply for emergency authorization for that age groups as early as September.
Moderna and Johnson & Johnson are also testing their vaccines on children up to the age of 17.
This information was updated on May 13, 2021.