The US Food and Drug Administration (FDA) gave its approval for emergency use of the BioNTech-Pfizer coronavirus vaccine in adolescents on Monday, the body said in a statement.
The decision allows for the vaccine to be administered to people aged 12 and up, bringing the minimum age down from 16.
“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” acting FDA Commissioner Janet Woodcock said in a statement.
“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” she added.
BioNTech-Pfizer is the first vaccine to be authorized for use on people younger than 16 in the US.
The head of the European Medicines Agency, Emer Cooke, told journalists on Monday that approval for the BioNTech-Pfizer vaccine for 12 to 15-year-olds in the EU may be given as early as this month.
“Right now, the goal we’ve set ourselves is approval in June. We are trying to see if we can accelerate that for the end of May,” she said.
The FDA assures parents of safety
The statement from the FDA said that some 1.5 million COVID-19 cases had been reported among individuals aged 11 to 17 between March 1, 2020, and April 30, 2021. The drug regulation body added that children and adolescents generally suffer milder symptoms of the disease.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, assured people that the data regarding the vaccine’s efficacy met the “rigorous standards to support the emergency use of this vaccine in the adolescent population 12 years of age and older.”
“Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations,” Woodcock added.
Vaccine developers study efficacy in children
Canada recently became the first country to authorize the use of the BioNTech-Pfizer vaccine for people aged 12 and over.
Schools across the US are hoping to vaccinate as many middle and high school pupils before the students return in the fall.
BioNTech-Pfizer and Moderna have both already begun trials on the vaccine’s efficacy for even younger children, carrying out studies on 6 month-olds, up to 11-year-olds. In the UK, AstraZeneca has been studying the effects of its own COVID-19 vaccine on young people aged between 6 and 17 years.
Experts have said that children will need to be vaccinated in order to reach the 70% to 85% needed for herd immunity to be achieved — the point at which enough people are immune to the virus that it can no longer spread.
