The FDA authorisation is based on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 individuals aged 12 to 15 years
Pfizer’s Covid-19 vaccine approved for individuals aged 12 to 15 years in US. (Credit: Wilfried Pohnke from Pixabay)
The US Food and Drug Administration (FDA) has approved Pfizer-BioNTech Covid-19 vaccine for emergency use in adolescents aged 12 to 15 years.
With the approval, the vaccine becomes the first Covid-19 vaccine approved in the US for use in this age group, said Pfizer.
Earlier this month, Canada authorised the use of Pfizer-BioNTech Covid-19 vaccine in children aged 12 to 15 years.
Pfizer chairman and CEO Albert Bourla said: “Today’s expansion of our EUA represents a significant step forward in helping the U.S. government broaden its vaccination program and help protect adolescents before the start of the next school year.
“We are grateful to all of our clinical trial volunteers and their families, whose courage helped make this milestone possible. Together, we hope to help bring a sense of normalcy back to young people across the country and around the world.”
The US regulator’s authorisation is based on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 individuals aged 12 to 15 years.
The results from the study showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and strong antibody responses.
Pfizer stated that it will continue to monitor the participants from the trial for long-term protection and safety for an additional two years after their second dose.
BioNTech CEO and co-founder Ugur Sahin said: “Since securing the EUA in December for individuals 16 years and older, we have been working tirelessly to get our COVID-19 vaccine authorised around the world so that governments can provide it to as many people as possible.
“Our work is not yet complete, as we continue our research into the use of our vaccine in paediatric populations. Our goal is to submit data for pre-school and school-age children in September.”
Pfizer and BioNTech have submitted the data from the study in adolescents aged 12 to 15 years for scientific peer review for potential publication.
Also, the data has been submitted to other regulators across the globe, including the European Medicines Agency (EMA).
Furthermore, a paediatric study is being carried out to evaluate the safety and efficacy of Pfizer-BioNTech Covid-19 vaccine in kids aged six months to 11 years.