Pfizer and partner company BioNTech have announced an expanded emergency use authorisation (EUA) for their COVID-19 vaccine from the US Food and Drug Administration to include children aged 12 to 15 years.
In a statement, the companies said that their COVID-19 jab is the first to be authorised in the US for use in this younger age group.
The expanded EUA is based on data from a Phase III clinical trial that enrolled 2,260 participants aged 12 to 15 years.
Previously announced topline results from this trial showed that the vaccine had an efficacy of 100% in participants with and without prior COVID-19 infection, as well as ‘robust’ antibody responses.
The vaccine was also found to be generally well-tolerated in this trial, with participants to be monitored for long-term protection and safety for an additional two years following their second dose.
Pfizer and BioNTech have submitted this data for scientific peer review for potential publication and also submitted the results to global regulators – including the European Medicines Agency (EMA).
“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,” said Ugur Sahin, chief executive officer and co-founder of BioNTech.
“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,” he added.
Pfizer and BioNTech are also currently evaluating the safety and efficacy of their COVID-19 vaccine in children aged six months to 11 years of age.