Pfizer Inc and its German partner BioNTech SE announced on Friday that they had submitted data to the European Medicines Agency supporting the use of their COVID-19 vaccination in children aged five to less than 12 years.
Despite the fact that the vaccine is currently not approved for that age group, it has been approved for use in children over the age of 12 in the United States and the European Union.
The companies petitioned US regulators earlier this month to seek emergency use authorisation for the shot in young children, and a US Food and Drug Administration advisory group is set to meet next month to assess the evidence.
While children are less prone to severe COVID-19, they can transfer the virus to others, including vulnerable populations.
In a 2,268-participant clinical trial, the Pfizer/BioNTech vaccine was demonstrated to generate a significant immunological response in children aged 5 to 11.