Pfizer/BioNTech submit data to EMA for COVID-19 vaccine in young children

Pfizer Inc and German partner BioNTech SE said on Friday that they had submitted data supporting the use of their COVID-19 vaccine in children aged between five and less than 12 years to the European Medicines Agency.

Although the vaccine is currently not allowed for that age group, it has been authorized for use in children over 12 years of age in both the United States and the European Union.

The companies earlier this month asked U.S. regulators to also grant emergency use authorization of the shot for young children, and an advisory panel to the U.S. Food and Drug Administration is expected to meet next month to review the data.

While children are less susceptible to severe COVID-19, they can spread the virus to others, including vulnerable populations more at risk of severe illness.

The Pfizer/BioNTech vaccine has been shown to induce a strong immune response in five to 11 year olds in a 2,268-participant clinical trial, the companies said on Sept. 20.