The European Union’s medicines regulator said on Monday it has started evaluating the use of Pfizer Inc and BioNTech’s Covid-19 vaccine in children between five and 11 years of age.
Pfizer and its German partner BioNTech last week submitted data that supports the use of their mRNA vaccine for young children.
The vaccine was found to induce a strong immune response in five to 11-year-olds in a clinical trial of 2,268 participants, the companies said last month.
The European Medicines Agency (EMA) said it will review data related to the vaccine, known as Comirnaty, including results from an ongoing clinical study.
The vaccine is currently not allowed for that age group. It has, however, been authorised for use in children over the ages of 12 years in both the US and European Union.
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 EMA human medicines committee’s opinion will be forwarded to the European Commission, which will issue a final decision on the matter.