Pfizer/BioNTech submit data to EMA for children’s COVID-19 vaccine
Although the vaccine is currently not allowed for that age group, it has been authorised for use in children over 12 years of age in both the US and the European Union (EU).
Pfizer and German partner BioNTech said last week that they had submitted data supporting an application for use of their COVID-19 vaccine in children aged five to 12 years to the European Medicines Agency (EMA).
Although the vaccine is currently not allowed for that age group, it has been authorised for use in children over 12 years of age in both the US and the European Union (EU).
The companies earlier this month asked the US regulators to also grant Emergency Use Authorisation (EUA) of the shot for young children, and an advisery panel to the US Food and Drug Administration (FDA) 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 20th September.
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