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Pfizer Submits Data For Approval Of Covid Jab For Ages 5 To 11 in Europe
NDTV
Pfizer and BioNTech are also trialling their vaccine on infants aged six months to two years, and on children aged two to five.
Pfizer and BioNTech said Friday they had submitted data to the EU's medicines watchdog for the approval of their coronavirus vaccine for children aged 5 to 11, following a similar step in the United States.
The vaccine makers announced last month that trial results had shown their jab was safe and created a "robust" immune response in that age group.
US pharma giant Pfizer and German partner BioNTech said they had submitted data from their study involving 2,268 children ages five to 11 to the European Medicines Agency (EMA) with a view to securing "Conditional Marketing Authorisation in the European Union".
"The same data have been submitted to the US Food and Drug Administration and will be filed with other regulatory authorities in the coming weeks," they added.