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Pfizer-BioNTech seek European Union authorization for COVID-19 vaccine for 5-11-year-olds

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eMediNexus    17 October 2021

Pfizer and BioNTech have requested to have their COVID-19 vaccine authorized for use in children 5 to 11 years of age across the European Union. If the regulators agree, it would be the first time that younger children in Europe would be able to get a COVID-19 vaccination. 

The companies stated that they submitted data to the European Medicines Agency (EMA), which includes late-stage results from a trial of the vaccine in over 2,200 children in the age group of 6 months to 11 years. The children were administered a lower dose than the one given to adults. A statement from the companies mentioned that there was a strong immune response in the children and the vaccine was found to be safe.

No COVID-19 vaccines are as yet licensed for use in children below 12 years of age in Europe or North America… (ET Healthworld – AP, October 16, 2021)

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