Pfizer-BioNTech seek EU agency nod for COVID vaccines for kids 5-11
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Berlin : Pharmaceutical company Pfizer and biotechnology company BioNTech informed they have requested to have their coronavirus vaccine licensed for children ages 5 to 11 across the European Union. If EU regulators agree, it would be the first opportunity for younger children in Europe to get immunized against COVID-19.
Pfizer and BioNTech said they submitted data to the European Medicines Agency (EMA), including late-stage results from a study testing their COVID-19 vaccine in more than 2,200 children ages 6 months to 11 years. The children received a lower dose than what's normally given to adults.
The companies said in a statement that the results showed a "strong immune response" in the children and that the vaccine was also found to be safe.
There are currently no COVID-19 vaccines licensed for use in children younger than 12 in Europe or North America; the ones made by Pfizer-BioNTech and Moderna are authorized for children 12 and older in the European Union.
Earlier this month, Pfizer and BioNTech asked the U.S. Food and Drug Administration (USFDA) to greenlight their vaccine for children ages 5 to 11.
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