BERLIN (AP) – Pharmaceutical company Pfizer and biotech firm BioNTech announced Friday that they have asked the European Union to authorize its COVID-19 vaccine for use in children between the ages of five and 11. If approved by EU regulators, it would be the first chance for children in Europe to be immunized.
Pfizer and BioNTech said they submitted the application to the European Medicines Agency (EMA), attaching the latest phase results of a study that tested their vaccine in more than 2,200 children between the ages of 6 months and 11 years. Children received lower doses than those 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 shown to be safe. There are currently no COVID-19 vaccines licensed for use in children under 12 years of age in Europe or North America. Those produced by Pfizer-BioNTech and Moderna are authorized in the EU only for children 12 years of age or older.
Pfizer and BioNTech this month asked the US Food and Drug Administration (FDA) to authorize the vaccine for children ages 5 to 11.
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