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Pfizer/BioNTech on Friday applied to the European Medicines Agency, EU's drug regulatory authority, for emergency use approval for its COVID-19 vaccine in children aged 12 to 15.
“This submission is based on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years,” said a statement from the pharma companies.
“Topline results from this trial, announced on March 31, 2021, showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and robust antibody responses,” it added.
The companies previously applied to the US Food and Drug Administration (FDA) for emergency use authorization.
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3 years ago
