Pfizer/BioNTech seeks EU jab approval for ages 12-15

Vaccine shows 100% efficacy in participants aged 12-15 years in Phase 3 trials, say pharma firms

By Busra Nur Cakmak

ANKARA (AA) - 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.

Kaynak:

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