Health, Latest on coronavirus outbreak

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

Busra Nur Cakmak   | 30.04.2021
Pfizer/BioNTech seeks EU jab approval for ages 12-15


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.

Anadolu Agency website contains only a portion of the news stories offered to subscribers in the AA News Broadcasting System (HAS), and in summarized form. Please contact us for subscription options.
Related topics
Bu haberi paylaşın