Europe – Vaccin PFIZER anti-COVID : le rapport d’évaluation de l’EMA

The applicant BioNTech Manufacturing GmbH submitted on 30 November 2020 an application for marketing authorisation to the European Medicines Agency (EMA) for Comirnaty, through the centralised procedure falling within the Article 3(1) and point 1 of Annex of Regulation (EC) No 726/2004. The eligibility to the centralised procedure was agreed upon by the EMA/CHMP on 23 July 2020.

The applicant applied for the following indication:

“Active immunisation to prevent COVID-19 disease caused by SARS-CoV-2 virus, in individuals 16 years of age and older. The use of Comirnaty vaccine should be in accordance with official guidance.”…