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A conditional marketing authorisation (CMA) for the COVID‑19 vaccine by BioNTech and Pfizer

21.12.2020 – Today, the European Commission has granted a conditional marketing authorisation (CMA) for the COVID‑19 vaccine developed by BioNTech and Pfizer, making it the first COVID-19 vaccine authorised in the EU. This authorisation follows a positive scientific recommendation based on a thorough assessment of the safety, effectiveness and quality of the vaccine by the European Medicines Agency (EMA) and is endorsed by the Member States.

BioNTech and Pfizer made a formal application for a conditional marketing authorisation on 1 December. This followed the analysis of their data in a ‘rolling review’ by EMA as from 6 October. Thanks to this rolling review, EMA managed to assess the conditional marketing authorisation application very rapidly. This procedure, specifically designed for emergency situations, ensures as swift an assessment as possible while ensuring that all requirements in terms of safety, effectiveness and quality of the vaccine are fully and thoroughly evaluated.

On the basis of EMA’s positive opinion, the Commission has verified all the elements supporting the marketing authorisation and consulted Member States before granting the conditional market authorisation. The BioNTech/Pfizer vaccine is based on messenger RNA (mRNA) technology. This allows cells to manufacture harmless fragments of viral proteins that the human body uses to build an immune response to prevent or fight subsequent, natural infection. When a person is given the vaccine, their cells will read the genetic instructions and produce fragments of the ‘spike protein’, a protein on the outer surface of the virus which it uses to enter the body’s cells, to replicate, and cause disease. The person’s immune system will then treat this protein as foreign and produce natural defences — antibodies and T cells — against it. More: here

Vir: EC Press

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