The European Medicines Agency's EU conditional marketing authorisations for COVID-19 vaccines

The Lancet

13 January 2021 - Few medicines are awaited as eagerly as COVID-19 vaccines. 

Extraordinary efforts by scientists, regulators, and developers enabled the European Medicines Agency (EMA) to recommend the first EU conditional marketing authorisation (CMA) for the BioNTech COVID-19 mRNA vaccine (nucleoside-modified) BNT162b2 (Comirnaty) some 9 months after the COVID-19 pandemic was declared. 

On 21 December 2020, the European Commission granted CMA, following the EMA's positive opinion, to BNT162b2 for active immunisation of individuals aged 16 years and older to prevent COVID-19, which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Read The Lancet article

Michael Wonder

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Michael Wonder

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Europe , Regulation , Vaccine , COVID-19