Paul-Ehrlich-Institut

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EMA re­ceives Ap­pli­ca­tion for Con­di­tion­al Mar­ket­ing Au­tho­ri­sa­tion of COVID-19 Vac­cine of As­traZeneca

On 11 January 2021 AstraZeneca submitted a conditional marketing authorisation application to the European Medicines Agency (EMA) for the COVID-19 candidate vaccine, which it developed together with the University of Oxford. On 5 October 2021, the rolling review process for the vaccine started: the successively submitted dossiers have been continuously evaluated by the experts from the national medicines authorities in Europe (NCAs) at the EMA since then. On 29 January 2021, the Committee for Medicinal Products for Human Use (CHMP) will decide on a possible recommendation for marketing authorisation by the European Commission.

Persons check documents (Source: Aymanejed/Pixabay.com)

The COVID-19 vaccine developed by Oxford University in the United Kingdom and the pharmaceutical company AstraZeneca is a vector vaccine. It consists of an innocuous virus from the adenovirus family (common cold viruses) from chimpanzees, which is non-replication competent in humans and has been modified in such a way that it contains the gene encoding an optimised surface protein of SARS-Coronavirus-2 (spike protein). The adenovirus is replication-incompetent and does therefore not cause disease. After vaccination, the vaccine virus containing the SARS-CoV-2 gene is transferred into a few human somatic cells only. The cells synthesize the spike protein encoded by the transferred gene. The immune system will recognise the spike protein as a foreign antigen and the production of antibodies and T-cells is induced, which shall infer protection against COVID-19 and a severe course of the disease.

Updated: 18.01.2021