Paul-Ehrlich-Institut

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Com­mit­tee for Medic­i­nal Prod­ucts for Hu­man Use Rec­om­mends Con­di­tion­al Mar­ket­ing Au­tho­ri­sa­tion for the COVID-19 Vac­cine from As­traZeneca

On 29 January 2021, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) recommended the conditional marketing authorisation for the COVID-19 vaccine from AstraZeneca. That way, a vector vaccine will be available possibly for the first time in the European Union (EU) and the European Economic Area (EEA) for the prevention of COVID-19 infections. If the European Commission follows the CHMP recommendation by granting the marketing authorisation, a third vaccine candidate will be ready for use to combat the COVID-19 pandemic in the EU/EEA shortly. A decision by the European Commission on the COVID-19 vaccine is expected soon.

COVID-19 Vaccine (Source: Insta_Photos/Shutterstock.com)

On 11 January 2021, AstraZeneca had submitted an application for a conditional marketing authorisation for its COVID-19 vaccine, which it had developed jointly with the University of Oxford, at the EMA. A conditional marketing authorisation is made with conditions, such as the requirement to confirm the safety and efficacy in further studies or to report results of ongoing clinical trials. For the purpose of optimising the time-period required for evaluating the data, the EMA had authorised a rolling review procedure for this vaccine, which it started on 5 October 2020. Since then, medicines experts from the Paul-Ehrlich-Institut and the other national medicines authorities in Europe have continuously been evaluating the documents that were successively submitted. The Paul-Ehrlich-Institut is represented in the CHMP with its expert, and is actively involved in the evaluation as part of the European marketing authorisation procedure.

The COVID-19 vaccine would be the first authorised vector vaccine against COVID-19. This vector vaccine belongs to the genetic vaccines and consists of an innocuous virus from the adenovirus family (common cold viruses) from chimpanzees as carrier (vector). This virus is not replicable in humans. It was modified in such a way that it contains the gene with the blueprint for the generation of a surface protein of the SARS-CoV-2 (spike protein). The spike protein stimulates the human immune system to produce an immune response. After the vaccination, the vaccine virus with the SARS-CoV-2 gene enters a small number of human body cells. The cells use the gene to produce the spike protein. The immune system recognises the spike protein as foreign and forms immune substances, e.g. antibodies and T-cells, which are intended to protect the vaccinated person from COVID-19 and a serious progression of the COVID-19 disease.

Unlike the already authorised mRNA-based COVID-19 vaccine products, this vector vaccine can be stored in the refrigerator in unopened 8- or 10-dose containers for six months, two days after opening. The efficacy of the vaccine product determined so far after two vaccinations at intervals of four to 12 weeks is 60% and thus suitable to make an important contribution to pandemic control. This is also supported by the good safety profile of Astra Zeneca's COVID-19 vaccine.

Updated: 29.01.2021