Paul-Ehrlich-Institut

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Eu­ro­pean Com­mis­sion grants con­di­tion­al mar­ket­ing au­tho­ri­sa­tion for COVID-19 Vac­cine As­tra Zeneca for the Eu­ro­pean Union

The conditional marketing authorisation (CMA) for the COVID-19 vaccine of the British-Swedish company AstraZeneca is valid for the member states of the EU and the EEA. At its meeting on 29 January 2021, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) previously recommended a conditional marketing authorisation. AstraZeneca's vaccine is the first vector vaccine approved against COVID-19. With its authorisation by the European Commission, three vaccines against COVID-19 disease are now available in the European Union (EU) and the European Economic Area (EEA). In Germany, a government batch release by the Paul-Ehrlich-Institut is additionally required before a vaccine can be used.

EU flags in front of the European Commission building in Brussels (Source: NakNakNak/Pixabay.com)

A rolling review process for COVID-19 Vaccine Astra Zeneca began on 5 October 2020, in order to review the vaccine in a time-optimised process with regard to comprehensive safety assessments by drug experts from the Paul-Ehrlich-Institut and the other national competent authorities in the EU. After receipt of the application for conditional marketing authorisation (CMA) on 12 January 2021, the CHMP was able to make a recommendation to the European Commission on 29 January 2021, to grant this authorisation. Based on this recommendation, the European Commission granted the marketing authorisation for the entire European Economic Area after consulting the Member States in the EU’s Standing Committee on Medicinal Products for Human Use.

The CMA for COVID-19 Vaccine AstraZeneca is based on results from clinical trials in people aged 18 years and older. While previous trials have predominantly involved participants from the 18 to 55 age group, current trials specifically involve participants aged 55 and older. In order to obtain an authorisation, vaccines must demonstrate a positive benefit-risk ratio. In the case of a conditional marketing authorisation, this is continuously reviewed by further studies and the evaluation of the resulting data by scientific experts conforming to the highest safety requirements.

A vaccination with COVID-19 Vaccine Astra Zeneca is given in two doses. The second dose is given four to twelve weeks after the first vaccination. This vector vaccine can be stored in the refrigerator in unopened 8- or 10-dose containers for six months and for 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%, which makes it suitable for making an important contribution to pandemic control. This is also supported by the good safety profile of Astra Zeneca's COVID-19 vaccine.

The approval of another vaccine candidate represents an important step in containing the SARS-CoV-2 pandemic. The close, global collaboration of all experts involved in vaccine development enables effective vaccines to be developed with the highest safety standards in an optimised timeframe. The scientists at the Paul-Ehrlich-Institut have helped to speed up the process by providing early scientific and regulatory advice to vaccine developers and by approving clinical trials, including combined clinical trials, in the rolling review process. The Institute is also represented by an expert on the CHMP and actively participates in the evaluations in the various European authorisation procedures.

In Germany, batches (production units) of a vaccine require government batch release by the Paul-Ehrlich-Institut before they can be distributed and used. Batch testing means that, among other things, experimental studies of the vaccine are conducted by the Paul-Ehrlich-Institut or another Official Medical Control Laboratory in Europe (OMCL) prior to batch release.

Updated: 29.01.2021