Paul-Ehrlich-Institut

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Eu­ro­pean Com­mis­sion Grants Con­di­tion­al Mar­ket­ing Au­tho­ri­sa­tion for COVID-19 Vac­cine by Janssen-Cilag N.V. for the Eu­ro­pean Union

The conditional marketing authorisation (CMA) for the COVID-19 Vaccine Janssen from the Belgian pharmaceutical company Janssen-Cilag International N.V., which is a subsidiary of the US company Johnson & Johnson, is valid for the member states of the EU (European Union) and the EEA (European Economic Area). The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) had recommended the conditional marketing authorisation on 11 March 2021. The vaccine from Janssen-Cilag International N.V. is the second authorised vector vaccine against COVID-19. Thus, four vaccines are available in Europe for the protection against COVID-19. In Germany, an official batch release by the Paul-Ehrlich-Institut is required before the vaccine can be used.

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

Like the COVID-19 vaccine from AstraZeneca, the Janssen’s COVID-19 vaccine is vector based and also uses an adenovirus (cold virus) to transfer the genetic information for the formation of the characteristic spike protein (S) to the body cells after the vaccination. The adenovirus vector of the COVID-19 vaccine from Janssen-Cilag is a harmless, non-replicable vector. The vector was modified in a way that it contains the gene for the formation of the spike protein of Coronavirus SARS-CoV-2. After the vaccination, a few body cells integrate the adenovirus vector, read the genetic blueprint of the spike protein and produce this protein based on the blueprint. The immune system recognises the spike protein as foreign and forms natural defences – antibodies and immune cells. If the vaccinated person later on is exposed to SARS-CoV-2, the antibodies recognise the virus, and T cells identify the virus-infected cells. The conditional marketing authorisation for the vaccine candidate from Janssen-Cilag International N.V. is performed on the basis of clinical trials with persons of 18 years of age and older. Other than the previously authorised vaccines in the EU, COVID-19 Vaccine Janssen (Ad26.COV2.S) requires only one dose. The storage temperature is between 2°C and 8°C.

The authorisation of an additional COVID-19 vaccine presents an important step in containing the SARS-CoV-2 pandemic. The close global cooperation between all experts involved in developing vaccines allows the development of effective vaccines in conformity with the highest safety standards within an optimum period of time. Scientists at the Paul-Ehrlich-Institut contributed to accelerating procedures by early scientific advice and the authorisation of combined clinical trials within a rolling review process. Besides, its experts represent the institute in the CHMP. It actively contributes to the evaluations in the various different European marketing authorisation procedures.

In Germany, batches (production units) of a vaccine require an official batch release by the Paul-Ehrlich-Institut, before they can be marketed and used. A batch release test includes experimental examinations for a vaccine by the Paul-Ehrlich-Institut or a different Official Medical Control Laboratory (OMCL) in Europe, before the batch is released.

Updated: 11.03.2021