Paul-Ehrlich-Institut

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Janssen-Cilag In­ter­na­tion­al N.V. ap­plies for a Con­di­tion­al Mar­ket­ing Au­tho­ri­sa­tion of its COVID-19 Vac­cine

On 16 February 2021, the EMA (European Medicines Agency) received an application for a conditional marketing authorisation (CMA) for the COVID-19 vaccine Janssen developed by Janssen-Cilag International N.V. (Johnson & Johnson). The conditional marketing authorisation is an accelerated marketing authorisation, which is granted with conditions. It serves to speed up the use of treatments and vaccines in emergency situations in the area of public health within the EU (European Union). The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) may give a recommendation for a marketing authorisation to the European Commission as early as March.

Person in front of a  laptop with documents (Source: ElleAon/Shutterstock.com)

This is the fourth CMA application for a COVID-19 vaccine since the beginning of the pandemic. It follows the marketing authorisations for the vaccines by BioNTech/Pfizer, Moderna, and AstraZeneca. Like the COVID-19 vaccine AstraZeneca, the vaccine from Janssen is a vector vaccine. It consists of an innocuous, non-replicable virus from the family of human adenoviruses (cold viruses). The virus was modified in such a way that it contains the gene for the production of the spike protein. This surface protein is required by the SARS Coronavirus-2 to enter the body cells. After the vaccination, the vaccine delivers the SARS-CoV-2 spike protein gene into the body cells. The cells read the gene and produce the spike protein. The immune system will recognise this protein as foreign, produce antibodies, and activate T-cells (white blood corpuscles). Finally, it will render the virus harmless and eliminate infected cells. If persons come into contact with the SARS-CoV-2 virus at a later point in time, their immune system will recognise the spike proteins on the virus and virus-infected cells, and will combat them.

The reason why the CHMP will possibly decide whether it will recommend a marketing authorisation for this vaccine for Europe is based on the fact that the vaccine has already undergone the rolling review since 1 December 2020. In this procedure, which serves the acceleration of the marketing authorisation procedure, data packages are submitted and assessed before the complete data are available for the formal application for a marketing authorisation.

Updated: 22.02.2021