Paul-Ehrlich-Institut

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Com­mit­tee for Medic­i­nal Prod­ucts for Hu­man Use (CHMP) Rec­om­mends Con­di­tion­al Mar­ket­ing Au­tho­ri­sa­tion of the COVID-19 Vac­cine by Janssen-Cilag In­ter­na­tion­al N.V.

On March 11, 2021, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) recommended the conditional marketing authorisation of the COVID-19 Vaccine Janssen by Janssen-Cilag International N.V. (Johnson & Johnson). If the European Commission grants the marketing authorisation, following this favourable opinion, a second vector vaccine for the prevention of COVID-19 infections will shortly be available in the European Union (EU) and the European Economic Area (EEA). Thus, a fourth vaccine candidate for containing the COVID-19 pandemic will be available for use in the EU/EEA.

COVID-19 Vaccines (Source: MFoto/Shutterstock.com)

On 16 February 2021, the EMA received an application for a conditional marketing authorisation (CMA) for the COVID-19 Vaccine Janssen (Ad26.COV2.S) developed by Janssen-Cilag International N.V. The conditional marketing authorisation is an accelerated marketing authorisation, which is granted with conditions. It serves to accelerate the use of therapeutic medicines and vaccines in emergencies in the area of public health in the EU (European Union).

Like the COVID-19 vaccine by AstraZeneca, Janssen’s COVID-19 vaccine is vector based and also uses an adeno virus vector to transfer the genetic information for the formation of the characteristic spike protein (S) to the cells. While the vector from AstraZeneca contains a harmless modified adenovirus from chimpanzees as vector, the vector for the vaccine by Janssen-Cilag is a harmless non-replicable adenovirus from humans. The virus was modified ina way that it contains the gene for the production of the spike protein of coronavirus SARS-CoV-2. After vaccination, few body cells integrate the adenovirus vector, read the genetic blueprint of the spike protein, and build the spike protein based this blueprint. The immune system recognises the protein as foreign and produces natural defences – antibodies and immune cells. If the vaccinated person later comes into contact with SARS-CoV-1, the antibodies recognise and neutralise the virus, and the T-cells kill virus infected cells. Other than the previously authorised COVID-19 vaccines in the EU, only one dose is required for COVID-19 Vaccine Janssen. The storage temperature is between 2°C and 8°C.

Updated: 11.03.2021