COVID-19 Vaccine Janssen


COVID-19 vaccine (Ad26.COV2-S [recombinant])

This medicine is authorised for use in the European Union.


COVID-19 Vaccine Janssen is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. COVID-19 is caused by SARS-CoV-2 virus.

COVID-19 Vaccine Janssen is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein found on SARS-CoV-2.

COVID-19 Vaccine Janssen does not contain SARS-CoV-2 itself and cannot cause COVID-19. 

Detailed information about this vaccine is available in the product information, which includes the package leaflet.

This EPAR was last updated on 01/12/2021

Authorisation details

Product details
COVID-19 Vaccine Janssen
Agency product number
Active substance
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S)
International non-proprietary name (INN) or common name
COVID-19 vaccine (Ad26.COV2-S [recombinant])
Therapeutic area (MeSH)
COVID-19 virus infection
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Publication details
Marketing-authorisation holder
Janssen-Cilag International NV
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Turnhoutseweg 30
B-2340 Beerse

Product information

29/11/2021 COVID-19 Vaccine Janssen - EMEA/H/C/005737 - IA/0034


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Pharmacotherapeutic group


Therapeutic indication

Prevention of coronavirus disease-2019 (COVID-19).

Assessment history

Safety updates


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