WHO recommendation Janssen–Cilag International NV (Belgium) COVID-19 Vaccine (Ad26.COV2-S [recombinant])

The active ingredient of COVID-19 Vaccine Janssen, also known as Ad26.COV2-S (recombinant), is a recombinant adenoviral vector that contains the sequence that encodes the spike protein (S) of the SARS-CoV-2 virus. After administration, the replication incompetent adenoviral particles will infect cells and the sequence encoding the SARS-CoV-2 Spike protein will be transcribed into mRNA and subsequently translated into SARS-CoV-2 Spike protein which will serve as antigen to trigger an immune response. The adenoviral particle contains the coding sequence of the SARS-CoV-2 Spike protein as an integral part of the genome of the adenoviral construct.

The applicant, Janssen – Cilag International N. V. (Belgium) (Janssen) has used the AdVac® vector platform considering the substantial nonclinical and clinical evidence from Janssen’s other vaccine development programs that also make use of Ad26 (e.g., Ebola vaccine Zabdeno®, and candidate vaccines against Zika, HIV and respiratory syncytial virus).

COVID-19 Vaccine Janssen is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

The use of COVID-19 Vaccine Janssen under the current emergency scenario was approved on 11 March 2021 by the European Medicines Agency (EMA). The vaccine is endorsed by other regulatory authorities (e.g., the Food and Drug Administration of the United States of America and Health Canada).