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

Product Overview

Type:                         COVID-19 Vaccine  (Ad26.COV2-S [recombinant])

INN:                           N/A

Trade name:              N/A

EUL holder:               Janssen–Cilag International NV

Country:                    Belgium

Responsible NRA:    European Medicines Agency (EMA)

Country:                     The Netherlands


WHO EUL recommendation

Effective date:            12 March 2021

Recommendation for an Emergency Use Listing of COVID-19 Vaccine Janssen Submitted by Janssen – Cilag International N. V. (Belgium)


Product description

Pharmaceutical Form:                   Suspension for injection                                    

Presentation:                                   2.5 mL(2R) vial

Number of doses:                            5 doses (0.5 mL per dose)

Route of administration:                Intramuscular

Age indication:                                18 years and older

Shelf – life:                                       24 months     Storage temperature:   -25°C to -15°C      

Refrigeration Storage Time (2°C to 8°C):      11 months


The shelf-life extension of 11 months is applicable to all batches produced, provided that the approved storage conditions have been guaranteed throughout the entire storage period, with the exception of batch XE533, manufactured at ASPEN site (South Africa).   At the time of posting this remark, the EUL holder was conducting an evaluation of this particular batch.                                     

Vaccine Vial monitor (VVM):        None

Preservative:                                    None

Adjuvant:                                           None

Diluent:                                               None

Handling of opened multi-dose vials: 

WHO recommends that opened vials of this vaccine should be discarded 6 hours after opening or at the end of the immunization session, whichever comes first.


Packaging description

Secondary Packaging: 

 a. Carton of 10 vials (50 doses/carton). Dimensions: 9.3 x 3.8 x 5.4 cm

Tertiary Packaging: 

 a. 48 secondary packaged cartons (480 vials/2400 doses). Dimensions: 39.3 x 24.8 x 13.1 

Cold Chain Volume in

secondary packaging:

 a. 3.82 cm3/dose          


Product characteristics and Package leaflet