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
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
Remarks:
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
Janssen Vaccines & Prevention B.V.
Archimedesweg 4-6, 2333 CN Leiden, The Netherlands
Janssen Biologics B.V.
Einsteinweg 101, 2333 CB Leiden, The Netherlands
Emergent Manufacturing Operations Baltimore LLC*
5901 East Lombard Street Baltimore, MD 21224, United States (USA)
* Site under investigation by relevant authorities due to non-GMP compliance. Refer to WHO website for the current GMP status. Refer to WHO website for the latest update status.
Janssen Biologics B.V.
Einsteinweg 101, 2333 CB Leiden, The Netherlands
Janssen Pharmaceutica NV
Turnhoutseweg 30, 2340 Beerse, Belgium
Aspen SA Sterile Operations
8B Gibaud Road, Korsten, Gqeberha, South Africa
Catalent Indiana LLC.
1300 S Patterson Drive, Bloomington. Indiana (IN) 47403. USA
https://biologics.catalent.com/our-locations/north-america/bloomington-usa/
Grand River Aseptic Manufacturing Inc.
140 Front Ave. SW. Grand Rapids, Michigan (MI) 49504. USA
https://www.grandriverasepticmfg.com/
Catalent Anagni S.R.L.
Fontana del Ceraso SNC, Strada Provinciale 12, Casilina 41, 03012 Anagni, Italy
Merck Sharp & Dohme LLC.
770, Sumneytown Pike, West Point, PA 19486, United States