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
Remark:
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
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Secondary Packaging: |
a. Carton of 10 vials (50 doses/carton). Dimensions: 9.3 x 3.8 x 5.4 cm |
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Tertiary Packaging: |
a. 48 secondary packaged cartons (480 vials/2400 doses). Dimensions: 39.3 x 24.8 x 13.1 |
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Cold Chain Volume in secondary packaging: |
a. 3.82 cm3/dose |