NUVAXOVID™ Omicron XBB.1.5
Product Overview
Type: COVID-19 vaccine (SARS-CoV-2 rS [Recombinant, adjuvanted])
INN: N/A
Trade name: NUVAXOVID
EUL holder: Novavax CZ a.s.
Country: Czech Republic
Responsible NRA: European Medicines Agency
Country: The Netherlands
WHO EUL recommendation
Effective date: 22 November 2023
Product description
Pharmaceutical Form: Sterile dispersion for injection
Presentation: 2.5 mL and 5 mL vial
Number of doses: 5 doses (0.5 mL per dose)
Route of administration: Intramuscular
Age indication: 12 years and older
Shelf – life: 12 months Storage temperature: 2°C to 8°C
Vaccine Vial monitor (VVM): None
Preservative: None
Adjuvant: Matrix-M1 (a saponin based adjuvant)
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 2 vials (10 doses). Dimensions: 3.6 x 9.2 x 6.2 cm b. Carton of 10 vials (50 doses). Dimensions: 3.6 x 9.2 x 6.2 cm |
|
Tertiary Packaging: |
a. Case of 60 vials (300 doses). Dimensions: 20 x 29.2 x 15 cm b. Case of 300 vials (1500 doses). Dimensions: 20 x 29.2 x 15 cm |
|
Cold Chain Volume: |
a. 20.50 cm3/dose (in secondary packaging) b. 4.11 cm3/dose (in secondary packaging) |
- Serum Institute of India Pvt Ltd., 105 – 110, Manjari site, Tal-Haveli,
Pune 412307, Maharashtra, India.
- Novavax CZ a.s., Bohumil 138, 281 63 Jevany, Czech Republic.
- Serum Institute of India Pvt Ltd., 105 – 110, Manjari site, Tal-Haveli,
Pune 412307, Maharashtra, India.