COVOVAX

Product Overview

Type: COVID-19 vaccine (SARS-CoV-2 rS Protein Nanoparticle [Recombinant])

INN: N/A

Trade name: COVOVAX™

EUL holder: Serum Institute of India Pvt. Ltd. (SIIPL)

Country: India

Responsible NRA: Central Drugs Standard Control Organization (CDSCO)

Country: India

WHO EUL recommendation

Effective date: 17 December 2021

Product description

Pharmaceutical Form: suspension for injection

Presentation: 2 mL and 5 mL vial

Number of doses: 1 dose and 10 doses (0.5 mL per dose)

Route of administration: Intramuscular

Age indication: 12 years and older

Shelf – life: 9 months Storage temperature: 2°C to 8°C

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) 1 dose presentation:
Carton with 50 vials (50 doses).
Dimensions: 18.5 x 9.5 x 4.5 cm

b) 10 dose presentation:
Carton with 50 vials (500 doses)
Dimensions: 18.5 x 9.5 x 6.0 cm

Tertiary packaging:

a) 1 dose presentation:
Carton with 1200 vials (1200 doses)
Dimensions: 71.5 x 60.5 x 63.5 cm

b) 10 dose presentation:
Carton with 1200 vials (12000)
Dimensions: 71.5 x 60.5 x 63.5 cm

Cold Chain Volume (in secondary packaging):

a) 15.8 cm³/dose

b) 2.1 cm³/dose

Drug substance - Manufacturing sites

Serum Institute of India Pvt. Ltd.
212/2, Hadapsar, Pune - 411028, INDIA

Serum Institute of India Pvt. Ltd.
S. No. 105-110, Manjari BK, Tal -Haveli, Pune-412307, INDIA

Drug product - Manufacturing sites

Serum Institute of India Pvt. Ltd.
212/2, Hadapsar, Pune - 411028, INDIA

Serum Institute of India Pvt. Ltd.
S. No. 105-110, Manjari BK, Tal-Haveli, Pune - 412307, Maharashtra, INDIA