COVAXIN


Suspension of supply

Product Overview

Type:                           Covid-19 vaccine (Whole Virion Inactivated Corona Virus vaccine)

INN:                             N/A

Trade name:               COVAXIN®

EUL holder:                Bharat Biotech International Ltd.

Country:                      India

Responsible NRA:     Central Drugs Standard Control Organization (CDSCO)

Country:                      India

 

WHO EUL recommendation

Effective date:             03 November 2021

 

Product description

Pharmaceutical Form:                   Suspension for injection                                   

Presentation:                                   2 mL, 3mL, 5 mL and 10 mL vial

Number of doses:                           1 dose, 5 doses, 10 doses and 20 doses (0.5 mL per dose)

Route of administration:                Intramuscular

Age indication:                                18 years and older

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

Vaccine Vial monitor (VVM):        None

Preservative:                                    Phenoxy ethanol      with concentration:   2.5 mg/dose

Adjuvant:                                           None

Diluent:                                               None

Handling of opened multi-dose vials: 

The vaccine can be kept and used for up to 28 days after opening, in accordance with WHO Policy Statement WHO/IVB/14.07 on Multi-dose Vial Policy (MDVP).

 

Packaging description

Secondary packaging:

a) Single dose presentation
Multipack of 36 vials (36 doses).

b) 5 doses presentation
Multipack of 36 vials (180 doses).

c) 10 doses presentation
Multipack of 16 vials (160 doses).

b) 20 doses presentation
Multipack of 16 vials (320 doses).
Tertiary packaging:

a) Single dose presentation
Thermocol box containing 32 multipacks of 36 vials (1152 vials/ 1152 doses). Dimensions: 65 x 5.2 x 4.2 cm.

b) 5 doses presentation
Thermocol box containing 32 multipacks of 36 vials (1152 vials/ 6760 doses). Dimensions: 65 x 5.2 x 4.2 cm.

c) 10 doses presentation
Thermocol box containing 32 multipacks of 16 vials (512 vials/ 5120 doses). Dimensions: 57.5 x 46 x 37 cm.

d) 20 doses presentation
Thermocol box containing 24 multipacks of 16 vials (384 vials/ 7680 doses). Dimensions: 57.5 x 46 x 37 cm.

 

Manufacturing sites

Bharat Biotech
Genome Valley, Shamirpet Mandal Medchal-Malkajgiri District
Telangana, 500078 - INDIA