COVID-19 Vaccine (Vero Cell), Inactivated

Product Overview

Type: COVID-19 Vaccine (Vero Cell), Inactivated

INN: N/A

Commercial name: N/A

EUL holder: Beijing Institute of Biological Products Co., Ltd. (BIBP)

Country: People’s Republic of China

Responsible NRA: National Medical Products Administration (NMPA)

Country: People’s Republic of China

WHO EUL recommendation

Effective date: 07 May 2021

Recommendation for an Emergency Use Listing of COVID-19 Vaccine BIBP submitted by Beijing Institute of Biological Products Co., Ltd.

Product description

Pharmaceutical Form: Suspension for injectionol

Presentation: 2 mL, 3 mL vial or 1mL non-auto disabled prefilled syringe (PFS)

Number of doses: 1, 2 and 5 doses of 0.5 mL each

Route of administration: Intramuscular

Age indication: 18 years and older

Shelf – life: 24 months

Storage temperature: 2°C to 8°C

Vaccine Vial monitor (VVM): Type 7

Preservative: None

Diluent: None

Special storage conditions: Not applicable

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:

1 dose presentation:

1) Syringe in paper holder:
Carton with 1 monodose prefilled syringe. Dimensions: 10.4 X 4.45 X 2.05 cm

2) Syringe with blister package:
Carton with 1 monodose prefilled syringe. Dimensions: 13.5 X 3.7 X 2.5 cm

3) 1 vial/carton packaging:
Carton with 1 monodose vial. Dimensions: 7.2 X 3.9 X 2.2 cm

4) 3 vials/carton packaging:
Carton with 3 monodose vials. Dimensions: 5.45 X 5.3 X 2.2 cm

5) 10 vials/carton packaging:
Carton with 10 monodose vials. Dimensions: 10 x 4.5 x 5.1 cm

2 or 5 dose presentation:

1) One vial/carton:
Carton with one 2-dose or 5-dose vial. Dimensions: 7.2 x 3.9 x 2.2 cm.

2) 3 vials/carton:
Carton with 3 multidose vials of 2-dose or 5-dose presentation. Dimensions: 5.45 x 5.3 x 2.2 cm.

3) 10 vials/carton:
Carton with 10 multidose vials of 2-dose presentation. Dimensions: 10 x 4.5 x 5.1 cm

Carton with 10 multidose vials of 5-dose presentation. Dimensions: 10 x 5.3 x 5.1 cm

Tertiary packaging:

1 dose presentation:

1) Outer box with 300 cartons with a total of 300 syringes (300 doses). Dimensions: 43.0 X 33.0 X 24.5 cm

2) Outer box with 240 cartons with a total of 240 syringes (240 doses). Dimensions: 42.0 X 32.0 X 27.5 cm

3) Outer box with 400 cartons with a total of 400 vials (400 doses). Dimensions: 43.0 X 31.0 X 23.5 cm

4) Outer box with 200 cartons with a total of 600 vials (600 doses). Dimensions: 46.0 X 29.0 X 13.0 cm

5) Outer box with 100 cartons with a total of 1000 vials (1000 doses). Dimensions: 42.5 x 27.5 x 24.0 cm.

2 or 5 dose presentation:

1) Outer box with 400 cartons with a total of 400 vials (800 doses for 2-dose presentation, and 2000 doses for 5-dose presentation). Dimensions: 43.0 x 31.0 x 23.5 cm.

2) Outer box with 200 cartons with a total of 600 vials (1200 doses for 2-dose presentation, and 3000 doses for 5-dose presentation). Dimensions: 46.0 x 29.0 x 13.0 cm.

3) For the 2-dose presentations: outer box with 100 cartons with a total of 1000 vials (1000 doses for 1-dose, and 2000 doses for 2-dose presentation). Dimensions: 42.5 x 27.5 x 24.0 cm.

4) For the 5-dose presentation: outer box with 100 cartons with a total of 1000 vials (5000 doses). Dimensions: 43.5 x 28.0 x 28.0 cm.

Cold Chain Volume (in secondary packaging):

1 dose presentation:

1) 94.9
2) 124.9
3) 61.8 cm³/dose
4) 21.2
5) 22.9

2 or 5 dose presentation:

1) 30.8 (2-dose)
12.3 (5-dose)

2) 10.5 (2-dose) cm³/dose
4.2 (5-dose)

3) 11.4 (2-dose)
4.5 (5-dose)