WHO recommendation of Sinovac COVID-19 vaccine (Vero Cell [Inactivated]) – CoronaVac.

Product Overview

Vaccine type:

COVID-19 Vaccine (Vero Cell), Inactivated

Commercial name:

CoronaVac

EUL holder:

Sinovac Life Sciences Co., Ltd.

Country:

China

URL:

https://www.sinovac.com

Manufacturing sites:

Sinovac Life Sciences Co., Ltd.

No. 21, Tianfu Street, Daxing Biomedicine Industrial Base of Zhongguancun Science Park, Daxing District, Beijing, P.R. China

Responsible NRA:

National Medical Products Administration (NMPA)

Country:

China

URL:

http://english.nmpa.gov.cn

WHO Recommendation

Effective date:

01 June 2021

Product Description

Pharmaceutical form:

Suspension for injection

Presentation:

Vial/non-auto disabled single use prefilled syringe

Number of doses:

1 and 2

Diluent:

Not applicable

Route of administration:

Intramuscular

Shelf-life:

12 months

at storage temperature:

2-8°C

Special conditions for storage:

Not applicable

Vaccine Vial Monitor:

Not applicable

Packaging:

For vials:

a) One (1) dose x vial

Secondary Packaging:
Carton with 40 monodose vials (40 doses)
Dimensions: 15.6 X 9.5 X 4.4 cm

Tertiary packaging:
Box with 30 cartons (1200 vials/ 1200 doses)
Dimensions: 32.7 X 30.2X 24.6 cm
Gross weight: ≤50Kg

 b) Two (2) doses x vial

Secondary Packaging:
Carton with 40 vials (80 doses)
Dimensions: 15.6 x 9.5 x 4.4 cm

Tertiary packaging:
Box with 30 cartons (1,200 vials/ 2,400 doses)
Dimensions: 32.7 x 30.2 x 24.6 cm
Gross weight: ≤50Kg

For Prefilled syringe:

Monodose 1 x PFS

Secondary Packaging:
Carton with 10 monodose PFS
Dimensions: 19.4 X 11.3 X 1.9 cm

Tertiary packaging:
Box with 60 cartons (600 syringes/ 600 doses)
Dimensions: 40.2  X 30.6  X 24.3 cm
Gross weight: ≤50Kg

Secondary and Tertiary packaging:

see under Packaging

Cold Chain Volume per dose in cm3 (in secondary packaging):

Vials
a) 16.30
b)  8.15

PFS
 41.65

Preservative:

Not applicable

with concentration:

Not applicable  

Handling of opened multidose-vials:

Not applicable