CoronaVac


Product Overview

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

INN:                                       N/A

Commercial name:              CoronaVac

EUL holder:                          Sinovac Life Sciences Co., Ltd.

Country:                                People’s Republic of China

Responsible NRA:                National Medical Products Administration (NMPA)  

Country:                                People’s Republic of China

 

WHO EUL recommendation

Effective date:           01 June 2021

Recommendation for an Emergency Use Listing (EUL) of SINOVAC Covid-19 vaccine (Vero cell) Inactivated -  CoronaVacTM (Published: 28 June 2021).

Variation to extend the age indication to children and adolescents from 3 to 17 years of age (Approved on 2 November 2022).

 

Product description

Pharmaceutical Form:            Suspension for injection

Presentation:                            1 mL vial or 1mL non-auto disabled single use prefilled syringe

Number of doses:                     1 dose and 2 doses of 0.5 mL each

Route of administration:         Intramuscular

Age indication:                         3 to 59 years of age

Shelf – life:                                24 months

Storage temperature:               2°C to 8°C

Vaccine Vial monitor (VVM):  None

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:

For vials:

a) One (1) dose x vial
Carton with 40 monodose vials (40 doses)
Dimensions: 15.6 X 9.5 X 4.4 cm

 b) Two (2) doses x vial
Carton with 40 vials (80 doses)
Dimensions: 15.6 x 9.5 x 4.4 cm

For Prefilled syringe:
a) Carton with 10 monodose PFS
Dimensions: 19.4 X 11.3 X 1.9 cm

Tertiary packaging:

For vials:

a) One (1) dose x vial
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
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:
a) Box with 60 cartons (600 syringes/ 600 doses)
Dimensions: 40.2  X 30.6  X 24.3 cm
Gross weight: ≤50Kg
Cold Chain Volume (in secondary packaging):

Vials
a) 16.30 cm3/dose
b)  8.15 cm3/dose

PFS
 a) 41.65 cm3/dose

 

Product information

WHO Package Insert – vaccine vials 
 

WHO Package Insert – pre-filled syringes