SKYCovione

Product Overview

Type: COVID-19 Vaccine (Recombinant protein subunit)

INN: N/A

Trade name: SKYCovione™

EUL holder: SK Bioscience Co., Ltd,

Country: Republic of Korea.

Responsible NRA: Ministry of Food and Drug Safety (MFDS)

Country: Republic of Korea

WHO EUL recommendation

Effective date: 16 June 2023

Recommendation for an Emergency Use Listing of SKYCovione (GBP510) submitted by SK Bioscience Co Ltd

Product description

Pharmaceutical Form: Suspension for injection

Presentation: 5 mL vial

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

Route of administration: Intramuscular

Age indication: 18 to 65 years of age

Shelf – life: 12 months Storage temperature: 2°C - 8°C

Vaccine Vial monitor (VVM): None

Preservative: None

Adjuvant: AS03

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:

Inner carton:
Vaccine: inner box of 1 vaccine vial (1 dose). Dimensions: 5.2 x 12 x 4.8 cm.
Adjuvant 1): inner box of 1 adjuvant vial (1 dose). Dimensions: 3.7 x 8.4 x 3.7 cm OR
Adjuvant 2): innver box of 1 adjuvant vial (1 dose). Dimensions: 4.2 x 8.8 x 3.7 cm

Outer carton:
Carton of ten (10) inner cartons contianing 1 vaccine vial + 1 adjuvant vial (10 vaccines/ 100 doses)
Dimensions: 100 x 5.5 x 12.1 cm

Tertiary Packaging:

Carton box containing 40 secondary outer cartons (400 vaccines/ 4 000 doses).
Dimensions: 33.1 x 36 x 41.6 cm

Cold Chain Volume
(in secondary packaging):

Vaccine: 3.00 cm³/dose
Adjuvant 1): 1.15 cm³/dose
Adjuvant 2): 1.37 cm³/dose