SPIKEVAX
Product Overview
Type: COVID-19 mRNA Vaccine (nucleoside modified)
INN: N/A
Trade name: SPIKEVAX
EUL holder: Moderna Biotech
Country: Spain
Responsible NRA: European Medicines Agency
Country: The Netherlands
WHO EUL recommendation
Effective date: 30 April 2021
Recommendation for an Emergency Use Listing of COVID-19 mRNA Vaccine (nucleoside modified) submitted by Moderna Biotech (Spain) (Published: May 2021)
Product description
Pharmaceutical Form: Suspension for injection
Presentation: 10R vial
Number of doses: 10 doses (0.5 mL per dose)
Route of administration: Intramuscular
Age indication: 6 years and older
Shelf – life: 9 months Storage temperature: -20°C ± 5°C
Refrigeration Storage Time (2°C to 8°C): 30 days (within the 9 months shelf-life)
Vaccine Vial monitor (VVM): None
Preservative: None
Adjuvant: None
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: |
a. Carton of ten frozen vials (100 doses). Dimensions: 12.7 X 5.5 X 6.1 cm |
|
Tertiary Packaging: |
a. 12 secondary packaged cartons (120 vials /1200 doses). Dimensions: 26.2 x 22.8 x 18.8 cm |
|
Cold Chain Volume in secondary packaging: |
a. 4.30 cm3/dose |
Product Characteristics and Package Leaflet
Lonza AG
Lonzastrasse, 3930 Visp, Switzerland.
Rovi Pharma Industrial Services, S.A.
San Sebastián de los Reyes, Paseo de Europa, 50, 28703. San Sebastián de los Reyes, Madrid, Spain.