COVID-19 mRNA Vaccine (nucleoside modified)
Product Overview
Type: COVID-19 mRNA Vaccine (nucleoside modified)
INN: N/A
Trade name: N/A
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
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Secondary Packaging: |
a. Carton of ten frozen vials (100 doses). Dimensions: 12.7 X 5.5 X 6.1 cm |
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Tertiary Packaging: |
a. 12 secondary packaged cartons (120 vials /1200 doses). Dimensions: 26.2 x 22.8 x 18.8 cm |
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Cold Chain Volume in secondary packaging: |
a. 4.30 cm3/dose |