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

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

WHO Product Information

WHO Package Leaflet