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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

WHO Product Information

WHO 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.