Product Overview

Type:                           COVID-19 mRNA Vaccine (nucleoside modified)

INN:                             N/A

Trade name:               N/A

EUL holder:                Moderna Biotech

Country:                      Spain

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

Country:                     Republic of Korea

WHO EUL recommendation

Effective date:             23 December 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:                                18 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