SPIKEVAX

Product Overview

Type:                           COVID-19 mRNA Vaccine (nucleoside modified)

INN:                             N/A

Trade name:               N/A

EUL holder:                ModernaTX, Inc

Country:                      United States of America

Responsible NRA:     Food and Drug Administration​ (FDA)

Country:                     United States of America

WHO EUL recommendation

Effective date:             06 August 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: 

The vaccine should be discarded within six hours after opening or at the end of the immunization session, whichever comes first and opened multidose vaccine vials that do not contain preservative should be kept cooled at temperatures between +2°C and +8°C during the immunization session.

Packaging description