Product Overview

Type:                           COVID-19 vaccine (SARS-CoV-2 rS [Recombinant, adjuvanted])

INN:                             N/A

Trade name:               NUVAXOVID

EUL holder:                Novavax CZ a.s.

Country:                      Czech Republic

Responsible NRA:     European Medicines Agency

Country:                      The Netherlands

WHO EUL recommendation

Effective date:             20 December 2021

Product description

Pharmaceutical Form:                   Sterile dispersion for injection                                   

Presentation:                                   2.5 mL and 5 mL vial

Number of doses:                           5 doses and 10 doses (0.5 mL per dose)

Route of administration:                Intramuscular

Age indication:                                12 years and older

Shelf – life:                                       9 months     Storage temperature:   2°C to 8°C      

Vaccine Vial monitor (VVM):        None

Preservative:                                    None

Adjuvant:                                           Matrix-M1 (a saponin based adjuvant)

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.