Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Novavax CZ a.s., Bohumil 138, Jevany, 28163, Czechia
Nuvaxovid dispersion for injection.
COVID-19 Vaccine (recombinant, adjuvanted).
| Pharmaceutical Form |
|---|
|
Dispersion for injection (injection). The dispersion is colourless to slightly yellow, clear to mildly opalescent (pH 7.2). |
This is a multidose vial which contains 10 doses of 0.5 mL.
One dose (0.5 mL) contains 5 micrograms of the of SARS-CoV-2 spike protein* and is adjuvanted with Matrix-M.
Adjuvant Matrix-M containing per 0.5 mL dose: Fraction-A (42.5 micrograms) and Fraction-C (7.5 micrograms) of Quillaja saponaria Molina extract.
* produced by recombinant DNA technology using a baculovirus expression system in an insect cell line that is derived from Sf9 cells of the Spodoptera frugiperda species.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| SARS-CoV-2 protein subunit vaccine (NVX-CoV2373) |
SARS-CoV-2 protein subunit vaccine (NVX-CoV2373) is composed of purified full-length SARS-CoV-2 recombinant spike (S) protein that is stabilised in its prefusion conformation. The addition of the saponin-based Matrix-M adjuvant facilitates activation of the cells of the innate immune system, which enhances the magnitude of the S protein-specific immune response. The two vaccine components elicit B- and T-cell immune responses to the S protein, including neutralising antibodies, which may contribute to protection against COVID-19. |
| List of Excipients |
|---|
|
Disodium hydrogen phosphate heptahydrate Adjuvant (Matrix-M): Cholesterol For adjuvant: see also section 2. |
5 mL of dispersion in a vial (type I glass) with a stopper (bromobutyl rubber) and an aluminium overseal with blue plastic flip-off cap.
Each vial contains 10 doses of 0.5 mL.
Pack size: 10 multidose vials.
Novavax CZ a.s., Bohumil 138, Jevany, 28163, Czechia
EU/1/21/1618/001
| Drug | Countries | |
|---|---|---|
| NUVAXOVID | Austria, Australia, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Japan, Lithuania, New Zealand, Poland, Romania, United Kingdom |
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