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Novavax NVX-CoV2373
NVX-CoV2373 is a protein subunit vaccine for Covid-19 from Novavax. It was the first protein sub-unit vaccine to be approved in Europe or the USA.
Marketing Name: Nuvaxovid, CovoVax (in India, Indonesia)
Funded, in part, by Operation Warp Speed (OWS).
Uses a proprietary Matrix-M™ adjuvant based on saponin.
Pre-Clinical
SARS-CoV-2 spike glycoprotein vaccine candidate NVX-CoV2373 immunogenicity in baboons and protection in mice1)
Clinical Trials
Clinical Trial Phase I/II: Phase 1–2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine2)
Clinical Trial Phase III:
PREVENT-19: Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine (North and South America)in NEJM3) and factsheet4)
Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine (UK) 5)
Efficacy of the NVX-CoV2373 Covid-19 Vaccine Against the B.1.1.7 Variant6)
Authorizations
November 1, 2021: Indonesia7)
November 17, 2021: Philippines8)
December 17, 2021: World Health Organization (WHO) granted Emergency Use Listing for Covovax.9)
December 20, 2021: EMA granted conditional marketing authorization.10)
February 3, 2022: UK granted EUA.11)
December 28, 2021: The Drugs Controller General of India (DCGI) has issued Emergency Use Authorization (EUA) for Covovax /Recombinant Spike Protein of SARS-CoV-2 Virus 5 mcg to induce immunity against SARS-CoV-2 to prevent COVID-19 for adults 18 years old and above.12)