====== Novavax NVX-CoV2373 ======

**NVX-CoV2373** is a protein subunit vaccine for Covid-19 from [[:Pharmaceutical corporations:Novavax|Novavax]]. It was the first protein sub-unit vaccine to be approved in Europe or the USA.

NVX-CoV2373 is engineered from the genetic sequence of the first strain of SARS-CoV-2. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate. 

Novavax' COVID-19 vaccine is packaged as a liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius.

Marketing Name: Nuvaxovid, CovoVax (in India, Indonesia)

Funded, in part, by Operation Warp Speed (OWS).

===== Patent =====
Patent: [[https://patents.google.com/patent/US20210228709A1|US20210228709A1]]

2020-01-27
Priority to US202062966271P

2021-03-18
Application filed by Novavax Inc

2021-07-29
Publication of US20210228709A1

2022-02-22
Application granted

2022-02-22
Publication of US11253586B2

Status
Active
2040-08-19

Anticipated expiration

===== Pre-Clinical =====

SARS-CoV-2 spike glycoprotein vaccine candidate NVX-CoV2373 immunogenicity in baboons and protection in mice((https://www.nature.com/articles/s41467-020-20653-8))

===== Clinical Trials =====

**Clinical Trial Phase I/II:** 
  * Phase 1–2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine((https://www.nejm.org/doi/full/10.1056/NEJMoa2026920?query=featured_coronavirus))
  * Immunogenicity and Safety Following a Homologous Booster Dose of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373): A Phase 2 Randomized Placebo-Controlled Trial((https://www.medrxiv.org/content/10.1101/2021.12.23.21267374v1))

**Clinical Trial Phase III:** 
  * PREVENT-19: Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine (North and South America)//in NEJM//((https://www.nejm.org/doi/10.1056/NEJMoa2107659)) and factsheet((https://www.novavax.com/sites/default/files/2021-06/Novavax-PREVENT-19-Trial-Data-Factsheet-2021-06-14-FINAL-EN.pdf)) \\
  * Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine (UK) ((https://www.nejm.org/doi/full/10.1056/NEJMoa2107659))

  * Efficacy of the NVX-CoV2373 Covid-19 Vaccine Against the B.1.1.7 Variant((https://www.nejm.org/doi/full/10.1056/NEJMoa2103055))

===== Authorizations =====
November 1, 2021: Indonesia((https://ir.novavax.com/2021-11-01-Novavax-and-Serum-Institute-of-India-Receive-Emergency-Use-Authorization-for-COVID-19-Vaccine-in-Indonesia)) \\
November 17, 2021: Philippines((https://ir.novavax.com/2021-11-17-Novavax-and-Serum-Institute-of-India-Receive-Emergency-Use-Authorization-for-COVID-19-Vaccine-in-the-Philippines)) \\
December 17, 2021: World Health Organization (WHO) granted Emergency Use Listing for Covovax.((https://www.who.int/news/item/17-12-2021-who-lists-9th-covid-19-vaccine-for-emergency-use-with-aim-to-increase-access-to-vaccination-in-lower-income-countries)) \\
December 20, 2021: EMA granted conditional marketing authorization.((https://ec.europa.eu/commission/presscorner/detail/en/ip_21_6966)) \\
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.((https://ir.novavax.com/2021-12-28-Novavax-and-Serum-Institute-of-India-Receive-Emergency-Use-Authorization-for-COVID-19-Vaccine-in-India#:~:text=Authorized%20Use%20of%20Novavax'%20Covid,18%20years%20old%20and%20above.)) \\
February 3, 2022: England, Scotland and Wales granted EUA.((https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-nuvaxovid)) \\