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covid-19_vaccines:nvx-cov2373 [2022/02/03 21:41]
brian [Clinical Trials] 		covid-19_vaccines:nvx-cov2373 [2022/03/31 09:19] (current)
mathew
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-===== Novavax NVX-CoV2373 =====+====== 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.+**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.  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. 
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 Funded, in part, by Operation Warp Speed (OWS). Funded, in part, by Operation Warp Speed (OWS).
  
 +===== Patent =====
 +Patent: [[https://patents.google.com/patent/US20210228709A1|US20210228709A1]]
  
 +2020-01-27
 +Priority to US202062966271P
  
-==== Pre-Clinical ====+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)) 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:** \\+===== 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))   * 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:** \\+**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)) \\   * 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))   * Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine (UK) ((https://www.nejm.org/doi/full/10.1056/NEJMoa2107659))
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   * Efficacy of the NVX-CoV2373 Covid-19 Vaccine Against the B.1.1.7 Variant((https://www.nejm.org/doi/full/10.1056/NEJMoa2103055))   * 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 ====+===== 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 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)) \\ 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 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 20, 2021: EMA granted conditional marketing authorization.((https://ec.europa.eu/commission/presscorner/detail/en/ip_21_6966)) \\
-February 3, 2022: UK granted EUA.((https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-nuvaxovid)) \\ 
 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.)) \\ 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)) \\
 +
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