Sanofi–GSK COVID-19 vaccine

The Sanofi–GSK COVID{{nbhyph}}19 vaccine is used as a booster for active immunisation against SARS{{nbhyph}}CoV{{nbhyph}}2 virus in order to prevent COVID{{nbhyph}}19.

The Sanofi–GSK COVID{{nbhyph}}19 vaccine is a recombinant protein subunit vaccine containing the SARS-CoV-2 spike protein, which is produced in insect cells via a baculovirus vector. It also includes an adjuvant made by GSK. It uses the same technology as Sanofi's Flublok influenza vaccine.{{Cite web|date=17 May 2021|title=Sanofi, GSK announce positive results for Covid-19 vaccine candidate|url=https://www.statnews.com/2021/05/17/sanofi-gsk-results-covid-19-vaccine/|access-date=18 May 2021|website=STAT}}{{Cite web|title=The Adjuvanted Recombinant Protein-based Vaccine Candidate|url=https://www.sanofi.com/COVID19-website/recombinant-vaccine|access-date=18 May 2021|website=Sanofi|archive-date=18 May 2021|archive-url=https://web.archive.org/web/20210518024730/https://www.sanofi.com/COVID19-website/recombinant-vaccine|url-status=dead}}

The Sanofi–GSK COVID{{nbhyph}}19 vaccine is under development by the French pharmaceutical company Sanofi and the British-American pharmaceutical company GlaxoSmithKline.{{Cite news|date=3 September 2020|title=Coronavirus vaccine trial begun by drug firms GSK and Sanofi|work=BBC News Online|url=https://www.bbc.com/news/business-54009633|access-date=20 April 2021}} Advanced clinical trials of the vaccine were delayed in December 2020 after it failed to produce a strong immune response in people over the age of 50, most likely due to an insufficient antigen concentration in the vaccine, delaying the launch of the vaccine to late 2021.{{cite web |url=https://www.fiercebiotech.com/biotech/weak-clinical-data-force-sanofi-gsk-to-delay-covid-19-vaccine |title=Weak clinical data force Sanofi, GSK to delay COVID-19 vaccine | vauthors = Taylor NP |date=11 December 2020 |website=Fierce Biotech |publisher= |access-date=25 January 2021 |quote=}}

In September 2020, Sanofi-GSK started for phase I trials with 440 participants in the United States.{{Cite journal|id=NCT04537208|title=Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older |url=https://www.clinicaltrials.gov/ct2/show/NCT04537208|website=ClinicalTrials.gov|date=3 September 2020}}

In February 2021, Sanofi-GSK started for phase II trials with 722 participants in the United States.{{Cite journal|id=NCT04762680|title=Study of Recombinant Protein Vaccine With Adjuvant Against COVID-19 in Adults 18 Years of Age and Older (VAT00002)|url=https://www.clinicaltrials.gov/ct2/show/NCT04762680|website=ClinicalTrials.gov|date=21 February 2021}}

On 27 May 2021, the vaccine began a Phase{{Nbsp|1}}III trial involving 35,000 participants,{{Cite news| vauthors = Armitage J |date=27 May 2021|title=GlaxoSmithKline shareholders "relieved" as Elliott rules out aggressive demands|work=London Evening Standard|url=https://www.standard.co.uk/business/glaxosmithkline-shareholders-relieved-as-elliott-rules-out-aggressive-demands-b937644.html}}{{cite press release | title=Sanofi and GSK initiate global Phase 3 clinical efficacy study of COVID-19 vaccine candidate | website=Sanofi | date=27 May 2021 | url=https://www.sanofi.com/en/media-room/press-releases/2021/2021-05-27-07-30-00-2236989 | access-date=22 July 2021}}{{cite web | title=Phase 3 Clinical Trial for COVID-19 Recombinant Protein Vaccine Candidate | website=Sanofi | url=https://www.sanofi.com/en/our-covid-19-vaccine-candidates/phase-3-clinical-trial-for-COVID19-recombinant-protein-vaccine-candidate | access-date=22 July 2021 | archive-date=23 July 2021 | archive-url=https://web.archive.org/web/20210723064010/https://www.sanofi.com/en/our-covid-19-vaccine-candidates/phase-3-clinical-trial-for-COVID19-recombinant-protein-vaccine-candidate | url-status=dead }} which increased to 37,430 participants with trials in Colombia, Dominican Republic, Ghana, Honduras, India, Japan, Kenya, Mexico,{{#invoke:Cite web ||title=Tarjeta del participante del estudio VAT00008: ejemplo central para adaptación a nivel de país |url=http://interoperabilidad.incmnsz.mx:8080/inv2014/seguimiento_protocolo/protocolos/3725//EN-ES_Subject%20Participation%20Card_Mx_VAT00008_Dr%20Sifuentes%20(1).pdf |trans-title=VAT00008 Study Participant Card: Central Example for Country-Level Adaptation |date=15 April 2021 |publisher=Salvador Zubirán National Institute of Health Sciences and Nutrition |website=incmnsz.mx}} Nigeria, Pakistan, Sri Lanka, Uganda, and the United States.{{#invoke:Cite web||title=Safety and efficacy of Monovalent and Bivalent Recombinant Protein Vaccines against COVID-19 in Adults 18 Years of Age and Older |url=http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=56682&EncHid=&userName=covid-19%20vaccine |website=ctri.nic.in |publisher=Clinical Trials Registry India |access-date=3 August 2021 |id=CTRI/2021/06/034442}}

In September 2021, Sanofi-GSK started a booster trial in the United Kingdom. In this study, they will enroll up to 3,145 volunteers who have previously completed a COVID-19 a full vaccine course between 4 and 10 months previously. The purpose of this study is to determine if the investigational COVID-19 vaccines are safe and can stimulate and broaden the immune response against the different COVID-19 variants that cause COVID-19 when given as a single booster injection in participants who have previously been vaccinated with a full course of an authorized COVID-19 vaccine.{{cite web|title=Covid-19 Booster Vaccine Clinical Study|url=https://www.sanofistudies.com/covidbooster#eligibility|website=Sanofi|date=22 October 2021|access-date=22 October 2021 |url-status=dead |archive-url=https://web.archive.org/web/20211030212712/https://www.sanofistudies.com/covidbooster |archive-date=30 October 2021}}

During its development, the vaccine was tested in several non-clinical models including mice, hamsters, rabbits and non-human primates.{{cite journal | vauthors = Francica JR, Flynn BJ, Foulds KE, Noe AT, Werner AP, Moore IN, Gagne M, Johnston TS, Tucker C, Davis RL, Flach B, O'Connell S, Andrew SF, Lamb E, Flebbe DR, Nurmukhambetova ST, Donaldson MM, Todd JM, Zhu AL, Atyeo C, Fischinger S, Gorman MJ, Shin S, Edara VV, Floyd K, Lai L, Boyoglu-Barnum S, Van De Wetering R, Tylor A, McCarthy E, Lecouturier V, Ruiz S, Berry C, Tibbitts T, Andersen H, Cook A, Dodson A, Pessaint L, Van Ry A, Koutsoukos M, Gutzeit C, Teng IT, Zhou T, Li D, Haynes BF, Kwong PD, McDermott A, Lewis MG, Fu TM, Chicz R, van der Most R, Corbett KS, Suthar MS, Alter G, Roederer M, Sullivan NJ, Douek DC, Graham BS, Casimiro D, Seder RA | display-authors = 6 | title = Protective antibodies elicited by SARS-CoV-2 spike protein vaccination are boosted in the lung after challenge in nonhuman primates | journal = Science Translational Medicine | volume = 13 | issue = 607 | date = August 2021 | pmid = 34315825 | pmc = 9266840 | doi = 10.1126/scitranslmed.abi4547 }}{{cite journal | vauthors = Pavot V, Berry C, Kishko M, Anosova NG, Huang D, Tibbitts T, Raillard A, Gautheron S, Gutzeit C, Koutsoukos M, Chicz RM, Lecouturier V | display-authors = 6 | title = Protein-based SARS-CoV-2 spike vaccine booster increases cross-neutralization against SARS-CoV-2 variants of concern in non-human primates | journal = Nature Communications | volume = 13 | issue = 1 | pages = 1699 | date = March 2022 | pmid = 35361754 | pmc = 8971430 | doi = 10.1038/s41467-022-29219-2 | bibcode = 2022NatCo..13.1699P }}{{cite journal | vauthors = Pavot V, Berry C, Kishko M, Anosova NG, Li L, Tibbitts T, Huang D, Raillard A, Gautheron S, Gutzeit C, Koutsoukos M, Chicz RM, Lecouturier V | display-authors = 6 | title = Beta variant COVID-19 protein booster vaccine elicits durable cross-neutralization against SARS-CoV-2 variants in non-human primates | journal = Nature Communications | volume = 14 | issue = 1 | pages = 1309 | date = March 2023 | pmid = 36894558 | pmc = 9998256 | doi = 10.1038/s41467-023-36908-z | bibcode = 2023NatCo..14.1309P }}{{cite journal | vauthors = Berry C, Pavot V, Anosova NG, Kishko M, Li L, Tibbitts T, Raillard A, Gautheron S, Cummings S, Bangari DS, Kar S, Atyeo C, Deng Y, Alter G, Gutzeit C, Koutsoukos M, Chicz RM, Lecouturier V | display-authors = 6 | title = Beta-containing bivalent SARS-CoV-2 protein vaccine elicits durable broad neutralization in macaques and protection in hamsters | journal = Communications Medicine | volume = 3 | issue = 1 | pages = 75 | date = May 2023 | pmid = 37237062 | pmc = 10212738 | doi = 10.1038/s43856-023-00302-z }}

In July 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) started a rolling review of Vidprevtyn, a COVID-19 vaccine developed by Sanofi Pasteur.{{cite press release | title=EMA starts rolling review of COVID-19 vaccine Vidprevtyn | website=European Medicines Agency (EMA) | date=20 July 2021 | url=https://www.ema.europa.eu/en/news/ema-starts-rolling-review-covid-19-vaccine-vidprevtyn | access-date=22 July 2021}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. The CHMP's decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and early clinical studies in adults, which suggest that the vaccine triggers the production of antibodies that target SARS-CoV-2, the virus that causes COVID-19, and may help protect against the disease. Vidprevtyn Beta was authorized for medical use in the European Union in November 2022.{{cite web | title=Vidprevtyn Beta Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1580.htm | access-date=3 March 2023}}

In July 2020, the UK government signed up for 60 million doses of a COVID-19 vaccine developed by GSK and Sanofi. It uses a recombinant protein-based technology from Sanofi and GSK's pandemic technology. The companies claimed to be able to produce one billion doses, subject to successful trials and regulatory approval, during the first half of 2021.{{Cite web|url=https://www.bbc.com/news/business-53577637|title=Coronavirus vaccine: UK signs deal with GSK and Sanofi|date=29 July 2020| work = BBC News }} The company also agreed to a $2.1 billion deal with the United States to produce 100 million doses of the vaccine.{{cite web | vauthors = Lovelace Jr B |url=https://www.cnbc.com/2020/07/31/us-agrees-to-pay-sanofi-and-gsk-2point1-billion-for-100-million-doses-of-coronavirus-vaccine.html|title=U.S. agrees to pay Sanofi and GSK $2.1 billion for 100 million doses of coronavirus vaccine|date=31 July 2020|publisher=CNBC}}

In March 2024, at the request of Sanofi Pasteur, the European Commission withdrew the marketing authorization for VidPrevtyn. Sanofi Pasteur said the decision for the discontinuation was due to commercial reasons.{{Cite web |title=VidPrevtyn Beta |url=https://www.ema.europa.eu/en/documents/public-statement/public-statement-vidprevtyn-beta-withdrawal-marketing-authorisation-european-union_en.pdf |website=European Medicines Agency}}

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• [https://www.sanofi.com/-/media/Project/One-Sanofi-Web/Websites/Global/Sanofi-COM/Home/common/docs/clinical-study-results/rdctcovid19vat00008protocol-v30-dated-18MAY2021.pdf Study of Monovalent and Bivalent Recombinant Protein Vaccines against COVID-19 in Adults 18 Years of Age and Older Protocol] {{Webarchive|url=https://web.archive.org/web/20210723062559/https://www.sanofi.com/-/media/Project/One-Sanofi-Web/Websites/Global/Sanofi-COM/Home/common/docs/clinical-study-results/rdctcovid19vat00008protocol-v30-dated-18MAY2021.pdf |date=23 July 2021 }}

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Category:Drugs developed by GSK plc

Category:American COVID-19 vaccines

Category:Products introduced in 2020

Category:Sanofi

Category:Protein subunit vaccines

Category:French COVID-19 vaccines

Category:British COVID-19 vaccines