Sanofi–GSK COVID-19 vaccine explained

Type:vaccine
Target:SARS-CoV-2
Vaccine Type:protein
Tradename:Vidprevtyn Beta
Routes Of Administration:Intramuscular
Atc Prefix:J07
Atc Suffix:BN04
Legal Eu:Marketing authorization granted
Legal Eu Comment:[1] [2]
Legal Status:List of COVID-19 vaccine authorizations
Drugbank:DB16427
Synonyms:VAT00002, VAT00008

The Sanofi–GSK COVID-19 vaccine sold under the brand name VidPrevtyn Beta, is a COVID-19 vaccine developed by Sanofi Pasteur and GSK.[3]

The Sanofi–GSK COVID19 vaccine was approved for medical use in the European Union in November 2022.[4] [5]

Medical uses

The Sanofi–GSK COVID19 vaccine is used as a booster for active immunisation against SARSCoV2 virus in order to prevent COVID19.

Pharmacology

The Sanofi–GSK COVID19 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.[6] [7]

History

The Sanofi–GSK COVID19 vaccine is under development by the French pharmaceutical company Sanofi and the British-American pharmaceutical company GlaxoSmithKline.[8] 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.[9]

Clinical trials

In September 2020, Sanofi-GSK started for phase I trials with 440 participants in the United States.[10]

In February 2021, Sanofi-GSK started for phase II trials with 722 participants in the United States.[11]

On 27 May 2021, the vaccine began a PhaseIII trial involving 35,000 participants,[12] [13] [14] which increased to 37,430 participants with trials in Colombia, Dominican Republic, Ghana, Honduras, India, Japan, Kenya, Mexico, Nigeria, Pakistan, Sri Lanka, Uganda, and the United States.

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.[15]

Non-clinical studies

During its development, the vaccine was tested in several non-clinical models including mice, hamsters, rabbits and non-human primates.[16] [17] [18] [19]

Society and culture

Legal status

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.[20] 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 approved for medical use in the European Union in November 2022.[21]

Economics

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.[22] The company also agreed to a $2.1 billion deal with the United States to produce 100 million doses of the vaccine.[23]

External links

Notes and References

  1. Web site: VidPrevtyn Beta . European Medicines Agency (EMA) . 4 November 2022 . 12 November 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  2. EMA recommends approval of VidPrevtyn Beta as a COVID 19 booster vaccine . European Medicines Agency (EMA) . 10 November 2022 . 12 November 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  3. Web site: Study of Recombinant Protein Vaccine with Adjuvant against COVID-19 in Adults 18 Years of Age and Older. . pactr.samrc.ac.za . Pan African Clinical Trials Registry . 24 March 2021 .
  4. Sanofi and GSK's next-generation COVID-19 booster vaccine VidPrevtyn Beta approved by the European Commission . GSK . 10 November 2022 . 12 November 2022.
  5. Press Release: Sanofi and GSK's next-generation COVID-19 booster vaccine VidPrevtyn Beta approved by the European Commission . Sanofi . 10 November 2022 . 12 November 2022.
  6. Web site: 17 May 2021. Sanofi, GSK announce positive results for Covid-19 vaccine candidate. 18 May 2021. STAT.
  7. Web site: The Adjuvanted Recombinant Protein-based Vaccine Candidate. 18 May 2021. Sanofi. 18 May 2021. https://web.archive.org/web/20210518024730/https://www.sanofi.com/COVID19-website/recombinant-vaccine. dead.
  8. News: 3 September 2020. Coronavirus vaccine trial begun by drug firms GSK and Sanofi. BBC News Online. 20 April 2021.
  9. Web site: Weak clinical data force Sanofi, GSK to delay COVID-19 vaccine . Taylor NP . 11 December 2020 . Fierce Biotech . 25 January 2021 .
  10. NCT04537208. Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older . ClinicalTrials.gov. 3 September 2020.
  11. NCT04762680. Study of Recombinant Protein Vaccine With Adjuvant Against COVID-19 in Adults 18 Years of Age and Older (VAT00002). ClinicalTrials.gov. 21 February 2021.
  12. News: Armitage J . 27 May 2021. GlaxoSmithKline shareholders "relieved" as Elliott rules out aggressive demands. London Evening Standard.
  13. Sanofi and GSK initiate global Phase 3 clinical efficacy study of COVID-19 vaccine candidate . Sanofi . 27 May 2021 . 22 July 2021.
  14. Web site: Phase 3 Clinical Trial for COVID-19 Recombinant Protein Vaccine Candidate . Sanofi . 22 July 2021 . 23 July 2021 . 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 . dead .
  15. Web site: Covid-19 Booster Vaccine Clinical Study. Sanofi. 22 October 2021. 22 October 2021 . dead . https://web.archive.org/web/20211030212712/https://www.sanofistudies.com/covidbooster . 30 October 2021.
  16. 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 . 6 . Protective antibodies elicited by SARS-CoV-2 spike protein vaccination are boosted in the lung after challenge in nonhuman primates . Science Translational Medicine . 13 . 607 . August 2021 . 34315825 . 9266840 . 10.1126/scitranslmed.abi4547 .
  17. Pavot V, Berry C, Kishko M, Anosova NG, Huang D, Tibbitts T, Raillard A, Gautheron S, Gutzeit C, Koutsoukos M, Chicz RM, Lecouturier V . 6 . Protein-based SARS-CoV-2 spike vaccine booster increases cross-neutralization against SARS-CoV-2 variants of concern in non-human primates . Nature Communications . 13 . 1 . 1699 . March 2022 . 35361754 . 8971430 . 10.1038/s41467-022-29219-2 . 2022NatCo..13.1699P .
  18. 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 . 6 . Beta variant COVID-19 protein booster vaccine elicits durable cross-neutralization against SARS-CoV-2 variants in non-human primates . Nature Communications . 14 . 1 . 1309 . March 2023 . 36894558 . 9998256 . 10.1038/s41467-023-36908-z . 2023NatCo..14.1309P .
  19. 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 . 6 . Beta-containing bivalent SARS-CoV-2 protein vaccine elicits durable broad neutralization in macaques and protection in hamsters . Communications Medicine . 3 . 1 . 75 . May 2023 . 37237062 . 10212738 . 10.1038/s43856-023-00302-z .
  20. EMA starts rolling review of COVID-19 vaccine Vidprevtyn . European Medicines Agency (EMA) . 20 July 2021 . 22 July 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  21. Web site: Vidprevtyn Beta Product information . Union Register of medicinal products . 3 March 2023.
  22. Web site: Coronavirus vaccine: UK signs deal with GSK and Sanofi. 29 July 2020. BBC News .
  23. Web site: Lovelace Jr B . U.S. agrees to pay Sanofi and GSK $2.1 billion for 100 million doses of coronavirus vaccine. 31 July 2020. CNBC.

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