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{{short description|Vaccine candidate against COVID-19}}
{{Short description|Vaccine candidate against COVID-19}}
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{{Use dmy dates|date=August 2021}}
{{Use dmy dates|date=August 2021}}
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| pronounce =
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| tradename = Vidprevtyn
| tradename = Vidprevtyn Beta
| Drugs.com =
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| ATCvet =
| ATCvet =
| ATC_prefix = J07
| ATC_prefix = J07
| ATC_suffix = BX03
| ATC_suffix = BX03 <!-- scheduled to be J07BN01 in 2023 -->
| ATC_supplemental =
| ATC_supplemental =


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| legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V -->
| legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V -->
| legal_US_comment =
| legal_US_comment =
| legal_EU =
| legal_EU = Marketing authorization granted
| legal_EU_comment = <ref name="VidPrevtyn Beta EPAR">{{cite web | title=VidPrevtyn Beta | website=[[European Medicines Agency]] (EMA) | date=4 November 2022 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/vidprevtyn-beta | access-date=12 November 2022}} Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref><ref name="EMA PR 20221110">{{cite press release | title=EMA recommends approval of VidPrevtyn Beta as a COVID 19 booster vaccine | website=[[European Medicines Agency]] (EMA) | date=10 November 2022 | url=https://www.ema.europa.eu/en/news/ema-recommends-approval-vidprevtyn-beta-covid-19-booster-vaccine | access-date=12 November 2022}} Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref>
| legal_EU_comment =
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->
| legal_UN_comment =
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| legal_status = <!-- For countries not listed above -->
| legal_status = <!-- For countries not listed above -->
[[List of COVID-19 vaccine authorizations]]


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{{COVID-19 pandemic sidebar}}
{{COVID-19 pandemic sidebar}}
The '''Sanofi–GSK COVID-19 vaccine''' code-named '''VAT00002''' and '''VAT00008''' (with adjuvant)<ref>{{#invoke:Cite web| |title=Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older (VAT00008) |url=https://clinicaltrials.gov/ct2/show/study/NCT04904549 |website=ClinicalTrials.gov |access-date=28 May 2021 }}</ref> is a [[COVID-19 vaccine]] candidate developed by [[Sanofi Pasteur]] and [[GlaxoSmithKline|GSK]].<ref>{{cite web |title=Study of Recombinant Protein Vaccine with Adjuvant against COVID-19 in Adults 18 Years of Age and Older. |url=https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=13475 |website=pactr.samrc.ac.za |publisher=Pan African Clinical Trials Registry |access-date=24 March 2021 |url-status=live}}</ref>
The '''Sanofi–GSK COVID-19 vaccine''' sold under the brand name '''VidPrevtyn Beta''', is a [[COVID-19 vaccine]] developed by [[Sanofi Pasteur]] and [[GlaxoSmithKline|GSK]].<ref>{{cite web |title=Study of Recombinant Protein Vaccine with Adjuvant against COVID-19 in Adults 18 Years of Age and Older. |url=https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=13475 |website=pactr.samrc.ac.za |publisher=Pan African Clinical Trials Registry |access-date=24 March 2021 }}</ref><ref>{{#invoke:Cite web| |title=Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older (VAT00008) |url=https://clinicaltrials.gov/ct2/show/study/NCT04904549 |website=ClinicalTrials.gov |access-date=28 May 2021 }}</ref>

The Sanofi–GSK COVID{{nbhyph}}19 vaccine was approved for medical use in the European Union in November 2022.<ref name="VidPrevtyn Beta EPAR" /><ref name="EMA PR 20221110" /><ref>{{cite press release | title=Sanofi and GSK's next-generation COVID-19 booster vaccine VidPrevtyn Beta approved by the European Commission | website=GSK | date=10 November 2022 | url=https://www.gsk.com/en-gb/media/press-releases/sanofi-and-gsk-s-next-generation-covid-19-booster-vaccine-vidprevtyn-beta-approved-by-ec/ | access-date=12 November 2022}}</ref><ref>{{cite press release | title=Press Release: Sanofi and GSK's next-generation COVID-19 booster vaccine VidPrevtyn Beta approved by the European Commission | website=Sanofi | date=10 November 2022 | url=https://www.sanofi.com/en/media-room/press-releases/2022/2022-11-10-15-36-50-2553486 | access-date=12 November 2022}}</ref>

== Medical uses ==
The Sanofi–GSK COVID{{nbhyph}}19 vaccine is used to provide protection against infection by the [[Severe acute respiratory syndrome coronavirus 2|SARS{{nbhyph}}CoV{{nbhyph}}2]] virus in order to prevent COVID{{nbhyph}}19.<ref name="VidPrevtyn Beta EPAR" /><ref name="EMA PR 20221110" />


== Pharmacology ==
== Pharmacology ==
VAT00008 is a [[Recombinant vaccine|recombinant]] protein [[subunit vaccine]] containing the SARS-CoV-2 [[coronavirus spike protein|spike protein]], which is produced in insect cells via a [[Baculoviridae|baculovirus]] vector. It also includes an [[Immunologic adjuvant|adjuvant]] made by GSK. It uses the same technology as Sanofi's [[List of seasonal influenza vaccines#Flublok/Flublok Quadrivalent|Flublok]] [[influenza vaccine]].<ref>{{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}}</ref><ref>{{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}}</ref>
The Sanofi–GSK COVID{{nbhyph}}19 vaccine is a [[Recombinant vaccine|recombinant]] protein [[subunit vaccine]] containing the SARS-CoV-2 [[coronavirus spike protein|spike protein]], which is produced in insect cells via a [[Baculoviridae|baculovirus]] vector. It also includes an [[Immunologic adjuvant|adjuvant]] made by GSK. It uses the same technology as Sanofi's [[List of seasonal influenza vaccines#Flublok/Flublok Quadrivalent|Flublok]] [[influenza vaccine]].<ref>{{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}}</ref><ref>{{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}}</ref>


== History ==
== History ==
VAT00008 is under development by the French pharmaceutical company [[Sanofi]] and the British-American pharmaceutical company [[GlaxoSmithKline]].<ref>{{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}}</ref> 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.<ref>{{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=}}</ref>
The Sanofi–GSK COVID{{nbhyph}}19 vaccine is under development by the French pharmaceutical company [[Sanofi]] and the British-American pharmaceutical company [[GlaxoSmithKline]].<ref>{{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}}</ref> 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.<ref>{{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=}}</ref>


=== Clinical trials ===
=== Clinical trials ===
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=== Legal status ===
=== 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.<ref name="EMA rolling review">{{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 © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> 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.<ref name="EMA rolling review" />
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.<ref name="EMA rolling review">{{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 © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> 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.<ref name="EMA rolling review" /> Vidprevtyn Beta was approved for medical use in the European Union in November 2022.<ref name="VidPrevtyn Beta EPAR" /><ref name="EMA PR 20221110" />


=== Economics ===
=== Economics ===

Revision as of 20:13, 12 November 2022

Sanofi–GSK COVID-19 vaccine
Vaccine description
TargetSARS-CoV-2
Vaccine typeProtein subunit
Clinical data
Trade namesVidprevtyn Beta
Other namesVAT00002, VAT00008
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status
Identifiers
DrugBank
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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][4]

The Sanofi–GSK COVID‑19 vaccine was approved for medical use in the European Union in November 2022.[1][2][5][6]

Medical uses

The Sanofi–GSK COVID‑19 vaccine is used to provide protection against infection by the SARS‑CoV‑2 virus in order to prevent COVID‑19.[1][2]

Pharmacology

The Sanofi–GSK COVID‑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.[7][8]

History

The Sanofi–GSK COVID‑19 vaccine is under development by the French pharmaceutical company Sanofi and the British-American pharmaceutical company GlaxoSmithKline.[9] 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.[10]

Clinical trials

In September 2020, Sanofi-GSK started for phase I trials with 440 participants in the United States.[11]

In February 2021, Sanofi-GSK started for phase II trials with 722 participants in the United States.[12]

On 27 May 2021, the vaccine began a Phase III trial involving 35,000 participants,[13][14][15] which increased to 37,430 participants with trials in Colombia, Dominican Republic, Ghana, Honduras, India, Japan, Kenya, Mexico,[16] Nigeria, Pakistan, Sri Lanka, Uganda, and the United States.[17]

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.[18]

Society and culture

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.[19] 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.[19] Vidprevtyn Beta was approved for medical use in the European Union in November 2022.[1][2]

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.[20] The company also agreed to a $2.1 billion deal with the United States to produce 100 million doses of the vaccine.[21]

References

  1. ^ a b c d "VidPrevtyn Beta". European Medicines Agency (EMA). 4 November 2022. Retrieved 12 November 2022. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  2. ^ a b c d "EMA recommends approval of VidPrevtyn Beta as a COVID 19 booster vaccine". European Medicines Agency (EMA) (Press release). 10 November 2022. Retrieved 12 November 2022. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  3. ^ "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. Retrieved 24 March 2021.
  4. ^ "Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older (VAT00008)". ClinicalTrials.gov. Retrieved 28 May 2021.
  5. ^ "Sanofi and GSK's next-generation COVID-19 booster vaccine VidPrevtyn Beta approved by the European Commission". GSK (Press release). 10 November 2022. Retrieved 12 November 2022.
  6. ^ "Press Release: Sanofi and GSK's next-generation COVID-19 booster vaccine VidPrevtyn Beta approved by the European Commission". Sanofi (Press release). 10 November 2022. Retrieved 12 November 2022.
  7. ^ "Sanofi, GSK announce positive results for Covid-19 vaccine candidate". STAT. 17 May 2021. Retrieved 18 May 2021.
  8. ^ "The Adjuvanted Recombinant Protein-based Vaccine Candidate". Sanofi. Retrieved 18 May 2021.
  9. ^ "Coronavirus vaccine trial begun by drug firms GSK and Sanofi". BBC News Online. 3 September 2020. Retrieved 20 April 2021.
  10. ^ Taylor NP (11 December 2020). "Weak clinical data force Sanofi, GSK to delay COVID-19 vaccine". Fierce Biotech. Retrieved 25 January 2021.
  11. ^ "Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older". ClinicalTrials.gov. 3 September 2020. NCT04537208.
  12. ^ "Study of Recombinant Protein Vaccine With Adjuvant Against COVID-19 in Adults 18 Years of Age and Older (VAT00002)". ClinicalTrials.gov. 21 February 2021. NCT04762680.
  13. ^ Armitage, Jim (27 May 2021). "GlaxoSmithKline shareholders "relieved" as Elliott rules out aggressive demands". London Evening Standard.
  14. ^ "Sanofi and GSK initiate global Phase 3 clinical efficacy study of COVID-19 vaccine candidate". Sanofi (Press release). 27 May 2021. Retrieved 22 July 2021.
  15. ^ "Phase 3 Clinical Trial for COVID-19 Recombinant Protein Vaccine Candidate". Sanofi. Retrieved 22 July 2021.
  16. ^ "Tarjeta del participante del estudio VAT00008: ejemplo central para adaptación a nivel de país" [VAT00008 Study Participant Card: Central Example for Country-Level Adaptation] (PDF). incmnsz.mx. Salvador Zubirán National Institute of Health Sciences and Nutrition. 15 April 2021.
  17. ^ "Safety and efficacy of Monovalent and Bivalent Recombinant Protein Vaccines against COVID-19 in Adults 18 Years of Age and Older". ctri.nic.in. Clinical Trials Registry India. CTRI/2021/06/034442. Retrieved 3 August 2021.
  18. ^ "Covid-19 Booster Vaccine Clinical Study". Sanofi. 22 October 2021. Archived from the original on 30 October 2021. Retrieved 22 October 2021.
  19. ^ a b "EMA starts rolling review of COVID-19 vaccine Vidprevtyn". European Medicines Agency (EMA) (Press release). 20 July 2021. Retrieved 22 July 2021. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  20. ^ "Coronavirus vaccine: UK signs deal with GSK and Sanofi". BBC News. 29 July 2020.
  21. ^ Lovelace Jr B (31 July 2020). "U.S. agrees to pay Sanofi and GSK $2.1 billion for 100 million doses of coronavirus vaccine". CNBC.
Scholia has a profile for Sanofi–GSK COVID-19 vaccine (Q106265257).
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