Sanofi–GSK COVID-19 vaccine
SARS-CoV-2 | |
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Vaccine type | Protein subunit |
Clinical data | |
Trade names | Vidprevtyn Beta |
Other names | VAT00002, VAT00008 |
Routes of administration | Intramuscular |
ATC code | |
Legal status | |
Legal status |
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Identifiers | |
DrugBank |
Part of a series on the |
COVID-19 pandemic |
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COVID-19 portal |
The Sanofi–GSK COVID-19 vaccine sold under the brand name VidPrevtyn Beta, is a
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 as a booster for active immunisation against
Pharmacology
The Sanofi–GSK COVID‑19 vaccine is a
History
The Sanofi–GSK COVID‑19 vaccine is under development by the French pharmaceutical company
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]
Non-clinical studies
During its development, the vaccine was tested in several non-clinical models including mice, hamsters, rabbits and non-human primates.[19][20][21][22]
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.[23] 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.[23] Vidprevtyn Beta was approved for medical use in the European Union in November 2022.[1][2][24]
Economics
In July 2020, the UK government signed up for 60 million doses of a
References
- ^ 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.
- ^ 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.
- ^ "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.
- ^ "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.
- ^ "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.
- ^ "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.
- ^ "Sanofi, GSK announce positive results for Covid-19 vaccine candidate". STAT. 17 May 2021. Retrieved 18 May 2021.
- ^ "The Adjuvanted Recombinant Protein-based Vaccine Candidate". Sanofi. Archived from the original on 18 May 2021. Retrieved 18 May 2021.
- ^ "Coronavirus vaccine trial begun by drug firms GSK and Sanofi". BBC News Online. 3 September 2020. Retrieved 20 April 2021.
- ^ Taylor NP (11 December 2020). "Weak clinical data force Sanofi, GSK to delay COVID-19 vaccine". Fierce Biotech. Retrieved 25 January 2021.
- ^ "Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older". ClinicalTrials.gov. 3 September 2020. NCT04537208.
- ^ "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.
- London Evening Standard.
- ^ "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.
- ^ "Phase 3 Clinical Trial for COVID-19 Recombinant Protein Vaccine Candidate". Sanofi. Archived from the original on 23 July 2021. Retrieved 22 July 2021.
- ^ "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.
- ^ "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.
- ^ "Covid-19 Booster Vaccine Clinical Study". Sanofi. 22 October 2021. Archived from the original on 30 October 2021. Retrieved 22 October 2021.
- PMID 34315825.
- PMID 35361754.
- PMID 36894558.
- PMID 37237062.
- ^ 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.
- ^ "Vidprevtyn Beta Product information". Union Register of medicinal products. Retrieved 3 March 2023.
- ^ "Coronavirus vaccine: UK signs deal with GSK and Sanofi". BBC News. 29 July 2020.
- ^ 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.