Sanofi–GSK COVID-19 vaccine
|Vaccine type||Protein subunit|
|Trade names||Vidprevtyn Beta|
|Other names||VAT00002, VAT00008|
|Part of a series on the|
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.
The Sanofi–GSK COVID‑19 vaccine is under development by the French pharmaceutical company Sanofi and the British-American pharmaceutical company GlaxoSmithKline. 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.
In September 2020, Sanofi-GSK started for phase I trials with 440 participants in the United States.
In February 2021, Sanofi-GSK started for phase II trials with 722 participants in the United States.
On 27 May 2021, the vaccine began a Phase III trial involving 35,000 participants, 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.
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. 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.
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. The company also agreed to a $2.1 billion deal with the United States to produce 100 million doses of the vaccine.
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- "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.
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- Armitage, Jim (27 May 2021). "GlaxoSmithKline shareholders "relieved" as Elliott rules out aggressive demands". London Evening Standard.
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- "Covid-19 Booster Vaccine Clinical Study". Sanofi. 22 October 2021. Archived from the original on 30 October 2021. Retrieved 22 October 2021.
- "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.
- "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.