The Sanofi–GSK COVID‑19 vaccine is under development by the French pharmaceutical companySanofi and the British pharmaceutical companyGlaxoSmithKline.[10] Advanced clinical trials of the vaccine were delayed in December 2020 after it failed to produce a strongimmune response in people over the age of 50, most likely due to an insufficientantigen concentration in the vaccine, delaying the launch of the vaccine to late 2021.[11]
In September 2020, Sanofi-GSK started for phase I trials with 440 participants in the United States.[12]
In February 2021, Sanofi-GSK started for phase II trials with 722 participants in the United States.[13]
On 27 May 2021, the vaccine began a PhaseIII trial involving 35,000 participants,[14][15][16] which increased to 37,430 participants with trials in Colombia, Dominican Republic, Ghana, Honduras, India, Japan, Kenya, Mexico,[17] Nigeria, Pakistan, Sri Lanka, Uganda, and the United States.[18]
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.[19]
During its development, the vaccine was tested in several non-clinical models including mice, hamsters, rabbits and non-human primates.[20][21][22][23]
In July 2021, theCommittee for Medicinal Products for Human Use (CHMP) of theEuropean Medicines Agency (EMA) started a rolling review of Vidprevtyn, a COVID-19 vaccine developed by Sanofi Pasteur.[24] 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.[24] Vidprevtyn Beta was authorized for medical use in the European Union in November 2022.[1][2][25]
In July 2020, the UK government signed up for 60 million doses of aCOVID-19 vaccine developed byGSK andSanofi. It uses arecombinant 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.[26] The company also agreed to a $2.1 billion deal with the United States to produce 100 million doses of the vaccine.[27]
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.[28]
^abcd"VidPrevtyn Beta".European Medicines Agency (EMA). 4 November 2022. Retrieved12 November 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
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