The Sanofi–GSK COVID-19 vaccine sold under the brand name VidPrevtyn Beta, is a

COVID-19 vaccine A COVID19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 ( COVID19). Prior to the COVID19 pandemic, an e ...

developed by Sanofi Pasteur and GSK. The Sanofi–GSK COVID19 vaccine was approved for medical use in the European Union in November 2022.

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 A subunit vaccine is a vaccine that contains purified parts of the pathogen that are antigenic, or necessary to elicit a protective immune response. A "subunit" vaccine doesn't contain the whole pathogen, unlike live attenuated or inactivated va ...

containing the SARS-CoV-2 spike protein, which is produced in insect cells via a baculovirus vector. It also includes an

adjuvant In pharmacology, an adjuvant is a drug or other substance, or a combination of substances, that is used to increase the efficacy or potency of certain drugs. Specifically, the term can refer to: * Adjuvant therapy in cancer management * Analgesic ...

made by GSK. It uses the same technology as Sanofi's

Flublok Influenza vaccines, also known as flu shots, are vaccines that protect against infection by influenza viruses. New versions of the vaccines are developed twice a year, as the influenza virus rapidly changes. While their effectiveness varies fr ...

influenza vaccine Influenza vaccines, also known as flu shots, are vaccines that protect against infection by influenza viruses. New versions of the vaccines are developed twice a year, as the influenza virus rapidly changes. While their effectiveness varies fr ...

History

The Sanofi–GSK COVID19 vaccine is under development by the French pharmaceutical company Sanofi and the British-American pharmaceutical company

GlaxoSmithKline GSK plc, formerly GlaxoSmithKline plc, is a British multinational pharmaceutical and biotechnology company with global headquarters in London, England. Established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham. GSK is the ten ...

. 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.

Clinical trials

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 PhaseIII 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.

Non-clinical studies

During its development, the vaccine was tested in several non-clinical models including mice, hamsters, rabbits and non-human primates.

Society and culture

Legal status

In July 2021, the Committee for Medicinal Products for Human Use (CHMP) of the

European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Euro ...

(EMA) started a rolling review of Vidprevtyn, a COVID-19 vaccine developed by Sanofi Pasteur. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged. 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.

Economics

In July 2020, the UK government signed up for 60 million doses of a

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.

References

External links

Study of Monovalent and Bivalent Recombinant Protein Vaccines against COVID-19 in Adults 18 Years of Age and Older Protocol
{{DEFAULTSORT:Sanofi-Gsk Covid-19 Vaccine Clinical trials sponsored by GSK plc American COVID-19 vaccines Products introduced in 2020 Sanofi Protein subunit vaccines French COVID-19 vaccines British COVID-19 vaccines