Sanofi - GSK SARS-CoV-2 Vaccine Description
The Sanofi - GSK SARS-CoV-2 vaccine candidate is a combination of innovative technologies to produce a recombinant protein-based vaccine with an adjuvanted to prevent COVID-19 disease.
The combination of a protein-based antigen together with an adjuvant is well-established and used in a number of vaccines available today. It can also improve the likelihood of delivering an effective vaccine that can be manufactured at scale.
Sanofi Pasteur will contribute its S-protein COVID-19 antigen, which is based on recombinant DNA technology. This technology has produced an exact genetic match to proteins found on the surface of the SARS-CoV-2 virus, and the DNA sequence encoding this antigen has been combined into the DNA of the baculovirus expression platform, the basis of Sanofi’s licensed recombinant influenza product in the US.
GSK will contribute its proven pandemic adjuvant technology. An adjuvant is added to some vaccines to enhance the immune response and has been shown to create a stronger and longer-lasting immunity against infections than the vaccine alone.
The companies announced they have established a Joint Task Force, co-chaired by David Loew, Global Head of Vaccines, Sanofi and Roger Connor, President Vaccines, GSK. This task force will seek to mobilize resources from both companies to look for every opportunity to accelerate the development of the candidate vaccine.
Sanofi stated it is leading the clinical development and registration of the COVID-19 vaccine and expects a Phase 1/2 study to start in September, followed by a Phase 3 study by the end of 2020. If the data are positive, regulatory approval could be achieved by the first half of 2021. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant to produce up to 1 billion doses per year overall.
Michael Szumera, global healthcare communications executive for Sanofi, stated on August 3, 2020, “Sanofi will contribute its S-protein COVID-19 antigen, which is based on recombinant DNA technology. This technology has produced an exact genetic match to proteins found on the surface of the virus, and the DNA sequence encoding this antigen has been combined into the DNA of the baculovirus expression platform, the basis of Sanofi’s licensed recombinant influenza product in the US.”
On July 31, 2020, the U.S. government stated it will provide funding up to $2.1 billion for development, including clinical trials and manufacturing scale-up, and delivery of an initial 100 million doses. The vaccines intended for the USA will be produced in Sanofi's Swiftwater, Pennsylvania facility.
In addition to the recombinant protein-based vaccine in collaboration with GSK, Sanofi announced on July 20, 2020, it is also developing a messenger RNA vaccine candidate in partnership with Translate Bio.
Sanofi - GSK SARS-CoV-2 Vaccine Indication
Sanofi - GSK SARS-CoV-2 Vaccine Candidate is indicated to prevent SARS-CoV-2 infection which leads to COVID-19 disease.
Sanofi - GSK SARS-CoV-2 Vaccine Dosage
Sanofi - GSK SARS-CoV-2 Vaccine News
August 4, 2020 - Sanofi confirmed its upcoming venture to develop a COVID-19 vaccine with fellow pharmaceutical giant GlaxoSmithKline and the United States government, including plans to conduct manufacturing at Sanofi’s Swiftwater, PA, location. The company is currently building up its industrial capabilities to manufacture up to one billion doses a year, some of which will be done locally. “Our Swiftwater facility will conduct finish and fill for the U.S. doses.”
July 31, 2020 - Sanofi and GSK announce a collaborative effort with the U.S. government to accelerate the development and manufacturing of a COVID-19 recombinant protein-based vaccine. The U.S. government will provide up to $2.1 billion, more than half of which is to support further development of the vaccine, including clinical trials, with the remainder used for manufacturing scale-up and delivery of an initial 100 million doses of the vaccine.
July 29, 2020 - Sanofi and GSK announced an agreement, subject to final contract, with the UK government for the supply of up to 60 million doses of a COVID-19 vaccine. The vaccine candidate, developed by Sanofi in partnership with GSK, is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine, and GSK’s established pandemic adjuvant technology. And, ongoing discussions with the European Commission, with France and Italy on the negotiation team and other governments, to ensure global access to a novel coronavirus vaccine
June 23, 2020 - Sanofi SA said it expects to get approval for the potential COVID-19 vaccine it is developing with Britain’s GlaxoSmithKline Plc. by the first half of 2021, faster than previously anticipated.
May 13, 2020 - Sanofi’s Chief Executive Officer Paul Hudson said in an interview with Bloomberg News, 'he warned that Europe risks falling behind unless it steps up efforts to seek protection against a pandemic that’s killed more than 290,000 people worldwide.
April 14, 2020 - Sanofi and GSK announce that they have signed a letter of intent to develop an adjuvanted vaccine for COVID-19, using innovative technology from both companies, to help address the ongoing pandemic.
February 18, 2020 - David Loew, Sanofi’s global head of vaccines, announced the company would partner with the U.S. Biomedical Advanced Research and Development Authority—known as BARDA—to make a vaccine using the company’s recombinant DNA platform.
Sanofi - GSK SARS-CoV-2 Vaccine Clinical Trials
- Sanofi is leading the clinical development and registration of the COVID-19 vaccine and expects a Phase 1/2 study to start in September, followed by a Phase 3 study by the end of 2020. If the data are positive, the companies can request U.S. regulatory approval in the first half of 2021.