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.
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.
“Sanofi and GSK bring proven science and technology to the fight against the global COVID-19 pandemic, with the shared objective of delivering a safe and effective vaccine,” said Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur, in a press release published on September 3, 2020. “The initiation of our clinical study is an important step and brings us closer to a potential vaccine that could help defeat COVID-19. Our dedicated teams and partner continue to work around the clock as we aim to deliver the first results in early December. Positive data will enable a prompt start of the pivotal phase 3 trial by the end of this year.”
The development of the adjuvanted COVID-19 vaccine candidate is being supported through funding and a collaboration with the Biomedical Advanced Research and Development Authority, part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
In July 2020, Sanofi and GSK announced a collaborative effort with the U.S. government to supply up to 100 million doses of their COVID-19 recombinant protein-based vaccine to meet the government’s Operation Warp Speed goal of making hundreds of millions of doses of safe and effective COVID-19 vaccines available as quickly as possible. The U.S. government has a further option to discuss the purchase of up to 500 million doses longer term.
Both companies also agreed (subject to final contract) with the UK government to supply up to 60 million doses of recombinant protein-based COVID-19 vaccine.
Thanks in part to an agreement signed September 18, 2020, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant with the intent to produce up to 1-billion doses per year overall to help meet the high and urgent demand for vaccines worldwide.
The companies stated 'A Phase 3 study is planned to begin by the end of 2020 and regulatory approval could be requested in the first half of 2021.'
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GSK is the leading manufacturer of vaccines globally.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain, and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
Sanofi - GSK SARS-CoV-2 Vaccine Indication
Sanofi - GSK SARS-CoV-2 vaccine candidate is indicated to prevent SARS-CoV-2 coronavirus infection which can lead to COVID-19 disease in humans.
Sanofi - GSK SARS-CoV-2 Vaccine News
September 22, 2020 - Sanofi and GSK announced agreements with the Government of Canada for the supply of up to 72 million doses of an adjuvanted COVID-19 vaccine, beginning in 2021. The Companies initiated a Phase 1/2 study on September 3 with a total of 440 subjects being enrolled, and anticipate first results in early December 2020, to support the initiation of a pivotal Phase 3 study before the end of the year.
September 17, 2020 - Sanofi and GSK finalized an agreement with the European Commission for the supply of up to 300 million doses of a COVID-19 vaccine, once the vaccine is approved. This final agreement confirms the announcement made on July 31, 2020, by both companies and marks a key milestone in protecting European populations against COVID-19. The contract will allow the purchase of a vaccine against COVID-19 for all Member States of the European Union (EU)
September 3, 2020 - Sanofi and GSK announced the start of the Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine. The vaccine candidate, developed in partnership by Sanofi and GSK, uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines with GSK’s established pandemic adjuvant technology.
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 Trial
Clinical Trial NCT04537208: Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older - last updated on September 21, 2020.
The primary objectives of the study are: To describe the neutralizing antibody profile at Day 1, Day 22, and Day 36 of each study intervention group; To describe the safety profile of all participants in each age group and each study intervention group up to 12 months post-last injection.
- The Phase 1/2 clinical trial is a randomized, double-blind, and placebo-controlled trial designed to evaluate the safety, reactogenicity (tolerability), and immunogenicity (immune response) of the COVID-19 vaccine candidate. A total of 440 healthy adults are being enrolled in the trial across 11 investigational sites in the United States.
- This is a parallel-group prevention study. Participants from 2 age groups (adults 18 through 49 years of age and adults 50 years of age and older) will receive either 1 injection (Cohort 1) or 2 injections (Cohort 2) of study vaccine or a placebo control.
- As a precautionary step, a sentinel safety cohort of 6 participants (younger adults only) within each dosing group from Cohort 1 will be enrolled. An early safety data review will be performed, including the evaluation of safety data and laboratory measures to Day 9. Upon acceptable safety demonstrated from unblinded data review by limited members of the Sponsor Study Team, the remaining participants will be enrolled simultaneously.
- The Companies anticipate first results in early December 2020, to support the initiation of a Phase 3 trial in December 2020.
- If these data are sufficient for licensure application, it is planned to request regulatory approval in the first half of 2021.