Sanofi - GSK COVID-19 Vaccine Description
The Sanofi - GSK vaccine candidate combines innovative technologies to produce an adjuvanted recombinant protein-based COVID-19 vaccine.
Combining a protein-based antigen and an adjuvant is well-established and used in several 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 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. The DNA sequence encoding this antigen has been combined into the baculovirus expression platform's DNA, based on 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 would 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. The U.S. government has a further option to discuss the purchase of up to 500 million doses longer term. Both companies agreed (subject to final contract) with the UK government to supply up to 60 million recombinant protein-based COVID-19 vaccine doses.
Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur, said 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.”
On October 28, 2020, Sanofi and GSK announced they initiated a Phase 1/2 study on September 3rd with 440 subjects enrolled and anticipated first results in early December 2020 to support the initiation of a pivotal Phase 3 study before the end of 2020. If these data are sufficient for licensure application, it is planned to request regulatory approval from the first half of 2021.
Sanofi and GSK announce on December 11, 2020, a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly. However, The Companies plan a Phase 2b study expected to start in February 2021 with support from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness Response (ASPR) under contract W15QKN-16-9-1002.
This Phase, 2b study, will include a proposed comparison with an authorized COVID-19 vaccine. If data are positive, a global Phase 3 study could start in Q2 2021. This study's positive results would lead to regulatory submissions in the second half of 2021, hence delaying the vaccine’s potential availability from mid-2021 to Q4 2021.
“We care greatly about public health, which is why we are disappointed by the delay announced today, but all our decisions are and will always be driven by science and data. We have identified the path forward and remain confident and committed to bringing a safe and efficacious COVID-19 vaccine. Following these results and the latest encouraging new preclinical data, we will now work to optimize our candidate further to achieve this goal,” added Thomas Triomphe, EVP, and Head of Sanofi Pasteur. “No single pharma company can make it alone; the world needs more than one vaccine to fight the pandemic.”
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 COVID-19 Vaccine Indication
Sanofi - GSK SARS-CoV-2 vaccine candidate is indicated to prevent SARS-CoV-2 coronavirus infection, leading to COVID-19 disease in humans.
Pediatric, oncology, and pregnancy vaccine efficacy verification are pending.
Sanofi - GSK COVID-19 Vaccine News
December 11, 2020 - Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve older adults' immune response. Phase 1/2 study interim results showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in older adults likely due to an insufficient concentration of the antigen. Sanofi and GSK adjuvanted recombinant protein-based vaccine candidate was selected in July 2020 by the U.S. government’s Operation Warp Speed to accelerate its development and manufacturing.
December 3, 2020 - Sanofi vaccines chief Thomas Triomphe said 'the company will announce the price of the potential COVID-19 vaccine it is developing with Britain's GlaxoSmithKline after it has released Phase I/II results of the trials. The company is expected to release the Phase I/II clinical trials this month (December).
October 28, 2020 - Sanofi and GSK announced they intend to make available 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine, if approved by regulatory authorities and subject to contract, to the COVAX Facility.
September 22, 2020 - Sanofi and GSK announced agreements with the Government of Canada to supply 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 440 subjects being enrolled. They anticipate the 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 to supply 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 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 to supply up to 60 million doses of a COVID-19 vaccine. Sanofi, the vaccine candidate, 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, France, and Italy on the negotiation team and other governments 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 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 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 COVID-19 Clinical Trials
Clinical Trial NCT04537208: Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older - Last updated on November 19, 2020. With an Estimated Study Completion Date: October 2021.
The study's primary objectives are: To describe the neutralizing antibody profile on Day 1, Day 22, and Day 36 of each study intervention group; describe the safety profile of all participants in each age group and each study intervention group up to 12 months post-last injection.
The interim Phase 1/2 results showed a level of neutralizing antibody titers after two doses comparable to sera from patients who recovered from COVID-19, balanced cellular response in adults aged 18 to 49 years, but insufficient neutralizing antibody titers in adults over the age of 50. The candidate showed transient but higher than expected levels of reactogenicity due to the suboptimal antigen formulation, with no serious adverse events related to the vaccine candidate. The most favorable results were observed in the group which tested the highest antigen concentration, combined with the GSK adjuvant, showing neutralization titers in 88% of participants. Seroconversion was observed in 89.6% of the 18 to 49 age group, 85% in the >50 age group, and 62.5% in the >60 age group.
The Phase 1/2 clinical study is a randomized, double-blind, and placebo-controlled study designed to evaluate the safety, reactogenicity, and immunogenicity (immune response) of the COVID-19 vaccine candidate. A total of 441 healthy adults participated in the study across 10 investigational sites in the United States. The participants received one or two doses of the vaccine candidate or placebo at 21 days apart.
Phase 2b Study:
The Companies plan a Phase 2b study expected to start in February 2021 with support from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) under contract W15QKN-16-9-1002. The study will include a proposed comparison with an authorized COVID-19 vaccine. If data are positive, a global Phase 3 study could start in Q2 2021.
This study's positive results would lead to regulatory submissions in the second half of 2021, hence delaying the vaccine’s potential availability from mid-2021 to Q4 2021.