Multinational pharma giants GlaxoSmithKline (GSK) and Sanofi are set to start the human trial phase of their protein-based COVID-19 vaccine.
The British pharmaceutical headquartered in Brentford, England, and the French pharma based in Paris, France collaborated back in April 2020, pooling its resources together to find a treatment against the highly contagious coronavirus disease (COVID-19).
A GSK-Sanofi Joint Venture
The new vaccine from both pharmaceutical giants is based on existing technology owned by Sanofi for its Flublok flu vaccines, together with an adjuvant from GSK. Adjuvants are pharmacological agents added to vaccines to improve the immune response, leading to increased antibody production and longer efficacy of the vaccine. Like most prospective COVID-19 vaccines, the Sanofi - GSK project will also be a two-dose vaccine.
The #COVID19 pandemic requires unprecedented collaboration. We've partnered with @Sanofi to develop an adjuvanted #vaccine candidate, which has just entered clinical trials. Learn more: https://t.co/6Gb5zRxIF2 #coronavirus pic.twitter.com/lfsT2UG8Gy — GSK (@GSK) September 3, 2020
In the upcoming human trial, the vaccine's Phase 1/ 2 clinical trial phase, will cover 11 sites in the United States and is expected to be completed in December later this year. In this phase, Sanofi plans to include 440 health adults, aged 18 to 49 years old, in the first half. They will receive the vaccine to evaluate the safety and immune response, finding the right dosage for treatment. In the second phase, a wider dataset will be available as the vaccine will include more people, including some 140 adults aged 50 years old and above.
"We think we can move very rapidly to expansion from the very first subjects that get the vaccine," said Sanofi vaccine research and development head John Shiver, in an article from STAT News.
Getting Boosts from Government Support
Should it be successful, it would open the road for a Phase 3 efficacy trial, covering thousands of people. After the 3rd phase, GSK and Sanofi will be requesting regulatory approval for its protein-based COVID-19 vaccine by the first half of 2021.
The combined manufacturing capabilities of both GSK and Sanofi will make it the largest in the world. Both pharmaceuticals are also looking to scale their capabilities to meet a target of one billion doses by 2021.
Global head of Sanofi Pasteur Thomas Triomphe said that the upcoming clinical trials are an "important step" in developing a potential vaccine that can finally defeat COVID-19. Sanofi Pasteur is the French pharma's vaccine division. Triomphe noted that their teams, as well as GSK's, are working "around the clock" to deliver results and meet the early December targets.
We're proud of our dedicated teams at @Sanofi, as well as our partner at @GSK, who have worked so hard to begin Phase1/2 clinical trials for a potential #COVID19 vaccine. — Sanofi Pasteur (@sanofipasteur) September 3, 2020
On the other hand, GSK Vaccines president Roger Connor said that their joint project "builds on the confidence shown by governments already." Connor also stressed that the progress of the project is important in addressing the global coronavirus pandemic.
In terms of governmental support, the United States government has already committed back in July to give the British and French companies $2.1 billion back in July to step up its development of the protein-based vaccine, allotting 100 million of the doses to the US in the event of success. The United Kingdom is also awaiting 60 million doses of the vaccine.
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