Sanofi and GSK Began Human Trials of Protein-Based COVID-19 Vaccine

The partnership of French drugmaker Sanofi S.A. (Sanofi) and Britain’s GlaxoSmithKline Plc (GSK) entered the global race for finding a COVID-19 vaccine as they declared to have started a human trial of their vaccine on Thursday, September 3, 2020. As explained by the press release by Sanofi, the clinical trial is currently in Phase 1/2 study and the result is expected by December this year.

These two world’s leading drug makers have signed a letter of intent to enter into a collaboration in mid-April 2020 to develop an adjuvanted COVID-19 vaccine, by combining their innovative technologies. On July 31, Sanofi and GSK announced a collaboration with the United States (U.S.) government to supply up to 100 million doses of their COVID-19 recombinant protein-based vaccine.

Sanofi and GSK explain, if the result of their human trial turns out to be successful in December, they would proceed to the final testing, i.e. Phase 3 in the same month, and get their vaccine approved in the first half of 2021. In addition, they are planning to ramp up their manufacturing to one billion doses next year.

Large Participants in Trial

The press release explains that the trial aims to examine the safety, tolerability, and immune response of the COVID-19 vaccine, which would be applied to 440 healthy adults and conducted across 11 investigational sites in the U.S. The vaccine candidate uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines, which are coupled with an adjuvant, a substance that acts as a booster to the vaccine, made by GSK.

Currently, some of the forerunner vaccines including the leading British pharmaceutical company, AstraZeneca’s drug have entered the final phase in search of finding a cure for the widespread virus. However, the companies stated that their respective experience in the field of medical research and vaccine were their advantages over other companies despite they entered into the competition a little late.

Meanwhile, the French drugmaker is also currently with another pharmaceutical company, a U.S.-based Translate Bio, which relies on a different technology of the vaccine called mRNA. In an interview with Reuters last week, Sanofi’s CEO Paul Hudson said that the company was very confident in its two coronavirus vaccine candidates.

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Need Multiple Approaches

Sanofi’s global head of vaccine research and development, John Shiver said, “The threat of this virus and pandemic are large enough that the world needs multiple types of approaches for it.” Reflecting on the need for multiple vaccines for the disease, Shiver stated that it could be possible to grant a license to one or more vaccines to be used in case of emergency, but stressed that the global need for Covid-19 vaccines cannot be filled by a few vaccine manufacturers.

As explained by Shiver, the Sanofi vaccine could be transported in liquid form and can be stored at refrigerator temperatures between 2 Celsius and 8 Celsius in contrast to other technologies of the mRNA vaccines that need to be transported frozen.

Thomas Triomphe, executive vice president and global head of Sanofi Pasteur, said, “The initiation of our clinical study is an important step and brings us closer to a potential vaccine which could help defeat Covid-19.” Meanwhile, Sanofi and GSK have been in talks with the European Union to supply it with up to 300 million doses.