As the COVID-19 pandemic rapidly spread across the globe earlier this year, Sanofi formed a global crisis team to tackle an unknown virus that had already spread from China to Europe. The team focused quickly on ensuring the ongoing manufacture and supply of its vaccines and treatments for dozens of diseases, and keeping employees safe with new sanitary measures. In parallel, Sanofi started figuring out how to deploy its resources to fight the coronavirus.
Early on, along with the worldwide healthcare community, Sanofi considered a range of options to attack COVID-19, initiating tests on existing treatments, while its vaccines unit, Sanofi Pasteur, began studying the new virus and forging strategic partnerships to pool science, expertise and resources. Today, with more information on the virus, it has become clear that the most effective way to a post-pandemic world are safe and effective vaccines.
Sanofi is pursuing two vaccine candidates
Sanofi recently announced the continuation of its work in COVID-19 vaccine development with the start of a phase 1/2 clinical trial, in partnership with GSK. The trial will enroll 440 healthy adults in the US to evaluate the vaccine’s safety, tolerability and immune response.
“We aim to deliver the first results in December. Positive data would enable a prompt start of a pivotal phase 3 trial by the end of this year,” said Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur.
A positive outcome from phase 3 trials could mean a request for regulatory approval in the first half of 2021.
Pooling science to build a vaccine
The COVID-19 vaccine candidate is being tested using vital ingredients from both Sanofi and GSK.
Sanofi is developing the antigen (the protein that stimulates the body’s immune response against the virus), which is based on recombinant DNA technology. “We are using an existing technology that was designed for influenza, and we’re applying it to the new virus that causes COVID-19 disease,” said John Shiver, Head of Sanofi Vaccine R&D. “Having the existing platform and partnerships are key to finding the optimal vaccine that we hope can both have impact against disease while contributing to vast and urgent global demand.”
And GSK is contributing an adjuvant, an ingredient added to enhance the immune response, which reduces the amount of vaccine protein required per dose and improves the chances of delivering an effective vaccine that can be manufactured at scale.
Sanofi is also exploring a second COVID-19 vaccine candidate, in partnership with Translate Bio, a clinical-stage messenger RNA (mRNA) biotechnology company. The project is on track to start clinical trials by December.
“As the world faces this unprecedented global health crisis, it is clear that no one company can go it alone. That is why Sanofi is continuing to complement its expertise and resources with that of our peers,” said Paul Hudson, Sanofi’s Chief Executive Officer
Scaling up manufacturing facilities
Collaboration is also key to increasing Sanofi’s large-scale manufacturing capabilities, with the target of producing up to one billion doses in 2021. Supply agreements have already been agreed with the US, UK, EU and Canada and the company will also supply to the COVAX Facility, a collaboration led by the WHO and GAVI that aims to secure successful and equitable access to COVID-19 vaccines worldwide.
“The company is working across six countries and in coordination with multiple partner manufacturing sites to be able to make vaccines at the extremely large scales required by the pandemic. The manufacturing process is a complex, never-ending job, but our aim is to supply the vaccine to as many as need it,” says Vincent Hingot, Head of Vaccine Industrial Affairs.
Reality safety check
While the urgency of developing an effective vaccine cannot be ignored, Sanofi’s top priority is safety. Our CEO, Paul Hudson, pledged with eight other biopharma CEOs to develop potential vaccines in accordance with high ethical standards and sound scientific principles regarding clinical trials and manufacturing processes.
Only vaccines that have passed an approved phase 3 trial will be submitted for approval or emergency-use authorization, a pledge that “will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.”
Solidarity is key to moving the fight against COVID-19 forward and, in time, to establishing a blueprint for collaboration and preparation for future pandemics.