As the COVID-19 pandemic rapidly spread across the globe in 2020, Sanofi considered a range of options to attack COVID-19, 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.
"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."
Paul Hudson, CEO Sanofi
Sanofi is developing two vaccine candidates
Sanofi has joined forces to develop two vaccine candidates to help prevent and control COVID-19.
Adjuvanted recombinant protein-based vaccine candidate: where do we stand?
In December 2020, initial results from a phase 1/2 clinical trial 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. A total of 441 healthy adults participated in the study in the US which evaluated safety, tolerability and immune response.
Sanofi is planning to launch a phase 2b study with an optimized candidate vaccine in February 2021, with support from the Biomedical Advanced Research and Development Authority (BARDA) in the US. 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. If the vaccine meets clinical requirements on safety and efficacy, and once approved by regulatory authorities, a vaccine can expected in the fourth quarter of 2021.
"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."
Thomas Triomphe, Executive Vice President and Head of Sanofi Pasteur
Messenger RNA vaccine candidate: where do we stand?
Developed in partnership with Translate Bio, the project is on track to start phase 1/2 clinical trials in early 2021.
Scaling up manufacturing facilities
Sanofi is increasing its manufacturing capabilities to be able to quickly deliver large quantities of future vaccines to meet global demand from around the world.
“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,” said Vincent Hingot, Head of Vaccine Industrial Affairs.
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.
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.”
“Our work, as always, is driven by science and our sense of responsibility,” said Paul.
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.
