At Sanofi, our purpose is to discover breakthrough medicines and vaccines to improve the lives of millions of people around the world. This drive to transform the practice of medicine has taken on increased urgency for everyone in the Sanofi family since the emergence of COVID-19 across the world.
Sanofi is rapidly responding to the evolving challenge of COVID-19. Our responsibility to our employees and their families, patients and caregivers, health care providers, public health officials and communities around the world drives us to act on our long history of innovation to bring cutting edge science and dedicated people to face this threat. We would like to take this opportunity to share our approach to this crisis.
We Are Leveraging Our Expertise in Vaccine Development
Sanofi Pasteur, the vaccines global business unit of Sanofi, is leveraging previous development work for a SARS vaccine as part of our goal to unlock a fast path forward for developing a COVID-19 vaccine. Sanofi is collaborating with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, expanding the company’s longstanding partnership with BARDA. That partnership includes an agreement signed last year to establish state of the art facilities in the United States for the sustainable production of an adjuvanted recombinant vaccine for use in the event of an influenza pandemic and based on the same technology platform that will be used for the COVID-19 program. BARDA and Sanofi Pasteur expanded this collaboration to accelerate into non-clinical studies and a Phase 1 clinical trial to evaluate the initial safety of the vaccine candidate.
In April 2020, Sanofi and GlaxoSmithKline (GSK) announced their collaboration in the fight against COVID-19. The companies are developing an adjuvanted vaccine for COVID-19, using innovative technology from both companies, to help address the ongoing pandemic. Through this collaboration, Sanofi will contribute its S-protein COVID-19 antigen (the protein that stimulates the body’s immune response against the virus), which is based on recombinant DNA technology, and GSK will contribute its proven pandemic adjuvant technology (ingredient added to enhance the immune response, and which may reduce the amount of vaccine protein required per dose). The use of an adjuvant can be of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protect more people. The combination of a protein-based antigen together with an adjuvant is well-established and used in a number of vaccines available today.
Most recently, the companies announced they were selected for Operation Warp Speed and have committed to supplying the United States government with 100 million doses of the COVID-19 vaccine. Sanofi is leading the clinical development and registration of the COVID-19 vaccine and expects a Phase 1/2 study to start in September, followed by a Phase 3 study by the end of 2020. If the data are positive, the companies can request U.S. regulatory approval in the first half of 2021. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant to produce up to one billion doses per year globally.
Additionally, Sanofi Pasteur and Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, are collaborating to develop a novel mRNA vaccine for COVID-19. This collaboration leverages an existing agreement between the two companies to develop mRNA vaccines for infectious diseases, including COVID-19. We are combining our deep vaccine expertise and support with Translate Bio’s mRNA platform to discover, design, and manufacture a number of SARS-CoV-2 vaccine candidates.
We Are Researching Existing Products as Potential Treatments for COVID-19
Sanofi is committed to making every effort to help countries across the world, including the U.S., combat the coronavirus outbreak. In March we announced the initiation of our global clinical trial program with our collaborator Regeneron Pharmaceuticals evaluating Kevzara® (sarilumab) in patients hospitalized with severe COVID-19. Kevzara is a fully-human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. The companies recently provided an update on their Phase 3 U.S. trial. A separate Phase 3 trial is ongoing outside the U.S.
Additionally, there has been increased questions around the off-label use of hydroxychloroquine in the management of COVID-19 based on preliminary results from independent studies from different countries. Sanofi divested this medicine in the U.S. in 2013 but is one of the main manufacturers globally.
To date there is insufficient clinical evidence to draw any conclusion over the clinical efficacy or safety of hydroxychloroquine (or chloroquine) in the management of COVID-19. Large clinical studies are being conducted to assess the benefit/risk profile of hydroxychloroquine in the management of COVID-19 patients and ensure patient safety. Any use of this medicine in the management of COVID-19 is considered an off-label use (i.e. in absence of a marketing authorization for the indication of COVID-19).
We Are Focused on Patient Needs
As a company, we take the health and safety of our patients seriously. We are continuing our work in providing resources and support to patients and their healthcare team. We remain focused on ensuring that those who need our medicines have access to them.
We Are Working to Avoid Shortages
We are working to maintain the supply of all of our medicines and vaccines through close collaboration with our suppliers throughout the world. Our global network of manufacturing plants is operational and the diversity of our global sourcing helps ensure business continuity across all our product lines. At this time, Sanofi does not anticipate shortages for patients resulting from the COVID-19 situation.
We Are Giving back to Our Communities
In addition to donating to relief efforts in the communities where we live and work, Sanofi employees around the country have mobilized to volunteer their medical expertise during the COVID-19 pandemic. Any employee who is a licensed medical professional is able to support their community hospital, relief organization, local testing site and more all while maintaining their Sanofi pay and benefits. We are extremely proud of our Sanofi colleagues who are working to help those in need during these difficult times.
We Are Ensuring the Safety of Our Employees
Our priority has been the safety and the health of our employees and their families around the world by implementing science-based recommendations to stop the spread of COVID-19. Sanofi activated our global crisis committee to help prevent employee exposure to the virus while actively monitoring the potential impact on our activities. Local crisis teams are also working in different countries to manage local realities in closer proximity to employees.
Sanofi is continually assessing the global health implications of the COVID-19 virus – and our role in addressing this challenge – and we remain committed to working closely with global health organizations and governments to minimize the risk and impact of COVID-19.