Sanofi to Work with U.S. Government on Coronavirus (COVID-19) Vaccine
As China and the world struggle to contain the coronavirus COVID-19 outbreak, government agencies and biopharma companies are working on treatments and potential vaccines. Moderna is working with the U.S. National Institutes of Health (NIH) on a vaccine. And now, Paris-based Sanofi’s Sanofi Pasteur, its global vaccines business, is collaborating on a vaccine with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response, part of the U.S. Department of Health and Human Services (HHS).
To date, there are more than 72,000 confirmed and suspected cases of COVID-19 and 1,023 deaths from COVID-19, most in mainland China. Many experts believe that number and what is being analyzed as a mortality rate of 2.3% may be understated the actual numbers.
Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, told CNN’s Jim Sciutto on “New Day” Tuesday, “My sense and the sense of many of my colleagues, is that the ultimate case fatality rate . . . is less than 2%. What is likely not getting counted is a large number of people who are either asymptomatic or minimally symptomatic, so the denominator of your equation is likely much, much larger.”
Sanofi plans to continue investigating an advanced preclinical SARS vaccine candidate that it had worked on during the 2002-2003 SARS outbreak. SARS stands for severe acute respiratory syndrome, and is caused by a coronavirus that has some similarities to the COVID-19 virus. The SARS virus mostly disappeared by 2004.
“Addressing a global health threat such as this newest coronavirus is going to take a collaborative effort, which is why we are working with BARDA to quickly advance a potential vaccine candidate,” said David Loew, Global Head of Vaccines at Sanofi. “While we are lending our expertise where possible, we believe the collaboration with BARDA may provide the most meaningful results in protecting the public from this latest outbreak.”
Typically, experts have indicated it would take three months to develop a vaccine (about two months, since the outbreak has been very active for at least a month) and up to a year or longer before it could become widely used because of the need for clinical trials.
Sanofi intends to leverage its recombinant DNA platform to produce a vaccine candidate to this new coronavirus. The tech platform creates an exact genetic match to proteins on the surface of the virus. This DNA sequence can then be combined into the DNA of the baculovirus expression platform, which is Sanofi’s licensed recombinant influenza product. It could then be used to rapidly manufacture large amounts of the coronavirus antigen that could be formulated to stimulate the immune system against the virus.
In non-clinical studies, the SARS vaccine candidate created an immune response and offered partial protection in animal models. This would give Sanofi a head start in developing a COVID-19 vaccine, and because there is a licensed vaccine based on the platform, research and necessarily materials can be manufactured fairly quickly for clinical testing. It’s also geared up for large-scale manufacturing.
“Emerging global health threats like the 2019 novel coronavirus require a rapid response,” said BARDA Director Rick A. Bright. “By expanding our partnership with Sanofi Pasteur and leveraging a licensed recombinant vaccine platform, we hope to speed development of a vaccine candidate to protect against a new virus.”
In December 2019, Sanofi and BARDA entered into a deal to found facilities in the U.S. for sustainable production of an adjuvanted recombinant vaccine in case of an influenza pandemic. It’s based on the same technology platform that will be used for this COVID-19 program.
Adjuvanted refers to adding ingredients to the vaccine to increase the immune response, creating longer-lasting immunity and minimizing the dose of the antigen needed. In short, they help vaccines work better. A recombinant vaccine is a vaccine created via recombinant DNA technology. This usually involves taking the DNA that codes for an antigen, likely part of the virus’s DNA or RNA that codes for a protein on the surface of the viral capsid.
Meanwhile, at least three drug companies are working on clinical trials in China of possible drugs against COVID-19. They include Gilead Sciences, AbbVie and Johnson & Johnson. State-owned pharmaceutical companies China Resources Pharmaceutical Group and China Medicine Health Industry Co. are rushing production of chloroquine, which appears to be effective in treating the coronavirus with no severe side effects.