The drug maker Sanofi Pasteur is entering the race to develop a vaccine to protect against the new coronavirus sweeping through China, the company announced Monday.
David Loew, Sanofi’s global head of vaccines, said the company would partner with the U.S. Biomedical Advanced Research and Development Authority — known as BARDA — to make a vaccine using the company’s recombinant DNA platform.
Loew said the company’s previous work to develop a vaccine for SARS — a cousin virus — gives it a leg up on this work.
Even so, the work won’t be quick. The timeline to a licensed vaccine, even with an emergency use approval, is likely three or four years, said John Shiver, Sanofi’s head of vaccine research and development. “That’s probably about as fast as that can really happen,” he said.
Neither Loew nor BARDA would reveal how much money the government agency would be injecting into the work. BARDA would only say that it is “reprogramming funds” to support the project.
“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 Loew.
“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,” he said.
Loew said Sanofi is going to develop a bank of vaccine candidates — think of them as prototypes — and produce pilot lots of the vaccines to use in testing. BARDA is financing the pilot lots, he said. Decisions about later-stage funding remain to be made. “That’s how far we got. We will have to negotiate with them all the next coming steps,” Loew said.
Sanofi expects to have a vaccine candidate to test in the lab within six months and could be ready to test a vaccine in people within a year to 18 months, Loew said.
Sanofi is the second major vaccine maker to announce it will try to make a vaccine against the new virus, which has infected over 70,000 people, mostly in China. Johnson & Johnson’s vaccine division, Janssen, has also announced it will try to produce a vaccine.
Smaller players in the vaccine world are already out of the gate with vaccine platforms — using DNA or messenger RNA — that hold promise of speeding up the phase of development to a vaccine prototype, with funding from the Coalition for Epidemic Preparedness Innovations, better known as CEPI.
But these companies — including Inovio and Moderna — are biotechs that do not have large-scale production facilities. Should their prototypes be successful, a producer with scalable manufacturing facilities would need to become involved.
Sanofi brings with it many advantages, including deep experience conducting clinical trials in the U.S. and beyond, including in China, Loew said.
And it has a licensed vaccine made using this platform — the flu vaccine Flublok; Sanofi acquired both the vaccine and the recombinant DNA platform with which it is made from Protein Sciences in 2017.
It is Protein Sciences’ work on a SARS vaccine that Sanofi hopes to build on here.
“We believe that the technology is robust in the sense that there’s some evidence from the SARS vaccine that it is immunogenic,” said Clement Lewin, who heads Sanofi’s BARDA liaison office.
“It’s a production platform that’s used in a vaccine licensed by the FDA, so regulatory agencies are familiar with it and we have shown that we can produce influenza vaccine at scale with that technology. So we should be able to produce commercial quantities, should they be needed,” he said.
Mark Feinberg, president and CEO of the International AIDS Vaccine Initiative, said it is important to have a variety of companies working on a vaccine for the virus, which causes a disease the World Health Organization has called Covid-19.
“I think you want to incentivize multiple manufacturers or developers to get involved, because you don’t ever know what’s going to work and what’s not going to work and it’s not appropriate to put all of your hopes on one single vaccine,” said Feinberg. As Merck’s former chief scientist, he was heavily involved in the company’s acquisition and early development of an Ebola vaccine that was licensed in late 2019. “Having a diversity of approaches and programs I think is in general is a good approach.”
Many major manufacturers have been slow to enter the effort to develop a Covid-19 vaccine; all the major producers have previous experience racing to develop vaccines amid outbreaks that never led to marketed products.
But Loew said when Sanofi saw that the coronavirus was continuing to spread, even despite the extraordinary containment measures imposed by the Chinese government, “that gave us really pause.”
“So we are concerned what’s going to happen when people come back to work,” he said, referring to the fact that in many parts of China, Lunar New Year holidays have been extended by weeks to keep people from mingling during commutes and at workplaces. “Because at one point people will have to come back to work.”