fter the World Health Organization declared the spread of the Zika virus constitutes a global public health emergency, Sanofi committed to researching a live vaccine to combat the infectious disease. In doing so, Sanofi became the first vaccine manufacturer to make such a commitment. But such undertakings are not easy and take time. We spoke with Nicholas Jackson, director of research at Sanofi-Pasteur, the drug maker’s vaccine unit, about the effort.
Pharmalot: You have extensive vaccine operations in various countries, including South America, but to what extent was the Zika virus on your radar until this crisis developed?
Jackson: Because of our network of investigators, doctors, and collaborators in Central and South America for our dengue vaccine that was recently licensed, we were aware of Zika last year. The people in these countries drew our attention to Zika, and we began monitoring it through our network … We’ve watched this build over the last few months.
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But we’re not working from the ground up. We have a nice jump-start. We already license three flavivirus vaccines against yellow fever, Japanese encephalitis, and dengue — they are from the same family of vaccines — and so we have boots on the ground. We have scientists, physicians, and epidemiologists who know the disease … and the industrial infrastructure. We know how to deal with this family of viruses.
Pharmalot: How much of a jump-start, exactly?
Jackson: It’s substantial. If you don’t have technology in house, you can spend months transferring technology into the lab. And without expertise in the lab, you would need to recruit people and that can take months. The infrastructure around the world can take years to develop. We should be able to slash years off a timeline that would be 10 years or more (needed to develop a vaccine).
But there are challenges. We need to know why (Zika) is there. Where is it going? And is it actually causing these problems? We need to understand the basic biology. That’s why collaboration will be so important at the international and regional level.
Pharmalot: So how much time does your head start save then?
Jackson: Unfortunately, at this early stage, we can’t yet get a reliable estimate. But we’re confident we can reduce the timeline by some years. And we have a strong sense of urgency … We need to work with regulatory agencies around the world to try to find innovative ways to accelerate (development). If we take the familiar textbook approach to vaccine development, it would potentially slow us down.
Pharmalot: Tell us about the trials that you plan and how soon these will begin.
Jackson: There is no timeline yet for the first clinical study … To develop a vaccine against Zika, we will need potentially to do trials all around the world, particularly in Central and South America. The first studies would normally be in people with no exposure to flaviviruses — people with clean clinical backgrounds in order to interpret early data … And we plan to use the same technology that we used for our dengue vaccine. That’s where we are today, designing vaccines for imminent head-to-head studies.
Pharmalot: To what extent could we have looked ahead and been prepared rather than find ourselves scrambling as we are? Last year, one of your former colleagues coauthored a paper urging a $2 billion fund to develop vaccines for infectious diseases, although Zika wasn’t on the list.
Jackson: If we look at the Ebola emergency, companies and organizations and agencies worked together and a vaccine was produced in a remarkably short period of time. I hope we can make a similar effort in this situation … But the microcephaly cases we’ve seen need to be confirmed that they are associated with Zika. Doctors were only talking about that in September … Then the Brazilian health ministry and PAHO (the Pan American Health Organization) were informed. So we’re only talking weeks where a clustering of events was noticed.
To a certain extent, development has to be reactive when something emerges that quickly during an outbreak for something that, until recently, was otherwise considered a benign virus. One in five people would have symptoms — headache, low fever, conjunctivitis, feeling poorly for a few days — that would not interest public health agencies. But since then, we’ve seen this potentially alarming association with a potential congenital defect. Clear clinical associations weren’t fully seen at the time they wrote that paper.
Pharmalot: And what will it cost to develop this?
Jackson: We can use the dengue vaccine as an example. It cost € 1.5 billion to research, develop, and license, including capital investment. But it’s too early today to have precision on the cost of developing a vaccine for Zika. But that jump-start I mentioned — established infrastructure — means the development cost going forward should be less than other examples.