While vaccines serve a substantial public health benefit, vaccines manufacturers face a very different value proposition from their typical drug development counterparts, with sales based largely on public purchasers.
Yet, the vaccines market is expected to reach $49 billion by 2022, according to research firm Markets and Markets, which projects a growth rate of 7.5%.
Among just a handful of manufacturers in the vaccines space, Sanofi Pasteur has carved out a strong niche, battling competitors like GlaxoSmithKline, Pfizer, Merck & Co., Johnson & Johnson, among others.
Sanofi Pasteur, the vaccines arm of the French pharma, has 3,000 employees in the U.S. and 15,000 globally. Headquartered in Lyon, France, the unit brought in 5.1 billion euros ($5.9 billion) in 2017 — nearly 15% of Sanofi's total revenues.
While the division has offerings for everything from yellow fever to tetanus, its main growth driver is the flu vaccine. It's he company's dengue vaccine, however, that has put Sanofi Pasteur in the headlines of late.
Earlier this year, the company released data showing Dengvaxia performed differently in seropositive versus seronegative individuals, increasing the likelihood of subsequent hospitalization in those patients who were seronegative. The data pushed the World Health Organization to revise its guidelines for the vaccine, and created a flurry of backlash from governments, particularly in the Philippines.
Sanofi Pasteur's Chief Commercial Officer in North America Elaine O'Hara chatted with BioPharma Dive about the dengue vaccine, Sanofi's position in the marketplace and the rapidly changing manufacture of vaccines.
This interview has been edited for clarity and brevity.
BIOPHARMA DIVE: The vaccines business model is an interesting one. It doesn't necessarily carry the same business incentives as other drug development areas. Can you tell me why Sanofi Pasteur has managed to thrive in this arena?
ELAINE O'HARA: To your point, it's an interesting business model because the cost of entry is extremely high. Our clinical studies technically have to cater to thousands of patients, so it's a little bit different than development if it's a small molecule component and how clinical studies are running when you're looking at small molecules.
Having said that, then, once you have established your presence in the vaccine marketplace, then it's a little bit different paradigm. You don't necessarily suffer the typical loss of exclusivity that you might see with respect to small molecules. So, high cost of entry, but once you're established, then it becomes quite a stable environment from a business model perspective.
We have five business units, and Sanofi Pasteur is really a significant contributor to our overall business in general. So, it's a very profitable business for the company.
Sanofi Pasteur recently inked a deal with Translate Bio. How does this mRNA technology fit with the rest of the development pipeline and your other programs?
O'HARA: From a research and development perspective, we're always looking at improving existing vaccines, as well as developing novel vaccines and continuing to innovate. We currently have six key vaccine projects in development in the U.S. for priority disease areas and that includes improved flu vaccines, new meningococcal and pertussis vaccines, respiratory syncytial viral vaccines, new yellow fever and rabies vaccines.
Now, with the partnership that we recently announced with Translate Bio, of course, it's a clinical stage messenger RNA therapeutics company and so the whole thought process there is this gives us another three-year collaboration where we can together jointly develop vaccines for up to five infectious disease pathogens.
The whole opportunity there is really to give us an opportunity to have the potential for rapid and versatile manufacturing, potentially reduce industrialization costs for multiple vaccines and then just give us an expanded breadth of immune response for infectious disease vaccines. It's a very innovative platform for us to continue to utilize within our current technology.
The company has been making significant investments recently in facilities around the world, including here in North America. You've mentioned a couple times the infrastructure and manufacturing. What impact does this investment have on your productivity?
O'HARA: A lot of our investment is largely around influenza, although we have other investments as well. I currently work at the Swiftwater site [in Pennsylvania] and that is where we manufacture a significant portion of our global supply for influenza.
During the last, I'd say, ten years, we have doubled our annual global production capacity of seasonal influenza vaccine to now more that 200 million doses. We're basically improving capacity investments and access with about $1.3 billion to support the changing needs of public health.
Since about 2000, the Swiftwater site, which I mentioned, has made a significant number of investments, which include a new formulation, filling and lyophilization facility with FDA licensure anticipated this year, within the second half.
We also have a quality control facility to provide testing capabilities for all products that are manufactured on site. We have a global clinical immunology facility which features biosafety level lab that supports the development of the company's new vaccine portfolio.
We recently acquired Protein Sciences, which has the capability both in Pearl River as well as Meriden, Connecticut. And we're also constructing a third facility as well. Again, it's a significant investment in capacity just because we continue to expand our influenza portfolio rather rapidly.
You mentioned your Protein Sciences acquisition. This gives you the capability for non egg-based flu vaccines. How will this change the process and market?
O'HARA: Flublok, it's approved for use in people who are 18 years of age or older. And essentially, that gives us the opportunity to use recombinant technology — which is not egg-based — to provide important influenza vaccination for adults.
But a significant portion of our overall manufacturing does in fact come from egg-based technology and modern egg-based vaccine production really does remain the most reliable method of delivering influenza vaccines in the U.S. today. More than 150 million doses of flu vaccines are going to be shared to help unique public health demands in the U.S.
While we may see a shift away from egg-based technology — and many companies are working on broadly protective as well as universal influenza vaccines — I think it's almost irresponsible for us to completely walk away. And that transition will happen, potentially over time. We really need to invest in other vaccine capabilities before we just wholesale move away.
How has guidance from the FDA and recommendations from them in this area helped you to make decisions as to where to move next?
O'HARA: So, there's been a lot of discussion at the government level. I think it's imperative that we look at this sort of together, jointly from a government perspective, as well as a manufacturer perspective to really navigate what is the best path forward. Particularly as it relates to pandemic preparedness.
I think there's definitely interest in non egg-based technology, but again, most of our discussions lately have focused on the importance of egg-based technology and making sure that we encourage people to get vaccinated on a seasonal basis so that we can provide public health, so that we can provide immunizations that are essentially life-saving.
Sanofi Pasteur has been in the headlines because of your dengue vaccine. Tell me about a bit about what happened here and what Sanofi Pasteur is doing to respond to the situation.
O'HARA: In the Philippines, there were some concerns around Dengvaxia. I think that we have a long-standing commitment to the global fight against dengue. We got this important vaccine to areas where there was high endemic need. Dengvaxia is actually licensed in 20 countries.
The issue that arose with Dengvaxia is just with respect to patients who were seronegative, that was something that we had to work with various governments to address. From Sanofi's perspective, we've worked long and hard to provide an innovative vaccine against dengue in spite of many challenges posed by the complex infection.
I think it remains a significant public health challenge, certainly in those endemic countries and we'll continue to work with governments to provide the solution in an appropriate fashion. Again, it's a very important vaccine for many countries. It's still recommended and supported by the WHO and we also have a large-scale program in Brazil as well.
Has this eroded people's confidence in your vaccines, or vaccines in general?
O'HARA: I certainly don't think so. Again, if you look at all of the disease areas in which Sanofi Pasteur and other manufacturers provide vaccines, these are preventable, life-threatening diseases.
When you look at the meningococcal disease as an example, as a leader in the market space, we continue to partner and to provide education so that we can actually raise the awareness around the importance of getting immunized. And that's one of the things we certainly struggle with the meningococcal disease and our Menactra vaccine.
While for example, we see that most children between the ages of 11 and 12 get their first dose, the problem is once they need to get their second dose at around 15 or 16, only about four out of 10 adolescents receive their second dose. So the importance of immunization remains incredibly strong; it's just we have to continue to remind and provide awareness and education to do so.
...I do think most of the folks who are working in vaccines are always concerned about the rate of vaccination and just the encouragement to have people get vaccinated against diseases is something that we get. It's almost like a daily battle.