Merck’s Julie Gerberding, Former CDC Director, on the Future of Vaccines
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manufacturing we do, the more we cover our fixed costs, and the less expensive on a per-dose basis our vaccines will become. So the more global our outlook, and the more we reach people in the developing world that are the hardest to reach, the more value we bring.
X: What are the biggest challenges in this job? I heard you talk on the panel about so many different priorities people have. There is getting vaccines we already have to people who need them, developing novel ones, optimizing existing ones, stockpiling for pandemics. What are your top priorities, and lower priorities?
JG: Our top vaccine priority is to get vaccines to the people who need them most. We are really working hard on access and coverage and completion. We have some products where we can give the first dose, but we need to make sure people get all the doses they need so they are completely covered. We have some challenges in opening markets in new environments, and really reaching the people there. And we have challenges in financing, in things like GAVI (Global Alliance for Vaccines and Immunizations) mechanisms, getting them to work in a reliable, long-term way. One of the things I think all the manufacturers face, whether they are in an emerging market environment or a multinational company, is that we need stability of forecasting. We can’t live in a situation where we might be able to provide 60 million doses to GAVI this year, but next year, they might not have money. We need stable, long-term commitments so we can do our own production forecasting, and achieve those cost savings that will allow us to be able to offer vaccines at the access price. That seems like an easy thing to do. GAVI is talking about five years of funding, but one of the things people don’t understand about vaccine manufacturing is that they have a much longer runway than pills. Our planning horizon is 10 years, not five years. We’ve got to know what we are doing 10 years from now, because if we have to scale up our production capability or change something, it takes that long to commission a vaccine production facility, or de-commission one and change it to do something else.
X: Do you see a real advantage here, though, with vaccines in terms of not having the patent cliff issue like you see with drugs? Because these products aren’t as easy to cheaply copy like conventional small-molecule pills.
JG: Sure. The business model is very different. It’s not about trying to maximize your unit profitability fast before your patent wears out. With a vaccine, it’s about how can we continue to position the product, or evolve the product in its life cycle so that it continues to deliver value to people. That can be forever. Our measles vaccine has been around a long time, and it’s still delivering enormous public health value. We don’t have the patent cliff in our way. A bigger challenge is that we, all of us in the world of vaccines, can imagine innovations, bio-process improvements, other things that might improve our ability to lower costs, or speed up production, or localize production in new markets, but the regulatory environment hasn’t caught up with our innovation capability. For me, the biggest single issue is improving regulatory science so that we have the opportunities to implement and execute on bio-process innovations that we think will accelerate market access for poor people.
X: What exactly is the problem at the regulatory level?
JG: In vaccines, the process is the product. Any change you make in how you process your route to the vaccine actually changes the product. Often, you are faced with needing to do clinical studies, or make macro investments in a way that would simply discourage you from moving in that direction. That’s a little different from making a tablet. As long as at the end of the day you have the stated composition of matter, and quality, there’s more flexibility. There are more stringent controls of biologics, for safety purposes. The intent is right, but we need to figure out mechanisms where we can have a continuous quality improvement process that works for the regulators and also allows us to accelerate innovations that allow greater market access.
X: When you talk about regulatory agencies, and government agencies that are the purchaser of vaccines, you get into politics. That brings the whole vaccine-denier world into the equation. How big of an obstacle is that, and how do you deal with it?
JG: On a global basis, it’s a small issue today. Most people in the world are so grateful … Next Page »