Julie Gerberding discusses the issue of vaccine safety without ever mentioning autism: ”It’s clearly a powerful local issue in many westernized or developed countries. It’s a growing issue. We have to work harder to engage people in the conversation. And that conversation needs to be led by trusted and credible people, not necessarily vaccine manufacturers.
To her way of thinking, there is no contoversy. All we need to do is have a conversation.
I met with Gerberding earlier this week while she was in Seattle for the Pacific Health Summit, an invitation-only gathering of health leaders in academia, industry, and government. She was there to discuss the next big challenges in the field of vaccines. Part of what brings Merck, Pfizer, GlaxoSmithKline, and other major vaccine companies into the conversation is the realization that vaccines are no longer just a low-margin, high-liability corporate backwater. New technologies propelled the vaccine market to more than $22 billion in sales in 2009, and projections are that it will keep growing by 10 percent a year over the next five years, according to Kalorama Information, a market research firm. For a diversified company like Merck, with $46 billion in total sales in 2010, vaccines are a sizable business segment.
Here’s what Gerberding had to say about the opportunities she sees in the vaccine business, plus a bit about what she’s learned in making the switch from the public sector to the private sector. The interview is edited for length and clarity as always. . . .
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: 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 to have their child immunized. They see the diseases, and understand how life-saving those vaccines can really be. If you are thinking globally, it’s not the most important obstacle we face. But it’s clearly a powerful local issue in many westernized or developed countries. It’s a growing issue. We have to work harder to engage people in the conversation. And that conversation needs to be led by trusted and credible people, not necessarily vaccine manufacturers.
X: So do you just get out of the way then?
JG: No, we have a responsibility. The most important component of our contribution is that we do make trustworthy, reliable products that address health needs. We should be proud of it. These are critically important products for global health and local health. We don’t need to be silent about the contribution we are making, and our employees should take pride in it. Having said that, for people who have already made up their mind that there are issues around the need for vaccines, the manufacturers are not likely to be the best resource for changing their minds. People need to hear balanced information from trusted peers, and/or their doctor. That’s what we need to learn—what really does motivate people’s behavior. The old model would say ‘we just need to give people better information. If they have the facts, they’ll make the right choice.’ The new model is that it’s not a left-brain decision for many parents—this is a right-brain, heartfelt decision. While they can understand objectively that vaccines are important means of protection, when they are sitting with a child on the lap and deciding to give them a shot, it becomes emotional for the parent. Not all parents respond to that situation the same way.