At the end of 2009, Julie Gerberding stepped down as director of the US Centers for Disease Control and Prevention to become president of Merck’s vaccine division. The move came a period of tumult, given that vaccine sales had dropped 2 percent amid manufacturing woes and controversy over the safety and marketing of the Gardasil vaccine for HPV, which can cause cervical cancer.
The challenges remain. The Merck vaccine division makes 14 of the 17 vaccines recommended by CDC for children and nine of the 10 recommended for adults. Nonetheless, Gerberding keeps a relatively low profile, but spoke earlier this week with Xconomy about innovation and funding for the Global Alliance for Vaccines and Immunizations (back story). An excerpt of their conversation is below.
However, she does not address a continued decline in vaccine sales, some of which can be traced to ongoing production problems, notably, for the ProQuad shot for Measles, Mumps, Rubella and Varicella (see page 29). Availability, in fact, is not expected at any time this year. Nor does she discuss setbacks Merck has encountered in broadening the market for Gardasil (read this). Nonetheless, she offers some views on the big picture...
Xconomy: What are the biggest challenges in this job? (The priorities include) 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? Gerberding: 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...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.
Xconomy: 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? Gerberding: 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.