Vaccines Force Their Way off Pharma’s Back Burner, as Price Increases Help Fuel New Wave of Innovation
A newfound energy is coalescing around the science and business of vaccines, and much of it is happening right here in Seattle. We explored the trend yesterday evening in our first Xconomy Forum in Seattle. The event, held at The Institute for Systems Biology, attracted more than 85 people for an hour of panel discussion with industry leaders and some lively networking before and after.
The major themes that I heard were that rising prices have sparked renewed interest in vaccines among the world’s leading drugmakers. Philanthropies and government health agencies are concentrating on how to better deliver vaccines to a worldwide market that hungers for them. And a whole lot of big biology questions still elude scientists, and have them thinking hard about new ideas.
There’s a reason that all these diverse actors are rowing in the same direction: Vaccines work. Along with improved sanitation, mass vaccination is one of the key forces credited with raising life expectancies from about 47 in 1900 to about 77 at the turn of the millennium in wealthy countries. “When you can give one, two, or three doses of something to a child and get lifelong protection against infection, it’s hard to find a more cost-effective public health intervention,” said Chris Elias, the CEO of PATH, an international nonprofit that works to improve global health.
Below are some of the highlights from the panel discussion, touching on the many pieces of the vaccine puzzle—the science, the regulatory hurdles, the strategies for raising capital for development, and the logistical challenges of making these vaccines ultimately effective in the real world. Thanks go out to everybody that helped support this event, the first of many Xconomy has cooking in Seattle. We thank the ISB for graciously hosting, and our event partner the Washington Biotechnology & Biomedical Association for its help with the logistics on other critical fronts. Kudos also go out to our underwriters, Alexandria Real Estate Equities, EMC, the Science and Technology Directorate of the U.S. Department of Homeland Security, as well as our venture members, Polaris Venture Partners and Arch Venture Partners.
And with that, our esteemed panelists:
On pricing: The prices of standard childhood vaccines like measles/mumps/rubella was about $7 a dose in the late 1980s and has quadrupled to about $28 now, Patrick said, citing a market research report. Another old standby, diphtheria/tetanus/pertussis has exploded from 30 cents a dose to $16.64, he said.
Polio vaccine, without any major technological advance, shot up from $1.60 a dose to $15.42, he says. “Pricing is helping drive the market,” he says. “People are recognizing the value they bring to the healthcare industry.”
On vaccines taking on greater priority within Big Pharma companies: “They used to view the vaccine divisions as a throwaway,” Patrick said. Not many years ago, companies like GlaxoSmithKline, Sanofi-Aventis, Merck used to generate about 3 to 5 percent of their revenues from vaccines, and now it is climbing to between 11 to 15 percent, he said. Elias jumped in with a question about whether this is because of growing vaccine revenue or failures of other drug products. “I don’t really care,” Patrick said. “What it means to the vaccine developer is that I get more R&D money, and attention, and probably a bigger bonus,” Patrick said.
On whether the FDA is placing impossible demands on developers to show proof of vaccine safety: “It hasn’t gotten any easier,” Patrick said. “With group A streptococcus [which can cause strep throat and a host of other more serious infections] you have the difficult problem of giving healthy people anything. Then you’re giving it to healthy children. The bar on safety is higher than if you are giving a dying cancer patient a new therapy.” When he was raising capital at ID Biomedical, the plan was always to run large trials, but they quickly started ballooning. “First we were looking at testing in 3,000 to 4,000 people, then it was 10,000 people, then it was 30,000 to 40,000 people. The investment seemed to never stop. It’s all because you’re looking for a small number of adverse events.”
And also on the difficult regulatory climate: When his previous company, ID Biomedical, had the impeccably good timing to buy a major flu vaccine factory in Canada just a couple months before the U.S. lost half its annual supply because of contamination at a Chiron factory in the U.K., it wasn’t a slam dunk. Patrick thought his company was poised to help fill the void. But even though the factory had capacity to make 10 million doses, and had been serving the Canadian market reliably for many years, the FDA refused to clear the product as safe until a time-consuming battery of tests were performed. “It was stunning to us,” Patrick says.
Steve Reed, CEO of Immune Design, founder of Infectious Disease Research Institute
On what it was like to raise money: “Three or four VC firms sought us out. I don’t think there was a huge appetite for this, but there was a significant appetite for a company with a breadth of technologies. The breadth of technology was important, and so was having an experienced management team that had made all the mistakes before.”
On challenges getting vaccine trials cleared by the FDA: “The FDA is certainly stretched and under a lot of pressure.” He noted how the agency has been reluctant to approve a GlaxoSmithKline cervical cancer vaccine, Cervarix, that contains an immune-boosting compound he worked on while at Seattle-based Corixa. This “adjuvant,” called MPL, has been given to 600,000 people in Europe and other countries around the world “without a lot of trouble,” Reed said. In the U.S., there was one adverse event in an allergy desensitization trial that has contributed to keeping it off the market here. There’s a strong suspicion at the agency toward adjuvants, that are made to boost the effectiveness of vaccines, that Reed says he thinks is unwarranted. “Perhaps the issue hasn’t been presented rationally to them,” he said.
On new technologies: “Intradermal deliver hasn’t really caught on, but now the skin is becoming a much more viable way to deliver vaccines. A lot of viable innate immune cells are just under the skin, and when you stick a needle in, you pass them by,” Reed says. Some microneedle technologies are not only less painful, but might work better at sparking immune defenses just under the skin, he said.
Denise Galloway, head of the Program in Cancer Biology in the Human Biology and Public Health Sciences Divisions of the Fred Hutchinson Cancer Research Center
On federal support for basic science in vaccines: “The NIH funding is at an all-time low, with just about 10 percent of grants getting funded. Everything is being hurt.”
There is actually some more support for vaccine work at the NIH’s in-house laboratories, just not as much available for grants to external researchers, Galloway said. She added there’s still support for therapeutic vaccines, like for cancer, that don’t prevent people from getting a disease but stimulate the immune system to fight it.
On lessons learned from working on the human papillomavirus vaccine: “With HPV, it’s a genital infection, and you’d think you’d need to stimulate secretory immunity. That’s not the case.” Instead, researchers found that boosting the immune response in the general bloodstream was good enough, and that might be applicable to other vaccine work, she said. “That was a surprise.”
On whether there’s hope for an HIV vaccine: “I don’t know. I think it’s important that we go back to the basic biology and try to get some new ideas.”
Chris Elias, CEO of PATH
On market failures: “A report from Mercer consulting a few years ago said that 80 percent of the vaccines are used in poor countries, and 80 percent of the revenue comes from rich countries.”
The GAVI Alliance (formerly known as the Global Alliance for Vaccines and Immunization) has significantly improved that model, Elias says, by putting up billions of dollars to buy vaccines in poor countries and providing certainty to manufacturers with longer-term contracts than historically used by UNICEF. “About 10 years ago, it was UNICEF doing one-year contracts. Now you have people doing three- and five-year contracts. It’s taken some of the uncertainty out of the market. They’ve made a market where there wasn’t one.”
On logistics of vaccine delivery: “We have what I call the innovation pile-up.” By that he meant that innovative new vaccines like Merck’s Gardasil, which can prevent most forms of cervical cancer, “pile-up” in storage because they are difficult to deliver in poor countries that lack a system for immunizing pre-adolescent girls. Then there’s the traditional challenge of proper storage and distribution, and keeping vaccines cold in hot, humid environments. “There’s no comparable investment” in solving these problems, Elias said.
On the market forces driving innovation in the developing world: “Pricing is not driving it in the developing world. What drives it in the developing world is increased volume of vaccination, and greater certainty,” from longer-term contracts, Elias said.
On whether there’s hope for an HIV vaccine: “We’re in a much better place than two years ago. The failure of the Merck trial caused a re-focusing of effort. We had all our eggs in one basket for a while and everybody thought it would work. Now people are trying new approaches.” He closed with a joke about his own sunny attitude. “Ben Franklin once said, ‘If you can’t find a bright side, polish a dull one.”