A Whole New World of Vaccines

In the "olden days" before the turn of the 21st century, immunization was not exactly headline-grabbing. Fascinating science, yes. One of the fundamental ways to keep children healthy, yes. But the object of intense business strategy-making, a key part of the fight against sexually-transmitted disease, and the focus of glamorous gatherings of the philanthropic elite - not so much. A few recent news items suggest that it's a whole new world. For example:

• In August, the New York Times described the extent to which pharmaceutical companies are banking on profits from their vaccine businesses, rather than from their therapeutic sides. This is a dramatic turnabout, given that the vaccine industry used to be the poor stepsister to the drug business. (We blogged about this phenomenon earlier.) Could it be that Big Pharma doesn't see many blockbuster drugs on the horizon and, after the Vioxx debacle, sees fewer and fewer products that will sell in such large volumes? Perhaps vaccines are among the only remaining products for the masses.
• The October 1st issue of Newsweek features an article on the science and financing of vaccines, with a helpful focus on the often-overlooked challenge of conducting large clinical trials, which are more difficult for vaccines than for most other products. (If you're injecting healthy people with biologically active material, you've got to pay extra-special attention to safety. And in looking for evidence about effectiveness in protecting against infectious disease in a population, the sample size typically has to be much larger than if you're measuring effectiveness of a product to treat people who have already been identified as being sick.) The pilot advance market commitment (AMC) for pneumo vaccine makes a cameo appearance in the article.
• At the Clinton Global Initiative this week, a high-profile panel explored vaccine development, with particular attention to how to expand coverage while at the same time providing incentives for R&D. Of particular note: Suresh Jadhav of the Serum Institute of India was on the panel and brought a powerful message to the assembled members of the global health gang: its not just the multinationals who see the promise of vaccines both for health and for the bottom line - emerging manufacturers are seeing a bright future in this growing market, too. (You can access the full webcast via the Kaiser Family Foundation.)
• In a remarkable display of (mostly) "girl-power," luminaries (including at least two princesses) gathered in Brussels this week to talk about cervical cancer and HPV, with attention to when, where and how to introduce the new vaccine; the HPV vaccine could prevent the deaths of something like 200,000 women in developing countries each year. It's pretty clear that the roll-out of the Merck and/or GSK products will depend on serious commitments from governments and donors, combined with - you guessed it - good demand forecasting. PATH already has a major project underway looking at precisely these issues, and at the CGI Merck just committed to contributing 3 million doses of their vaccine, Gardasil, to developing countries over the next five years.

All this is some combination of well choreographed public relations (of course) and something quite real: To achieve the broadly shared ambitions of better health in low-income countries, there's a growing recognition among donors and developing country governments of the potential of immunization. At the same time, the commercial interests are intensifying, both among Big Pharma and emerging suppliers - and they are carefully watching for potential opportunities to reach both rich and not-so-rich markets. Meaning that maybe there's a chance for genuine win-win solutions (the AMCs and more) to be developed.