Not long ago, vaccines were Big Pharma's neglected stepchild-cheap, one-time treatments that scarcely made a profit. The pharmaceutical industry was moving away from them in a hurry.
Not long ago, vaccines were Big Pharma's neglected stepchild—cheap, one-time treatments that scarcely made a profit. The pharmaceutical industry was moving away from them in a hurry.
Today, vaccines are hot. Fear of bioterrorism and pandemic influenza have boosted government funding for R&D. Hefty contributions from the Bill & Melinda Gates Foundation have fueled partnerships to develop innovative treatments for neglected diseases. New commercial products, such as Wyeth's Prevnar pneumococcal conjugate vaccine and Merck's Gardasil vaccine for HPV (human papillomavirus), are commanding premium prices in the West and seeking distribution in the third world.
These trends were visible at the May annual meeting of the Biotechnology Industry Organization (BIO), which highlighted vaccine development and global health initiatives. A sign of the times: At the event, BIO announced plans to sponsor an annual conference called Partnering for Global Health, starting next year, to build on private-sector expansion in this area.
Investing in Vaccines
Pharma companies traditionally have promoted third world health by donating drugs that often were discovered by chance (see "Fighting River Blindness"). Today, third world product development is "a strategic responsibility" for industry, said Genzyme Senior Vice President James Geraghty. Finding new medical solutions for third world killers can benefit a company's basic development program and also provide a valuable psychological boost for employees, he explained. But while hundreds of new drugs are in development to treat cancer, asthma, and other conditions prevalent in the West, pharma is supporting relatively few for third world diseases, Geraghty added.
Fighting River Blindness
The big gains in vaccine development arise from a growing number of public–private partnerships, according to experts at BIO and the International Conference on Global Health held in Washington, DC, a few weeks later. The Malaria Vaccine Initiative organized by Seattle-based PATH (formerly known as the Program for Appropriate Technology in Health) now has a candidate vaccine from GlaxoSmithKline nearing Phase III clinical trials. PATH's Meningitis Vaccine Project is even further along, closing in on its goal to develop a low-cost vaccine (in the range of 40 cents a dose) to prevent the meningitis epidemics that plague Africa. Phase II trials have been so successful that the sponsors expect to move directly into large-scale production next year. The Aeras Global TB Vaccine Foundation is working with the Dutch biotech Crucell NV to utilize its advanced vector and large-scale cellular production systems to develop effective treatments.
Project BioShield also is providing R&D support for new vaccines for anthrax and smallpox, among other treatments. A sign of success is the recent contract to purchase millions of doses of a new, safer smallpox vaccine from Bavarian Nordic of Denmark. The Biomedical Advanced Research and Development Authority (BARDA), established in April, is implementing new policies to extend federal support for testing and developing medical countermeasures. FDA also has finalized guidance for developing seasonal and pandemic influenza vaccines, which describes pathways for accelerated approval of new products in case of emergency or shortage.
While vaccine R&D may have many rewards, the risks continue to rear up. MedImmune has run into trouble with FDA over manufacturing violations for FluMist. Merck's rollout of its HPV vaccine was marred by opposition to proposed vaccination mandates. FDA has raised safety concerns about Dendreon's Provenge that will delay approval of this new prostate cancer treatment vaccine at least another year. Continued litigation over an alleged vaccine–autism link threatens to deplete federal vaccine compensation funds and industry resources.
Meanwhile, vaccine researchers have made little progress developing an AIDS vaccine. AIDS treatment as it is carried out today is unsustainable, noted Tadataka (Tachi) Yamada, president of the Gateses' Global Health Program; 45 million individuals are infected with the disease, and all ultimately will need second-line treatment, a situation that already is creating tension about access to these more effective therapies. It will be a "great failure of modern medicine," Yamada commented at BIO, if collaborative efforts do not succeed in this area.
While new vaccine development is encouraging, these successes also raise concerns about global distribution and access. Most vaccine manufacturing takes place in Europe and the United States, which will demand first access to products in the case of disease outbreak. Indonesian health officials recently raised the issue by demanding access to vaccines developed with the help of bird flu viral samples collected from the country's sick patients.
The World Health Organization (WHO) is responding with collaborative efforts to expand global vaccine-production capacity in Latin America and Asia. WHO is exploring a vaccine stockpile for developing nations and has urged increased use of seasonal flu vaccine to develop the delivery infrastructure in anticipation of a pandemic.
National leaders at the G8 summit in Germany last month pledged added support to fight AIDS and other third world diseases, spurred partly by President Bush's proposal to double funding of the President's Emergency Plan for AIDS Relief (PEPFAR) to $30 billion over five years. The G8 members urged the pharmaceutical industry to provide access to HIV medicines at affordable prices and to support local production by voluntary license.
Such comments reflect growing international support for compulsory licensing of critical drugs considered too expensive for global use. To avoid such demands, Yamada advised, industry must articulate clear, rational pricing policies based on no-profit pricing. He advised manufacturers to make treatments available in the poorest regions at $1 or less a dose, with price differentiation for rich, poor, and in-between nations. There's no reason, said Yamada, why a more industrialized nation such as Brazil should demand the same price as, say, Rwanda. But failure to make drugs and vaccines affordable in a rational way, he said, "could be the death knell of this industry."
Merck's "affordable pricing" policy, for example, offers no-profit prices for its antiretrovirals to those countries ranked lowest on the United Nations Development Program's Human Development Index (HDI)—a category that does not include Brazil or Thailand. Most pharma companies similarly offer no-profit prices and free technology transfer to help local drug manufacturers produce generic medicines.
Even no-profit prices, however, may be too high for many poor nations. Most large-scale vaccination programs require subsidies from donor organizations to ensure a large market for lower-priced treatments. PATH has launched a program to provide HPV vaccines to developing nations where cervical cancer screening is sparse and the disease highly lethal. The initiative involves pilot programs to test effective educational and distribution approaches for HPV vaccines from both Merck and Glaxo, which will set the stage for GAVI (Global Alliance for Vaccines and Immunization), UNICEF, and other donors to negotiate prices they hope will be much lower than current US rates.
One test of international vaccine-pricing policy may involve Prevnar, which had sales of nearly $2 billion in 2006 in the United States and other industrial countries. Wyeth wants to expand sales to the developing world, but at its "normal price." GAVI and the World Bank hope to generate competition by establishing an advance market commitment backed by several donor countries and the Gateses' foundation that guarantees purchase of a new vaccine against pneumococcus more specific to Africa, at an affordable price.
Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at firstname.lastname@example.org