Lives Lost As Vaccine Programs Face Delays

By Justin Gillis
Washington Post Staff Writer
Monday, December 19, 2005

Companies have developed two vaccines that theoretically could save the lives of several million children over the next decade, but efforts to get them to the poor countries that need them most are lagging.

One vaccine, which protects against a life-threatening form of pneumonia, has been available to children in the United States for five years and has had a dramatic impact on disease here. The other, a vaccine that protects against a deadly form of diarrhea, is poised for a rollout soon among middle-income countries in Latin America.

The vaccines are the subject of special programs designed to speed them to poorer countries. With the Bill & Melinda Gates Foundation spending billions of dollars to improve global health and encouraging efforts to solve long-standing problems, excited doctors have been trying to create a system that would get such vaccines to rich and poor alike at the same time.

But the efforts have faltered amid a dizzying array of snafus, misjudgments and business difficulties. One company cannot produce enough vaccine, and studies needed to support widespread use of another have been slowed by behind-the-scenes squabbling. The problems have proved so vexing that the vaccines are expected to take an additional three to five years to reach the poorest villages.

Historically, vaccine companies rarely focused on lower-income markets and would not scale their manufacturing plants to produce excess vaccine for them. Life-saving shots would trickle down to poor countries after decades on the market, costing many lives.

To break that cycle, the Global Alliance for Vaccines and Immunization, a disease-fighting coalition in Geneva, selected the pneumonia and diarrhea vaccines for special emphasis three years ago. The alliance of governments and organizations, known as GAVI, is closely tied to the World Health Organization but receives much of its funding from the Gates Foundation in Seattle.

In establishing the program to accelerate a vaccine against the diarrhea-causing intestinal germ called rotavirus, organizers said in a statement, they aimed to ensure "that rotavirus vaccine is available to children in developing countries at the same time as those living in the developed world."

That is now all but certain not to happen, nor has it happened with the pneumonia vaccine. Some experts see the problems as a harbinger of bigger trouble to come, as the Gates Foundation funds development of vaccines for malaria and tuberculosis that could save tens of millions of lives but might face similar deployment hurdles.

Prevnar, the pneumonia vaccine sold by Wyeth, a drugmaker in Madison, N.J., has had a sharp impact in the United States. Though expensive, it has been a runaway success, with sales topping $1 billion a year -- a first in the history of vaccines.

The company initially underestimated demand even in rich countries and has struggled to expand a complex manufacturing procedure. Wyeth says it is working on a version of the vaccine that it hopes to sell to poor countries at reduced prices, but many public-health experts believe the supply situation will not be solved until new manufacturers come into the market in several years.

Wyeth's critical supply decisions had already been made by the time GAVI funded a $30 million program at Johns Hopkins University nearly three years ago to accelerate introduction of Prevnar or a similar vaccine to poor countries.

The director of that project, Orin Levine, has worked with Wyeth to refine its long-term plans but has focused mainly on laying the groundwork for a rollout in poor countries once competing vaccines are licensed. Levine's efforts have received high marks, even though doctors are disappointed to see lives lost to a vaccine-preventable disease. The germ in question, Streptococcus pneumoniae , kills an estimated 1.6 million people a year, about half of them children in poor countries.

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