Lives Lost As Vaccine Programs Face Delays

The case of rotavirus vaccine is more troubling to many experts, for a plentiful vaccine that became available last year is not being widely used.

Most people have never heard of rotavirus, but every child in the world contracts it early in life. In such places as the United States, some children are hospitalized with rotavirus diarrhea, but they get good care and do not die. In countries with poor health systems, children often progress to catastrophic dehydration and an estimated 440,000 die of rotavirus every year.

Reading that statistic was one of the things that drew Bill Gates, the Microsoft Corp. founder, into global health issues in the 1990s. "I thought, 'Rotavirus? -- I've never even heard of it,' " Gates recalled in a speech in May. " 'How could I never have heard of something that kills half a million children every year?' "

Further study convinced him that many millions of poor children die of preventable diseases. One of the Gates Foundation's first big moves was to grab underused vaccines, such as one against a serious liver virus, and make them more widely available, a strategy that is on track to save millions of lives.

Public-health doctors wanted to go further, proving that new vaccines can be made available worldwide as soon as they are ready. It seemed for a while that rotavirus vaccine would be the case in point.

Past experience suggested potential safety problems with a vaccine, so GlaxoSmithKline PLC of London, the drug company furthest ahead with a new product, launched huge trials in Latin America. Merck & Co. of Whitehouse Station, N.J., is also working on a vaccine.

Heartened by statements from GAVI about a quick rollout, Glaxo's biologicals division in Belgium built a plant able to supply much of the world with its vaccine, Rotarix.

Even with a manufacturer willing to sell to poor countries, public-health doctors still have a formidable list of tasks to introduce a vaccine. Many health ministers will not embrace a new vaccine until they see studies convincing them that the disease in their country is severe and that the vaccine is cost-effective in combating it. Moreover, money must be identified to help poor countries pay for the vaccine.

The Rotavirus Vaccine Program, similar to the Hopkins program on pneumonia, was set up in 2003 to tackle those problems. People close to the situation said there has been considerable tension behind closed doors between its managers and GlaxoSmithKline. Executives at the company's biologicals division said they had difficulty getting the program to commit to funding and a strategy for tests in Africa and Asia.

"We're a bit frustrated," said Deborah E. Myers, director of external and government affairs at GlaxoSmithKline Biologicals. "We've asked about what we need to do to supply information to make the case. We could never get them to make a decision."

John Wecker, a former pharmaceutical executive who directs the Rotavirus Vaccine Program, acknowledged vigorous discussions. "I think it's fair to say that we've struggled sometimes with the manufacturers" about how to proceed, he said. But the main problem, he said, was not any lethargy in his program but the sheer difficulty of setting up complex research in poor countries. Key studies are finally underway but are not close to being finished.

Christopher J. Elias, president of the Program for Appropriate Technology in Health, a Seattle organization that houses and oversees the rotavirus program, said he thought it was making progress. "In terms of whether it's working, the only honest answer is that it's too soon to tell," he said.