Vaccines for All - Pharmaceutical Executive

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Vaccines for All
A new equation to bridge health and wealth


Pharmaceutical Executive


Stopping the Decade Delay

In 1974, the World Health Organization established its Expanded Program on Immunization (EPI) to guide and support vaccinations for some of the world's biggest killers, including tuberculosis, polio, measles, and diphtheria-tetanus-pertussis. But chronic underfunding of vaccine programs meant that immunization rates remained low among the world's poor. At the end of the 1990s, fewer than half the children in sub-Saharan Africa were immunized, and three million lives were being lost each year to preventable infectious diseases.

As time passed, WHO expanded the EPI list with vaccines for yellow fever, hepatitis B, and Haemophilus influenzae type b (Hib). But the high cost of these new vaccines kept them out of reach. In the early '80s, when a hep B vaccine became available, according to the World Bank, a three-dose course cost more than $150—far too much for the poorest countries.

But there's more to vaccine access than price. There's also the lag between when a vaccine is licensed in the developed world and when it becomes available in developing nations—traditionally 10 to 15 years. "When we really got going in the early '80s, we were just piggybacking off developed countries," says Stephen Jarrett, deputy director of UNICEF's supply division. "Companies were selling vaccines at high prices, but they recovered all their costs, so we managed to get low prices for developing countries."

But it now appears that the vaccine lag need not be a permanent feature of global healthcare. In the past few years, a pharma company working with public health authorities was for the first time able to bring a new vaccine to a developing market in less than a year, if only for a single country.

The vaccine in question is Merck's RotaTeq, approved in February 2006 for the prevention of rotavirus—which is responsible for the deaths of an estimated 600,000 children a year. A GAVI-funded group called the Rotavirus Vaccine Program investigated the disease in the world's 72 poorest countries, where many health authorities were still unaware of the link between fatal diarrhea and rotavirus.

Nicaragua, a member of the bottom 72 and one of the poorest nations in the Western Hemisphere, suffered an outbreak of rotavirus in 2005, the year before RotaTeq received FDA approval. More than 50,000 cases were reported and 52 children died. Nicaragua couldn't pay for RotaTeq, but did strike an innovative deal with Merck. In exchange for a three-year supply of donated vaccines, it agreed to undertake a demonstration project that would add to the body of evidence on how this new vaccine would work in a resource-constrained setting.

"We wanted to change the history of the slow rollout of a new vaccine," says Mark Feinberg, MD, vice president of medical affairs and policy at Merck, who has long chartered access issues for the company. "But there were questions over whether a poor country like Nicaragua could effectively introduce it."

But with government backing—and high public awareness of the toll rotavirus was taking—Nicaragua rolled out the immunization campaign. In just a few months, the country achieved the world's highest rotavirus immunization rate, exceeding even the United States.

The official results of the demonstration project are due later this year, as well as the results of African and Asian clinical trials of RotaTeq and Rotarix (rotavirus vaccine, live), GSK's rotavirus vaccine, conducted by PATH. Those results are expected to form the basis for recommending, funding, and rolling out rotavirus vaccines in the 72 GAVI-eligible countries. By 2025, this vaccine should save 2.4 million lives, according to PATH.

The speed of introduction is a testament to just how much the landscape has changed.

Nina Schwalbe, GAVI's head of technical policy, says—aside from more reliable funding—it comes down to new partners that help mobilize the vaccine infrastructure. "There's PATH, which tests vaccines in developing countries, and WHO that approves them and signals to countries that they are beneficial. There's GAVI—the 'Sam's Club' of vaccines—and UNICEF, which is the major procurement agency for vaccines." That doesn't even take into account the other nonprofits that educate, advocate, and build the investment case for vaccines in developing countries.

This web of interconnected health agencies, health systems, funders, and companies is now mobilizing behind a vaccine for pneumococcal disease, which kills almost a million children each year, 90 percent in developing nations. The Pneumococcal Accelerated Development and Introduction Plan (PneumoADIP), a project based at Johns Hopkins University and funded by GAVI, is working to bring Wyeth's Prevnar, a seven-valent pneumococcal conjugate vaccine, to several countries over the next few years. (Meanwhile, Wyeth is developing a next-generation dose of Prevnar that offers more protection.) To facilitate this rollout, Wyeth plans to donate 3.1 million doses of Prevnar in 2009, to be used in Rwanda and Gambia, the first two African countries to introduce the vaccine.

The GAVI Alliance is still deciding which vaccines to fund—and like everyone else, seeing how the financial crisis pans out. But with several new therapies on or close to market, their short list of diseases to tackle over the next few years include cervical cancer, typhoid, Japanese encephalitis, and rubella.


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