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Getting to Market
In July 2004, Rotarix was approved for use in Mexico, where one in 50 children is hospitalized for rotavirus infection, and GSK introduced the vaccine to private markets in the country in January 2005. It began by supplying the vaccines to pediatricians. Though the company won’t reveal sales figures, they are “in line” with expectations, says Pierrick Rollet, director of life cycle management. The company also expects the Mexican government to decide soon to include the vaccine in its general vaccine protocol. After Mexico, GSK plans to introduce the vaccine to other countries in Latin America as well as Asia this year and next. In the meantime, it is already licensed in the Dominican Republic and Kuwait, and GSK is in the process of obtaining licenses for it in 25 other countries, according to Myers.

In pursuit of opening up the widest possible market for Rotarix, the company is doing a complex dance with international agencies and national health authorities. GSK’s chief goal is to get GAVI to approve Rotarix for funding. But to do that, GSK must first get the blessing of the WHO, because that is a prerequisite for UNICEF to buy the vaccine, and UNICEF is the procurement organization for GAVI. Once GAVI approves the vaccine, individual countries can make a request to receive funding for vaccine purchase. Even then, the vaccine must be approved for use by each country. If the process sounds complicated, that’s because it is. “This is the first vaccine [not previously approved for use in developed countries] that GAVI will be considering for eligibility of funding. They’re trying to decide what the process is. We’re waiting for instructions on how to proceed,” says Myers.

While it waits on those commitments, GSK plans to introduce the vaccine to private markets. Regardless of the outcome of negotiations with GAVI and others, GSK is deeply committed to Rotarix. “We can’t afford to back out now. I think the bulk of the investment is done,” says De Vos. Indeed, GSK recently completed a 450-million-euro (about $550 million) manufacturing facility in Belgium that primarily produces Rotarix.

GSK is not alone in its quest. Merck continued developing its rotavirus vaccine when RotaShield was withdrawn from the U.S. market in July 1999. Based on a bovine rotavirus that, like RotaShield, is engineered to include surface proteins from predominant human rotavirus strains, Merck’s vaccine has done well in trials in the United States and Finland. Merck hopes to introduce it to the United States and Europe in this year or next.

The ultimate success of Rotarix remains to be seen, but Myers sees it as a model for GSK’s future and the future of the vaccine industry. The launch has also taught GSK lessons about how best to bring a vaccine to market in the developing world. For starters, Myers believes there was insufficient public education in preparation for the vaccine’s introduction. “Most mothers understand that their children have diarrhea, but they don’t know about rotavirus and the impact that the virus can have on the health of their child,” she says. In hindsight, GSK also would have started the prequalification process with the WHO sooner – before seeking licenses in individual countries – to prevent a holdup after licenses were granted.

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