In 1999, a group of malaria vaccine experts submitted a white paper to the foundation arguing that preventing malaria must be a “global priority” and proposing an “independent organization in control of adequate resources, with a sole mandate to develop, test and field promising malaria vaccines.” Later that year, we made a $50 million grant to the Seattle-based organization Program for Appropriate Technology in Health (PATH) to create MVI. We have since made two additional grants to MVI, for a total commitment of $257.6 million.

MVI’s mission is to accelerate the development of promising malaria vaccines and ensure that these vaccines are accessible to the people in developing countries who need them. To fulfill this two-part mission, MVI takes a two-pronged approach. First, it provides resources to help candidates move out of the laboratory to development and to clinical trials. Second, it conducts research and builds relationships with key health organizations and governments of developing countries to help make sure that vaccines will be introduced and distributed.

A Promising Candidate
The most advanced candidate that MVI has supported, known as RTS,S, was originally developed by GSK in the 1980s as a vaccine for travelers. The vaccine showed convincing protection in trials involving adult volunteers in the United States. Subsequently, in a larger trial involving semi-immune adult men in the Gambia in 1998, it proved partially effective: It protected about 70 percent of the trial participants from infection, but only very briefly. The protection waned after just two months. Since travelers are less interested in a malaria vaccine that isn’t completely effective, it was obvious that the market for RTS,S would be limited to Africa, where the impact of the disease is greatest.

However, there was enough data to suggest that RTS,S might provide more effective protection in immune-naïve children—those whose immune systems are not already primed to fight infection--in malaria-endemic regions. That’s why, in 2001, MVI and GSK formed a partnership to develop the vaccine for children in developing countries.

The Need for Partnerships
Developing a vaccine for any disease is risky and expensive, and drug companies like GSK are accountable to their shareholders. Funding from MVI can decrease the risk for vaccine developers. However, MVI must also ensure that these investments result in vaccines that are affordable in the developing world. Developing-country governments can’t commit to buying vaccines they can’t pay for.

These goals aren’t easy to reconcile, which is why partnerships between the pharmaceutical industry and the public sector have been rare. And yet partnerships are absolutely essential to vaccine development for neglected diseases. The public sector can help drive research and conduct clinical trials, while the capability to develop and manufacture vaccines on a large scale rests almost exclusively with industry.

In 2003, MVI, GSK, and other partners launched a trial to assess RTS,S’s effectiveness. More than 2,000 children between the ages of 1 and 4 received three doses of RTS,S, and the six-month results were very encouraging. The group of children that received RTS,S showed a significant reduction (30 percent) in malaria cases compared with a control group, and the number of severe cases declined 58 percent. In a follow-up study at 18 months, the results were similar: Clinical cases were reduced by 35 percent, and severe cases were reduced by 49 percent.

In October 2005, on the heels of these positive results, we made a $107.6 million grant to MVI to help it and its partners bring RTS,S through a series of additional trials and eventually to licensure, should it continue to meet its milestones.

Next: Results