No group of children suffer more from vaccine-preventable diseases than those in developing world countries. Recently, David Kaslow, Vice President for Essential Medicines at PATH, an international nonprofit health organization in Seattle, weighed in on the subject (Kaslow DC. “Vaccine Candidates for Poor Nations Are Going to Waste,” Nature. 2018 Dec;564 (7736):337-339).
Kaslow outlined the steps required to make a vaccine. Step 1: proof-of-concept clinical trials usually involving tens or hundreds of people. Researchers often refer to this step as “the valley of death” because so many candidates fail. Kaslow believes that organizations like the National Institutes of Health (NIH), the European Union, the Wellcome Trust in London, and the Bill and Melinda Gates have stepped forward to help fund trials at this stage. About 240 vaccine candidates are now in development for diseases like malaria, tuberculosis, and pneumonia, which disproportionally affect people in low- and middle-income countries.
It’s the final step that has Kaslow worried. To perform so-called Phase III trials, which involve several thousand to tens of thousands of people, manufacturers must invest in production facilities, which are enormously expensive. Most vaccines die at this stage because, as Kaslow writes, “No single organization or group is striving to support the formidably challenging second phase of vaccine development for diseases that mainly affect emerging economies.”
To get to this final stage, Kaslow argues that “the main stakeholders must come together to define a new path for the sustainable development of vaccines that are socially justified but that have no business case.” Kaslow believes that the same groups that have been supporting the first phase of vaccine research must now come together and specify which organizations or alliances should drive development for the next phase. Otherwise, he argues, despite available technology to solve the problem, people will continue to suffer needlessly.