Gates Package — page 1046

in Africa are working with the WHO country to the entire country--a decision that will save tens of thousands of children every year.24 What we've learned is that creating an entire vaccine-making ecosystem is a long walk down a hard road. But the obstacles can be overcome. For one thing, there's the issue of regulatory approvals. The WHO has to green-light every vaccine factory before it can start production. If you built your factory in a country with what's known as a "gold-standard" regulator, then the WHO review is relatively speedy. If not, then the WHO review is a lot more thorough and time-consuming. Today, only a handful of developing countries have gold-standard regulators, and most are in South Asia or Southeast Asia., But regional agencies in Africa are working with the WHO and the European Union to improve the quality of regulation on the continent. Governments are also collaborating on regional standards for vaccines, so manufacturers don't have to meet different safety and efficacy requirements in each country. There's another challenge in addition to the approval process: Vaccine manufacturers need other products to make between outbreaks, or they'll go out of business. As new vaccines become available for diseases like malaria, tuberculosis, and HIV, they'll increase the overall size of the vaccine market, potentially making room for new producers. And in the meantime, countries can take on the fill-and-finish process--putting vaccines made elsewhere into vials and distributing them. *** In the mid-2000s, during a trip to Vietnam, I visited a rural health clinic, hoping to get a firsthand look at some of the challenges the staff there were dealing with. As a big fan and