Gates Package — page 1042

The key decisions that determined how quickly there would be enough vaccine supply for the entire world were made in 2020. In the first half of that year, the Gates Foundation worked with many of the companies in the vaccine ecosystem on ways to maximize the number of vaccines produced. The approach used wasn't simply to make the intellectual property available and ask manufacturers to do their own factory design and trials, but rather to cooperate and share all the information--including factory design and methods for verifying the quality of the vaccines--and work together with regulators. Until 2020, such deals were rare, but given the urgency of producing lots of vaccines quickly, they were the best way to get additional factories into production without compromising regulatory approval or quality. These deals are known as second sourcing. In a second-source deal, one company with a viable candidate agrees to work with another company to make that vaccine in its own facility.19 They share not only the recipe but also the knowledge about how to use it, as well as personnel, data, and biological samples. These are complex arrangements that involve accounting for the costs and time associated with the transfer, negotiating the necessary licenses, and settling on terms that will be acceptable to both parties. And there are lots of incentives pushing against them for both companies: Imagine Ford inviting Honda to use its factories for making Accords. But when they work, these arrangements are remarkable: It was a second-source deal with AstraZeneca--not a government-mandated intellectual property waiver--that allowed Serum Institute of India to produce 100 million doses at a very low cost and in record time. Before COVID, most vaccines destined for low- and middle-income countries were created not via second-source agreements, but by low-cost manufacturers who got philanthropic funding to do some of the development on their own.