Gates Package — page 164

The volunteers for this effort would likely be rather like our military servicemembers --- and we regularly accept the morality of putting military volunteers at risk. The most salient hurdle might be in determining the infectious dose with which volunteers would be exposed. 10. Would this program be international? That seems highly desirable as a matter of efficiency, production capacity, morality, and US international standing. Even by a narrow definition of American interest, it is in our interest to suppress the disease everywhere. The mechanisms of international cooperation, however, demand attention. 11. Has a vaccine ever been developed as fast as now proposed? Yes. During World War II the US developed more than 20 vaccines, some of them at speeds comparable to this. A wartime mentality catalyzes accomplishment by reevaluating risks and investments that are not well advised in peacetime. 12. Doesn't the World War II experience highlight the risks of speed? Yes. Notably, for example, an adjuvant for a Yellow Fever vaccine caused 50,000 people to develop jaundice." Care will need to be taken to minimize risk, but risks must always be weighed against rewards. 13. Can we generalize to the broader population from challenge trials with a limited range of volunteers? Efficacy and safety with a healthy younger population may suggest, but would not demonstrate, efficacy in other segments of the population, but it would warrant vaccine production for the population that is tested and intense testing with older populations. Attachment 2 This document has benefited from discussions with the following. I am grateful for their help, but no one listed below is responsible for this paper's conclusions or errors. The individuals with asterisks next to their names are invited to the March 31 meeting. Those not asterisked can be invaluable participants. It is imperative though to strain to reduce the numbers in an online conference call. 1. Barry Buckland -- Executive Director of NIIMBL - former Merck head of BioProcess Development* 2. Robert Califf, Former Director of FDA and Former Director, Center for Actionable Health Data Science (Duke)* 3. Michael Callahan -- Mass General Hospital, former DARPA Program Manager * 4. Richard Danzig -- Johns Hopkins Applied Physics Laboratory* 5. Emilio Emini- Gates Foundation, Previously Director of Wyeth Vaccine Programs (as an observer)* 6. John Erickson -- Senior Fellow at NIIMBL-- former GSK manufacturing 7. Mark Feinberg -- head of IAVI*