Gates Package — page 161

Draft -- Not for Further Circulation Without Author's Approval A Six Month "Wartime" Vaccine Program v2 (March 29, 2019) Contact: Richard Danzig -- @email.com A vaccine is the single most important tool now missing in our fight against the corona virus. As many as 100! separate efforts are proceeding with unprecedented speed and resources to develop one or more vaccines. Though in the recent past it has taken at least a decade to move from conception to widespread distribution, these efforts are on an ambitious trajectory to produce a vaccine in 12-18 months. This paper proposes that a previously unrealistic goal of six months should be pursued and this can be done with justifiable risk. Peacetime constraints inhibited the 12-18 month plan from being accelerated further. A wartime effort can move twice as fast by embracing three innovations: e previously unthinkable government support in the form of underwriting costs, indemnification, maximum speed FDA review, acceptance of additional clinical and manufacturing risk appropriate to the enormous benefit, engagement of reluctant actors, and, if necessary, use of the Defense Production Act; e evaluation by a cohort study or human challenge trials rather than traditional clinical trials; e identification, funding and preparation of manufacturing assets before trials demonstrate success. These ideas have been vetted in discussion with leaders in the vaccine industry. This path can get us there if an overarching strategic plan is developed immediately, government actors embrace it, and initial actions are taken in the first half of April. The reward warrants the effort: wide availability of an effective vaccine in October could invaluably protect health care workers and other essential personnel, would greatly diminish a second cold weather wave of COV-19, permit economic recovery by assuring immunity to workers and consumers who receive it, and, through sharing globally, create immense goodwill and respect for America. A meeting will be held on March 31 at 8am California time to assess these ideas and no doubt to develop others that would contribute to a six-month vaccine. The agenda for a two and a half-hour meeting is: I. 20 minutes: brief general reactions, including expressions of enthusiasm and skepticism. Il. 60 minutes: participants construct the basics of a six-month plan, identifying the major initiatives that would need to occur to make the plan viable. This discussion will proceed without respect to whether participants are persuaded such a plan is likely to succeed.