Gates Package — page 162

Ill. 30 minutes: discussion of whether participants view the plan as plausible enough to be worth the opportunity costs (distraction, etc.) and risks it will entail. IV. 40 minutes: If the plan is considered to be worth further effort, the group will discuss how to progress, including engagement of the US, European, India, and the PRC. Attachment 1 provides a Q&A on some key points about the plan along with footnotes pointing to some relevant reading. [Footnote not provided in this draft.] Attachment 2 lists those with whom the plan has been discussed. It does not imply endorsement. An asterisk indicates those who should be invited to the planned teleconference. It further lists a small number of others are proposed for invitation to the teleconference. Suggestions are welcome for others who might be especially important contributors. This meeting will not involve government participants after this first meeting. One question to be discussed is also when and how to engage governments Attachment 1 1. Isn't it very possible that present initiatives will not yield a good vaccine candidate in which case this strategy will not be rewarding? Yes. Decades after starting the search for an AIDS vaccine, we have not secured one. This strategy does not increase the odds of discovering a vaccine, it merely --- but if successful hugely beneficially --- accelerates the availability of that vaccine if it is discovered. 2. How substantial is the likelihood that mutations in Covid-19 will undercut the utility of a vaccine? That is distinctly possible, but most assessments have concluded that the virus is particularly stable, suggesting that immunity from infection or vaccine is likely to be long-lasting. The possibility of mutation argues for the six-month strategy. A longer period between development and distribution exposes us to greater risks from mutation. 3. What is the six-month goal? To have production at the level of tens of millions of doses per week by October 15, rapidly ramping up to hundreds of millions of doses per week using multiple facilities. 4. Can we put in place production capabilities without knowing which of a number of vaccines might establish their value in as yet uncompleted clinical trials? An RNA vaccine is in a class by itself in both its challenges and its potential. It needs to be addressed separately. Putting that vaccine aside for purposes of this discussion, modern front-end production equipment (vessels, etc.) has high fungibility between the three main forms of production: bacteria, mammalian cells and yeast. Requirements for GMP can in the main be met in advance, particularly if regulators participate in real time rather than review afterwards. Purification requirements are more varied. Fill/finish is relatively straightforward (though there is a risk that capacity could become limiting). A critical first step would be to survey the CMC (chemical, manufacturing and control) executives