[Cathy Slack]

Hi all, IRB reviewers also need to see in the protocol the steps that will be taken to offset harm from VISP – it helps them decide if the risks from vaccine administration will be reduced to an acceptable minimum, and then be sufficiently outweighed by the potential benefits. I suspect for the P5 studies being to be implemented in Southern Africa there will be interest from IRBs to see if the measures introduced to offset VISP in, for example, the US can be achieved as comprehensively outside of that setting.