Thursday, November 13, 2014

Difficult situation arising regarding the conduct of the Phase 2/3 trials of Ebola vaccine in Liberia/Sierra Leone. The companies (first GSK; now also J & J, who do not even have a candidate ready) are balking at going ahead with the trials unless they get “global indemnification”. This is unprecedented to demand for a Phase 2/3 trial since we (NIH) are the sponsors and we are liable. Nonetheless, GSK feels that although the PREP act would protect us and indirectly them, they feel that in international courts GSK (even though they are not the sponsors of the trial) could be sued given the sensitive nature of the situation (African countries, instability in the countries, brand new vaccine platform for them –Cad3 vector -, accelerated development with questions regarding lot consistency (because of the fast pace of development). This would be terrible if the trials are stalled because of this. I have phone call today with Moncef Slaoui, Chairmen of GSK for Global Vaccines. Also, despite our conclusions from meeting on Nov. 11 (see above) the Oxford/Wellcome Trust people are working with MSF to start “open label” trials with various therapeutics without a control arm. What the hell is going on here? I am very disappointed in the Brits, especially the Wellcome Trust and Oxford people who clearly are grandstanding. Call with Moncef Slaoui went well. Reasonable discussion. I stated that the USG could never give “global indemnification” since it would invite frivolous lawsuits. Moncef felt the same about our providing insurance for them since it would also invite lawsuits. We agreed upon some form of a process that provides for limited liability and cpas on settlements. I will follow-up with summary e-mail to Moncef with copy to Ron Klain with who I spoke tonight and relayed to him the conversation with Moncef. Ron is flexible, but said that we cannot “guarantee” anything to Moncef, but we will proceed in good faith to find a solution.