Diary Prequel Package — page 356

We had a conference call yesterday (Sunday) with Canadian health authorities to inquire about the availability of their experimental VSV Ebola vaccine. On the call were our HHS team with me, Cliff Lane, Hilary Marston, Nicki Lurie, Dawn O'Connell (Sec. Burwell's Chief-of-Staff), Tom Frieden and CDC folks, Robin Robinson, Leslie Dasch (Counsellor to Burwell). On the Canadian side there was Gregory Taylor (Deputy Chief Public Health Officer), Judith Bosse (Assistant Deputy Minister, Infectious Diseases prevention and Control Branch), Theresa Tam (Branch Head, Health Security Infrastructure branch) and Supriya Sharma (Assoc. Assist. Deputy Minister, health Products and Food Branch). The Canadians are still in preclinical studies and have not yet gone into humans. There is an ongoing disagreement between me and Tom Frieden. Tom wants to give the vaccine to health workers in Africa even before it has gone into a phase 1 trial (I believe that he has been speaking with his CDC people who are preparing to go to Africa and are understandably concerned about their risk). I do not believe that Tom understands the clinical trial process since he says that we are "ethically obliged" to allow the healthcare workers to make the decision themselves about whether they are willing to take a potentially unsafe, potentially ineffective vaccine. If this were a drug to be given to a desperately ill patient, then that is one thing about going directly from preclinical to human treatment. However, this is a vaccine to be given to a healthy person. On the call with the Canadians, I pointed out our experience with the HIV vaccine which was effective in monkeys, but in humans it actually significantly increased the risk of acquisition of HIV infection. In order to expedite things Cliff Lane will organize a quick phase 1 trial at the NIH Clinical Center to test the safety of the Canadian vaccine. Once again, I have been all over the press. Last night I was on CNN with Jim Sciutto as well as on CNN International. Today I will do the Diane Rehm Show. August 12, 2014 - We are having a daily (including Saturday and Sunday) conference call with Secretary Burwell and a separate call among NIHers with Francis Collins. Press interest in dying down somewhat (I was only on Colombian (Bogotá) radio and Czech Radio only. The issues are centering now around the ethics of using experimental drugs (we actually have none available) and vaccines (getting ready to go into Phase 1 with the NIH (VRC) Chimp Ad3 vector with Ebola env gene inserts) prior to proof of safety and efficacy. The Canadians also have 2 VSV Ebola vaccines. There is no more ZMapp left - 2 courses went to Brantley and Rightbol, 1course went to the Spanish priest who died, and 2 courses were sent to Liberia to treat 2 Liberian doctors who contracted Ebola caring for patients (President of Liberia appealed to President Obama. The USG put Liberia in touch with Larry Zeitlin and MAPP Biopharmaceuticals. August 13, 2014 - My invited Perspective on Ebola came out online at 5:00 PM in the New England Journal of Medicine. Cliff Lane and I are trying to reconcile the need for data of safety and efficacy of the NIH vaccine and the need to get it to people who need it. We drew up a proposal for a Randomized Clinical Trial (RCT) to take place in the countries in Africa right after the Phase 1 here at the NIH. This would settle the ethics issue (randomization is "fair" and also would collect data to prove efficacy and safety. I