AGENDA. Day 1 - Monday, 6 June 2016

Transcription

1 Day 1 - Monday, 6 June 2016 WHO Consultation on Considerations for Regulatory Expectations of Zika vaccines for use during an Emergency Starling Hotel and Conference Center 6-7 June 2016 AGENDA Chair: David Kaslow, PATH Time Topic Presenter/facilitator Notes Introduction and purpose of the meeting 09:00 09:15 Meeting objectives and introductions Chair, secretariat Acknowledge the focus of this meeting is the emergency context; will need to eventually consider approval/use strategy beyond the PHEIC 09:15-09:30 Lessons learned from the emergency vaccine development for Ebola Karen Midthun Setting the scene 09:15 09:45 Current understanding of ZIKV epidemiology Pedro Vasconcelos, Evando Chagas 09:45 10:15 Current understanding of pathological effects of ZIKV infection (teratogenic effects, GBS, others) 10:15 10:45 Interaction with other flaviviruses (pre-existing immunity, co-infection, cross-reactivity) Tom Solomon, U Liverpool Alan Barrett, UTMB Observations from the Ebola emergency vaccine development pathway. Update on the epidemiology of disease and current spread, do we have new information on attack rates and basic characteristics of transmission? Mechanistic and epidemiologic insights into ZIKV severe disease and their implication for vaccine development Vaccination in the context of pre-existing flavivirus immunity, challenges of assessing and interpreting 1 P a g e

2 10:45 11:00 Discussion 11:00 11:30 Coffee break Vaccine development status 11:30 12:00 Draft WHO TPP for Emergency Use: rationale and elements 12:00-12:30 Overview of current ZIKV vaccine candidate pipeline, by platform and development status Secretariat Rick Bright, BARDA 12:30 13:30 Lunch break 13:30 14:00 Options for Zika Vaccine Development Barney Graham, NIAID 14:00 14:30 Status of preclinical model development for Zika Heather Greenstone, disease, including challenge and pregnancy NIAID models Potential clinical trial end points 14:30 15:00 Regulatory approval strategy for/lessons learned/precedence from other licensed flaviviruses YF, JE, WNV, TBE, Dengue Heidi Meyer, PEI 15:00 15:30 Feasibility of clinical endpoint evaluation Kayvon Modjarrad, WRAIR immunological data due to crossreactivity; flavivirus infection in Zika immune subjects Describe scope and purpose of TPP, and its specific attributes and underlying assumptions; highlight main comments from public consultation phase Most up-to date information on the pipeline, can be orally complemented by WHO additional information Recapitulation of human Zika disease and prenatal pathology in various animal models; feasibility of model/s supporting an immunological endpoint as a surrogate of protection Regulatory approaches that have been used for other flavivirus vaccines, in particular JE and TBE. What were particular challenges? Lessons learned. Disease epidemiology and possible clinical end points in conjunction with the current Zika epidemic; what could be clinical case definitions and laboratory confirmations? 2 P a g e

3 15:30 16:00 Coffee break 16: Feasibility of immunological endpoint evaluation Alan Barrett, UTMB What do we know about immunological mechanisms of protection? Can we infer from other flaviviruses? What would be needed to develop a surrogate marker of protection? 16:30 16:50 Status and potential role of human challenge/protection studies Anna Durbin (phone), JHU Status of human challenge model, safety/ethical concerns, potential role in clinical development decision making 16:50 17:10 Tools for the standardization of assays Mark Page, NIBSC Approaches and status update of activities to enable the comparison of data between laboratories and over time 17:10 17:40 Feedback from manufacturers 17:40 18:05 Wrap up and Identification of main discussion points for day 2 18:05 Closure of day 1 Cocktail Reception D Kaslow, PATH 3 P a g e

4 Day 2 - Tuesday, 7 June 2016 Chair: Elwyn Griffith, ECBS Time Topic Presenter/facilitator Notes Considerations for emergency use authorization Preparing for safety evaluation of candidate Zika vaccines what are major considerations? Theresa Finn, FDA I A discussion of safety evaluation in relation to GBS (with reference to experience H1N1 pandemic vaccine) and progressive collection of safety data in women of childbearing age 9:30 9:45 Ethics considerations for the development of a Douglas Wassenaar vaccine against ZIKV 9:45 10:15 Endemic country regulatory perspective on emergency vaccines against ZIKV (according to current TPP) Bruno Diniz, ANVISA Including any update on an accelerated approval process 10:15 10:45 Endemic country regulatory perspective on emergency vaccines against ZIKV (according to Maria de la Luz Lara Mendez, COFEPRIS Including any update on an accelerated approval process current TPP) 10:45 11:15 Coffee break 11:15 11:45 FDA regulatory perspective on emergency vaccines against ZIKV (according to current TPP) Lu Borio/Theresa Finn, FDA Including a brief presentation of FDA s accelerated approval process 11:45 12:15 EU regulatory perspective on emergency vaccines against ZIKV(according to current TPP) Marco Cavaleri, EMA Including a brief presentation of EMA s accelerated approval process 12:15 12:45 WHO EUAL considerations Carmen Rodriguez, WHO 12:45 13:45 Lunch break 13:45 14:15 Vaccine platform specific regulatory considerations Heidi Meyer, PEI Are there particular regulatory considerations in relation to various technology platforms with reference to the TPP? 14:15 14:45 Challenges in developing candidate ZIKV vaccines: what regulatory flexibility might be needed? tbd What flexibilities would be allowed for manufacturers, such a s lot consistency, multi-use of facilities, etc. 4 P a g e

5 14:45 15:45 Panel discussion with manufacturers Facilitator: D Kaslow Coffee break 16:15 17:45 CLOSED session Facilitator: E Griffith Derivation of recommendations; temporary advisers and participants I P a g e