Let s outsmart epidemics

Transcription

1 Let s outsmart epidemics

2 Coalition for Epidemic Preparedness Innovations A New Era for Vaccines against Emerging Infectious Diseases Richard Hatchett, MD

3 Epidemics Present a Global Challenge

4 Global Impact of Epidemics Spanish Flu SARS Zika $ $ $ Ebola: global impact $ over 11,000 Deaths 2.8 billion Estimated negative economic impact ( ) Source: Yamay et al, 2017: Financing of international collective action for epidemic and pandemic preparedness Ebola: Economic impact Sierra Leone Impact of Ebola on GDP (%) Projected GDP Actual GDP Ebola: impact on health Systems Most maternal and child health indicators significantly declined during Ebola outbreak Malaria morbidity and mortality in Ebola-affected countries caused by decreased health-care capacity

5 Epidemics Persist Plague in Madagascar cnn.com Diphtheria cases in Cox s Bazar, Bangladesh reported by date of illness onset from 3 November 2017 through 12 December Diphtheria outbreak in Cox s Bazar, Bangladesh voanews.com Lassa in Nigeria Ilpopulista.com

6 Lassa outbreak in Nigeria From 1st January to 17th June 2018, a total of 2022 suspected cases have been reported from 21 states. Of these, 438 (including 38 HCWs) were confirmed positive, 10 are probable, 1563 negative 5595 contacts identified 108 deaths in confirmed cases and 10 in probable cases. Case Fatality Rate in confirmed cases is 25% Confirmed cases in Nigeria

7 Ebola outbreak in DRC 28 deaths, 52 confirmed and probable cases Case fatality ratio = 54% Five cases among HCWs 172 contacts remain under active follow up The Ministry of Health (MoH) is leading the response in the affected health zones with support from WHO and partners. Confirmed and probable Ebola virus disease cases by date of illness onset from 4 April through 26 June 2018 (n=52)

8 Nipah outbreak in India Kozhikode District, Kerala 17 deaths, 19 cases Case fatality rate (89%) extremely high Laboratory testing is being conducted by the Manipal Institute of Virus Research and the National Institute of Virology, Pune. First NiV outbreak reported in Kerala State and third NiV outbreak known to have occurred in India, with the most recent in 2007.

9 The threat emerging diseases The zoonotic disease potential Key factors affecting spillover and outbreak risk Population movements and land use change Urbanisation and poverty Weak health systems Trans-border trade of animals and food Epidemic hotspots Estimated risk of event locations after factoring out reporting bias Key challenge for vaccine based response: Current approach takes too long time to enable a vaccine to be developed in time to mitigate an outbreak Wardeh et al Sci Data Allen et al Nature Communications

10 WHO R&D Blueprint priority pathogens 10

11 CEPI... We are a global coalition of public, private, philanthropic and civil society organisations We will stimulate, finance and coordinate vaccine development for emerging infectious diseases We identify priority threats and act when market forces fail to drive needed development We will build capabilities for rapid response to unknown threats We will move vaccine candidates through late preclinical studies to proof of concept and safety in humans before epidemics begin New vaccines for a safer world

12 CEPI s strategic objectives Preparedness Response Sustainability Access 12

13 Davos 19. January, 2017 Launch of CEPI World Economic Forum

14 CEPI s First Investors In addition: EU plans to co-fund with up to 250 mill Note: Exchange rates NOK / USD: 8.44: EUR / USD 0.89; CAD / USD: 1.34; AUD / USD 1.32; Source: World Bank; CEPI donation data; BCG analysis

15 Pathogens selected for vaccine development Pathogen No. of votes Percent of members voting for this pathogen MERS % Lassa 15 75% Nipah 11 55% Chikungunya 9 45% Rift Valley 5 25% Total votes 60 (3 votes, 20 people) CEPI SAC, November

16 CEPI s initial target diseases MERS Lassa Nipah Disease X? Starting point: List of priority pathogens defined by the WHO R&D Blueprint CEPI s Scientific Advisory Committee chose three initial diseases based on expected Public health impact Risk of an outbreak occurring Feasibility of vaccine development

17 Just-in-Case Vaccines: MERS-CoV, Lassa, Nipah More than 30 proposals received in first round Applications from: Academic institutions, biotechs, large pharmaceutical companies and Product Development Partnerships Broad diversity in vaccine platform technologies Proposals from North America, Europe, Africa, Middle East, South East Asia and Australia New vaccines for a safer world

18 Four partnership agreements signed Novel proprietary platform to develop vaccines against Lassa Fever and MERS Up to $37.5million Lassa vaccine could enter phase 1 clinical trials by late 2018/early Using Inovio s ASPIRE platform to develop DNA vaccines against Lassa Fever and MERS Up to $56.0m Consortium includes, Laval University, NIH, USAMRIID, VGXI/GeneOne Life Science, IVI Partnership to support development of IAVI s replicating viral vectorbased Lassa vaccine candidate, Up to $10.4 million to support the first phase of the project, with options to invest up to a total of US$54.9 million over five years (including stockpile). Partnership to advance development and manufacture of a vaccine against the Nipah virus Up to $25 million Profectus to receive development funding for advance its Nipah virus vaccine; Emergent tol provide technical and manufacturing support for the CEPIfunded program. PATH to work on clinical development.

19 Awardees and consortia partners Themis Bioscience Institut Pasteur, France European Vaccine Initiative, Germany Paul-Ehrlich- Institute, Germany Inovio Pharmaceuticals USAMRIID, USA University of Laval, Canada Wistar Institute, USA Rocky Mountain Labs VGXI, USA Profectus BioSciences, Inc. PATH- USA Henry M. Jackson Foundation, USA Emergent BioSolutions, USA University of Texas Medical Branch, USA IAVI Imperial College, London, UK Center for Infectious Disease Research, UK Ragon Institute of MGH, MIT and Harvard, USA The Scripps Research Institute, USA University of Texas Medical Branch, USA Tulane University, USA 06/07/

20 CfP1 - CEPI Priority pathogen portfolio Scope of CEPI funding Early Pre-clinical Pre-clinical Proof of concept Phase I Phase II Safety and immuno Investigational stockpile Phase IIb/III efficacy in an outbreak Registration Introduction Inovio DNA IAVI* VSV Themis Measles vector Profectus subunit Inovio DNA Themis* Measles vector Under contract negotiation Adeno Vector* Adeno Vector* Adeno Vector Lassa VSV* Measles Vector MVA Nipah MERS CoV VSV VSV * Investment to next stage gate 20

21 Just in Time Vaccines: Platform Technologies CEPI will support the development of vaccine platform technologies that can be rapidly be deployed against known and newly emerging pathogens, to limit or prevent future outbreaks of known or new diseases Disease X? New vaccines for a safer world 21

22 CfP2: Mitigating outbreaks by reducing vaccine development time use CEPI will accelerate development by use of vaccine technology platforms Aspirational goals 16 weeks from identification of pathogen to product for clinical trial 6 weeks from first dose to clinical benefit 8 weeks to manufacture 100,000 doses CEPI funding approach Test platform versatility on three pathogens, two into phase I Promising technologies DNA RNA / Self amplifying Recombinant proteins Viral vectors Approved by CEPI Board June, Due Diligence ongoing. Contracts to be signed before end of

23 Access chain Discovery Regulation Delivery Development Stockpiling Effective push and pull incentives Liability and indemnification Research capacity Clinical protocols

24 IT-Governacne Vendor governance Services A challenge on many fronts FY 2022 Vaccines have completed P2 Research capacity in countries at risk Stockpiles in place Delivery and dispensing plans in place No vaccines Limited Research Capacity No stockpiles No plans for delivery FY2018 Competence Tools and Technology Reporting

25 CEPI is both Facilitator and Funder in a Complex Ecosystem CEPI as facilitator Phase 1. Discovery 2. Development/ Licensure 3. Manufacturing 4. Delivery/ Stockpiling 5. Last Mile Current Stakeholders Academia Governments WT/NIH EC/IMI GLOPID-R Industry Regulators Biotech Industry Governments Regulators WT/NIH EC/IMI Bill and Melinda Gates Foundation BARDA/DTRA etc. WHO Biotech PDPs Industry BARDA CMOs Regulators Governments WHO GHIF GAVI UNICEF PAHO Governments WHO Industry Pandemic Emergency Facility (World Bank) WHO Contingency Fund Countries WHO UNICEF Responding Organizations (e.g. MSF) Significant focus by others CEPI as funder Significant focus by others New vaccines for a safer world 25

26 The CEPI ecosystem a snapshot The Board Investors Joint Coordinating Group Scientific Advisory Committee Partners

27 A busy year

28 Discussion Coalition for Epidemic Preparedness Innovations

29 Coalition for Epidemic Preparedness Innovations CEPI s Governance and Advisory bodies

30 CEPI ecosystem: many opportunities to engage Board subcommittees Audit & risk Resource mobilization Compensation & nomination Executive & investment Board Investors Council Formal reporting line Informal relationship JCG CEPI Partners SAC Secretariat Task forces

31 CEPI s Board Jane Halton (chair) Awa Coll-Seck David Reddy Rajeev Venkayya Joanne Liu John Nkengasong 31

32 Investors Council Purpose: to enable Investors to have a clear role in CEPI s governance and to have access to the Secretariat and CEO. As not all Investors sit on the board, the council is a bespoke arrangement to facilitate investors having a strong role and oversight of CEPI s activities and its development. Responsibilities Nominating four investor board members (1 foundation and 3 sovereign) Right of review on proposals of over $100m Supporting resource mobilisation Organisation: Chaired by Germany and co-chaired by Japan Self-governing, secretariat support from CEPI Has a resource mobilisation sub group: chaired by Gates Along with independent board members, the investors are part of the Members meeting. 06/07/

33 SAC Membership Helen Rees (Chair) Wits Reproductive Health and HIV Institute Inger Damon US Centers for Disease Control and Prevention Myron Levine University of Maryland James Robinson (Vice Chair) James Robinson Biologics Consulting Delese Mimi Darko Ghana Food and Drug Authority Yves Lévy INSERM Alash le Abimiku Institute of Human Virology John Edmunds London School of Hygiene & Tropical Medicine Kathleen Neuzil University of Maryland Non-voting members Alan D. Barrett University of Texas Medical Branch George Fu Gao Chinese Center for Disease Control and Prevention Stanley Plotkin VaxConsult Vaseeharan Sathiyamoorthy World Health Organization Daniel Brasseur Consultant Christian Happi African Center of Excellence for Genomics of Infectious Diseases Connie Schmaljohn USAMRIID Ali Alloueche Takeda Christian Bréchot Institut Pasteur Penny Heaton Bill & Melinda Gates Medical Research Institute Kenji Shibuya Department of Global Health Policy, University of Tokyo Kathrin Jansen Pfizer Paula Bryant US National Institutes of Health Tom Kariuki Alliance for Accelerating Excellence in Science in Africa Peter Smith London School of Hygiene & Tropical Medicine Jean Lang Sanofi Pasteur Ralf Clemens Bill & Melinda Gates Foundation Phil Krause US Food and Drug Administration Michel De Wilde Consultant Johan van Hoof Johnson & Johnson 06/07/

34 Joint Coordinating Group Membership Chair: Peggy Hamburg Permanent Members Wellcome EMA FDA AVAREF NIBSC GAVI UNICEF MSF IFRC WHO Others to be invited to join meetings: e.g. National Regulatory Authorities 06/07/

35 Plague in the 14 th Century million dead Long-term population declines Major shock that fractured economic system of feudalism Pamuk S. European Review of Economic History 2007;11:

36 Reconstructing the evolution of plague Emergence of ymt gene, prior to 951 BCE, facilitating survival in flea gut Point mutation in pla gene essential for development of bubonic plague Emergence of flagellar frameshift mutation in flhd gene after Bronze Age, allowing immune evasion Rasmussen S, et al. Cell 2015;163:

37 Predicting future epidemics and risks The total number of viruses that infect a given species and the proportion likely to be zoonotic are predictable The proportion of zoonoses per species is predicted by phylogenetic relatedness to humans, host taxonomy, and human population within a species range. Olival KJ, et al.. Nature 2017;546;647 43