te tekna na cepi s mission and activit vities ies rega

Te Tekna na CEPIs mission and activit vities ies rega garding ding COVI VID-19 19 Bjrg Nilsson, Head of Communication Nordic Countries Stig Tollefsen, PhD, Senior Scientist, CEPI Ebola vaccine trials Lessons learned 9 months

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  1. Te Tekna na CEPI’s mission and activit vities ies rega garding ding COVI VID-19 19 Bjørg Nilsson, Head of Communication Nordic Countries Stig Tollefsen, PhD, Senior Scientist, CEPI

  2. Ebola vaccine trials – Lessons learned 9 months Vaccination ------- Guinea ------- Liberia ------- Sierra Leone University of Pennsylvania – Susan Ellenberg http://slideplayer.com/slide/12512808/

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  4. Our mission CEPI accelerates development of vaccines against emerging infectious diseases and enables equitable access to these vaccines for affected populations during outbreaks 4

  5. Our Strategic Objectives Sustainability Preparedness Response Create durable and equitable Advance access to safe and Accelerate the research, solutions for outbreak response effective vaccines against emerging development and use of vaccines capacity infectious diseases during outbreaks 5

  6. A global partnership The Board Investors Joint Scientific Coordination Advisory Group committee Partners 6

  7. A sustainable partnership 7

  8. The number of new emerging infectious diseases is on the rise “I don't think we've ever had a situation where we're responding to so many emergencies at one time. This is a new normal.” - Dr. Mike Ryan, Executive Director of WHO’s Health Emergency Programme (June 2019) 8 8

  9. And the costs of EIDs are vast, in both human and economic terms $60 bn >$200 bn $570 bn $2.8 bn Globally China The estimated annual The minimum average global cost of cost for progressing one COVID-19 estimated moderately severe to vaccine against each of severe pandemics (Fan WHO’s 11 priority VY, et al, NBER 2016) epidemic infectious costs diseases (Gouglas D, et al. Lancet 2018) Q 1 2020 9

  10. Epidemics affect us all • They often arise in the most vu vulnerable pop populatio ions – which are and will continue to be the focus of our work • The threat posed by epidemics and pandemics represent one of humanity’s greatest challenges: o Parad Paradox of of Prog Progress: Dense cities, global trade, easy travel and ecological change mean they spread faster and further that ever before o Harm arm is is Im Immedia iate and and Lon Long-Lasting: They cause disruption in travel, businesses to close, economies to struggle, and undermine fragile public health capabilities o Co Cost sts are are Clea Clear: The human and economic costs are staggering • There are many examples of the harm infectious diseases can cause, from the loss of life and economic harm to the downfall of empires 10

  11. What is a va vaccine? ine? “A vaccine is a biological preparation that provides active ac acquired im immunity to a particular disease. A vaccine typically contains an an ag agent th that at re rese sembles a a dis disease-causing microorganism and is often made from weakened or killed forms of the microbe, its toxins, or one of its surface proteins.” Nick Jackson – Head of Programs and Innovative Technology 11

  12. Vaccination Sir Edward Jenner 1749-1823 Berkeley, UK «In 1717 learned about variolation in Istanbul» Lady Mary Wortley Montagu 1689-1762 London, UK Jenner inoculating J. Phipps 1796 12

  13. Innate response Immune Adaptive response Response Response 13 1 2 1 2 Time

  14. Interactions between the innate and adaptive immune systems Acute infection Innate immune response Antimicrobial activity Cytokine release Fever Adaptive immune response There is a cross-talk between the innate and the adaptive immune systems

  15. Vaccination and the immune system • Vaccination prepares the immune system to handle the challenge. • B cells • T cells Antibody production • Regulate the adaptive immune response (CD4) • Antigen presentation • Cytotoxic effects (CD8) • Plasma cells secrete antibodies • T-reg Naïve T cell B cells Plasma B-cell Th2 cell Cytotoxic Th1 cell T-cell 15

  16. CEPI’s priority pathogens MERS Lassa Nipah Chikungunya Rift Valley fever Disease X 5 vaccine 6 vaccine 4 vaccine 2 vaccine 2 vaccine 3 platform candidates candidates candidates candidates candidates technologies 16

  17. Disease X What is it? “Disease X” represents the knowledge that a serious international epidemic could be caused by a pathogen currently unknown to cause human disease. Where does it occur? By their very nature, we cannot predict what or where “Disease X” is likely to emerge. What we do know is that new diseases emerge all the time, from locations all around the world. Who does it affect? Developing countries, particularly those with high rates of biodiversity, are at heightened risk, because of the increased risk of outbreaks and the limited capacity for surveillance and response in these countries. 17

  18. Platform technology Correlates of Protection lists WHO lists Prototype Pathogen lists Tec echnolo logy TPP PP (Target product profile le) • Regula Re latory asp spects • Scope br Sc broadened be beyond vac vaccine platforms • Candidate I • Monoclonal antibodies Pre-clin PoC • Immunoprophylactic platforms such as gene encoded antibodies Candidate II Pre-clin PoC Engineering lot • Other innovations As pir irational l Cha Characteristics Candidate III • GMP Phase I Pre-clin PoC Time • 16 weeks from antigen to clinic • 6 weeks to clinical benefit 3 years • 8 weeks to manufacture 100,000 doses 18

  19. 19

  20. Disease X: COVID-19 As of 22 March: CONFIRMED CASES: 311988 DEATHS: 13407 RECOVERIES: 93790 COUNTRIES: 169 The rapid global spread and unique epidemiological characteristics of the novel coronavirus disease, COVID- 19, is deeply concerning. CEPI has moved with great urgency and in coordination with WHO, who is leading the development of a coordinated international response. We have initiated several programmes which will leverage our work on MERS and innovative new technologies to speed up vaccine development against COVID-19. 20

  21. CEPI’s response to COVID-19 We hope to get a vaccine through to clinical testing in 16 weeks – this is an extremely ambitious timeline and is unprecedented in the field of infectious diseases. We have already announced the following partnerships and programmes of work: • Inovio – Nucleic Acid platform • University of Queensland – Recombinant protein • Moderna – mRNA platform • CureVac - mRNA platform Novavax, Inc. - recombinant protein nanoparticle • technology • The University of Oxford - ChAdOx1 vectored vaccine • The University of Hong Kong - live-attenuated influenza vaccine platform • Institut Pasteur – measles vector 21

  22. An Epidemic Cannot Be Defeated Without Access To The Vaccines • Equitable Access: CEPI has obligation to ensure that appropriate vaccines are first available to populations when and where they are needed to end an outbreak or curtail an epidemic, regardless of ability to pay • Access to to Mark rkets: CEPI vaccines may be used in areas where final regulatory approvals have not been granted – emergency use – and where regulatory processes not fully developed. • Access and Sustainability: CEPI provides funding for vaccine and platform development and enabling science. • We seek to further develop push and pull funding mechanisms for R&D, capacity building and to promote sustainable manufacturing and distribution. 22

  23. CEPI’s COVID -19 vaccine portfolio diversifies platform technologies, partnership types, geographical presence and risks. Total Technology Antigen Partner type Geo allocation Manufacturing project platform scalability budget (High/medium/lo (m$) w) $8.9m DNA Spike-protein Biotech USA Low Inovio $21m mRNA Spike-protein Biotech USA Medium/High Moderna* $8.4 mRNA Spike-protein Biotech Germany Medium/High CureVac Adjuvants $2.15m Protein Spike-protein Academic Australia Medium/High Queensland Spike-protein $12.8m Industry United States High Nanoparticulate Novavax $46m Spike-protein Industry Belgium High Viral vector Janssen IP-Themis Academic/ France, Germany, $12/28m Viral vector Spike-protein Medium/High University of Industry India Pittsburgh Spike-protein Biotech $8.3m Protein China Medium/High Clover timer (phase 3 staged) * Funded jointly with US NIAID - CEPI funding for GMP material; Phase 2 work under negotiation 0.35m Viral vector Spike-protein Academic UK Low University of Oxford University of Hong 0.6m Viral vector RBD domain Academic Hong Kong High 23 Kong

  24. Virus S protein binds to ACE2 receptor 24

  25. Ab to Spike, ADE of disease Wang et. al 2016 Wan et. al 2020 25

  26. Inovio (Nucleic acid platform) • Date of announcement: 23 January 2020 • Inovio will be working to advance their MERS vaccine candidate using its DNA Medicines platform to deliver optimized synthetic antigenic genes into cells. • These will then be translates in to antigens that activate an individual’s immune system to generate robust immune response 26

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