CEPI and COVID-19 VACCINES June 9, 2020 Nicole Lurie, MD, MSPH Strategic Advisor to the CEO and Incident Manager, COVID response team CEPI A world in which epidemics are no longer a threat to humanity CEPI accelerates development of vaccines against emerging infectious diseases and enables equitable access to these vaccines for affected populations during outbreaks 2 Image left slide (right-click to replace image) CEPI Strategic Objectives Preparedness Response Sustainability Advance access to safe and Accelerate the research, Create durable and equitable effective vaccines against development and use of solutions for outbreak emerging infectious diseases vaccines during outbreaks response capacity 3 3 Column slide Small images or graphics can be used to highlight key items. These should always be circular CEPI has multiple investments against its 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 4 COVID-19 portfolio goals Speed Scale Access Developing Covid-19 vaccines at Scaling up and scaling out vaccine Working with global partners to pandemic speed manufacturing capacity ensure fair allocation of COVID-19 vaccines 5 CEPI vaccine development so far…. 23th May 31st Dec 2019 11th March 12th April 14th Feb First meeting of the ACT WHO notified of pneumonia-like case Wellcome Trust launch First cases reported in WHO declares Accelerator cluster in Wuhan, China COVID-Zero resource Africa SARS-CoV-2 a Coordination Group global pandemic mobilisation 10th Jan th 11 Feb th th th 24 April 4 June First genetic sequences SARS-CoV-2 included 10 March Global launch of ACT GAVI, Global Vaccine released disease named COVID- GPMB calls for scaled- Accelerator Summit/COVAX AMC 19 by WHO up global response (US$8billion) announced Jan 2020 Feb Mar Apr May June 31st Jan 25th May 23rd April CEPI announces 4th development First in human - PhI PhI clinical trial clinical trial starts for partnership th th th starts for CEPI 4 May Novavax 23rd Jan 10 -20 March 4 new (8 total) CEPI partner Oxford CEPI announces second Call CEPI announces 3 COVID-19 3rd June COVID-19 vaccine University for Proposals to expand vaccine development CEPI partners with development partnerships th portfolio programmes 6 April AstraZeneca for globally 4th May 8th Jan CEPI partner Inovio starts accessible vaccine 3rd Feb European Commission CEPI contacted awardees first in human clinical trial supply CEPI launches Call for 17th March pledging marathon to raise th Proposals for COVID-19 US$8.3 billion 7 Jan CEPI partner Moderna 4th June CEPI activated response vaccines 16th April 27th April rd enters first in human CEPI forms partnering 3 Feb CEPI partner w/IVI CEPI announces 9th vaccine clinical trial agreement with U. of GSK/CEPI collaboration on and KNIH for PhI/II development partnership Queensland and CSL adjuvant technology trial in South Korea 11th May CEPI expands partnership with Novavax Only a fundamental paradigm shift provides potential of rapid vaccine development with appropriate safety standards Traditional Target ID, development partner selection, Phase I Phase IIa Phase IIb Phase III Licensure paradigm and pre-clinical 12 months 12 months 12-18 months 18-36 months 12-36 months 6- 11.5 years 6 - 24 months Outbreak Target ID, development partner paradigm selection, and pre-clinical 12 - 18 months 4 - 8 months Go/no-go decision to Clinical development invest in candidates Early stage Late stage 3 - 4 months 6 - 8 months First in Scale from Emergency human n=10s to n=100s authorization Major Speed: Accelerate and advance Scale: Adaptive versus rigid Access: Geographic spread of development stages in parallel with development process and earlier manufacturing and development sites shifts continuous risk-benefit monitoring; launch of scale-up and pursuit of emergency authorization quickly raise and deploy funds before licensure Lurie N, et al. New Engl J Med. 30 March 2020. DOI: 10.1056/NEJMp2005630 CEPI currently supports 9 vaccine candidates, with more to come University of COVID-19 Clover Merck / University of AZ / Inovio Queensland CureVac Moderna Novavax BioPharma Themis Hong Kong Univ. Oxford / CSL Location USA Australia Germany USA China India USA China UK Platform DNA Protein RNA mRNA Protein Viral Vector Protein Viral Vector Viral Vector Full-length S Full-length S Full-length S Receptor protein / Adjuvants Antigen / Full-length S protein / Full-length S Full-length S protein Full-length S Binding Full-length S saponin- Adjuvant protein MF59 or AS03 protein protein / AS03 or protein Domain / protein based Matrix- or CPG1018 CPG1018 AS03 M Current Phase 1 Preclinical Preclinical Phase I1a Preclinical Preclinical Phase I Preclinical Phase I/II phase (1) Richter (1) Lonza Helm, Locations (USA); (1) Emergent Germany; (2) of large CureVac [potentially (USA); (2) SK CDMOs AstraZeneca Eurogentec, CSL/Seqirus Clover (China) SII, India scale mfg (Germany) (2) Lonza Bio (KOR); (3) (China) (UK) Belgium, (3) (DS) (CH); (3) Praha (CZ) Inovio San Singapore] Diego. Paradigm shift in Vx Development (SPEED-ACCESS-SCALE) In Disease X, fundamental paradigm shifts in vaccine development related to speed, scale, and access are required to ensure development advances as fast as possible while still meeting robust clinical efficacy and safety requirements: 1) Speed is paramount: rapidly accelerate target identification and development of vaccine candidates by using existing and previously validated (where possible) platforms for Disease X vaccines. 2) Parallel versus sequential: launch parallel processes wherever possible to minimize or eliminate whitespace between stages of development (e.g., conduct first in-human clinical trials while in parallel continuing animal studies, ramp-up clinical scale manufacturing while in parallel continuing to advance early stage trials). 3) Adaptive versus rigid development processes: apply integrated and adaptive trial design (e.g., ring vaccination) to replace classical development stages (i.e., Phase I, IIa, IIb/III) with consolidated early-stage development (10s of subjects) and late-stage development (100s of subjects) to accelerate trial timelines. 4) Continuous monitoring and rigorous benefit-risk decision making based on specific scenarios: track real-time epidemic status (e.g., severity of morbidity and mortality rates) to inform benefit-risk decisions at any point in time with pre-established clinical efficacy, safety, and other non-clinical “no go” criteria, as well as accumulation of effectiveness data from every exposed subject. 5) Prioritize rapid and equitable access: pursue emergency authorizations as soon as the benefit-risk profile is sufficiently established for broad scale use (rather than wait for regulation / market authorization). Challenges ahead • Resource mobilization, financing and advanced market commitment • Liability / indemnification • Balancing fair allocation/equitable access with sovereign country needs • Safety monitoring and vaccine literacy/confidence • Delivery / distribution/ last mile 9 10 COVAX facility as a global approach 11 Front-runners, Hurdles, and Insider Perspectives: The Race to Develop and Implement a Safe and Effective COVID-19 Vaccine HHS National Vaccine Advisory Committee (NVAC) Meeting June 9, 2020 Amy Walker Senior Manager, Infectious Diseases Policy, BIO Objectives • Review current COVID-19 vaccines pipeline and status of R&D • Overview of challenges to COVID-19 vaccine development BIO’s Approach to COVID-19 Pipeline Analytics BIO Industry Analysis + misc sources 1. Drug Name 2. Phase 3. Sponsoring Company 1. Originating Company 2. Pipeline Category (Antiviral, etc.) 3. Drug Origin Type (Repurposed, etc.) bio.org/covidpipelinetracker 4. Modality 5. Strategy 6. Target Family Note: BIO de-duplicates multiple programs and trials for same drug Biomedtracker, Biocentury, BIO Industry Analysis (Data as of 6/4/2020) Timing of Response >550 unique development programs launched in 20 weeks Week 1 after SARS-COV2 sequence published by China, Jan 10th Week of first press release announcing program Biomedtracker, Biocentury, BIO Industry Analysis (Data as of 6/4/2020) 3 COVID-19 Pipelines Vaccines Antivirals & Antibodies Treatments for COVID-19 Illness Biomedtracker, Biocentury, BIO Industry Analysis (Data as of 6/4/2020) 16 Clinical-Stage COVID-19 Vaccines Biomedtracker, Biocentury, BIO Industry Analysis (Data as of 6/4/2020) Many Technologies Deployed for Many “Shots on Goal” • Full Vaccine Pipeline • Clinical Stage Vaccines (Phase 1, 2, 3) Biomedtracker, Biocentury, BIO Industry Analysis (Data as of 6/4/2020) Supported by BARDA US focused Clinical Stage Pipeline & Preclinical “Watchlist” Jointly developed Preclinical Phase 1 Phase 2 Phase 3 Viral Vector Viral Inactivated RNA1 (support from NIH, CEPI) DNA Cell Based Recombinant protein Source: Biomedtracker, Biocentury, BIO Industry Analysis 1. PrEP Biopharm vaccine dsRNA, all others mRNA Info as of May 25, not exhaustive Oxford, Astrazeneca: ChAdOx1. Symvivo: bacTRL-Spike. Baylor College: BCG tuberculosis vaccine. Sinopharm with two vaccines in phase 1 trials (one beginning Apr 12 the other Apr 27) Manufacturing & Scale Up Headlines featured here are a sample of ongoing work, not exhaustive Challenges to COVID-19 Vaccine Development • Scientific • Understanding of disease • Understanding of populations most at-risk • Shifting epidemiology • Manufacturing • Record time scale-up • Fill/finish