Overview. Vaccine innovation With people, for people: The (A) citizens' view. Vaccine impact in perspective. Vaccine research in perspective

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1 Overview Vaccine innovation With people, for people: The (A) citizens' view Disclaimer about the citizen Ending AIDS? A history lesson A way forward hopefully Mitchell Warren Executive Director, AVAC 12 March 2014 New Horizons for Vaccine Research and Innovation, Brussels Vaccine research in perspective Vaccine impact in perspective Duration between discovery of microbiologic cause of selected infectious diseases and development of a vaccine Virus or bacteria Year cause discovered Year vaccine licensed Years elapsed Typhoid Haemophilus Influenzae Malaria 1893 None Pertussis Polio Measles Hepatitis B Rotavirus HPV HIV 1983 None Source: AIDS Vaccine Handbook, AVAC, 2005 Baseline 20th century annual morbidity and 1998 provisional morbidity from nine diseases with vaccines recommended before 1990 for universal use in children in the United States Virus or bacteria Baseline 20 th Century Annual Morbidity 1998 Provisional Morbidity % Decreased Smallpox 48, % Diphtheria 175, % Pertussis 147,271 6, % Tetanus 1, % Polio 16, % Measles 503, % Mumps 152, % Rubella 47, % Haemophilus influenzae type b 20, % Source: MMWR, US Centers for Disease Control & Prevention, April 1999 Challenging tradition Vaccines are cheap and effective and end epidemics or at least they did New vaccines may not be cheap, nor as effective as earlier ones, nor easy to administer as part of EPI programmes The mantra is vaccines are the most costeffective public health interventions, but will this be true in the future? Sprint or marathon or relay race? About AVAC Founded in 1995 as the AIDS Vaccine Advocacy Coalition to Promote increased funding and investment in HIV vaccine research by government agencies, private industry, and non-governmental organizations; Identify barriers to the development of a vaccine; and Increase public awareness of the need for a well-funded, coordinated HIV vaccine research program.

2 Invest Now to Save Lives and Funds But we need a vaccine! Baseline Baseline New HIV infections New infections that could be averted between 2011 and million New HIV infections New infections that could be averted between 2011 and million Investment Framework Investment Framework But we need a vaccine to get to zero Towards an improved investment approach for an effective response to HIV/AIDS, B Schwartlander et al, Lancet, 2011, 377: 9782, Towards an improved investment approach for an effective response to HIV/AIDS, B Schwartlander et al, Lancet, 2011, 377: 9782,

3 And vaccine science is hard For scientists For funders For trial participants For potential users For advocates R&D advocacy vs. Delivery advocacy Just as we balance science of development/discovery with science of delivery Building a constituency Everyone needs a vaccine for AIDS, but everyone isn t a constituency. It is people known to be at high risk, those with the same demographics as the epidemic, who will benefit most immediately and most directly from your vaccine if they will take it, and if they can get it. Bill Snow Eradication dreams? Though the dream of eradication continues to animate scientists, doctors and public health officials, the history is at best rocky. In the past century, eradication efforts failed against hookworm, yellow fever and malaria. Today the struggling drive against polio has raised new questions about whether eradication of any disease is achievable, and, if so, whether the cost in terms of effort and dollars would be worth it, given all the other diseases that need attention. To Conquer, or Control? Disease Strategy Debated, New York Times, 20 March nlx= ttjc+exbayx3f5wup2dzng Leadership matters (and money, too) History may not always repeat itself, but it rhymes a lot. Attributed to Mark Twain (Who did say, It is not worth while to try to keep history from repeating itself, for man's character will always make the preventing of the repetitions impossible. ) FDR and Basil O Connor count dimes at the White House

4 Community matters Elvis gets vaccinated during a polio vaccine promotion campaign, Polio Pioneers, Provo, Utah. This souvenir button went to all children who received all three shots. Just two drops

5 A vaccine that sits on the shelf is useless. Albert Sabin Central Africa Pakistan Nepal Sudan India: National Immunization Day 2 million volunteers to immunize over 150 million children in just a few days.

6 Eight lessons from history 1. Expert opinion is not always correct; paradigms change 2. Vaccine development cannot go faster than scientific knowledge 3. Be guided by data, especially from clinical trials wherein even small numbers can provide critical information 4. There can be more than one way to develop successful vaccine 5. High expectations of current interventions could delay vaccine development 6. Appropriate funding is critical, but needs to be allocated strategically 7. Prepare for success but expect, and manage, setbacks 8. Political and community support is essential to sustain the effort, with private foundations playing a critical role A tale of two vaccines: lessons from polio that could inform the development of an HIV vaccine, J Esparza, AIDS 2013, 27:1 5. Political and community support Without informed community involvement and advocacy: Vaccine R&D may not be prioritized; Resources may not be sufficient; Trial approval may be slower; Recruitment may be slower and retention may be compromised; Trial conduct may be disrupted; Licensure may be delayed; Procurement may be limited; Demand and distribution may be reduced; and People may not come to be vaccinated. Challenges (& Opportunities) Ahead Where to From Here Translate complex science to the community Translate complex community needs, perceptions, expectations, etc. to the scientific community Increase literacy of researchers, community representatives, media, policy makers, other stakeholders Complexity & innovation for future products and trials Easy to say what should be done; hard to do it Maintain openness and transparency Accuracy: these are complicated issues; communicate honestly and articulate what a trial will (and won t) answer Exercise balance, discipline, creativity, innovation, diversity, risk-taking, flexibility especially in our decisionmaking processes Sustain capacity scientific, clinical, trial site, community, policy, financial Manage expectations especially as they continue to evolve Acknowledgements Bill & Melinda Gates Foundation USAID IAVI Jose Esparza, Bill & Melinda Gates Foundation Bill Snow, Global HIV Vaccine Enterprise Seth Berkley, GAVI Debbi Birx, Ambassador-Designate for the US Office of Global AIDS Coordination Helen Rees, Wits Reproductive Health & HIV Institute David Gold, Global Health Strategies Peter Piot, London School of Hygiene & Tropical Medicine Beth Waters