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A Decade of Progress in Global Immunisation. Sir Gustav Nossal Department of Pathology The University of Melbourne Australia. IVI 10th Anniversary International Symposium, Seoul, Korea, April 2, 2008. A Decade of the International Vaccine Institute.

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A Decade of Progress in Global Immunisation

Sir Gustav Nossal

Department of Pathology

The University of Melbourne


IVI 10th Anniversary International Symposium,

Seoul, Korea, April 2, 2008

A Decade of the International Vaccine Institute
  • Development of new vaccines has accelerated markedly.
  • Dynamic new funding sources for global immunization.
  • The IVI’s Special Niche:

– Critical analyses of disease burden.

– Cost-benefit analyses and priority setting.

– Early clinical trials of safety and immunogenicity.

– Controlled trials of vaccine efficacy.

– Large scale demonstration projects.

What Has Allowed IVI To Be So Successful?
  • Dynamic Leadership
  • Skill and Experience of the Staff
  • Extraordinary Networking
  • Extensive International Collaboration
  • Outstanding Support from Korean Government
  • Major Gates Foundation Funding
How To Thrive Without The Big Three?
  • Concentrate on the less glamorous and more neglected killers:

– Diarrheal Diseases

– Acute Respiratory Infections

– Mosquito-Borne Viral Diseases

  • Concentrate Laboratory Studies on Pivotal Areas:

– Mucosal Immunity

– Innate Immunity

– Better Adjuvants

Where Does The IVI Fit In?
  • Best conceptualized as part of the United Nations new thrust to meet the Millennium Development goals.
  • Extreme poverty can be eradicated. Improvement in health outcomes will be central to that.
  • This paper will argue that the world can afford to make a real impact on the communicable diseases which so unfairly still affect the poorer countries.
In July, 2005, the G8 group of nations committed themselves to a new global imperative:get rid of extreme poverty in the world, especially in Africa
  • What is needed is a new Marshall Plan.
The Moral Imperative of Poverty Reduction

“Our policy is directed not against any country or doctrine but against hunger, poverty, desperation and chaos. There’s no doubt in my mind that the whole world hangs in the balance.”

U.S. Secretary of State George C. Marshall, 1948, commenting on the Marshall Plan for the reconstruction of Europe which cost USA 4% of GDP for some years (today’s equivalent $500 billion/year).

“Make Poverty History”

Bono and Bob Geldof, July 2005

The Moral Imperative of Health
  • Important from a humanitarian point of view
  • Important from an educational point of view
  • Important from an economic point of view
  • A virtuous circle unites health, education and economic growth
  • 41 life-saving interventions would cost $40 per person per year and save 8 million lives per year
  • Economic benefit would be $6 for every dollar spent
The Moral Imperative of Health (continued)

“There is absolutely no excuse for us to live on a planet where, at 10 cents per $100, millions of lives could be saved every year. It’s hard to understand why we kill people, but absolutely unthinkable how we let millions of people die when we stand by without understanding what is in our own interest and moral obligation.”

Jeffrey D. Sachs, Earth Institute, Columbia University, 2003.

2007 World GDP $51 trillion; 10 cents/$100 = $51 billion2007 U.S. Health Expenditure $2.2 trillion2007 World Health Expenditure $5 trillion; 1% = $50 billion

The Moral Imperative of Communicable Diseases

Within health, the aid priorities should be:

  • Infectious Diseases
  • Nutrition, especially micronutrients
  • Antenatal and Obstetric Care
  • Birth spacing
  • Diabetes
Health Progress is Possible
  • Deaths in children under 5 a record low in 2006, 9.7 million versus 13 million in 1990.
  • Sub-Saharan Africa 4.8 million, South Asia 3.1 million.
  • Among preventable deaths:

Pneumonia 1.8 million

Diarrhoea 1.6 million

Malaria 780 thousand

Measles 390 thousand

AIDS 290 thousand

Global Fund to Fight AIDS, TB and Malaria
  • In first 5 years of programme, U.S. $8.4 billion pledged to 136 countries.
  • 770,000 patients on HAART.
  • 9.4 million people given HIV testing/counselling.
  • 2 million people on TB chemotherapy.
  • 18 million insectide-impregnated bednets distributed.
  • 23 million malaria treatments given.
President’s Emergency Plan for AIDS Relief
  • President Bush requests $5.8 billion for F.Y. 2008.
  • $4.2 billion goes to HAART for 15 focus countries.
  • Funds also provided to Global Fund and malaria control.
  • Aim is to treat 2 million people in 2008 combining both funds.
  • Goal for G8 and UN: By 2010, 100% coverage of AIDS patients.
  • 2 billion people infected
  • 9 million new cases per year
  • 2 million deaths per year
  • DOTS works reasonably well; resistance to first line drugs a problem: MDR; XDR
Polio Eradication is Still Problematic
  • 4 Polio endemic countries:
  • (Cases to date 2008)

India (132)

Nigeria (46)

Afghanistan (4)

Pakistan (2)

  • 5 Importation countries remain of 27 re-infected.
  • Somalia now polio free; last case March 25, 2007.
  • “Finishing the job of polio eradication is our best buy.
  • We must do it”

Margaret Chan

  • At least 300 million attacks per year
  • At least 1 million deaths
  • Resistance to drugs; Anopheles resistance to insecticides
  • Insecticide – impregnated bed nets
  • New drugs: “Medicines for Malaria”; 5 artemisinine derivatives
The Moral Imperative of

Acute Respiratory Diseases and Meningitis

  • 7 to 11-valent pneumococcal conjugate vaccines work well but are expensive
  • Genome mining to find one or more common protein vaccines would help greatly
  • Haemophilus influenza B and Neisseria meningitidis C conjugate vaccines have been very successful
  • N. meningitidis A conjugate is being trialled for Africa
  • N. meningitidis B and non-typable Haemophilus require more work
The Moral Imperative of Diarrhoeal Diseases
  • Two rotavirus vaccines have been registered and more are in the pipeline
  • 600,000 deaths per year
  • Pre-clinical vaccines for shigellosis look good; clinical research is slow
  • Good vaccines against cholera and typhoid exist but are not being used
  • Progress with enterotoxigenic E. coli vaccine is fairly good
The Moral Imperative of Vaccines Which

Prevent Viral Causes of Cancer

  • Increased use of hepatitis B vaccine through GAVI is heartening
  • Some research progress towards a hepatitis C vaccine
  • The human papilloma virus vaccine has been brilliantly successful
  • For the second generation, more HPV genotypes will have to be included
  • Plans for a Helicobacter pylori vaccine are on hold. Peptic ulcer disease and gastric cancer are very important
Other Vaccines of the Future
  • Bird Flu
  • SARS
  • Dengue
  • Anti-terrorism
  • Schistosomiasis
  • Leishmaniasis
  • Hookworm
  • Group A streptococci
  • and many many more !
Progess of the GAVI Alliance 2000–2007
  • 36.8 million extra children received standard vaccines.
  • 176 million children received any or all of hepatitis B, Hib and yellow fever vaccines.
  • Measles deaths reduced by 60% (aiming for 90% by 2010).
  • Estimated 2.9 million deaths prevented.
  • Bill Gates re his $1.5 billion donation: “My best investment ever”.
GAVI Alliance Challenges
  • 28 million children each year still not immunised.
  • Still 2.5 million vaccine-preventable deaths each year.
  • Need $10 to 15 billion extra over next ten years.
International Finance Facility–Immunisation
  • Bonds issued through the international capital markets guaranteeing large, immediately available sums and are redeemed via legally binding pledges from governments of donor countries.
  • On 14 November, 2006 IFFIm placed US$1 million 5 year bonds at 5.2%. Investors included central banks, major funds but also “Mums and Dads”.
  • Over the next 10 years, IFFIm plans to raise US$4 billion for the GAVI Alliance.
  • Donor countries are France, Italy, Norway, South Africa, Spain, Sweden and the U.K.
Advanced Market Commitments (AMCS) for Vaccines
  • A new mechanism for development and subsidised purchase of priority vaccines, including ones not yet invented.
  • On 9 February 2007, Streptococcus pneumoniae was chosen as the first target as it kills 1.6 million people annually.
  • US$ 1.5 billion pledged with Italy and the U.K. contributing the lion’s share.
  • AMCS will fund research, support development, provide funds for a sustainable supply and negotiate a reasonable price.
Progress with Specific Vaccines: African Meningitis
  • WHO–PATH Meningitis Vaccine Initiative on track using monovalent Mening A conjugate.
  • Production is by Serum Institute of India, Pune, in association with 2 CRO’s for technology transfer.
  • 8 June 2007: 600 12-23 month old children I Mali and The Gambia make 20 times more antibody than with unconjugated vaccine.
  • Dell Foundation to fund demonstration study: Single dose all 1-29 year olds in Burkina Faso in 2009.
  • $400 million will be required to immunize 350 million people in 20 other countries.
Progress with Specific Vaccines – Malaria
  • GSK sporozoite vaccine RTS, S with AS02D adjuvant shown to be safe and immunogenic in children aged 3 to 5 in Mozambique.
  • Per cent efficacy and duration of protection remain problems with this vaccine.
  • Two studies of blood stage antigen AMA-1 are in Phase I clinical trial.
  • Steve Hoffman’s live, attenuated, mosquito salivary gland-derived vaccine (Sanaria) 90% effective in human volunteers for 4 years. Clinical trials are planned for 2008.
Progress with Specific Vaccines – Tuberculosis
  • September 2007 Aeras Tuberculosis Vaccine Foundation receives $200 million from Gates Foundation.
  • Strategies include new BCG strains with genes for selected soluble antigens; as well as novel recombinant proteins with novel adjuvants; and also prime–boost regimens using adenovirus 35. Promising antigens include ESAT6, Ag85B, TB 10.4 and HSP90.
  • 6 Phase I studies have started or are about to start. Latest is Peter Andersen Ag85B and TB10.4 in IC31 adjuvant from Intercell.
  • 2 Phase 3 trials hoped for by late 2010.
World effort in AIDS vaccine research now
  • US$ 800 million/year.
  • Strong attempts to achieve co-ordination and collaboration.

– Gates Collaboration for AIDS Vaccine Discovery

– N.I.H. Vaccine Research Center (intramural) and Centers for HIV/AIDS Vaccine Immunology (extramural)

– International Aids Vaccine Initiative

– Euro Vacc

– South African AIDS Vaccine Initiative

  • GHAVE: The global HIV/AIDS Vaccine enterprise (communication, knowledge management, policy development).

Progress with Specific Vaccines – HIV / AIDS (1)

Progress with Specific Vaccines – HIV / AIDS (2)
  • About 30 candidates in early clinical trials.
  • 2 candidates in efficacy trials:

– Sanofi-Pasteur canarypox vector with HIV inserts, boost with Vaxgen gp120 (16,000 persons in Thailand).

– Merck on September 21, 2007, STOPPED its trial of adenovirus serotype 5 with gag, pol and nef expressed because of failure to prevent infection or to lower set point.

Progress with Specific Vaccines – HIV / AIDS (3)

Some Promising Strategies:

  • Mimic trimeric env. structure
  • Stabilize or mimic intermediate (cross-linked env-CD4) in HIV binding process, e.g. gp120-CD4 complexes or analogues.
  • Mimotopes of those epitopes to which broadly neutralizing monoclonal antibodies bind.
  • New adjuvants, new prime-boost regimens.
  • Shorten clinical trials by looking for what reduces the set point of virus load.