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FACT SHEET In the pipeline: the status of future global health vaccines Vaccines are one of the most cost-effective interventions in public health. However, vaccine development requires years of research as well as significant financial investment. For diseases more common in low- and middle-income countries, it can be difficult to create the economic drivers to spur research. In recent years, innovative funding mechanisms and product development partnerships (PDPs) have stimulated the advance of several vaccines that could have a significant impact on the health of the world’s poor. This fact sheet describes a select number of gloal health vaccines currently in development.

The vaccine development pipeline1

Clinical trials











HIV/AIDS is a devastating viral disease that weakens the immune system. Infections that would normally be mild can become life-threatening. Vaccine status. The search for a vaccine against HIV has been hampered by the virus’s ability to mutate rapidly. Today, 30 vaccine candidates that stimulate T-cells are in the pipeline, but even if one of these is successful it may only suppress the virus, not eliminate it.2 Researchers are now turning to vaccine candidates that would also stimulate antibodies. The largest HIV vaccine trial to date, a Phase III trial, occurred in Thailand in 2009. Although this trial was ultimately unsatisfactory, it did provide some clues as to how the virus operates.3 Potential impact. UNAIDS estimates approximately 34 million people were living with HIV at the end of 2010.2 Worldwide, US$16 billion is spent each year on treatment and prevention.4 Hookworm is a parasite that enters the body through contact with infected soil and migrates to the intestines, causing lethargy, anemia, and stunting in children. Vaccine status. Clinical testing is set to begin in 2011.5 The Human Hookworm Vaccine Initiative was awarded US$12 million to fund multiple phase I clinical trials.6 Potential impact. Nearly 600 million people suffer from hookworm infection.7 Hookworm infection has been shown to reduce school attendance and decrease income later in life.

Malaria is caused by the Plasmodium parasite, which enters the body via the bites of infected mosquitoes. Once in the body, the parasite infects red blood cells. Vaccine status. A vaccine may be available as early as 2015 if Phase III trials of a candidate called “RTS,S” are successful.8 RTS,S has been in development for 40 years. Other vaccine candidates are in early stages of testing. Potential impact. Annually about 250 million people contract malaria and one million die. Malaria kills a child every 30 seconds and 1/5 of all childhood deaths in Africa are due to the disease. Overall malaria can decrease a country’s GDP by as much as 1.3%.9 Schistosomiasis is caused by worms that live in the intestinal or urogenital tract. Affecting primarily schoolaged children, it causes anemia and stunts physical and mental development. Though effective treatment exists, rapid re-infection often occurs. Vaccine status. A vaccine for urinary schistosomiasis is currently in Phase III clinical trials and a vaccine to prevent the intestinal form of the disease will soon begin clinical trials.10, 11 Potential impact. Schistosomiasis affects 400-600 million people.7 Though the vaccines in development would not stop all infections, they would prevent the severe infections that cause disability. A reduction in worm burden would also lead to decreased transmission of the disease. Tuberculosis (TB) is a bacterial disease that attacks the lungs, the kidneys, spine, and brain. Vaccine status. The current Bacillus Calmette-Guérin (BCG) vaccine for TB protects infants from certain forms of tuberculosis, but does not provide sufficient protection against the more common pulmonary TB.12 A new vaccine is in Phase II trials with results expected in 2012.13 Potential impact. TB kills 1.8-2 million people annually. In 2009, 11,545 cases of TB cases were reported in the United States.14 Over the past 12 years, the U.S. Government has provided approximately $953 million to fight TB abroad through United States Agency for International Development.15

JULY 2011

References 1. U.S. Food and Drug Administration. Vaccine product approval process. 2009 [cited 2011 5 July]; Available from: biologicsbloodvaccines/developmentapprovalprocess/biologicslicenseapplicationsblaprocess/ucm133096.htm 2. UNAIDS. Global AIDS response continues to show results as a record number of people access treatment and rates of new HIV infections fall by nearly 25%. [cited 2011 5 July]; Available from: Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, et al. Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. New England Journal of Medicine. 2009; 361(23): 2209-20. 4. Schwartlander B. Towards an improved investment approach for an effective response to HIV/AIDS. The Lancet. 2011; 377(9782): 2031-41. 5. Sabin Vaccine Institute. Human Hookworm Vaccine Initiative: About the vaccine. [cited 2011 July 5]; Available from: http://www. 6. Bill & Melinda Gates Foundation. Major funding announced to continue the development of a vaccine for leading disease affecting global poor. 2011 [cited 2011 5 July]; Available from: 7. Hotez P. A handful of 'antipoverty' vacines exist for neglected diseases, but the World's poorest billion people need more. Health Affairs. 2011; 30(6): 1080-7. 8. Loucq C, Birkett A, Poland D, et al. Producing a successful malaria vaccine: innovation in the lab and beyond. Health Affairs. 2011; 30(6): 1065-71. 9. World Health Organization. 10 facts on malaria. 2009 [cited; Available from: html 10. Hotez P, Bethony J, Diemert D, Pearson M, Loukas A. Developing vaccines to combat hookworm infection and intestinal schistosomiasis. Nature Reviews Microbiology. 2010; 8: 814-26. 11. Institute national de la sante et de la recherche medicale. Devlopment of a theraputic schistosomiasis vaccine. 2009 [cited 2011 5 July]; Available from: 12. Gothefors L. The impact of vaccines in low- and high-income countries. Annales Nestle. 2008; 66: 55-69. 13. Barker L, Leadman A, Clagett B. The challenges of developing new tuberculosis vaccines. Health Affairs. 2011; 30(6): 1073-9. 14. Centers for Disease Control and Prevention. Trends in Tuberculosis, 2009. [cited 2011 5 July]; Available from: tb/publications/factsheets/statistics/TBTrends.htm 15. United States Agency for International Development. Tuberculosis. [cited 2011 5 July]; Available from: work/global_health/id/tuberculosis/index.html

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In the Pipeline: the Status of Future Global Health Vaccines  
In the Pipeline: the Status of Future Global Health Vaccines  

Vaccines are one of the most cost-effective interventions in public health. However, vaccine development requires years of research as well...