CE Boston University School of Public Health Department of Global Health- Culminating Experience Fall 2014 Option 1: Policy Brief Title: The Challenges of Funding the Research and Development of an Ebola Vaccine for Liberia Organization: GSK, other vaccine/pharmaceutical companies Problem Purpose Statement: This year’s Ebola outbreak in Western Africa is something the world has never seen before. Not only has this Ebola outbreak infected and killed more people than ever reported, but it has also infected an area that has never seen Ebola before. Efforts to contain and treat infections have fallen short and the entire global community is wondering: where will it strike next? Although unlikely, we cannot underestimate Ebola’s power to strike anywhere it desires. Therefore, the more appropriate question may be, what can we do to prepare? Liberia and the other unsuspecting West African countries hit by this devastating Ebola outbreak are without the resources needed to contain it. Changing cultural norms to try and contain the virus is far from a realistic solution to stop the spread. Ideally, a vaccine must be developed to offer immunity to those at risk, and GSK is currently working on developing one (12). The problem is, however, those who at the highest risk of the disease are also the ones who cannot afford their protection. (3,5,9). Whether or not the market is there, the vaccine is still desperately needed now, and will need to be available for use in future emergency epidemics. The purpose of this policy brief is to emphasize the seriousness of this disease and the fact that public health need of an Ebola vaccine outweighs the monetary return on the investment. This policy brief will make recommendations to incentivize the research and development of a rare disease vaccine, such as Ebola, for use in places like Liberia, where there is a dire need but no paying market. Working Outline I. Introduction A. Defining the problem 1. Ebola outbreak in Western Africa a. Etiology b. Outbreak B. Answer the “so what?” question 1. Largest Ebola outbreak recorded to date 2. Vaccine can offer widespread protection/immunity from the disease 3. Uncertainty of the occurrence of Ebola outbreaks- no successful preparation plan in place II. Current Situation A. Liberia plagued by civil war, diminished public health infrastructure 1. Cannot tackle problem on their own 2. Highest known infection and casualty count 3. Containment measures not enough? 4. Describe cultural practices/behaviors that put Liberians at risk and the of challenges implementing a behavior change or launching mass educational campaigns- Why a behavior change won’t suffice. B. Ebola vaccines in development 1. Difficult to create 2. Who will pay for the R&D? 3. The need for consistent R&D for protection in future outbreaks 4. Proper storage and storage capacity of vaccines, proper transport, guarantee of lot potency III. Potential Solutions A. Identify stakeholders 1. Who is for vaccine R&D in a non-existent market? a. Who are the outside funders? 2. Who is against vaccine R&D in a non-existent market? a. Appeal to morals, human rights b. Destructiveness of the outbreak B. Try to restore public health infrastructure in Liberia 1. Training staff 2. Establishing emergency vaccine storage 3. Educating the population IV. Discussion and Recommendations A. Market to travel-vaccine/travel-doc industry $$$ B. Potential for non-emergency use? I.e. infant vaccination schedules? C. Tax breaks for big pharma? D. Relabel other existing treatments that may be effective V. Conclusion A. Although outbreaks are often eventually contained, this is the largest-to-date and cannot be ignored. It will come back again. B. Increased trade and travel and potential for genetic drift/shift in disease makes for important reasons to fund a vaccine- for the U.S. could one day be the country for which it is marketed. Work Plan for Submitting Drafts In order to complete the option 1 culminating experience during the fall 2014 semester, the following deadlines will be adhered to: Draft 1: Oct. 10th, 2014 Draft 2: Nov. 7th, 2014 Draft 3: Dec. 5th, 2014 Final Submission: Dec 19th, 2014 Working Bibliography 1. Kuehn BM. Malaria Vaccine, Ebola Therapy Promising in Early Studies. JAMA. 2014 Jan;310(13):1327–8. 2. Awasthi S. Next generation of human vaccines. Hum Vaccin. 2008;4(5):344–6. 3. Cooper C. Ebola outbreak : Why has ‘Big Pharma’ failed deadly virus ' victims ? The Independent. 2014 Sep 7; 4. Easter A. Ebola. Am J Nurs. 2002;102(12):49–52. 5. Fox M. ‘No Market’: Scientists Struggle to Make Ebola Vaccines , Treatments. NBC. 2014 Jul 29; 6. Hayden EC. World struggles to stop Ebola. Nature. 2014;512:355–6. 7. Hunt J. How Fujifilm Came to the Ebola Fight. The New Yorker. New York; 2014 Sep 5; 8. Jäger S, Cimermancic P, Gulbahce N, Johnson JR, McGovern KE, Clarke SC, et al. 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