The Rotavirus Vaccine Program Accelerating Vaccine Development and Introduction Through Public Private Partnerships Vaccine development
The Case for Investing in Vaccines Successful introduction and use of a new vaccine in developing countries requires the commitment of precious health care resources. In order to confidently make that commitment, global and national decision makers require appropriate information about disease burden, vaccine efficacy and safety, the cost-effectiveness of vaccine use, vaccine demand, and communication and advocacy tools. 2, 3 Together, this information will present a clear case for investing in rotavirus vaccines.
The decision whether or not to introduce a rotavirus vaccine depends heavily on the availability of data detailing the burden of rotavirus4. Where country level disease burden information has been insufficient, vaccine uptake has been slow.5 To date, global estimates of the rotavirus burden have been developed6, however, country level data including trend analysis and prevalence rates are insufficient for regional and local decision-making. Supporting country level surveillance is an area for public-private collaboration, and in the case of rotavirus, there is precedence. In 2000, a partnership that included public sector representatives the US Centers for Disease Control and Prevention, World Health Organization, PATH’s Children’s Vaccine Program, and private sector participants (GlaxoSmithKline, Inc. and Merck & Co. Inc) established the Asian Rotavirus Surveillance Network (ARSN). The ARSN has been successfully collecting important new information pertaining to the burden of rotavirus in Asian countries.7
Determining the safety, efficacy and impact of vaccines in developing countries is paramount to establishing the value of new vaccines. 8 Through clinical trials, important data for decision makers and for manufacturers are generated, including immunogenicity and safety information, efficacy data, and vaccine monitoring data from various populations in developing country settings. Similarly, vaccine impact studies represent an opportunity for the public and private sector to evaluate the beneficial reductions of mortality and morbidity in “real-life” demonstrations, as well as gain important information regarding how new vaccines can be successfully integrated into existing vaccine programs such as the Expanded Program on Immunization. Working in partnership with manufacturers in conducting clinical trials, the public sector helps to shape the clinical trial agenda to meet the specific information needs of developing countries. One important consideration is where and how much efficacy, safety and impact data should be collected in order to confidently conclude that a new vaccine is appropriate for the target population. While the public sector must come to its own consensus decision, the manufacturers can be partners in providing access to potentially relevant data, as well as important insights into their product.
One of the concerns raised by both the public and private sectors has been the inability of manufacturers to effectively predict the demand for vaccines, which in turn has led to shortages of vaccine supply. Collaborative efforts by the public and private sector partners to collect market research data and to develop demand forecasting models specifically for the developing world represents an opportunity to overcome what is historically viewed as a market failure. |
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