Despite impressive public health gains made in the 1980s and 1990s, severe dehydration caused by diarrheal disease still contributes significantly to childhood morbidity and mortality in the developing world. Today, diarrheal disease is responsible for an estimated 1.6 to 2.4 million deaths annually , making it the second leading infectious disease killer of children under five. Among diarrheal diseases, rotavirus gastroenteritis is a leading cause of morbidity and mortality in this population.
Each year, rotavirus is responsible for an estimated 450,000–700,000 deaths among children under five, and another 2 million are hospitalized . Over 80 percent of rotavirus deaths occur in developing countries, where access to emergency treatment such as intravenous rehydration is limited. The primary mode of rotavirus transmission is fecal-oral, and it causes rapid dehydration due to vomiting and diarrhea.
A unique feature of rotavirus is its global scope. Nearly every child in the world, regardless of geography, socio-economic status, or gender will get at least one rotavirus infection before age five .
Among diarrheal diseases, rotavirus is an exception to the management rules. Traditional diarrheal disease prevention efforts, such as improving hygiene, sanitation, and access to clean water, are not sufficiently effective in preventing rotavirus, as evidenced by the near universal rate of infection. And, because of the profuse and persistent vomiting that usually accompanies severe cases, oral rehydration therapy is a very difficult treatment to successfully administer. A vaccine is considered to be the most effective prevention method.
The World Health Organization (WHO) has made the development and distribution of rotavirus vaccines in developing countries a high priority . As a result, manufacturers, governments, and global health organizations are working together with the GAVI Alliance to accelerate the availability of safe and efficacious rotavirus vaccines for children in developing countries .
In 2006, a three-dose oral rotavirus vaccine developed by Merck & Co. Inc. was approved for use by the U.S. Food and Drug Administration (FDA). In addition, a two-dose oral vaccine developed by GlaxoSmithKline was approved by the European equivalent of the FDA, the European Agency for the Evaluation of Medicinal Products. Both vaccines have demonstrated high levels of safety and efficacy in major clinical trials in the U.S., Latin America, and Europe [6, 7], and as a result the WHO's Strategic Advisory Group of Experts (SAGE), has indicated that adoption of rotavirus vaccines in these regions is warranted . In June, 2007, the GAVI Alliance announced it would subsidize the cost of rotavirus vaccines to GAVI eligible countries (those with a gross national income of less than US$1,000 per capita) in Latin America and Europe, making these vaccines available to these countries at US$0.30 per course .
As of June, 2007, four non-GAVI eligible countries in Latin America (Brazil, Panama, Venezuela, and El Salvador) have introduced rotavirus vaccine into their Expanded Program on Immunization (EPI) programs. Mexico is offering the vaccine free of charge in 10 of its poorest states, and Nicaragua, a GAVI-eligible country, has introduced the rotavirus vaccine into the EPI system as part of a demonstration project with Merck & Co. Numerous other countries around the world have licensed rotavirus vaccines, allowing them to be sold through the private sector.
To determine efficacy of these vaccines in developing- country settings, clinical trials of both vaccines are planned or are underway in Africa and Asia. If proven efficacious, introducing these vaccines into the public sector EPI programs of low-income countries is a global health priority . The question remains however, is this global prioritization of rotavirus vaccines shared by developing countries where the disease is relatively unknown?
The WHO has issued general guidelines for vaccine introduction which provide countries with a framework for considering the evidence about specific diseases and the operational, technical and policy steps necessary for vaccine introduction .
The guidelines indicate that the vaccine introduction process begins by determining the public health priority of a particular disease, suggesting that in countries where the disease is not a priority adoption of the vaccine is not assured. The guidelines recommend conducting qualitative investigations of the public health community and decision makers to gauge the concern about the disease and the priority of the vaccine.
This paper summarizes the results of a formative research survey of public health providers in five low-and middle-income countries to determine levels of knowledge about rotavirus and rotavirus vaccines, perceptions of diarrheal disease as a problem and priority for the public health system, and knowledge of the causes, prevention methods, and treatment of diarrheal disease. The formative research results presented here utilized focus group discussions (FGD) and one-on-one, semi-structured interviews to answer surveys, and were supported by funding provided by the GAVI Alliance in support of the Rotavirus Vaccine Program (RVP). RVP is a partnership between WHO, the U.S. Centers for Disease Control, and PATH, a US-based international health organization. The mission of RVP is to accelerate the availability of rotavirus vaccines in developing countries
The results of the surveys have informed the development of a knowledge translation approach to bridging the gap between a global scientific agenda of vaccine development, and the local public health agenda of diarrheal disease control. We hypothesize that this approach–the Enhanced Diarrheal Disease Control Initiative–may help prioritize diarrheal disease sufficient for consideration of the vaccine evidence and potentially prioritization of the vaccine, as well as consideration of other diarrheal disease interventions, such as zinc treatment, and oral rehydration therapy.