Vietnam’s Institute of Vaccines and Medical Biologicals (IVAC) recently announced the approval of Rotavin for clinical use by the US Centers for Disease Control and Prevention and Vietnamese National Institute for Control of Vaccine and Biologicals.
The research and aim for domestic production of a rotavirus vaccine began in 1998 and proved successful after more than 10 years of study. By the end of this year, Rotavin will be the first domestically produced Rota vaccine to enter the local market alongside Rotarix (GSK, Belgium) and RotaTeq (Merck), both of which have been tested in Vietnam.
Compared to its costly counterparts, Rotavin is expected to be a fraction of the cost. According to IVAC, the price of the Vietnamese-made vaccine is one-third the cost of an imported vaccine (one imported vaccine shot costs around US$34). Le Thi Luan, Vietnam’s deputy director of the Ministry of Health’s Center for Research and Production of Vaccines and Biologicals, also reassured consumers “the quality of the vaccine is equivalent to Belgium’s Rotarix vaccine which is used in Vietnam.” An evaluation of the drug was conducted and the results show it is safe for both adults and children. The vaccine has been tested on 30 adult patients and 1,000 children aged between six and 12 weeks old in the two northern provinces of Phu Tho and Thai Binh.
Rotavirus (RV) is the leading cause of severe diarrhea in children worldwide and one of the most preventable public health challenges we face today. According to the most recent World Health Organization (WHO) estimates, rotavirus is responsible for more than 500,000 child deaths every year. While nearly every child in the world is at risk of rotavirus infection, most deaths occur in developing countries, where health resources are scarce.
Rotavirus vaccines are the best tool available for protecting children against severe and deadly diarrhea. In countries where they have already been introduced, rotavirus vaccines have proven to be highly effective and have saved thousands of children’s lives. For example, even though the prevalence is comparatively low in the U.S. versus those from developing countries, routine vaccinations for rotavirus have been widely available. Since its implementation in 2006, it has been suggested that vaccinations prevented 40,000 to 60,000 rotavirus hospitalizations each year in the U.S.
In Asia and Africa, where more than 85% of rotavirus-related deaths occur, prevention through vaccination would have a substantial impact on diarrhea and child mortality. Sadly, where the need is the greatest, rotavirus vaccines are highly expensive and access is a major challenge. In the words of Dr. Julian Lob-Levyt, chief executive officer of the GAVI Alliance*, “It is in the lowest-income countries, where access to health care is most limited and the disease burden heaviest, that these vaccines are most desperately needed.” In Vietnam, rotavirus infections account for more than half of annual hospitalized diarrhea cases among children aged below five years of age.
Data from Vietnam’s sentinel hospital surveillance identified rotavirus in 44%-64% of children admitted for acute diarrhea treatment. Estimates from safety study of the rotavirus vaccine (Rotavin-M1) revealed 122,000-140,000 hospitalizations and 2900-5400 deaths per year are caused by rotavirus among children less than 5 years of age. In recent years, new vaccines to prevent rotavirus diarrhea have been developed and introduced by numerous manufacturers. The Vietnamese government, encouraged by success of other locally produced vaccines over the past decades, and in an effort to promote self-reliance and provide affordable supply for its own population, has made it a policy priority to accelerate the production of the rotavirus vaccine. It hopes that Rotavin – like several locally produced vaccines for poliomyelitis, cholera, Japanese encephalitis, and Diphtheria-Pertussis-Tetanus – will contribute to significant reduction in childhood mortality.
Optimism abounding, the approval of Rotavin is certainly a step forward in the right direction for Vietnam and the world. This is welcome news in addition to the GAVI Alliance’s campaign to raise funds to support the introduction of rotavirus vaccines in at least 44 low-income countries by 2015. However, since vaccines alone will not rid the world of Rotavirus, the WHO encourages delivery of rotavirus vaccines as part of an integrated set of interventions critical to preventing and treating the many causes of diarrheal disease. Alongside the focus to strengthening health care systems, other proven, complementary interventions to address the other causes of diarrhea include access to clean, safe water, improved hygiene, sanitation, and increase availability of oral rehydration solution.
* Formerly the Global Alliance for Vaccines and Immunization. GAVI Alliance is a global health partnership between the private and public sectors, committed to the mission of saving children’s lives and protecting people’s health by increasing access to immunization in poor countries. www.gavialliance.org
http://www.thanhniennews.com/2010/Pages/20110707130244.aspx
http://health.asiaone.com/Health/News/Story/A1Story20110709-288291.html
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