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RotaFlash: New Indian rotavirus vaccine ROTAVAC® holds great promise for reducing the burden of rotavirus disease

13 March 2014

Innovative collaborative vaccine development effort addresses major health problem

Results from the Phase 3 efficacy trial of ROTAVAC®, a new rotavirus vaccine developed and tested in India, were published today in The Lancet. The article provides detailed, peer-reviewed safety and efficacy results for this new vaccine and reaffirms previously announced early findings including:

  1. ROTAVAC® significantly reduced severe rotavirus diarrhea in Indian children by 56 percent during their first year of life, with protection continuing into their second year of life.
  2. The vaccine’s efficacy during the first year of life is comparable to that of the two currently licensed rotavirus vaccines, Rotarix® and RotaTeq®, in developing country settings.
  3. There is clear evidence of protection against different rotavirus strains circulating in India even though the vaccine is composed of only one unusual rotavirus strain (G9P[11]) isolated from an Indian child.

ROTAVAC® was developed through an innovative public-private partnership that combined the experience and expertise of Indian and international scientists. PATH has been a key partner in the vaccine’s collaborative development and evaluation since 2001 and has worked with several partners on the Phase 3 clinical trial, including the Indian Department of Biotechnology, the Society for Applied Studies, and Bharat Biotech.

The tremendous burden of rotavirus in India

India has the largest number of under-five rotavirus deaths in the world. ROTAVAC® is the first rotavirus vaccine to show protective efficacy in India, a country which accounts for about a quarter of global deaths from rotavirus.

Click to view figure 1. Number of <5 child rotavirus deaths by country, 2008.

Rotavirus, the leading cause of severe and fatal diarrhea worldwide, accounts for almost 10 percent of all under-five deaths, 39 percent of all diarrhea-related hospital admissions, and about two million outpatient visits among Indian children. Due to this tremendous burden of severe rotavirus diarrhea in India, ROTAVAC® could have a substantial public health benefit in reducing deaths and hospitalizations from severe rotavirus diarrhea.

Increasing children’s access to rotavirus vaccines

The results of the clinical trial demonstrate that ROTAVAC® is efficacious in preventing severe rotavirus diarrhea in low-resource settings in India. The manufacturer, Bharat Biotech, has submitted an application to the Drugs Controller General of India for the licensure of ROTAVAC® for use in Indian infants. If licensure is granted, the vaccine will be available for purchase by India’s private healthcare facilities. If the Government of India decides to introduce the vaccine into the country’s Universal Immunization Programme, it will then be available to all infants in India free-of-charge.

Bharat Biotech and its partners also intend to seek prequalification of ROTAVAC® by the World Health Organization. If ROTAVAC® becomes prequalified, the vaccine could become more widely available to other high-burden countries through the GAVI Alliance and the PAHO Revolving Fund.

Novel collaborative model for future vaccine development

Two companion pieces to The Lancet's article highlight the unique and innovative aspects of the collaborative approach to ROTAVAC’s development pathway. The first piece, a viewpoint article, describes how ROTAVAC® was the product of “unique and unconventional” team science work in India that combined the expertise and interests of highly diverse multinational groups of clinical and translational investigators with the goal of developing a safe, effective, and affordable vaccine for India and the developing world. The second piece, a commentary by Dr. Shabir A Madhi of the National Institute for Communicable Diseases and Dr. Umesh D. Parashar of the US Centers for Disease Control and Prevention, highlights how the “successful alliance” between donors, governmental institutions, and the private sector provides an example of how risk and cost sharing can work to develop a sustainable source of life-saving vaccines for low-income countries. A similar model was used with MenAfriVac®, the first meningococcal vaccine developed at an affordable price for African countries, where the burden of meningitis is highest.

Read PATH’s announcement about today’s publications here.

PATH collaborates on rotavirus vaccine activities with the CDC, WHO, UNICEF, vaccine manufacturers, and countries around the world. RotaFlash is funded by the GAVI Alliance.

For information on rotavirus disease and vaccines and to access the RotaFlash archives, please visit the website. For information on diarrheal disease, please visit DefeatDD’s website. For information on the GAVI Alliance’s support for rotavirus vaccine introduction, please click here.
Figure 1 derived from: World Health Organization. Estimated rotavirus deaths for children under 5 years of age: 2008, 453 000. January 2012. Available at: Accessed March 12, 2014.
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