The Government of India’s Department of Biotechnology (DBT) and Bharat Biotech announced positive results from a Phase III clinical trial of a rotavirus vaccine developed and manufactured in India. The clinical study “demonstrates for the first time that the India-developed rotavirus vaccine is efficacious in preventing severe rotavirus diarrhoea in low-resource settings in India.”  DBT Secretary Dr K. Vijay Raghavan commented, “This is an important scientific breakthrough against rotavirus infections, the most severe and lethal cause of childhood diarrhoea, responsible for approximately 100,000 deaths of small children in India each year. The clinical results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India.”

The vaccine was developed through a unique social innovation partnership that brought together the experience and expertise of Indian and international researchers as well as the public and private sectors. The vaccine originated from an attenuated (weakened) strain of rotavirus that was isolated from an Indian child at the All India Institute of Medical Sciences in New Delhi in 1985-86. Since then, partners have included DBT, Bharat Biotech, the US National Institutes of Health (NIH), the US Centers for Disease Control and Prevention (CDC), Stanford University School of Medicine, and the nongovernmental organization, PATH.

The randomized, double-blind, placebo-controlled Phase III clinical trial enrolled 6,799 infants in India (aged six to seven weeks at the time of enrollment) at three sites—the Centre for Health Research and Development, Society for Applied Studies (SAS) in New Delhi; Shirdi Sai Baba Rural Hospital, KEM Hospital Research Centre in Vadu, Pune; and Christian Medical College (CMC) in Vellore…
Full announcement: http://www.defeatdd.org/sites/default/files/node-images/ROTAVAC%20press%20release_FINAL_0.pdf
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   Results of the ROTAVAC Rotavirus Vaccine Study in India – Statement of Anthony S. Fauci, M.D.
Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health
Excerpt
We congratulate the Program for Appropriate Technology in Health (PATH), Bharat Biotech International, Ltd., and the scientists, government and people of India on the important results from the ROTAVAC rotavirus vaccine study.

Highly contagious rotaviruses are the leading cause of severe diarrheal illnesses among infants and young children in both developed and resource-limited countries. Each year, rotavirus-induced diarrheal disease kills roughly 435,000 children younger than 5 years old and hospitalizes an estimated two million children worldwide, largely in developing countries. The youngest children — those between 6 months and 2 years of age — are most vulnerable.

Since 2006, two oral rotavirus vaccines have been licensed and available in North and South American, European and Eastern Mediterranean countries, where they have significantly reduced the burden of rotavirus-induced diarrhea. Based on that success, the World Health Organization recommended in 2009 the inclusion of rotavirus vaccine in all national immunization programs. However, access to vaccines can be slow and limited in the areas of the world where they are needed most.

ROTAVAC is a new rotavirus vaccine that consists of a strain of the virus that was isolated, manufactured and tested in India. The ROTAVAC trial represents a significant victory for India’s scientific community. Based on the study’s successful findings, infants in India will gain access to a licensed vaccine and its significant protection against severe rotavirus-induced gastroenteritis.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, was a partner in the public/private collaboration to develop and test this important vaccine. In the early 1990s, NIAID established an interagency agreement with the Centers for Disease Control and Prevention, and made several grant awards through the NIAID Indo-U.S. Vaccine Action Program….
Full media release: http://www.nih.gov/news/health/may2013/niaid-14.htm
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PATH congratulates the government of India’s Department of Biotechnology and Bharat Biotech on their release of positive phase 3 clinical trial results for ROTAVAC®, the first efficacious rotavirus vaccine to be developed exclusively in India. Results demonstrate the vaccine successfully protects against rotavirus infections, one of the most lethal forms of diarrhea in young children.

“The clinical study results showing ROTAVAC to be safe and efficacious are tremendously exciting,” said Steve Davis, PATH president and CEO. “This unique social innovation partnership, which brought together a consortium of scientists and experts from a range of agencies and sectors in India and the United States, provides a great collaborative model for meeting a public health need—a more affordable rotavirus vaccine…PATH is pleased and honored to have played a role in reaching this incredible milestone, and we congratulate all of the partners involved on these positive clinical trial results.”

PATH provided technical assistance to Bharat Biotech and the consortium on issues such as vaccine stability, the development of special harvesting techniques, using cleaner preparation methods, and designing and implementing clinical trials that meet international standards…

Full announcement: http://www.path.org/news/an130514-rotavac-results.php