The Government of India's Department of Biotechnology (DBT) and Bharat Biotech yesterday announced positive results from a Phase III clinical trial of a rotavirus vaccine developed and manufactured in India.
"We congratulate the Programme 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," Anthony S Fauci of National Institute of Allergy and Infectious Diseases (NIAID) said in a statement.
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 Organisation recommended in 2009 the inclusion of rotavirus vaccine in all national immunization programmes. However, access to vaccines can be slow and limited in the areas of the world where they are needed most.
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"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 statement said.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, was a partner in the public/private collaboration to develop and test this important vaccine.
We are deeply gratified to have played a role in establishing the safety and efficacy of the ROTAVAC vaccine.