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The medical journal The Lancet today published results from a phase 3 efficacy trial of ROTAVAC®, a new rotavirus vaccine developed in India. In follow-up to a May 2013 announcement about the study’s early results, the article includes more detailed data from the phase 3 study, which showed that ROTAVAC® significantly reduced severe rotavirus diarrhea by more than half—56 percent during the first year of life, with protection continuing into the second year of life. The vaccine’s efficacy compares favorably with the efficacy of the currently licensed rotavirus vaccines in low-resource countries.

ROTAVAC® 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. As a partner in the development of ROTAVAC® since 2001, PATH worked with the Indian Department of Biotechnology, the Society for Applied Studies, and Bharat Biotech on this phase 3 clinical trial. The history of this development journey is described in detail in a companion article also published by The Lancet today, highlighting the “team science” approach which combined the expertise and interests of highly diverse multinational groups of clinical and translational investigators with a common goal to develop a new rotavirus vaccine for India and the developing world.

In addition to these articles, The Lancet has published a related 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. They provide helpful context regarding how this collaboration across the public and private sectors, with partners sharing both risks and costs associated with ROTAVAC®’s development, could be viewed as an alternative model for developing new lifesaving vaccines for use in low-income countries.

An excellent safety and efficacy profile

The results of this phase 3 study provide a high degree of confidence in the efficacy of ROTAVAC®. The vaccine protected against rotavirus gastroenteritis of varying degrees of severity, with protection generally increasing with clinical severity. Moreover, ROTAVAC® also showed impact against severe diarrhea of any cause.

The randomized, double-blind, placebo-controlled phase 3 clinical trial was conducted in 6,799 infants in India (aged six to eight weeks at the time of enrollment). The infants received three doses of ROTAVAC® or a placebo at the ages of 6, 10, and 14 weeks. The vaccine was well tolerated when administered with other childhood vaccines, including oral polio vaccine. In addition, the vaccine demonstrated an excellent safety profile. The rates of adverse events observed in the trial were similar among those who received the vaccine and those who received the placebo.

The rotavirus strain that forms the basis of ROTAVAC® is unusual and rarely causes clinical disease in India or elsewhere. The successful protection demonstrated by the vaccine in this study across a broad array of commonly circulating rotavirus genotypes in India argues strongly that ROTAVAC® will provide protection throughout India and in other regions of the world.

Aiming towards global access

Bharat Biotech has submitted an application for the licensure of ROTAVAC® to the Drugs Controller General of India (DCGI), and initially the vaccine will be available for purchase by India’s private health care facilities. If the government of India decides to introduce the vaccine into the country’s Universal Immunization Programme, it will also be made 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. Once prequalified, the vaccine could be purchased by UNICEF and the Pan American Health Organization as a vaccine offered to countries eligible for receiving subsidized vaccines from the GAVI Alliance.

A collaborative vaccine development pathway

ROTAVAC® originated in India 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 1985–1986. Since then, partners have included the government of India’s Department of Biotechnology, the Society for Applied Studies, Bharat Biotech, the US National Institutes of Health, the US Centers for Disease Control and Prevention, Stanford University School of Medicine, and PATH. The vaccine development partnership was supported by the Department of Biotechnology, the Bill & Melinda Gates Foundation, the Research Council of Norway, and the UK Department for International Development. Bharat Biotech invested important technical, manufacturing, and financial resources towards vaccine development.

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Posted March 12, 2014.