Rotavac, a fruit of global collaboration

Rotavac, a fruit of global collaboration

Rotavac, also known as 116E, has travelled a long way to reach its current status as a vaccine that is proven safe and effective in protecting infants ...

Rotavac, also known as 116E, has travelled a long way to reach its current status as a vaccine that is proven safe and effective in protecting infants against severe rotavirus diarrhoea. Interestingly, it is a product of an innovative international model of collaboration across agencies, sectors, continents and cultures. Over the years, the global team contributing to the development of Rotavac has included scientists and health experts from Department of Biotechnology (DBT), Indian Council of Medical Research (ICMR), Indian Institute of Science (IISc), All India Institute of Medical Sciences (AIIMS), National Institute of Immunology in India (NII), Society for Applied Studies (SAS)in India, Bharat Biotech International, Stanford University School of Medicine, the US National Institutes of Health (NIH), the US Centers for Disease Control and Prevention (CDC), etc. The idea for an Indian-based rotavirus vaccine sparked in the mid-1980s, when two different groups of scientists working in India discovered unusual strains of rotavirus that infected newborns in hospital nurseries. Dr M K Bhan, who later became the Secretary of DBT, was among the scientists at AIIMS who discovered one of these strains (116E) during his routine testing of newborns in New Delhi. He brought in Dr Roger Glass, a diarrhoeal expert working at the CDC's rotavirus laboratory, to join in the study of the strain. Meanwhile, Dr Durga Rao of IISc contacted Stanford University's Dr Harry Greenberg, a rotavirus and vaccine expert, to collaborate on a discovery of a similar strain (I321) by his institute in newborns at hospitals in Bangalore and Mysore. The neonatal strains 116E and I321 showed much promise for use as vaccines because all of the infants naturally infected with these strains demonstrated a strong immune response to rotavirus when they were exposed to the pathogen again, meaning that they did not experience severe diarrhoea. For over two decades, the two independent research teams worked in parallel under the auspices of the Indo-US Vaccine Action Programme (VAP) to study the two different naturally occurring, weakened strains and develop new rotavirus vaccines for infants. In 2000, a consortium of partners including Bharat Biotech and others submitted a proposal to PATH, a non-profit body, and DBT for support to move the two vaccine candidates through production, testing, and surveillance. Through the Bill & Melinda Gates Foundation-funded Children's Vaccine Program, PATH joined the collaborative effort in 2001. Since then, PATH has provided technical assistance to Bharat Biotech and the consortium on issues like vaccine stability and the development of special harvesting techniques. Subsequently, the phase 1 trial was completed at AIIMS in July 2003 with no major adverse events reported. With trials on children and infants revealing that 116E strain provided greater immunity to the disease, the consortium discarded 1321 strain and instead focused on 116E which was later named as Rotavac. And the phase 1b/lla trials were concluded in February 2008 while the phase III trials which began in 2011 were conducted on 6,799 infants at three locations in New Delhi, Pune and Vellore. An independent group of experts served as Data Safety Monitoring Board (DSMB) for the Phase III study. At a meeting in February 2013, the DSMB determined that the trial met the highest standards for ethics and patient care, besides complying with international standards for good clinical practices. It concluded that the clinical trial results warranted an application for early licensure of Rotavac with the Central Drugs and Standards Control Organization headed by the DCGI. The vaccine is a true model of successful partnership between the United States and India. With the costs of the development shared by several partners, Bharat Biotech has agreed to fix price of one dose of the vaccine at $1(nearly Rs 54/dose).
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