ROTAVAC

*Dr. H. R. Keshavamurthy

The Prime Minister, Shri Narendra Modi, launched the first indigenously developed and manufactured Rotavirus vaccine: 'Rotavac’, . This indigenously developed vaccine will boost efforts to combat infant mortality due to diarrhoea. 

Each year, diarrhoea caused by rotavirus results up to 10 lakh hospitalizations and kills nearly 80 thousand children under the age of 5 years. Besides causing emotional stress to the affected families, it also pushes many Indian families below the poverty line and also imposes significant economic burden on the country.

        What is Rotavirus infection?

Rotavirus is the most common cause of severe diarrheal (gastro enteritis) disease in infants and young children globally. Children under five years of age, especially those between 6 months and two years are most vulnerable to this disease. Rotaviruses are estimated to be responsible for approximately 5, 27,000 deaths each year, with more than 85% of these deaths occurring in low-income countries in Africa and Asia, and over two million are hospitalized each year with pronounced dehydration.

Among 43 countries participating in the Global Surveillance Network for rotavirus in 2009, 36% of hospitalizations for diarrhea among children aged below 5 years were caused by rotavirus infection. Rotavirus affects populations in all socio-economic groups and is equally prevalent in industrialized and developing countries. So differences in sanitation practices or water supply are not likely to affect the incidence of the infection.

Rotavirus

 The name Rotavirus comes from the characteristic wheel-like appearance of the virus when viewed by electron microscope (the name rotavirus is derived from the Latin word Rota, meaning "wheel”). Rota viral diarrhea is an infection of the stomach and bowel. It spreads when infected children do not maintain proper personal hygiene. Virus spreads by contact or airborne route. Most cases of gastroenteritis in children are mild and usually pass within 3-5 days without the need for treatment. However, young children, particularly those under two years of age, are at risk of dehydration. So it is very important that they drink plenty of fluids. In severe cases of gastroenteritis, where there has been significant fluid loss, hospital treatment may be required so that fluid can be replaced through drips.

   The first rotavirus infection tends to be the most severe because the body builds up immunity (resistance) to the virus afterwards. This is why these types of infections are extremely rare in adults. It is estimated that every child will have at least one rotavirus infection before the age of five. Most infections occur among children aged between three months and three years old.

Indian Scenario

In India, nationally representative data on the incidence of severe rota virus disease is lacking. However, studies have revealed that on an average 34% of all diarrheal hospitalizations are due to rota virus infection and the proportion of severe rota viral infection has not decreased in the last few years, similar to the global trend indicating that improved sanitation and use of anti-biotics have not been effective on rota virus. The prevalence of Rota virus in new born is high in India to the extent of 73%, but these infections are normally a- symptomatic and the likelihood of acquiring infection increases with the length of stay in the hospital.

While some studies in India have found no association between rotavirus infection and time of year, most have observed an increase in rotavirus-associated diarrhea during the winter months, October to February, throughout the country. The observed proportion of rotavirus cases occurring in the cooler season has ranged from 59% to 72%.

Treatment & Prevention

No specific treatment exists for rotavirus gastroenteritis, and repeat infections are common in children. Since 2006, vaccines are available for rotavirus infection. Prior to the availability of a vaccine, almost all children became infected with rotavirus by their third birthday. Repeat infections with different viral strains were possible. After several infections with different strains of the virus, children acquire immunity to rotavirus. Adults sometimes get infected, but the resulting illness is usually mild.

Vaccination

Use of vaccine should be part of a comprehensive diarrhoeal disease control strategy including, among other interventions, improvements of hygiene and sanitation, administration of oral rehydration solution and overall improved case management.

The new vaccine ROTAVAC has been developed under an innovative public-private partnership model. It involved partnership between the Ministry of Science and Technology, the institutions of the US Government, various government institutions and NGOs in India, supported by the Bill and Melinda Gates Foundation. Funding by Government of India supported basic research in educational and scientific institutions in India. This was also supplemented by the support of U.S. Government institutions like the National Institute of Health. The Gates Foundation and Bharat Biotech India Limited contributed towards product development and testing. The successful launch of the first indigenously developed and produced vaccine today was the result of an extraordinary effort spread over the last 25 years. .

The Bharat Biotech India Limited that was involved in the development and production of the vaccine was selected in 1997-1998 by the India-U.S. Vaccine Action Programme and the standard government procedures. The company has given undertaking to keep the cost of the vaccine at US$ 1 per dose. This is the third such vaccine available globally against Rotavirus and, at the current prices, the cheapest and cost effective in terms of disability adjusted life year that satisfy the WHO/ UNICEF criteria for a cost- effective  intervention.

 ROTAVAC is an oral vaccine and is administered to infants in a three-dose course at the ages of 6, 10, and 14 weeks. It is given alongside routine immunizations in the UIP vaccines recommended at these ages.. Improving the overall performance of the immunization system is critical to the success of any vaccine introduction.

ROTAVAC represents the successful research and development of a novel vaccine from the developing world with global standards. The Prime Minister lauded this initiative as an example of India's capabilities for high-end research and development; manufacture of sophisticated pharmaceutical products in India; and, effective Public-Private-Partnership model for finding affordable solutions to societal challenges.

He hoped that the development of the rotavirus vaccine would inspire higher levels of research, development and manufacturing activities in India, not just in medical science, but also in other advanced areas of science and technology. On the launch occasion Prime Minister felt that solutions found in India would have great relevance to the rest of the world, especially the developing world.

 * Dr. H. R. Keshavamurthy is Director (M&C), Press Information Bureau, Kolkata.