Every year, India spends a whopping Rs 3.4 billion to treat rotavirus diarrhea. Yet, one lakh children die every year due to this severe infection in the intestinal tract caused by the rotavirus. With diarrhea being the third leading cause of childhood mortality in the country after birth complications and pneumonia, it is no surprise that India has the dubious record, along with Nigeria, for being responsible for 42 per cent of child deaths on account of diarrheal disease according to a recent Global Burden of Disease study. Even for the 32.7 lakh children who are taken to hospital annually due to several diarrheal episodes, a dark future awaits as the after effects include stunted growth and poor intellectual development.
“This is why we prioritise prevention and protection followed by treatment. Since diarrhea in infants is associated with teething, it doesn’t get taken seriously and by the time the children are brought, the diarrhea is severe. Rotavirus is the most common cause of severe diarrhea and is one of the foremost causes of under-five child mortality. But the good thing is that it is vaccine preventable,” Dr NK Ganguly, Advisor, Translational Health Science and Technology Institute, and former Director General of the Indian Council of Medical Research.
However, a majority of the 26 million underprivileged children continued to fall prey to this infection due to a lack of access to quality health care. Despite the presence of Rotateq and Rotarix, the two licensed rotavirus vaccines produced by private corporations Merck and GlaxoSmithKline respectively, they have been out of reach for many because of their high prices. The first move to bridge this gap came in 2016 with the launch of Rotavac, the first rotavirus vaccine indigenously produced by the government in partnership with Bharat Biotech.
In March 2016, the government included Rotovac in its Universal Immunisation Programme (UIP) after clinical trials showed it was able to reduce severe rotavirus diarrhoea by 56 per cent during the first year of a child’s life with continued protection in second year of life. It was the first time a rotavirus vaccine was included in UIP, Rotovac was rolled out initially only in Andhra Pradesh, Haryana, Himachal Pradesh and Odisha. In February 2017, it was extended to Assam, Madhya Pradesh, Rajasthan, Tamil Nadu and Tripura. But it is still not available in all the states yet.
Much of the success of this vaccine is dependent on its management by frontline health workers who must ensure the cold chain is maintained for the orally administered vaccine to be effective. This is has not been easy. Opportunities to improve immunization coverage and quality have been lost due to shortage of trained health workers, lack of accountability and, lack of coordination between state and central governments.
However, the production of a heat stable rotavirus vaccine which does not require refrigeration has come as a ray of hope for children. Launched by Serum Institute of India in November this year, Rotasiil is India’s second indigenously made vaccine and said to be the world's first thermostable rotavirus vaccine.
“In India there is problem of power outages and space for cold chain equipment. Transport and storage of vaccines at 2–8 degrees centigrade is a challenge. This vaccine overcomes all these problems. It can be stored at temperatures of 25 degrees or less. We found that not keeping in the cold chain does not have any adverse effect neither does the vaccine lose its efficacy,” said Dr Prasad S Kulkarni, Medical Director at Serum Institute of India.
According to Dr. M.K. Bhan, former Secretary, Department of Biotechnology, Rotasiil is a big win for the children of the country as it will support the government’s efforts to roll out the rotavirus vaccine across the country through its UIP.
A child needs a three‐dose course at 6, 10, and 14 weeks of age, and will get Rotasiil at the same time as routine vaccinations under UIP to get complete protection from rotavirus.
The Institute has received an order of 3.8 million doses from the government for immunization programme. While it will be supplied to the government at Rs 65 a dose, Rotasiil will be available in the private market at Rs 700–800 per dose, almost 25 to 30 per cent lower than GSK and Merck vaccines, according to the Serum Institute of India, one the world's largest producer of measles and DTP vaccines.
The trial to evaluate this vaccine in the Phase 3 efficacy study was conducted by Serum Institute in association with PATH, an international non-profit health organization.
Initiated in May 2014, it was carried out across six clinical sites that represented different climatic, geographical, and sociocultural environments. So a combination of urban and rural sites were chosen in Pune, Kolkata, Sewagram, Delhi, Manipal, and Jammu and 7,500 healthy infants aged between 6 to 8 weeks were enrolled for the trial. They were followed up for two years. During this time, the parents were provided with mobile phones to ensure prompt contact with the study team in case the infant develops gastroenteritis or any other illness. The parents were also given a diarrhea diary card to capture signs and symptoms of gastroenteritis including diarrhoea, vomiting, and fever and provided with a digital thermometer to monitor body temperature.
At the end of phase 3, the vaccine was found to be nearly 55 per cent effective against the most severe and potentially life threatening cases of rotavirus diarrhea, which has the highest risk of dehydration, hospitalizations, and deaths. “India has recorded more than 20 percent (47,100) of all the rotavirus deaths in the world. This makes vaccines crucial in the fight against the deadly diarrhea and dehydration caused by rotavirus,” said Neeraj Jain, India country programme leader, PATH.
While the vaccine ensures protection from rotavirus, children can still suffer from other milder forms of diarrhea. Therefore, it is crucial that breastfeeding, and good hygiene and sanitation practices continue to be followed by communities. According to Jain, 150 districts in India had become open defecation free. However, there were still many challenges before the country could attain the goal of eliminating diarrhea, he said.
“One huge challenge is the existence of inequities that exacerbate the vulnerabilities of the urban poor and tribal population. One glove does not fit all and there is an urgent need to upscale good interventions,” pointed out Paul Francis of World Health Organisation (WHO).
One such good initiative has been implemented by Save the Children, a not for profit working for child rights, under its Stop Diarrhea Initiative. Based on a seven-point plan proposed by WHO and UNICEF for prevention and control of diarrhea, it has managed to motivate the community to end open defecation in Gauridut Purwa, one of the most backward hamlet in Payagpur block of Bahraich district in Uttar Pradesh. This intervention has not only led to the use of community managed toilets constructed by the organization but now the users collect small contributions from each household and buy soaps and other items needed to keep the toilet clean. They also discuss other health and hygiene issues like hand washing and immunization of children.
“If we practice the PPT (prevent, protect, treat) model supported by good communication strategies that inform and educate, we can achieve a lot. An integrated approach has to be adopted to defeat diarrhea,” said Dr OP Singh, team leader, Stop Diarrhea Initiative, Save the Children.
In Bihar’s Phulwari Sharief district, the focus has been to improve the quality of water with the help of women self help groups. “Sanitation around the water hand pumps is equally important to maintain hygiene. We set up hand washing stations at public places and schools and can see a visible change resulting from the change in behaviour,” said Tinni Sahwney, CEO, Aga Khan Foundation.
Data indicates that India's child diarrheal mortality rate is substantially higher than countries like Bangladesh and China. Diarrheal diseases are inextricably linked to malnutrition and stunting and India has the highest number of stunted children due to malnutrition. Unless there is a multi-sectoral convergence to make this a people’s movement, 12 lakh children will continue to die before their fifth birthday.