The vaccine is expected to curb the incidence of diarrhoea among young children, which is responsible for 13% of all under-five deaths in India.
Swaminathan speaks about the importance of the vaccine, tuberculosis drugs and the need for innovative approaches to deal with under-funding of health research in India. Excerpts from an interview:
How significant is the launch of the rotavirus vaccine?
It is a very significant event because it is the first time that India is launching a vaccine that has been developed indigenously right from the initial stages. There were many partners and funding from many sources and eventually it was the Department of Biotechnology that took it up and got into partnership with Bharat Biotech to produce it for India. The role of ICMR is significant in the sense that ICMR had set up a network of rotavirus surveillance sites across India that have been functioning for 10 years now. So we have really good epidemiological data on diarrhoea and rotaviral diarrhoea and so now once the vaccine is introduced, the same network will be able to provide data on the impact that the vaccine is having in terms of reducing morbidity and mortality.
The efficacy of the vaccine is 50-60%. Is that a good efficacy rate or are we looking to improve upon that?
It can certainly be better because 50-60% is not the ideal efficacy rate. And so there is research underway to improve efficacy because one of the observations that has been made is that the efficacy of oral vaccines is generally lower in India than it has been in developed countries -- the same had been observed with polio also. The exact reason is not known, but it could be related to the high rate of enteric infections (related to the intestines) that children here have. People are looking at various strategies to increase the efficacy of the vaccine and of course there are people who are looking at different vaccines also. So maybe in the future better vaccines may be available. But at this point in time, we have a good, cost-effective vaccine.
There was a lot of controversy regarding the rotavirus vaccine in India. Some experts say that the data wasn’t shared properly?
The thing is, when you do a large multi-centric trial, the data has to be seen holistically. Normally in multi-centric trials, you do not analyse the data by site because when you work out the sample size and the power of the study, it is done keeping in mind the overall number. So if you really want to study, for instance, the differences between Delhi and Chennai, then you need to have enough number of children in each site. In this efficacy study, that was not done, so it is not reasonable to suggest that we should analyse site by site. To address the concern of intussusception (folding of intestine, which can be fatal), there will be an intensified surveillance for rotavirus at selected sites. Within 6 months or a year, we’ll have data one whether there is increased risk of intussusception.
The new TB drug Bedaquiline will be available to only 600 patients while there are 75,000 new cases of drug resistant TB in India annually. Isn’t there a discrepancy there?
First of all, this drug has not gone through a clinical trial and therefore there has not been a lot of experience with it in terms of its safety. Cardiac toxicity (damage to heart by harmful chemicals) is one of the things that has been described with this drug. So, the talk is that ‘let’s get experience in 500-600 people first and then we can scale it up’. The second thing is the cost again. Initially it will be available through a grant for a few thousand patients. After that India will have to buy the drug from the company for which each course costs ₹ 1 lakh per patient.
So there will be no trial?
A global trial is planned and India is part of it. The trial will try to shorten TB treatment to six months using Bedaquiline and other drugs. The trial should start in the next two-three months in Chennai and Ahmedabad. Drug Controller General of India has already approved it. So far the drug seems to be fairly safe.
In a recent conference you warned that zoonotic diseases, or diseases derived from animals, are likely to rise in the future. Why is this the case?
Most of the infections in humans are coming under control, primarily because of immunization and other measures we have undertaken. So, newer organisms will start infecting us. Diseases like small pox and polio have been brought under control. But there are always new threats. Viruses mutate. A virus that does not cause any infection today may become infectious after mutation. Many viruses reassert -- that is, they combine with a similar virus and become virulent. Zoonotic viruses have that history, be it HIV or ebola.
You had said ICMR is under-funded and cannot meet its research requirements. Has the new budget addressed it?
It definitely has. But for the future we have to look at ways of working more innovatively, rather than waiting and expecting funds to flowing. We realize we can do a lot in partnerships and thus share costs.
What we are thinking is that we’ll start working in partnership with other organizations like the department of biotechnology, ministry of AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy) and ministry of health and family welfare. Thus, we will be able to synergise our activities.
You also spoke about the rural health budget. What exactly has happened in that space?
In rural we have got one scheme under rural research, that is the model rural health research units. Fifteen of them have been sanctioned and 12 have already been given funds. They have either started or are starting very soon. They will offer a very good platform for rural research in India. They will be well equipped and staffed and will be well-connected to the nearby primary health centre or community health centre. They will also be mentored by a local medical college. They will be able to do investigations which primary health centres could not earlier. One mandate is point of care diagnostics in rural areas. Roughly ₹ 100 crore has been allocated for the scheme under the 12th five-year plan.