Even as India is considering inclusion rotavirus vaccine in its national childhood immunisation programme against rotavirus diarrhoea, experts in the field have criticised the government move on the plea that “careful evaluation of available evidence does not support the launch of the programme in India. It will divert funds from more life saving interventions and could cause harm”.

Questioning the evidence used to support the vaccination, Jacob Puliyel, consultant paediatrician, St Stephen’s Hospital, Delhi and Joseph Mathew, associate professor, Advanced Paediatric Centre, Postgraduate Institute of Medical Education and Research, Chandigarh in their article in British Medical Journal wrote that the programme to immunise all the world’s children with the rotavirus vaccine is based on mistaken assumptions.

Putting across the argument that natural infections not protective in India, the two experts said that the local rotavirus strains in India are different from those in other regions like Mexico. Studies have shown that two episodes of natural infection in India, unlike in Mexico, afford little protection against subsequent infections, perhaps because of the rapidly evolving strains. Given that these data contradict the Mexico data that was used as evidence for launching universal vaccination, urgent reappraisal of the recommendation is warranted.

Contradicting GAVI Alliance's plea that rotavirus vaccination is a key step towards lowering child mortality, the experts said “The estimate of deaths from rotavirus was arrived at by multiplying the mean rotavirus detection rate in a country by the diarrhoea case fatality rate, assuming a uniform mortality rate for all causes of diarrhoea. This is inappropriate for two reasons. Firstly, deaths from rotavirus infection can be prevented by simple measures to correct dehydration. Bacterial diarrhoea, on the other hand, is more often associated with sepsis and systemic complications and is likely to have a higher mortality. Secondly, in up to 58 per cent of cases positive for rotavirus there is coinfection with other pathogens. Attributing all deaths to rotavirus whenever the virus is isolated overestimates rotavirus mortality. To promote the uptake of expensive vaccine, GAVI often supplies vaccines to developing countries at highly subsidised rates for a limited period. Later, the subsidy is withdrawn and poor countries have to pay the full market price. In this manner they are often unfairly lured into a debt trap. Developing countries must estimate affordability and cost- benefits of vaccines against the market price at which it will be available to them in the long term. In India, vaccinating the birth cohort of 25 million with a vaccine that costs $14/child (two doses) would cost $350m. The entire immunisation budget for 2011- 12 was $240m, the experts said.

Inclusion of rotavirus vaccine in the national immunisation programme is a long term and binding commitment. It must be based on hard nosed, pragmatic evaluation of the evidence. The commercial interests of the manufacturers must not be allowed to influence decision making. Unfortunately the existing evidence does not support the inclusion of current rotavirus vaccines into the immunisation programme in India, Jacob Puliyel and Joseph Mathew in their article wrote.