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IMA cautions against scaling up Hep B vaccination without adequate analysis of pilot study
Joe C. Mathew, New Delhi | Tuesday, June 6, 2006, 08:00 Hrs  [IST]

A systematic analysis carried out by Indian Medical Association (IMA) on the issues related to Hepatitis B vaccination has found the magnitude of the problem of Hepatitis B in India to be much lower than what has been officially perceived. The actual rate is just 2.1 per cent among the non-tribal population of the country as against the generally quoted 5 per cent, it is learnt.

The death rate from hepatocellular carcinoma was found to be very low as it constitutes just 1.6 per cent of all cancer deaths happening in the country. The findings may weaken the government stand to include Hepatitis B vaccination in the National Immunization Programme (NIP).

The soon-to-be-announced position document, which analyzed all available scientific literature, also pointed out that no proper evaluation was carried out on the outcome of the pilot Hepatitis B vaccination project carried out in 15 selected cities and 32 districts in 17 states of the country. Even-though the pilot study was meant to assess the real impact of Hepatitis B vaccination, no data was available to collate the evidence about the success of the project, the IMA study noted. The IMA observation goes against the reported claim made by the central government on the success of the pilot project and its plans to upscale the project on a national scale.

The IMA had tried to understand the proportion of newborns in the pilot cities who received 3 doses of hepatitis B vaccine, compare the carrier rate of Hepatitis B in children under 5 years of age in cities covered under the pilot project with that of its pre-pilot-project status and know the carrier rate among children who have not received birth dose compared to those who got the birth dose. Since no data was available to prove that vaccination starting at 6 weeks was efficacious, the IMA position document states that one cannot really defend the incorporation of Hepatitis B vaccination in NIP without analyzing these parameters.

The IMA sub-committee on Immunization, which prepared the position paper on "Issues Related to Hepatitis B Vaccination in India: Systematic Review of Literature" has concluded that the scaling up from a donor-funded pilot study costing Rs 27 crore to universal immunization that would cost Indian exchequer Rs 500 crore annually without proper analysis of the benefits of the pilot study would be irresponsible and difficult to defend.

The IMA position was let known at a national meeting of experts which included all major stakeholders like WHO, UNICEF, Health Ministry and professional medical associations. The observations made by IMA committee was endorsed by the experts, it is learnt.

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