HBV vaccine: need for debate

It is learnt that the central government is about to include Hepatitis B vaccination in the Expanded Programme of Imunisation. The Expenditure Finance Committee has recommended an allotment of Rs. 2,825 crore during the Ninth Plan for this purpose. This decision involves an annual expenditure of Rs. 565 crore, whereas the Central Government’s allotment in 1998-99 for control of malaria and tuberculosis was Rs. 290 crore and Rs. 105 crore receptively. In our view, the decision to commit hundreds of crores of rupees of taxpayers’ money is being taken without critically assessing the risk due to Hepatitis B virus (HBV) in the overall health scenario in our country; without estimating the cost-efficacy of this vaccine; without adequately studying its protective efficacy in Indian infants, and without seriously considering ways to substantially reduce the cost of the programme.

It is a matter of great concern that vaccine manufacturers have launched an aggressive and unethical campaign in favour of universal vaccination. As a result, HBV vaccination is being made almost compulsory in schools; doctors are being given one vial free for buying 10, and claims are made that Hepatitis-B is an important public health problem compared to AIDS. This campaign has been joined by politicians like Kirit Somaiya and Uddhav Thackarey. Many experts seem consciously or unconsciously unduly influenced by this campaign. The decision to include the HBV vaccine in universal immunisation is being taken at the behest of vested interests.

It is claimed that 4.7 per cent of the Indian population are HBV carriers, and 25 per cent of these carriers will die due to the effects of this carrier-status. Alternative, detailed estimates suggest that only about 1.4 per cent of Indians are carriers. Second, the majority of carriers eventually eliminate the virus from their body. Only a minuscule proportion develop cirrhosis or cancer of the liver in later years. Liver cancer takes 40 years to develop. As a result, untimely deaths due to the long term consequences of HBV are comparatively few. It is estimated that not more than 0.1 per cent of newborns in India today will eventually die of hepatitis B. (Seven per cent die of other diseases during the first year of life!)

Moreover, the vaccine is comparatively costly, reducing its cost efficacy when compared to other vaccines such as measles. It is more important to increase the budget for the control of tuberculosis, malaria and other more significant killer diseases, and only then to consider Hepatitis-B vaccination as a part of the childhood immunisation schedule. If HBV vaccination is introduced, the following cost-saving and effective measures must be considered:

Intradermal vaccination, which uses smaller doses, will reduce the vaccine cost by 80 per cent, and has been established to be as effective as intramuscular vaccination. Vaccine manufacturers and their experts are suppressing this fact.

Selective Immunisation: in countries like the UK and Japan, all pregnant women have their blood tested for the presence of the HBV’s surface antigen. Only the small proportion of surface antigen-positive mothers are followed up to have their babies immunised immediately after birth. A modified version of this strategy in India would selectively detect and immunise the most vulnerable and most infectious newborns born to “envelope-antigen positive” mothers. This strategy, would entail an annual expenditure one-sixth to one-twentieth of that required to immunise all newborns.

In consumers’ and the national interest, we demand that there be an adequate public debate on this issue in various fora, where experts present statistics which can be cross checked. Experts and consumer representatives from various organisations should be properly consulted before taking a decision on universal HBV vaccination. Guidelines also need to be formed and strictly implemented on the relationship between medical experts, medical conferences, and the drug industry.