The Centre has decided to start a comprehensive two-year feasibility and efficacy study all over the country before the inclusion of hepatitis B vaccination under the Universal Immunization Programme (UIP). According to highly placed official sources in Pune and Delhi, the universalisation of hepatitis B vaccine will have to wait till the national study gets over.

The Union Ministry of Health and Family Welfare department has received the formal approval on January 9, 2002 on funding of the projects by Global Alliance for Vaccines & Immunization (GAVI), an alliance of WHO, Unicef and other donor agencies. Our Delhi bureau had reported on August 16, 2001 that GAVI had agreed to allocate a sum of Rs 30 crore as initial contribution.

The study will be conducted in 32 districts and 15 urban areas, it is learnt. In the study, the government will explore the feasibility of including the hepatitis vaccination in the current immunization schedule, whether the UIP will be able to take this additional load, whether the vaccine protect against the disease, and understand the financial implications of the vaccination projects when done on a national scale. Vaccinations are usually done free under the government-sponsored national immunization programmes but vaccine manufacturers get paid for the vaccine stocks the government takes from them after the tender process.

An industry source said India's UIP requirement is said to be 75 million doses per annum. Pharma companies appear keen to participate in the pilot projects all over the country. The inclusion of hepatitis B vaccine in the immunization schedule is significant, as it would mean tendering for vaccine supply. This entails huge orders for pharma companies who would like to make the most of it.

India's number one hepatitis B vaccine maker, Wockhardt Ltd is shortly expected to ramp up their production lines to 100 million doses of the recombinant vaccine per annum. According to a company source, it would definitely participate in the pilot projects this year.

According to some leading medical experts, almost 95 per cent of hepatitis patients recover completely and the fatality rate is very low in India. Indian researchers have suggested that the utility of vaccination be studied with the help of proper epidemiologic data. The weighted prevalence of hepatitis B in India has been estimated to be 4.7 per cent, which makes India an intermediate prevalence country.

Medical experts are of the opinion that unless the prevalence rate in adults is clearly known, no one can say whether India requires universal immunization with hepatitis B vaccine or not. So far no studies have been conducted in this country in this respect.