With all major vaccine manufacturers either introducing or planning to introduce HIB meningitis vaccine in the country, the complaints raised by a section of medical experts on the irrelevance of promoting the vaccine without adequate proof of its necessity, is demanding serious attention.
The expert opinion, raised in a paper published in "Expert Rev. Pharmaconomic Outcomes Res 5 (5) 2005," suggests an alleged internationally funded research build-up over the last few years to promote the interest of vaccine manufacturers. The research paper said that the incidence of Hib disease in Asia is very low - six in 100,000 compared with 109 in 100,000 in the Western Pacific. It said that the thrust of Hib research was to convince health planners that Hib was a major problem that had gone unrecognized due to poor microbiologic facilities and the technical inability to culture the organism.
Criticising the supportive attitude of the Union government and the World Health Organisation (WHO) in asserting the seriousness of Hib disease in the country, the paper said that the opinion was against the available proof. "An invasive bacterial infections surveillance group study performed over 4 years, in six large referral hospitals in India, employed sophisticated culture techniques to isolate the organism. These studies revealed a remarkably low incidence of Hib disease. Not convinced, the WHO undertook a large population based study. The study found the incidence of Hib disease at nine per 100,000. It merely confirmed the low incidence of Hib", the paper stated. It also noted that though WHO completed the study in 2002 and the findings presented at a conference but it was not published. "Research designed to promote the interest of vaccine manufacturers, and its selective publication, make health planners look at health economic evaluations with skepticism," it said.
Dr Rajiv Arora and Dr Jacob M Puliyel, authors of the paper, further argues that any demand for inclusion of Hib under universal immunization programme of the central government should therefore be dealt with caution.
Dr Jacob said that the argument blatantly used to try to make vaccine universal is that the price of the vaccine can come down if its uptake can be increased. "Data from overseas are misleadingly extrapolated to the Indian population to convince the government to underwrite the vaccination programme," he stated.
It should be noted that major initiatives in Indian vaccine development are backed by organizations like WHO, GAVI, Bill & Melinda Gates Foundation, etc. Some of the prominent ones which are at various stages of development include anthrax, HPV, HIV, typhoid, Japanese encephalitis, malaria, cholera, rotavirus, Hib meningitis, and improved versions of TB vaccine, and others. Wyeth Lederle, GSK, Serum Institute, Shanta Biotech, Bharat Biotech, Panacea Biotec are all having active interest in Hib vaccine.
The WHO's stated position on Hib vaccine is that all commercially available Hib conjugate vaccines are all of known good quality. "The indication for the use of these vaccines is protection of children below five years of age, particularly infants. WHO encourages the introduction of Hib vaccines worldwide. However, because of differences in epidemiology, health priorities and economic capacity, Hib vaccines will in practice be introduced at different speeds into national immunization programmes. The emphasis is on introduction in countries with the highest disease burden".