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The 2005 action plan of the up government to deal with je mentions vaccines almost as a footnote. Now, after many high-profile visits of politicians of various ilk to the affected areas, suddenly, "vaccines" have become the sure-fire solution to eastern up 's ills. The cry to make more vaccine doses available in the state is today almost universal.
The World Health Organization has approved only one vaccine: that derived from mouse brain infected with the virus. This was first licensed in Japan in 1954, and is in production in India, South Korea, Taiwan, Thailand and Vietnam. Its sole manufacturer in India is the Central Research Institute (cri) in Kasauli, Himachal Pradesh, run by the Union ministry of health and family welfare.
Vaccine making is a cumbersome, eight-month-long process.A strain of je virus is injected into the brain of mice and allowed to multiply for four days. Thereafter, the brain in taken out and the virus separated. The virus is then inactivated -- killed. This takes about 40 days. The vaccine is then purified and checked for quality parameters over two months. Then it is sealed and freeze-dried.
cri's current capacity is 500,000 doses every eight months. It is trying to increase this to one million. Increasing to five million is likely to take two years. As a single mouse provides two doses, the institute will need 2.5 million mice. The existing stock of mice cannot be bred fast enough to meet that target. Moreover, mice need to be kept in a controlled environment to ensure quality. This would require 300 additional rooms to house the cages and 300 additional employees -- one person can attend to 250 cages with three to four mice each. Rooms require land. Thus, the je vaccine business is unprofitable for private companies (but see box: Should India import vaccines?).
K P Kushwaha, pediatrician in charge of the epidemic at brdmc, says the actual number of vaccines needed to cover all children in Gorakhpur is 40 million. up chief minister Mulayam Singh Yadav has sought Central approval to import only 7.5 million doses. Such permission isn't really necessary, for health is a state subject in India. The up government, quite clearly, wants to avoid accountability in purchasing vaccine.
The state government has issued contradictory statements at various points in time about funding vaccine import. It has expressed willingness to pay for the imports, at the same time asking the Centre to provide funds because cri failed to meet demand. It's another matter that cri wasn't paid for the vaccine they provided earlier. The institute has written off payments due from various state governments. It now supplies only as much as the states are willing to pay for. up has received about 100,000 vaccine doses in 2005. But a look into the vaccine delivery record raises serious doubts about the state government's ability to deliver vaccine to people, even if it has all the doses it needs.
cri began to produce the je vaccine in 1987. Pipraich block of Gorakhpur was one of the first places it was tried out, in 1988, with help from brdmc's community health department. 4,342 people in the 3-25 years age group got the first dose. Of them, 3,164 got the second dose, and 2,267 the booster shot. Blood samples were taken before and after vaccination. Tests showed 85 per cent people had successfully developed antibodies. During the 1988 epidemic, vaccinated people were unaffected. Though the results were encouraging, the sample size was too small for definitive analysis. A larger pilot project was needed.
That came in 2002. The health department provided 40,000 doses to Gorakhpur district. These were delived in 12 sub-centres of Chargawan, one of the worst-hit blocks. The physician at the primary health centre was willing to take the risk of trying them out, when other physicians were reluctant. 12,859 children in the age group of 5-15 years were given the first dose; 12,800 got the second dose; 11,293 got the booster dose. People involved in the project say the results were promising. But why did the project omit children below 5 years of age? Because the immunisation drive up launched in 2004 focused only on children in the 1-3 years age group.
This is a puzzle. The 1988 project was for 3-25 years, the 2002 project was for 5-15 years, and the 2004-2005 immunisation drive was for 1-3 years. The basis of these decisions is unclear. And after receiving flak for mismanagement this year, the government is unwilling to share the paperwork on this.
The only details they are willing to share are the number of people who have been administered vaccines. In 2004, children of 1-3 years in Gorakhpur and Kushinagar districts were given two rounds of the vaccine, and the booster dose is being given in 2005. All blocks of Gorakhpur, except Gola and Derwa, were included in this drive. 145,980 children got the first dose, 140,519 got the second, and 107,728 the booster shots. Despite this, many children 1-3 years old are reporting the disease: brdmc data shows that by September 22, 220 children below 2 years and 420 children under 5 years came there. This data hasn't been broken up regionwise, so it isn't clear if the 1-3 years cases are from blocks where vaccination was carried out. Is the government vaccination data true?
Social groups working in Gorakhpur say vaccination hasn't been carried out. Shiraz Wajih, president of the Gorakhpur Environmental Action Group, posed this question to a gathering of village folk from Sardar Nagar and Compierganj blocks. Nobody had heard of je vaccination. R N Yadav, a practising physician in Sardar Nagar, told Down To Earth that, to his knowledge, no vaccination had been carried out. To check this out on the village level, Down To Earth visited Sarai Guleria village (also called Saraiyya) in Chargawan block, which was covered in the 2002 project as well as the 2004-05 drive (see box: The mystery...). Even if only some children got left out and people are generally unaware of what goes on in the village, this is a violation of the research guidelines of the Indian Council of Medical Research: in case of a pilot project, villagers have to be expressly informed.
Microbiologist T N Dhole of Lucknow laments the lack of documentation on the vaccination drives: "Show us a child who has been vaccinated and we will check for antibodies in the blood to see if it has actually been vaccinated." As urgent as the need to import vaccine is an investigation into how up conducts its immunisation drives. In this, up will do well to look at how other endemic states cope. Andhra Pradesh's efforts have drawn appreciation (see box: Ability to deliver). Perhaps a more in-depth enquiry is essential before projecting Andhra as a model of je control. But one thing is certain: up is a model of how not to control je.