Debate rages on HIB vaccine

 
By Vibha Varshney
Published: Monday 15 October 2007

the Union ministry of health and family welfare has given the go-ahead for including an expensive vaccine into the country's immunisation programme despite the absence of scientific data. A meeting of the national technical advisory group on immunization (ntagi) held in July 16, 2007, decided that Haemophilus influenzae b (hib) vaccine would be included in the country's health programme after introducing it in a few states first.

"We do not have any data on hib vaccine and its use in India," accepts an official from the health ministry. Indian Council of Medical Research (icmr) also accepts there is limited data. icmr, however, is in favour of the vaccine's use. "The vaccine's use in developing countries has resulted in significant reduction in the disease," says Ambujam Nair Kapoor, the council's deputy director general.

The need for the vaccine has been debated for long. Lack of facilities to culture the bacterium is among the reasons for the lack of data. To allay the fears and to assess the vaccine's need, hib Initiative sanctioned a probe study in India in December 2005. The initiative was launched by gavi Alliance (alliance of major stakeholders in immunisation programmes). It was a joint venture between icmr and Johns Hopkins University, usa. However, the probe study had to be stopped because the who came up with a position paper on hib in November 2006 saying everyone needed the vaccine.

According to norms, it would have been unethical to continue with the probe study because it required that half the people taking part in it would not be vaccinated. who, in its paper, says that "the lack of local data on disease burden should not delay the introduction of hib vaccines, especially in countries where overwhelming regional evidence points to a high burden. In such countries, data from comparable neighbouring areas should be considered sufficient evidence of the local situation".

But hib does not travel across borders in ways that would require vaccinating entire regions. Jacob Puliyel of St Stephens Hospital, Delhi, says the position paper is factually wrong because it does not use data from India. "who chooses to extrapolate convenient data," he says. For instance, a study carried out in Bangladesh suggests the vaccine is extremely effective. The study, published recently in Pediatric Infectious Disease Journal, met with resistance as reduction of the disease in the control group was only found in cases where the group was significantly richer and lived in better houses.

Ajay Gambhir of the Indian Medical Association says the procedure of introducing the vaccine is not correct. "These decisions should be made on the basis of data on disease burden. If we go ahead with introducing the vaccine without data, others will follow," he says.

The cost issue will also have to be dealt with. "The vaccine's cost will be negotiated. The price will be lower than current prices because India is eligible for funding from gavi," says Lois Privor-Dumm, director, communication strategy, Johns Hopkins Bloomberg School of Public Health, Baltimore, us.

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