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HEALTH-INDIA: Infant Deaths Cast Doubt on Vaccination Policy

Ranjit Devraj

NEW DELHI, Aug 27 2010 (IPS) - The deaths of four infants during a recent vaccination drive in Lucknow, capital of northern Uttar Pradesh state, has raised questions about the Indian government’s plan to introduce five-in-one vaccines in a countrywide immunisation programme.

Union health minister Ghulam Nabi Azad told journalists this week that “action would be taken against those found guilty of negligence.” He refused to speculate on the cause of the deaths, but said an investigation has been launched and would submit its report shortly.

Unconfirmed reports said the Lucknow vaccinations on Aug. 21 were carried out as a pilot project to test the efficacy of pentavalent vaccines. The health ministry is planning to introduce these vaccines into its Expanded Programme of Immunisation (EPI), to replace the standard triple vaccine now in use.

Pentavalent vaccines provide protection against hepatitis B and haemophilus influenza type B (Hib), that causes pneumonia and meningitis, in addition to the triple vaccine’s protection against diphtheria, pertussis and tetanus (DPT).

“We need to definitely know whether pentavalent vaccines were used in Lucknow,” Dr. Mira Shiva, an expert on pharmaceuticals and member of the Central Social Welfare Board, told IPS.

Shiva is part of a group of eminent doctors and public health experts who have filed a suit against the government’s use of pentavalent vaccines on the grounds of safety and higher costs saying it would still leave some 10 million rural children uncovered each year.

Members of the litigant group include: Prof. Debabar Banerji of the Centre for Social Medicine and Community Health, Jawaharlal Nehru University, Ritu Priya, advisor to the National Rural Health Mission, K.B. Saxena, former union health secretary, Gopal Dabade of the non-profit Drugs Action Forum and Jacob M. Puliyel, paediatrician at St. Stephens hospital in Delhi.

The experts have argued that pentavalent vaccine costs about eight dollars per dose, while the trivalent DPT inoculation costs just three cents, and is manufactured in the country.

What has really strengthened the case of the petitioners is that the pentavalent vaccine has been linked to infant deaths in neighbouring countries like Pakistan, Sri Lanka and Bhutan which accepted them on advice from the World Health Organisation (WHO).

The petitioners submitted in the Delhi High Court on Feb. 3 that the government had not conducted proper evaluations of the vaccine, and were acting in a “disjointed and uncoordinated manner” under pressure from the WHO. They warned that introducing the vaccine would invite “disaster for immunisation in the public health system.”

Pentavalent vaccines were launched in Bhutan in September 2009 but their use was suspended Oct. 23, three days after five infants died at the referral hospital in the capital Thimphu. Four more infants died soon after being vaccinated, in the towns of Samtse and Paro.

A joint investigation by the Bhutanese government, WHO and UNICEF from Oct. 29 to Nov. 24 concluded that the pentavalent vaccine did not cause the deaths.

However, the independent Bhutan Observer newspaper reported on Aug. 6 that Thimphu would not reintroduce the vaccine until June 2011 “due to the inability of national experts to establish the true cause of death in each case.”

Sri Lanka withdrew pentavalent vaccines in April 2008 after 25 adverse reactions and five deaths, but reintroduced them this year after the WHO declared the vaccine as “unlikely” to be fatal. Pakistan, which reported three deaths, has also reintroduced the vaccine on WHO assurances.

Dabade and Puliyel, who closely studied the WHO report on Sri Lanka, told IPS that the global body had tweaked protocol while writing it. “WHO usually has six classifications for adverse effects following immunisation – certain, probable, possible, unlikely, unrelated and unclassifiable. But the report removed the ‘probable’ and ‘possible’ categories and classified the Sri Lankan deaths under the ‘unlikely’ category,” they told IPS.

By changing its own criteria, the WHO had become open to the charge of orchestrating an “elaborate cover up.” This should be an eye-opener for the Indian Council of Medical Research (ICMR) which has recommended that pilot studies of the vaccine should be carried out, they added.

Puliyel has also questioned the value of introducing Hib vaccines “in all routine immunisation programmes”, a recommendation by the WHO which has been accepted by India’s National Technical Advisory Group on Immunisation (NTAGI).

“WHO recommends that the Hib vaccine should be universally included in immunisation programmes, irrespective of a particular country’s disease burden or the natural immunity within the country against (the infection),” Puliyel said.

As far as India is concerned, Puliyel said, it was unfortunate that NTAGI chose to overlook studies carried out by the ICMR at Vellore in South India. These studies showed the incidence of pneumonia requiring hospital care from all causes, including Hib, was a low three in 100 while that of meningitis was just two in 100.

Puliyel added that in the West, the vaccine may have reduced the incidence of Hib disease but led to “a proportionate increase in non-Hib strains of H. influenzae.”

“The fact that this push and pull over vaccines is happening when alarm bells are sounding over how vaccine manufacturers influenced WHO decisions during the recent swine flu scare, does not inspire confidence,’’ Dabade commented.

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