Pentavalent vaccine linked to child deaths in Sri Lanka, Bhutan; ball in high court
THE Union health ministry is pushing for the inclusion of the pentavalent vaccine in the universal immunization programme (UIP) for children. In April, the government tried to convince the Delhi High Court to clear the vaccine by submitting a World Health Organization (WHO) report that said there was no problem with the vaccine. The court is hearing an appeal by health activists challenging the ministry’s move on the grounds that the vaccine had killed children in Sri Lanka and Bhutan. The next hearing of the case is on July 30.
The pentavalent vaccine is meant to protect children against hepatitis B and haemophilus influenza, type B (Hib) bacteria that causes pneumonia and meningitis. The vaccine also prevents diphtheria, pertussis and tetanus (DPT) that are already covered under UIP.
WHO report misleading
Five children had died in Sri Lanka in 2008 and eight in Bhutan in 2009 after they were administered the pentavalent vaccine. There is no final report on deaths in Bhutan, though it has removed the vaccine from its immunization programme. WHO’s expert group inquiry report on Sri Lanka said there was no conclusive evidence to link the vaccines to the deaths. Activists said the WHO report on deaths in Sri Lanka is misleading. The experts manipulated the standard WHO protocol while preparing the report, said Gopal Dabade, health activist with the Hyderabad non-profit Drugs Action Forum. WHO has six classifications for adverse effects following immunization (AEFI)—certain, probable, possible, unlikely, unrelated and unclassifiable.
The expert group removed two categories— possible and probable—and put the deaths in the unlikely category. At the same time the report admitted there was no conclusive evidence regarding an alternate cause for the deaths. Dabade said if the two classifications had not been eliminated, the incidents would have been put in the probable category meaning they are probably linked to the vaccine. “The report, as of now, gives the impression that the vaccine had nothing to do with the deaths which is not true,” said Dabade.
The report did not classify the deaths as certain because one of the children was malnourished and two others suffered from Reye’s Syndrome (genetic disorder affecting brain and liver). The question WHO should answer is whether the children would have died at that point of time even if they had not been administered the vaccine, said Dabade. WHO did not respond to queries mailed by Down To Earth.
Rs 350 for one dose
The Indian Council for Medical Research (ICMR) has recommended that the pentavalent vaccine should be introduced in select areas on a pilot basis. “This issue of change of classification never came to our notice,” said V M Katoch, director general of ICMR. The latest edition of ICMR’s Journal of Medical Research has an editorial discussing the deaths.
The health activists who petitioned the court last year said the government would have to spend Rs 350 on one dose of the pentavalent vaccine against the Rs 15 it spends on one dose of DPT which is yet to reach 53 per cent of the rural population. The National Technical Advisory Group of Immunization that advises the ministry on vaccines had also recommended introduction of Hib in UIP. “They (the advisory group) completely ignored the ICMR study in Vellore district which showed incidence of pneumonia due to all possible causes that required hospital attention was a low three in100, and that of meningitis was two in 100,” said Jacob Puliyel, paediatrician at St Stephens hospital in Delhi.
The petition also raised the issue of public sector vaccine units in India shutting down (see ‘Out of stock’, Down To Earth, July 15, 2009). The units were reopened but will be forced to close down since they do not have the capacity to manufacture pentavalent vaccine, the activists said. But Katoch said the public sector units can manufacture the vaccine, though that might take time.
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