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Child Health

Five-in-one vaccine led to child deaths- experts (New Kerala-30 July 2010)

By Killugudi Jayaraman, Bangalore, July 29 - The pentavalent or the five-in-one vaccine that has been
recommended in India by the National Technical Advisory Group on Immunization actually killed
children in Sri Lanka and Bhutan, warns an article in the latest issue of the British Medical Journal
(BMJ).

The report by a group, including paediatricians, professors, health activists and a former Indian health
secretary, cautions against the introduction of the five-in-one vaccine that combines antigens against five
diseases - diphtheria, pertussis, tetanus (DPT), hepatitis B and Haemophilus Influenzae type B (HIB) - in
a single shot.

"Our article describes how the World Health Organisation (WHO), in an elaborate cover-up, changed its
own criteria for classifying adverse effects to say the vaccine was not responsible for the deaths in Sri
Lanka," Jacob Puliyel, head of paediatrics at St Stephen's Hospital in Delhi and key author, told IANS.

Former union health secretary K.B. Saxena, professors of community health in Jawaharlal Nehru
University in Delhi Debabar Banerji, Imrana Qadeer and Ritu Priya, co-conveners of All India Drug
Action Network Mira Shiva and Gopal Dabade and former adviser in finance ministry N.J. Kurian are the
other authors of the report.

The authors point out that the pentavalent vaccine was withdrawn in Sri Lanka in April 2008 after 25
serious adverse reactions that included five deaths and Bhutan stopped its use within two months of
introduction in July 2009 after eight deaths.

Bhutan has so far resisted pressure from WHO to restart immunisation but Sri Lanka reintroduced the
vaccine this year after a WHO expert panel, which investigated the events, declared that the vaccine was
'unlikely' to have caused the deaths.

The panel, however, could not conclusively attribute the deaths to any other cause.

However, Puliyel and co-authors who obtained the full report of the investigation say the WHO panel in
Sri Lanka did not follow the standard protocol of the UN agency for classification of adverse events
following immunisation but instead used its own method.

The authors point out that the Sri Lankan deaths would have been classified as 'very likely' or 'probably'
related to the vaccine, had the standard WHO classification been employed.

Changing its own criteria for classifying adverse effects following vaccination is "an elaborate cover up"
by WHO to remove any connection between pentavalent vaccine and the deaths in Sri Lanka, alleges
Puliyel.
The authors also ask the wider question whether this new classification of adverse events adopted for Sri
Lanka should be allowed to replace the standard WHO classification.

If so, deaths occurring following any vaccination will almost always be blamed on something else and not
the vaccine and "lives may thus be put at risk," they say.

The article also questions the need for HIB vaccine in the country, saying WHO's own studies have
shown that the incidence of the disease in India is lower than projected and studies elsewhere in Asia
show that the vaccine does not significantly reduce the burden of disease compared with placebo.

Another letter published in the same journal notes that there have also been three deaths in Pakistan -- one
child who died within half an hour of receiving the pentavalent vaccine and two others who passed away
within 14 hours of the administration.

"In no case was the vaccine blamed and no alternate cause of death was found for any of the deaths," says
its author S.K. Mittal, chairman of paediatrics department at Pushpanjali Crossway Hospital in
Ghaziabad, near Delhi.

Mittal says that although Pakistan reintroduced the vaccine on assurance from WHO that the deaths were
not related to it, "the large cluster of 'sudden deaths' in Asia, following immunisation with pentavalent
vaccine needs to be investigated dispassionately before more lives are lost".