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The authors point out that the pentavalent vaccine was withdrawn in Sri Lanka in April 2008 after 25 serious adverse reactions that included five deaths and Bhutan stopped its use within two months of introduction in July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