Five-in-one vaccine led to child deaths in Sri Lanka - BMJ
July 29, 2010 03:01 pm
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The authors point out that the pentavalent vaccine was withdrawn in Sri Lanka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”.
IANS