Officials are pushing to include the pentavalent vaccine in India's universal immunization program despite concerns about its safety. The vaccine protects against five diseases but was linked to child deaths in Sri Lanka and Bhutan. Health activists have challenged the move, arguing that a WHO report clearing the vaccine was misleading and manipulated. The next court hearing on the issue is scheduled for July 30th.

1. NEWS
Officials push five-in-one vaccine
Pentavalent vaccine linked to child deaths in Sri Lanka, Bhutan; ball in high court
RAVLEEN KAUR dents would have been put in the prob- The health activists who petitioned
able category meaning they are probably the court last year said the government
THE Union health ministry is pushing linked to the vaccine. “The report, as of would have to spend Rs 350 on one dose
for the inclusion of the pentavalent vac- now, gives the impression that the vac- of the pentavalent vaccine against the Rs
cine in the universal immunization pro- cine had nothing to do with the deaths 15 it spends on one dose of DPT which is
gramme (UIP) for children. In April, the which is not true,” said Dabade. yet to reach 53 per cent of the rural pop-
government tried to convince the Delhi The report did not classify the ulation. The National Technical
High Court to clear the vaccine by sub- deaths as certain because one of the chil- Advisory Group of Immunization that
mitting a World Health Organization dren was malnourished and two others advises the ministry on vaccines had
(WHO) report that said there was no suffered from Reye’s Syndrome (genetic also recommended introduction of Hib
problem with the vaccine. The court is disorder affecting brain and liver). The in UIP. “They (the advisory group) com-
hearing an appeal by health activists question WHO should answer is whether pletely ignored the ICMR study in Vellore
challenging the ministry’s move on the the children would have died at that district which showed incidence of
grounds that the vaccine had killed chil- point of time even if they had not been pneumonia due to all possible causes
dren 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
AGNIMIRH BASU / CSE
deaths in Bhutan, though it has
removed the vaccine from its immu-
nization programme. WHO’s expert
group inquiry report on Sri Lanka said
there was no conclusive evidence to link
the vaccines to the deaths. WHO manipulated the standard protocol to
Activists said the WHO report on
deaths in Sri Lanka is misleading. The conclude deaths were not linked to the vaccine
experts manipulated the standard WHO
protocol while preparing the report, administered the vaccine, said Dabade. that required hospital attention was a
said Gopal Dabade, health activist with WHO did not respond to queries mailed low three in100, and that of meningitis
the Hyderabad non-profit Drugs Action by Down To Earth. was two in 100,” said Jacob Puliyel, pae-
Forum. WHO has six classifications for diatrician at St Stephens hospital in
adverse effects following immunization Rs 350 for one dose Delhi.
(AEFI)—certain, probable, possible, The Indian Council for Medical The petition also raised the issue of
unlikely, unrelated and unclassifiable. Research (ICMR) has recommended that public sector vaccine units in India
The expert group removed two cate- the pentavalent vaccine should be intro- shutting down (see ‘Out of stock’, Down
gories—possible and probable—and duced in select areas on a pilot basis. To Earth, July 15, 2009). The units were
put the deaths in the unlikely category. “This issue of change of classification reopened but will be forced to close
At the same time the report admitted never came to our notice,” said V M down since they do not have the capaci-
there was no conclusive evidence Katoch, director general of ICMR. The ty to manufacture pentavalent vaccine,
regarding an alternate cause for the latest edition of ICMR’s Journal of the activists said. But Katoch said the
deaths. Dabade said if the two classifica- Medical Research has an editorial dis- public sector units can manufacture the
tions had not been eliminated, the inci- cussing the deaths. vaccine, though that might take time. ■
14 Down To Earth • July 16-31, 2010