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New Delhi, Aug. 20: The
health ministry breached standard procedures and immunised
nearly nine million children in four states with a Chinese-made
vaccine against Japanese encephalitis (JE) without human
safety studies of the vaccine in India.
Contrary to claims by health officials
that a consensus had emerged to immunise children with the
vaccine before the monsoon, top medical scientists had questioned
the wisdom of rushing into mass immunisation without local
safety and efficacy studies.
As the immunisation campaign progressed
from May through July this year across 11 districts of Uttar
Pradesh, Assam, Bengal and Karnataka, officials recorded
504 adverse reactions and 22 deaths among the immunised
children.
Health officials have described
the deaths as “coincidental events” that had nothing
to do with the vaccine. They said local safety studies were
not necessary because there was abundant data on the vaccine’s
safety from China where it has been used for 18 years on
more than 200 million children. South Korea and Nepal have
also used the vaccine, and a scientific advisory body to
the World Health Organisation had last year described the
vaccine as showing “excellent safety and efficacy”.
The decision to use the Chinese
vaccine followed an outbreak of JE in eastern Uttar Pradesh
last year that had killed more than 1,800 children. “We
exercised diligence and took into account the experience
of other countries,” Prasanna Hota, health secretary,
told The Telegraph.
He said the campaign was an “emergency
measure” for districts vulnerable to JE, a viral infection
that is spread by mosquito bites and can cause life-threatening
encephalitis and brain damage.
India has been importing JE vaccines
because indigenous production of an alternative vaccine
cannot meet its demand. The Chinese vaccine contains a live,
weakened JE virus that cannot cause disease but protects
people from the wild virus.
But the deaths and adverse reactions
such as convulsions, seizures and respiratory distress in
just a tiny fraction of the vaccinated children have rekindled
a debate in medical circles over the vaccine’s use
without local studies.
Scientists say they are baffled
at how the Indian Council of Medical Research (ICMR) endorsed
the vaccine without insisting on local safety and efficacy
studies.
“We should have proved safety
for ourselves,” said Thekakara Jacob John, a senior
virologist, formerly with the Christian Medical College
in Vellore. “Diligent science demanded that immunisation
was preceded by a safety and efficacy study in India.”
Two years ago, when a company
had applied to market an injectible polio vaccine in India,
the ICMR had insisted on local studies and waived them only
after the company produced data from 13 studies completed
in India. Safety studies are standard practice, said a top
scientist who requested anonymity.
Health officials said studies
to evaluate the safety of the Chinese vaccine are now under
way in 1,440 children in Burdwan (Bengal) and Bellary (Karnataka).
“It’s strange nine
million children immunised and now they’re evaluating
safety,” said a senior medical researcher. “At
best, these findings would be of academic interest. Why
this eyewash?”
Health officials also point out
that on the ICMR’s suggestions, the vaccine was injected
into brains of mice to test its toxicity before its use
on children. “But animal studies cannot replace human
safety studies,” said Pradeep Seth, former head of
microbiology at the All India Institute of Medical Sciences.
The animal toxicity study appears
to have been designed “to show you’re doing something,
when you’re not doing the right thing”, said Jacob
John. However, health officials say speed has probably prevented
fresh outbreaks this year.
What Happened?
- Chinese-made JE vaccine administered to nine million
children
- No safety studies conducted
- 22 deaths, 504 adverse events reported. Health officials
deny link to vaccine
- Health ministry accused of breaching standard procedures
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