The Telegraph
Since 1st March, 1999
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Vaccine for children without trials

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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