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Resource centre on India's rural distress
 
 

Vaccine survey amid alert -GS Mudur
-The Telegraph

New Delhi: The Indian government will study 100,000 infants to evaluate a home-grown vaccine against rotavirus gastroenteritis, released this month amid concerns raised by a paediatrician about the risk of an intestinal side-effect.

Doctors from Delhi, Pune and the Christian Medical College, Vellore, will measure -- through what could be India's largest study - any vaccine-associated risk of intussusception, a disorder in which the intestine telescopes into itself and may need surgical treatment.

Prime Minister Narendra Modi had on March 9 launched the rotavirus vaccine that had passed safety and efficacy trials on 6,600-odd infants between 2006 and 2013.

The Hyderabad-based Bharat Biotech is manufacturing the vaccine, developed under a 30-year research effort by Indian and US scientists that was funded by both governments and the Bill and Melinda Gates Foundation. The company has invested in a production line for 500 million doses a year.

Under the new study, one lakh infants will receive three doses of the oral vaccine for a year so that the intussusception risk can be measured more precisely. The study will be monitored by the Union health ministry, department of biotechnology and the Indian Council of Medical Research.

"The clinical trials followed the highest standards of safety. The proposed study is intended to generate additional safety data and understand a background event which increases slightly in overall numbers within a short period post-vaccination," biotechnology secretary Krishnaswamy VijayRaghavan told The Telegraph .

Medical researchers associated with the clinical trials have said the trials did not reveal any vaccine-related risk of intussusception, a condition that could cause bowel obstruction. But a paediatrician from Delhi's St Stephen's Hospital, who has campaigned against several other vaccines too, has for some time been voicing concerns about this risk.

In a letter published today in Vaccine, a peer-reviewed journal, Jacob Puliyel cited data from the vaccine's clinical trials to claim a possibly higher risk of intussusception than a US vaccine that was withdrawn in 1999 because of its intussusception risk.

Researchers involved in the clinical trials, independent paediatricians, and government officials say the concerns raised by Puliyel are invalid and misleading, and appear to be part of his longstanding campaign against various life-saving vaccines. They say anti-vaccine campaigns could hurt children by delaying the spread of life-saving vaccines.

"It is incorrect and immoral to constantly raise scares against life-saving vaccines by selectively presenting data from diverse sources and ignoring data that does not support the premise that vaccines are not needed, ineffective or carry risks," VijayRaghavan said.

Of the infants involved in the clinical trials, about 4,500 received the vaccine and about 2,100 received a placebo, or a sham vaccine. Ultrasound follow-up found intussusception in 17 children who received the vaccine and six who received the placebo.

These figures, Puliyel says, translate into an additional 11 cases of intussusception per 10,000 vaccinated.

This is "five to ten times higher" than the risk of intussusception with the US vaccine withdrawn from the market about a year after its release in 1998, and "nearly 70 times higher" than the risk with the current internationally licensed vaccine, Puliyel wrote in the journal.

But doctors who did the clinical trials say Puliyel has selectively picked figures to make misleading claims.

They say it is wrong to compare the intussusception rates in the Indian trials with those associated with the foreign vaccines because the infants in India were followed up longer and more intensively.

"There is a narrow one-to-three-week window of the risk of intussusception associated with the rotavirus vaccine," Gagandeep Kang, professor of infectious diseases at the Christian Medical College, Vellore, said.

"Not a single child in our trial developed intussusception within this period."

The first child detected with intussusception during the trial developed it 36 days after a dose of the placebo. Among the vaccine recipients, the first child was observed with intussusception 112 days after the third dose of the vaccine.

Kang and her colleagues believe the intussusception they detected had nothing to do with the vaccine. Many infants develop intussusception for various unidentified reasons. At times, the disorder resolves by itself but some children need emergency surgical care.

The infants in the Indian trials were followed up for two years. Throughout this period, the researchers brought in for diagnosis and treatment any child with even minor symptoms of intussusception.

In contrast, the trials of the foreign vaccines followed the children up for intussusception over only five or six weeks.

But Puliyel claims there is no scientific basis for a sharp three-week cut-off for the risk window.

"That there was a significantly higher incidence of intussusception among the vaccine recipients than the placebo group should warrant a more detailed study," he said.