Doctor warns against indigenous rotavirus vaccine

As an indigenous vaccine against rotavirus hits the market, a long-term critic of the vaccine programme has waved a red flag on possible adverse health consequences over its large-scale use.

Jacob Puliyel, head of paediatrics at St Stephens Hospital in Delhi, claimed the indigenous vaccine carried a significantly higher chance of developing intussusception—a complication of the intestine in which the organ is devoid of blood supply.

“The risks are 5-10 times higher (with the indigenous vaccine) than the Rota-Shield vaccine (withdrawn from the US market years ago), and nearly 70 times higher than the current, internationally licensed vaccine RotaTeq,” wrote Puliyel in a letter in the journal “Vaccine” on Sunday.

Developed by Hyderabad-based Bharat Biotech, the indigenous vaccine was commercially rolled out earlier this month by the Prime Minister Narendra Modi, who had announced his government's plan to introduce rotavirus vaccine in the immunisation programme.
Rotavirus is the commonest cause of diarrhoeal deaths among children. The estimated diarrhoeal death count in India is up to 80,000 every year, along with 8 lakh instances of hospitalisation.

The Union Health Ministry plans to introduce a vaccine against rotavirus in the immunisation programme, beginning with a few selected districts, for which 1 crore doses will be procured.

If incorporated in the public-funded immunisation programme, the vaccine could reduce thousands of under-five deaths and out-of-pocket expenditure.

A team of researchers from All India Institute of Medical Sciences in Delhi, Christian Medical College in Vellore, KEM Hospital in Pune, Centre for Health Research and Development and PATH had earlier reported 23 cases of intussusception in a study involving more than 6,000 children.

Ultrasound evidence of intussusception was found in 17 who had received the vaccine and in six babies receiving placebo. “There was not only an excess of 11 cases of intussusception per 10,000 vaccinated, but the cases are far more in Vellore than in Delhi,” Puliyel told Deccan Herald.

He asked the research team to publish city-specific data so other scientists can examine the possibility of the vaccine carrying higher risks in some areas. “The risks of intussusception outweigh the potential benefits of vaccination in disease and mortality reduction, particularly in areas where diarrhoeal diseases continue to be a major killer of children,” countered Jacob John, a professor of community medicine at CMC and lead
author of the study on intussusception surveillance.

“Nonetheless, monitoring safety will continue to be critical both pre-licensure and after introduction, because vaccination safety at the level of the individual child and of programmes is necessary to manage rare side effects and to prevent undue harm from the newly developed vaccines,” he added.