public health

Is the indigenous Rotavirus vaccine safe for children?

Some health activists don't think so. A PIL filed before Supreme Court seeks the complete data of the vaccine's clinical trial.

A month after the first indigenous anti-diarrhoea rotavirus vaccine was launched in India, a health rights activist on Monday filed a public interest litigation seeking to prevent the vaccine – Rotovac – from being included in the country’s Universal Immunisation Programme. The petition argued that the government has not publicly disclosed the complete data related to the clinical trial yet, and that the vaccine could possibly have side effects on a significant population.

Rotavirus infections are the leading cause of severe diarrhoea among children. In India, about one lakh children die due to rotavirus diarrhoea annually, while another 10 lakh children are hospitalised because of it. For a start, it has been introduced in four states – Andhra Pradesh, Haryana, Himachal Pradesh, and Odisha. It will be made available in the rest of the country in phases.

Dr Pradeep Haldar, deputy commissioner in department of Health and Family Welfare, who handles the immunisation programme, said he did not want to comment on the issue.

‘Make data public’

The Rotovac clinical trial was conducted on 6,799 infants at three centres – Delhi, Pune and Vellore – between 2011 to 2013. Voices against the introduction of the vaccine, produced by Hyderabad-based Bharat Biotech Limited, started to be raised after the aggregated data of the vaccine efficacy during its trials was published in two peer-reviewed scientific journals – Vaccine and Lancet in 2014.

Both studies said that the vaccine was safe for children, and that the risk of intusussception – intestinal obstructions that may need urgent surgery to prevent death among infants – was not clinically significant in the population studied. However, the segregated data from the three centres, which could possibly indicate if different populations had different reactions to the vaccine, has not been released.

Dr Jacob Puliyel, an expert member of the National Technical Advisory Group on Immunisation, an apex body that advises the government on immunisations, wrote to government authorities and to Christ Medical College, which led the clinical trial in Vellore, to release the data.

Puliyel, who heads Paediatrics at St Stephens Hospital in Delhi, deduced from the aggregated data that the number of cases of intussusception in infants administered the vaccine during its trial were the highest at the Vellore centre. He wanted the trial data from all three centres to ascertain if a certain population was more susceptible to its side-effects as compared to others.

If Puliyel’s calculations are to be believed, the Vellore trial shows an excess of 11 cases of intussusception per 10,000 vaccinated children as compared to the trial figures from Delhi. This is five to 10 times higher than the risk of intussusception with the Rotashield vaccine – which was withdrawn from the market – and nearly 70 times higher than the risk associated with the current internationally licensed vaccine, RotaTeq.

Puliyel filed a writ petition seeking the segregated data before the Delhi High Court last July. At the time, the government, as well as CMC Vellore, argued that:

“… site specific data on safety is inappropriate for release as per protocol and its inappropriate interpretation or publication which would lead to disinformation about the product (that has been) developed by government with great effort and expense, and will give unfair advantage to multinational products which were never tested in India, (and) yet (were) licensed.”

The High Court dismissed Puliyel‘s plea last October. When the matter went into appeal before the Supreme Court, it held that Puliyel could not file a PIL as he was a serving member of the body that advised the government on immunisations. But the questions in the petition were left unaddressed.

Matter of public health

On Monday, S Srinivasan from LOCOST, a company based out of Vadodara that produces low cost medicines for the poor, filed a similar PIL for the Supreme Court to look into. His lawyer, Neha Rathi, said that the matter could come up in two weeks.

The petition states:

“Concealment of this vital data does severe injustice to the thousands of infants who participated in this study, the researchers who painstakingly conducted the trials and the medical/scientific community who depend on this data for their work,” 

With fewer resources in rural areas to handle side-effects like intusussception, the recommendation to include the vaccine into a major government programme has to be done carefully, argued a letter to the editor published in the journal Vaccine last year.

The question is: will parents whose children will be immunised be told about this indigenous vaccine’s possible side-effects so that they can make an informed choice?

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