Earlier this year, rotavirus vaccine 116E was launched with much fanfare. The celebration of this vaccine that would protect infants against rotavirus gastroenteritis was on two counts. It was developed locally and its price was pegged at $1, less than competing rotavirus vaccines that sell in the country.

But the rollout of this indigenous vaccine as part of the Government’s expanded immunisation programme has hit a road-block, following a public interest litigation that sought complete data from the clinical trials done on the said rotavirus vaccine.

The petitioner Jacob Puliyel, a paediatrician, is also member of the National Technical Advisory Group on Immunisation, the highest advisor to the Government on such issues.

The case revolves around the rotavirus vaccine and its potentially-fatal side effects, at one level. But the petition makes a broader point for guidelines to be framed regarding compulsory publication of complete and segregated research results from clinical trials done on humans in line with World Health Organisation norms.

Explaining why scientific transparency was crucial, Puliyel cautions, “People could otherwise lose trust in programmes that can be important tools of public health. “All we need is openness, the data is available,” he says, adding that there were enough experts to assess this data. “In the past, a shadow has been cast on the pentavalent vaccine as well, following incidents of infant death.” Losing public confidence is a risk the Government would not want to take, especially when it is being lauded internationally on the success of its polio immunization programme. The multicentre trials to assess safety and efficacy of the indigenous rotavirus vaccine were done at Delhi, Vellore and Pune.

Rotavirus case And the data emerging from here was to support further studies involving one lakh infants.

Over 6,700 infants had been initially given the vaccine and the placebo (an inert substance), says the petition and one of the secondary outcomes was to assess safety in terms of the number of “intussusceptions” (intestinal obstructions) witnessed during the trial. Puliyel explains that these obstructions may need urgent paediatric surgical interventions to prevent death.

But here’s where it gets complicated, as the data varies from the different centres and so does its interpretation. Puliyel says that the data revealed is inadequate to reflect the correct picture on the occurrence of side effects and hence the vaccine should not be rolled out to more children till the entire data is scientifically assessed.

How and why An expert with a vaccine-maker adds that transparency is needed on clinical trial data and the procurement process – how and why a particular product was chosen in a public health programme. But a top scientist closely involved with the 116E vaccine counters that the trials were transparent and data was filed with the regulator. Transparency should not be confused with “causal interpretation,” he says, calling for a balanced approach to handle modern technologies. Data should be analysed as per protocol, he adds.

Pointing out that there is enough public scrutiny, he agrees that an independent mechanism with expertise and international exposure could be set up to oversee such initiatives before they are rolled out into the public. Nevertheless, he adds, the regulatory mechanism in the country has never been as good as it is now. And if trials need to be done on an international scale, the budget of the country’s leading research institutions should be increased from the present ₹500-odd crore, he says.

While the scientists differ on the scale of the trial and the access that should be given to clinical trial data – a key concern that Government needs to keep its eye on is that patient safety is not lost in the quibble over scientific interpretations.

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