SC dismisses plea for centre-wise data of anti-diarrhoea vaccine trial

The Supreme Court on Tuesday dismissed a plea seeking centre-wise data of the clinical trial of anti-diarrhoea vaccine Rotavac, saying it cannot sit in appeal over the decision taken by an expert committee on the issue.

Rotavirus vaccine, Rotavac, claims that it protects children from viruses, which are the leading cause of severe diarrhoea among them.

A bench of justices B R Gavai and K V Viswanathan passed the order while hearing a plea seeking directions to the Centre and others to make public the "segregated data" on the results of third phase of clinical trial of Rotavac involving 6,799 infants.

The plea had stated the trials were conducted at three centres at Delhi, Pune and Vellore to gauge the safety and efficacy of the vaccine.

It had claimed that the data should have been examined by the National Technical Advisory Group on Immunization (NTAGI) in "public interest but such is the secrecy surrounding it, it has not been provided even to this apex body".

During the hearing, the bench observed, "How can we sit in appeal over the decision of an expert committee?".

"We will not sit in appeal over the decision of the NTAGI," it said.

Advocate Prashant Bhushan, appearing for the petitioner, said the trial was conducted and data has been collected.

"What is the harm in release of this data?" he said.

An advocate, appearing for one of the respondents, claimed that the petition was "half-baked" and the petitioner has not done proper research before approaching the apex court with a public interest litigation (PIL) in the matter.

"Thank you. Dismissed," the bench said.

The apex court had in July 2016 sought responses from the Centre and others on the PIL which said the segregated data was crucial to know if the vaccine was safe in all areas or if some groups are more "susceptible to adverse effects of the vaccine".

It had also sought directions to the Centre and others to provide the petitioner the complete segregated results of the clinical trial of Rotavac vaccine conducted in all three centres, including the number of intussusceptions in the two-year trial period at each centre.