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Plea In SC Seeks Release Of Rotovac Clinical Trial Data

18 February 2020


New Delhi: A plea has been moved in the Supreme Court seeking directions to the Centre to furnish the segregated data of the Rotovac clinical trial (Phase III) in the public domain.

The trial involves 6,799 infants at three centres -- Delhi, Pune and Vellore -- between 2011 and 2013 to gauge the safety and efficacy of the vaccine.

The petitioner, S. Srinivasan, claims to be the managing trustee of Low Cost Standard Therapeutics (LOCOST), Vadodara, Gujarat.

"The segregated data is crucial to know if the vaccine is safe in all areas or if some groups are more susceptible to adverse events from the vaccine. The very raison d'etre of such multicentre trials is to compare results among the centres," said the petition.

The petition, filed through advocate Prashant Bhushan, contended that this data should have been examined by the National Technical Advisory Group on Immunization (NTAGI) in public interest, but such is the secrecy surrounding it that it has not been provided even to this apex body.

The petitioner contended that there is a need for disclosure of the segregated data of the Vellore centre in order to ascertain whether a certain section of the population is more susceptible to adverse effects of the vaccine.

The petition contended that the authorities concerned have shown complete secrecy on the matter and have not disclosed segregated (meaning dis-aggregated) data from all the centres and have only released aggregated data i.e. the results of all three centres clubbed together.

"Concealing 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", said the petition.

The petitioner urged the top court to issue directions to the Centre to provide the petitioner the complete segregated results (centre-wise data) of the clinical trial of Rotavac vaccine conducted in all the three centres, including the number of intussusceptions in the two-year trial period at each centre.

"Issue an appropriate writ restraining the respondents from including Rotavac from Universal Immunization Policy of the government of India till the complete data from the said clinical trial is not disclosed to the key stakeholders, including the petitioner," said the petition.

The petitioner also urged the top court to issue directions to place before the NTAGI the complete segregated results of the clinical trial of Rotavac vaccine for examination and scrutiny.