The Supreme Court today issued notice to the Centre, the Department of Bio-Technology (DBT) and Christian Medical College, Vellore in a PIL filed by S Srinivasan seeking complete centre-wise results of the clinical trial of anti-diarrhea vaccine Rotavac.

Srinivasan is the management trustee of Locost (Low Cost Standard Therapeutics), Vadodara, Gujarat. Prashant Bhushan is his counsel in the Supreme Court.

The clinical trial of Rotavac was conducted between 2011-2013 on 6799 infants in three centers - Delhi, Pune and Vellore to ensure its safety in terms of the number of intussusceptions (a potentially fatal side-effect) in the 2-year trial period.

The petitioner claims that the aggregated data published in a UK-based journal shows that the number of cases of intussusceptions in infants who were administered Rotavac vaccine in Vellore centre were the highest and there was a huge difference in the number of cases of intusseception between result in Delhi and Vellore.

The petitioner has alleged that DBT had failed to make available the complete de-aggregated data (center-wise data) before launching the vaccine.

The very raison d’etre of such multi-center trials is to compare results among centres, but without data the vaccine was allowed to be launched, the petition alleges.

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 advisory body, the petition further alleges.

The petition claims that data is required to ascertain whether a section of the population is more susceptible to adverse effects from the administration of the vaccine.

As of March 2016, the vaccine is being administered in Haryana, Himachal Pradesh, Orissa and Andhra Pradesh with plans to add it to the Universal Immunization Policy of the Government, claims the petition.

Read Rotovac petition

Photo by Rhoda Baer