Covid-19 vaccine trials: There is a case for placing all relevant data in public domain, says SC

Rejecting the allegations of non-disclosure of segregated clinical data and haste in granting approval to Covaxin and Covishield, the two main Covid vaccines approved by government, the SC said the results of Phase III clinical trials of these vaccines have been published, in line with the requirement under the statutory regime in place, the GCP guidelines and the WHO Statement on Clinical Trials.

“The material provided by the Union of India, comprising of minutes of the meetings of the SEC, do not warrant the conclusion that restricted emergency use approvals had been granted to Covishield and Covaxin in haste, without thorough review of the relevant data. Relevant information relating to the meetings of the SEC and the National Technical Advisory Group on Immunization are available in public domain and therefore, challenge to the procedures adopted by the expert bodies while granting regulatory approval to the vaccines on the ground of lack of transparency cannot be entertained,” it said.

The judges, however, also held that there is a case for placing all the relevant data in public domain without undue delay, but in the process the privacy of those individuals that participated in the trial has to be protected.