Plea in Bombay High Court seeks information on safety, efficacy of COVID-19 vaccines; alleges violation of “right to know” by DCGI

A petition has been filed in the Bombay High Court seeking directions to the Drug Controller General of India (DCGI) to furnish information submitted to it by Serum Institute of India (SII) and Bharat Biotech International (BBI) pertaining to the safety and efficacy of the COVID-19 vaccines that will be distributed by them..The plea has been filed by RTI activist and journalist Saket Gokhale, who has also sought the Court’s intervention in order to remedy the violation of his “right to know” guaranteed under the fundamental right to expression under Article 21 of the Constitution of India..Gokhale had sent a Right to Information (RTI) application to the DCGI on January 4, seeking information on the safety, efficacy and other relevant data submitted by SII for the COVID-19 vaccine “Covishield” and BBI for “Covaxin”..He filed his RTI application under Section 7 of the Right to Information Act, which stipulates that requested information must be provided within 48 hours when it pertains to “life and liberty.”.To substantiate why the information pertained to “life and liberty”, Gokhale stated in his RTI application that Government of India was beginning Phase 1 of its COVID-19 vaccination programme soon, and therefore, it becomes even more pertinent to have this information made available in the public domain..After he received no reply to his application, Gokhale has moved the High Court. His plea states,.“The Covid-19 vaccination process in India is being rolled out in phases... Therefore, lack of clarity of safety and efficacy data of M/s Bharat Biotech’s “Covaxin” (which is being administered in the clinical stage still) in the public domain arguably presents an imminent threat to the life of the 1st vaccinated group while also having an effect on the life of the public in general which includes the Petitioner. While the former threat is imminent, the threat to the general public and the Petitioner is also equally real while it might not be “imminent” on the present day.”.Gokhale states that crucial information pertaining to the human trials conducted for the COVID-19 vaccines has not been published in the public domain.“Lack of information in the public domain regarding the safety & efficacy of clinical trials of Covaxin, it is impossible for anyone to provide an informed consent thus exposing receipients to 2 risks: (1) either take the vaccine & bear the consequences or (2) remain unvaccinated and make yourself susceptible to a Covid-19 infection”, his plea states..He has contended that the information sought by him is completely within the “public interest” domain with zero implications on the matter of internal public security or external security of the nation..Despite this fact, DCGI has not even communicated any objections to this information falling within the purview of “life and liberty”, he claims..It is also submitted that with vaccines still in trial stages, as is the case for “Covaxin”, approving the same without releasing the efficacy and safety data of the vaccines in the public domain cannot ensure scrutiny by independent experts which would only help in providing better feedback and making the final vaccine more safe.