NEW DELHI: The Supreme Court on Tuesday reserved its order on a public interest plea to make public the “segregated data” relating to the trials in the development of the Covid vaccines andagainst any mandatory vaccination.
Pune-based Serum Institute and Hyderabad-based Bharat Biotech – manufacturers of Covishield and Covaxin respectively, told the
court that they are under no legal or otherwise obligation to make public the data relating to three stages of trials that were undertaken
for developing vaccines to combat and contain Covid-19.
Segregated data relates to different age groups and sections involvedin the course of trials.
A bench comprising Justices L. Nageswara Rao and Bhushan.R. Gavai reserved the verdict as lawyer Prashant Bhushan pointed to holes in the working of multi-layered evaluation and regulatory mechanism involving the Subject Expert Committee (SEC), National Technical
Advisory Group on Immunisation (NTAGI) and the Drugs Controller General of India (DCGI).
Questioning the Centre’s claim that they have a robust multi-layered evaluation mechanism with domain experts, Bhushan pointed out that the decision for vaccinating children in the age group of 12-14 years has been done without the approval of the apex National Technical Advisory roup on Immunisation. He said that several NTAGI members have publicly opposed this decision.
Bhushan appeared for PIL petitioner Dr. Jacob Puliyel who is a vaccine expert and was earlier a member of the National Technical Advisory Group on Immunisation (NTAGI).
In another instance relating to the grant of emergency use approval to Covaxin “within two days”, Bhushan pointed out that on December 30, 2020, Subject Expert Committee (SEC) asked Bharat Biotech to “update and present immunogenicity, Safety & efficacy data for further consideration”. On January 1, 2021, SEC recommended that “the firm should try to expedite the recruitment and may perform interim efficacy analysis for further consideration of restricted emergency use approval” However, on January 2, 2021, SEC granted EUA.
Opposing the plea for making public, the data relating to trials including clinical trials, both Serum Institute and Bharat Biotech,
told the court that they can be asked to make public data on clinical trials and studies only in the face of “overriding public intertest”
and described it a “very narrow window” that can’t be taken recourse to in the case of Covishield and Covaxin vaccines which have proved their efficacy in combating and containing Covid-19.
Asserting that their Covaxin is entirely indigenous, Bharat Biotech said that they have proprietary right over the data and the Drugs
Controller General of India to whom data is disclosed for the purposes of approval is also under mandate to maintain its confidentiality.
Bharat Biotech also questioned the legal right and locus of the PIL petitioner Jacob Puliyel to seek putting in public domain the
segregated data relating to trials.
Adverting to Solicitor General Tushar Mehta’s argument that public disclosure of trial data could promote “vaccine hesitancy” by people
drawing their own conclusions distinct from that of the expert bodies, Bhushan said that keeping data away from public gaze will generate suspicion and feed conspiracy theories. He cited the recent judgment of a USA court directing the Food and Drug Administration (FDA) to make public the data it relied on to licensed Pfizer’s Covid vaccine.
Reon the Centre’s claim that the Covid vaccination is not mandatory, Bhushan pointed to orders issued by various State
government, including Tamil Nadu, that effectively makes vaccination mandatory.
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