SC seeks govt’s reply on vaccine trials data plea
NEW DELHI : The Supreme Court on Monday sought the Centre’s response on a petition seeking transparency of data on clinical trials conducted for Covid-19 vaccines even as it avoided passing any order that could add to vaccine hesitancy, noting the still grave pandemic situation in the country.
A bench of justices L Nageswara Rao and Aniruddha Bose said, “We will issue notice on the petition. But we don’t want that our notice should send a signal on (the) safety of the vaccines.”
The petition has been filed by Jacob Pulayil, a former member of the government’s apex body on immunisation, National Technical Advisory Group on Immunization, and is being argued by advocate Prashant Bhushan. It has named the Centre, Central Drugs Standards Control Organisation represented through Drug Controller General of India (DCGI), Indian Council of Medical Research (ICMR) and vaccine manufacturers Bharat Biotech (Covaxin) and Serum Institute of India (Covishield) as respondents.
The petition has demanded that the government and DCGI provide segregated data for each of the phases of the clinical trials. Bhushan said though vaccination has not been made mandatory by the government, people are being deprived of their livelihood and access to essential services for not being vaccinated. Bhushan sought an interim stay on such mandates.
The bench said, “We cannot take responsibility for passing any order which can increase the number of casualties or endanger public health.”
The judges appreciated the petitioner for raising a good legal point on the personal autonomy of citizens and the right to their livelihood vis-à-vis their right to public health, but they did not lose sight of the “bigger picture”.
“As it is, we are fighting with vaccine hesitancy. The situation is so grave that we are still not out of the pandemic. Looking at this position, we cannot decide if any order passed by us can lead to a bigger problem,” the bench said.
Till Monday night, India has fully vaccinated 513, 914,567 people.
“You know the ground situation. Vaccine hesitancy is coming from rural areas and not from the educated class in urban areas. Our apprehension is that a detailed enquiry into this issue will amount to throwing a spanner into what is already existing, leading to more doubts,” the bench observed.
Bhushan submitted that never before has a universal vaccination programme in the country been given emergency use authorisation without disclosing data on the approval process, clinical trials and post-vaccination effects.
“This is a clear violation of the basic norms of scientific disclosures and the guidelines with respect to disclosure of clinical trial data, as laid down by the World Health Organization and followed by the ICMR,” the petition said.
The court said it would hear the matter again after four weeks.