SC seeks govt’s reply on Covid-19 vaccine trials data plea
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.
Before issuing the notice, the court raised its apprehensions that a notice could lead to more doubts in people’s minds about the efficacy of vaccines.
“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.
Further, the petition quoted the Helsinki Declaration of 2013 on Ethical Principles for Medical Research involving human subject adopted by the World Medical Association which casts a duty on researchers to publicly disclose all negative, inconclusive and positive results of their research. Contrary to creating doubts, Bhushan said that interference by the court will reassure citizens.
The bench said that globally, this issue of compulsory vaccination without informed consent has been engaging the attention of courts across various jurisdictions. The judges cited a ruling by an Indiana court in the US that approved a vaccine mandate issued by Indiana University to its students. This ruling has been challenged before the Supreme Court of the United States. It also referred to a recent European Union decision upholding the Czech Republic’s decision on mandatory vaccination of children.
Bhushan said, “This is not an anti-vaccine petition.” He referred to a 2011 decision passed by the top court in Aruna Shanbaugh matter where the court upheld citizens’ right to refuse medical treatment as part of their right to live with dignity and make an informed choice. He cited examples of 16 countries that had banned the use of Astra-Zeneca vaccine (branded Covishield in India).
Bhushan said that circumstances warranting emergency approvals to vaccines cannot be a reason for trial data to be withheld from public scrutiny. He alleged that data on Adverse Events Following Immunization was being suppressed, endangering more lives.
The court said it would hear the matter again after four weeks.