SC issues notice on petition seeking clinical trial data of Covid-19 vaccines

The Supreme Court on Monday sought the response of the Centre on a petition seeking transparency of data on clinical trials conducted for Covid-19 vaccines.

However, the Court cautiously avoided passing any order stalling compulsory vaccine mandates noting that the pandemic situation in the country was still grave and any order passed at this stage could lead to a bigger problem. The matter will be taken up after four weeks.

The 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 safety of the vaccines.”

The petition has been filed as a public interest litigation by Jacob Pulayil, a former member of the Government’s apex body on immunization - National Technical Advisory Group on Immunization. It has named Centre, Central Drugs Standards Control Organization 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 argued by advocate Prashant Bhushan demanded that the Government and the DCGI should provide segregated data for each of the phases of clinical trials undertaken with regard to the vaccines administered in India. Bhushan said though vaccination has not been made mandatory by the Government, compulsory vaccine mandates are being issued depriving persons of their livelihood and access to essential services for not being vaccinated. Bhushan sought an interim order staying such mandates.

The bench said, “We cannot take responsibility of 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 personal autonomy of citizens and right to their livelihood vis-à-vis right to public health but did not lose sight of the “bigger picture”.

“As it is, we are fighting with vaccine hesitancy. Almost 50 crore citizens in the country have already got their vaccine. 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.

Before issuing notice, the Court raised its apprehensions that a notice by the Court could lead to more doubts in public mind about efficacy and safety 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 authorization 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 (WHO) 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 had been engaging the attention of courts across various jurisdictions. The judges cited a ruling by an Indiana court in the U.S which 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 made reference to a recent European Union decision upholding 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 Court upheld the citizen’s 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 which had banned the use of Astra-Zeneca vaccine (branded as Covishield in India)

Bhushan said that circumstances warranting emergency approvals to vaccines cannot be a reason for trial data (that has been collected and on the basis for which approvals have been given), to be withheld from public scrutiny. He alleged suppression of data on Adverse Events Following Immunization (AEFI) which was endangering more people to suffer the same fate.

As per data maintained by AEFI Secretariat of the Ministry of Health and Family Welfare, 492 severe and serious (including death) AEFI have been classified. The petition quoted a news report stating that as on March 29, a total of 180 deaths have been reported in the country following vaccination.

In a lighter vein, the Court noted, “The country is fighting COVID vaccine shortage and now we are dealing with another dimension in this case.” Another bench of the Supreme Court is already examining the issue of vaccine preparedness in a suo moto petition where the Government had disclosed a comprehensive plan to vaccinate all citizens by this year end.