Allow Doctors & Individuals To Report Adverse Effects Of Vaccination In Virtual Platform; Make Reports Publicly Accessible : Supreme Court To Centre

"...the Union of India is directed to facilitate the reporting of suspected adverse events by individuals and private doctors on a virtual platform and the reports so made shall be publicly accessible after being given unique identification numbers, without listing any personal or confidential data of the persons reporting. All necessary steps to create awareness of, and to navigate, this platform for self-reporting shall be effectuated by the Government, roping in and training relevant participants right from the ground level of vaccine administration."

In a plea challenging vaccine mandates and seeking disclosure of clinical trial data of COVID-19 vaccines administered in India, Advocate, Mr. Prasant Bhushan, appearing on behalf of the petitioner, had apprised a Bench comprising Justices L. Nageswara Rao and B.R Gavai, that the existing AEFI reporting system permits only District Immunisation Officers (DIOs) or the vaccinators to report AEFIs. He sought the repository of AEFIs to be expanded in terms of Vaccine Adverse Effect Reporting System (VAERS) prevalent in the United State of America, which publishes all vaccine injury reports every Friday. He impelled the Court to ensure that doctors and individuals are also able to report adverse events and the same can be published, without compromising on the privacy of the person reporting. This submission found favour with the Court. It was also observed, the Union Government has urged all medical professionals, including the ones at private hospitals to report adverse events. Noting the importance of data pertaining to AEFIs, which helps to ascertain the safety of the vaccines and also furthers scientific studies qua pandemic, the Court permitted the expansion of the scope of reporting.

The petitioner had alleged that the AEFI reporting system lacked transparency and no data pertaining to the AEFIs already classified have been made publicly available. The Court noted that a robust mechanism is in place for identification and monitoring of AEFIs. Addressing the issue of unavailability of data regarding adverse effects occurring due to COVID-19 vaccines, it opined that the results of causality assessment of AEFI cases, which are conducted at the state and the national levels by experts trained as per the causality assessment checklist, based on the definition and algorithm developed by the WHO, were publicly available on the website of the Ministry of Home and Family Welfare.

As per the rules for classification of AEFIs as revised by the World Health Organisation in 2018, during the post-marketing surveillance only the reactions which are previously acknowledged to be caused by the vaccine can be classified as vaccine-related reactions. The previous acknowledgment comes from the Phase III trial, which the petitioner claimed was botched as the placebo arm was prematurely unblinded. With respect to the abandoning of Phase III trials, the Court noted that the unblinding of the placebo arm was at the recommendation of the Subject Expert Committee (SEC). It further observed that the petitioner has not assailed recommendation of the domain experts, but had sought revamping of the adverse effects reporting system, primarily for augmentation of the monitoring process and for publishing results publically. Controverting the petitioner's claims, the Court noted that, the Union Government had stated that unidentified events were also being collated and studied by the Pharmacovigilance Programme of India (PvPI) and the Central Drugs Standard Control Organisation (CDSCO).

The petitioner had also alleged that there was a lack of awareness about the adverse effect reporting system. The Union Government had argued that state officers, medical officers, private practitioners, frontline health workers and even nurse midwives have been made aware of the AEFIs. The Court observed that collection of requisite data is preceded by the participation of individuals in the reporting of adverse events, which need to be enhanced.

For detailed coverage of the judgment, refer this report - Nobody Can Be Forced To Get Vaccinated; Vaccine Mandates Not Proportionate : Supreme Court