'Out Of 180 Crore Doses, Only 0.004% Adverse Effects' : Centre Tells Supreme Court In Plea For Vaccine Trial Data

On Tuesday, the Supreme Court continued hearing the submissions in the plea seeking the Court's directions to the Central Government to publicize the data relating to clinical trials and post vaccine efficacy of the COVID vaccines, in consonance with the requirement of the International medical norms. The Petitioner, Dr. Jacob Puliyel, a former member of the National Technical Advisory Group of Immunization, also assailed the functioning of the Adverse Events Following Immunization (AEFI) reporting system, which, he claimed, lacked transparency. The petitioner had further challenged the 'coercive' mandates issued by States, particularly, Delhi, Madhya Pradesh, Maharashtra and Tamil Nadu and the non-disclosure of clinical trial data for the vaccines that are being administered to children in India and a stay on the coercive COVID-19 vaccine mandates introduced in various states and by private establishments for children in the age group 15-18 years. On the last occasion, Advocate, Mr. Prashant Bhushan had argued that without disclosing any data on clinical trials and post vaccination efficacy of the vaccines, some States had imposed vaccine mandates which are not proportionate to personal liberty. He had also argued that in absence of trial data informed consent of the people cannot be obtained, which is a violation of the principle of self determination elucidated in Article 21 of the Constitution. Appearing before a Bench comprising Justices L. Nageswara Rao and B.R. Gavai, the Solicitor General of India, Mr. Tushar Mehta questioned the bona fides of the petitioner. He expressed his concern that any interference by the Apex Court at this stage would create vaccine hesitancy amongst the people of the country. Mr. Mehta controverted the petitioner's argument qua lack of transparency in the approval process of the vaccines as well as in the functioning of the reporting of adverse effects. At the outset he put forth some broad principles to assist the Bench as to why it would not be appropriate to entertain the petition. He submitted that the scope of judicial review ought to be modulated considering the magnitude of the crisis. It was asserted that the present case was not such wherein the petitioner is asserting their rights. Moreover, he argued that wisdom of the domain expert ought not to be substituted by that of the Court. Mr. Mehta submitted that a procedure for granting approval was already in place and was followed while seeking approval for the two vaccines being administered in India. "There are some broad propositions which might guide your lordships' discretion in entertaining a 32 petition or not. The first consideration would be the magnitude of the problem which not only the nation but the entire human kind faced…It is not just India but the world community is responding to this unprecedented situation. Second, your lordships will examine that this is not a petition filed by an individual saying my personal right is being affected…It is in the nature of PIL where petitioner says the petitioner says I have no personal rights. There is a PIL which states that others be not vaccinated because I have not satisfied myself about the data. Third, some articles were shown. They have not assisted with the law by which the process of vaccination is covered. There are layers in the process where domain experts apply their mind periodically repeatedly and thereafter take a particular call. That might be a ground to not substitute the views of the experts. Next point can be the procedure which the Central Govt. has followed. As on date, the stand taken by the Central Government is that vaccines are voluntary. There are some States joined as parties who have mandated it. I would also assist your lordships that even a mandate would be a legal mandate and would pass the muster of constitutional validity. Ultimately, it has to balance competing fundamental rights." He apprised the Bench that till 13.03.2022, 1,80,13,23,547 doses of vaccines have been administered. "What is the factual situation on ground?…We have data to show it is safe, effective and immunogenic. As per the last available figure, as on 13.03.2022, total 180,13,23,547 doses have been administered." He further stated that till 13.03.2022, there were 77314 people who have been adversely affected. The degree of adversity was categorised as minor; severe and serious. Minor cases are those where no medical intervention was required, severe are those cases where medical intervention is required and the serious cases involve the possibility of death. He also pointed out that the data pertaining to the adverse effects were contemporaneously placed in the public domain. "Adverse events - 77314 i.e. 0.004% adverse impact observed. This adverse event includes minor, serious and severe events…Minor means it is self limiting; no medical...

'Out Of 180 Crore Doses, Only 0.004% Adverse Effects' : Centre Tells Supreme Court In Plea For Vaccine Trial Data

Sohini Chowdhury

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