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COVID:Can we get into area of expertise? SC on data disclosure of clinical trials of vaccines

PTI Mar 03, 2022

The Supreme Court on February 2, sought to know if it can examine the issue of clinical trials of COVID-19 vaccines which is the domain of experts.


A bench of Justices L Nageswara Rao and B R Gavai said the decision on vaccination has been taken based on some data by experts. "Can we get into the area of expertise? Union of India has taken the decision on the basis of some data. Can we go into the correctness or otherwise of expert reports?

"Science is a matter of opinion. Can we delve deep into this area that we don't understand? There could be different opinions. We are not experts. Don't ask us to go deep into this area..," the bench observed while responding to the submissions of advocate Prashant Bhushan, appearing for a petitioner seeking disclosure of data on clinical trials of COVID-19 vaccines.

At the outset, Bhushan submitted that whether to get vaccinated or not is an individual decision and in the absence of informed consent, mandatory vaccination was unconstitutional. "I have decided that I will not take this vaccine and it will cause me more harm than good. What I have studied in two years is that if you are healthy, the chance you get COVID is virtually nil. The long-term effects of vaccines are not there," the advocate said.

Bhushan contended that imposing a vaccine mandate puts fetter upon the right to access essential goods and services. The welfare policy of vaccination cannot affect the right to life and livelihood, and there is no reasonable nexus too, he said. "Your lordships are aware, all of you are vaccinated, but got infected again in Omicron. There are many people I know who got infected or died despite taking vaccines. If you are healthy, the chances of infection are very very less.

"Vaccines do not offer full protection. There are many cases of an outbreak among fully vaccinated people. Therefore coercing vaccines do not serve a public health purpose," Bhushan said. He said vaccine manufacturing companies have a vested interest in hiding adverse effects and data has to be put out in the public domain in accordance with WHO norms. Bhushan further said that children are hardly affected by COVID and the chance of a child dying due to COVID is one in a million.

"Chance of a child dying due to vaccine is much more than that. Why would you give a child a vaccine when the chances of dying due to it are more than dying due to COVID? "It is unethical and irresponsible to use such untested vaccines on children. Why would you give such untested vaccines to children? Now it is mandated for attending classes," he said. The hearing remained inconclusive and will continue on March 8.

The apex court had in August last year asked the Centre, Bharat Biotech, Serum Institute of India (SII), and others to respond to the plea seeking directions for disclosure of data on clinical trials of COVID-19 vaccines as also on post-jab cases. Bhushan had then told the court that it was not an anti-vaccine petition and transparency on the issue was needed as disclosure of data would rather clear all the doubts and hesitancy.

While making clear that the petitioner was not seeking to stop the ongoing vaccination, he had said the plea has also raised the issue of coercive vaccine mandates being issued like putting a certain restriction on travel if someone is not vaccinated. The bench had issued notices to the Centre and others, including the Indian Council of Medical Research (ICMR), seeking their responses on the petition.

Bhushan had earlier said that as per serosurvey of ICMR, almost two-thirds of the country's population has already had COVID and it is without any doubt that immunity gained from it is much more lasting and superior than what is gained from these vaccines. The apex court is hearing a plea filed by Dr Jacob Puliyel, who is a former member of the National Technical Advisory Group on Immunisation and has sought directions to also disclose post-vaccination data regarding adverse events.

The plea has sought directions to make public the segregated data of clinical trials for vaccines that are being administered in India under the emergency use authorisation granted by the Drugs Controller General of India. It has also sought the apex court's declaration that vaccine mandates, even by way of making it a pre-condition for accessing any benefits or services, are a violation of the rights of citizens and are unconstitutional. 

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