New Delhi: The central government told the Supreme Court on Tuesday that raw data on COVID-19 clinical trials can not be disclosed to the public as it would lead to an irresponsible evaluation by the public, misinformation and misinterpretation which would "not enhance but harm public interest". The government also said that getting vaccinated against Covid-19 can be mandatory in future.
The government stated that as per the WHO guidelines, key outcomes of trial data was supposed to be out which is there in the public domain and not raw trial data. Centre reasoned that a committee of experts have examined the data and each stage of the trial was thoroughly examined by various committees consisting of experts.
The Supreme Court bench comprising of Justice L Nageswara Rao and Justice BR Gavai was hearing a plea by Jacob Puliyel seeking disclosure of COVID-19 trial data. Solicitor General (SG), Tushar Mehta, appearing for the government, submitted before the court that there are stages like chemical testing, animal testing, human clinical trial, trials of quantity of vaccine per person, immunogenicity stage (determining whether vaccine is safe for humans) etc in a vaccine's trial.
"These trials happen on a site where a neutral investigator is appointed, an ethics committee is constituted, good clinical practice guidelines are followed, statutory authorities conduct surprise inspections and there are various statutory provisions that are adhered to within the trial. And data regarding all this is published on the Family and Health welfare website and nothing happens in an opaque manner which the petitioner alleged," Mehta said.
One of the contentions raised in the plea was also of some states making vaccination mandatory. SG submitted before the court today that it is not mandatory right now but can be made mandatory in future if such a situation arises. Condemning the PIL, SG said that such PILs just criminally waste the time of the court, creating frustration in people's minds as other cases' hearings get affected.
Talking about adverse impact of COVID-19 vaccines, the SG argued that out of total vaccines administered, 77,000 cases were reported to have an adverse impact, which is 0.04%. And among these, 1,046 cases are reported to be of death but causality assessment is yet to be done so it is not confirmed that the deaths happened due to vaccine and not any other reason. In causality assessment, if an immunized person has some adverse event, there will be a system to find out if the vaccination is the reason behind it.
SG argued that petitioner has not shown any legal material anywhere in the world that compels to show raw data. The raw data is examined and it can't be demanded by anyone to satisfy his curiosity or create hesitancy regarding vaccine. SG argued that it would also lead to hesitancy among people coming to volunteer for trial if their data is disclosed.
"Here people are queuing up for vaccination and there one gentleman wants his curiosity to be satisfied," argued SG. Courts must do justice by maintaining social balance by interfering wherever necessary and refusing where not necessary.
Criticising the PIL, SG argued that it is being used as suspicious product of mischief, some persons with vested interest indulge in passing time and such PILs should be thrown out with exemplary costs. "Right to die might be a fundamental right but right to infect me is not a fundamental right. Balance fundamental rights of others," submitted SG. The matter will be continued for hearing again on 21st and 22nd March and is likely to be concluded by then.
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