SC notice to Centre, others on plea seeking disclosure of data on COVID vaccines’ clinical trials

PTI, Aug 9, 2021, 3:06 PM IST

New Delhi: The Supreme Court Monday asked the Centre, Bharat Biotech, SII and others to respond to a plea seeking directions for disclosure of data on clinical trials of COVID-19 vaccines as also on post-jab cases.

The apex court, while referring to the issue of “vaccine hesitancy” in India, especially in rural areas, observed that the World Health Organization (WHO) says that nobody will be safe unless everybody is vaccinated.

“We are fighting with vaccine hesitancy in this country. The WHO says one of the major problems in the world is vaccine hesitancy. If we will launch an investigation into this, would it not be throwing doubts in the minds of people,” a bench of justices L Nageswara Rao and Aniruddha Bose observed.

Advocate Prashant Bhushan, appearing for the petitioner, said it is not an “anti-vaccine petition” and transparency on the issue was needed as disclosure of data would rather clear all the doubts and hesitancy.

Bhushan, while making clear that petitioner was not seeking to stop the ongoing vaccination, said the plea has also raised the issue of coercive vaccine mandates being issued like putting certain restriction on travel if someone is not vaccinated.

The bench issued notices to the Centre and others, including Indian Council of Medical Research (ICMR), Bharat Biotech and Serum Institute of India (SII), seeking their responses on the petition within four weeks.

Observing that it does not want to get into the scientific decisions taken by the experts, the bench said personal autonomy will have to be balanced with public health.

“We will issue notice. We will get the response from them,” the bench said, adding, “There is no way we can stop the vaccine”.

Bhushan said if the data is not made public, it would lead to more rumours and there would be more reasons for concern.

He said as per sero-survey of ICMR, almost two-third 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.

“Are you suggesting that the vaccination has to be stopped,” the bench asked.

Bhushan said “no” and added that people cannot be coerced to take vaccine and data of clinical trials and post vaccination must be disclosed.

The bench observed that over 50 crore vaccine doses have been administered in the country so far and once it entertains this plea, a signal should not go that there is any doubt over these vaccines.

Bhushan referred to reports and argued that they say vaccine hesitancy is more among those who are educated people.

“We are only trying to look at it from another angle and the bigger picture,” the bench said, adding, “In this country, vaccine hesitancy is mainly coming from the rural areas.”

Bhushan told the bench that the government says vaccine is totally voluntary but now people are coerced to take vaccine.

“You cannot deny any service or job to anybody,” he said while referring to vaccine mandates.

However, the bench observed, “We are not willing to accept your submissions on this because you are pressing personal autonomy against larger public interest. WHO says unless everybody is vaccinated, nobody is safe”.

Bhushan said there are reports and data that vaccines are not that effective against Delta variant of virus which is spreading in several countries.

The bench then referred to today’s media report about mixture of COVID-19 vaccines in India — Covishield and Covaxin — being more effective.

When Bhushan referred to the apex court’s landmark verdict on passive euthanasia, the bench observed that the judgement may not be applicable when larger public interest is involved.

“This is the most important PIL (public interest litigation) that I have filed. This can affect the lives of crores of people,” Bhushan said, adding, “This is not an anti-vaccine petition”.

The bench said there are still four lakh active coronavirus cases in the country.

The apex court said the plea has raised some seminal issues and there are reports that the country is fighting vaccine shortage.

“Let it go on. Let the people get vaccinated,” the bench said, adding it would examine the issues raised in the plea.

The bench was hearing the 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, is a violation of rights of citizens and is unconstitutional.