India says no legal compulsion to take Covid-19 doses; parents of vaccine-deceased say government forced them

“The concept of informed consent is inapplicable to the voluntary use of drugs such as a vaccine,” said the Union Government to Supreme Court

BySumit Jha

Published Nov 30, 2022 | 6:39 PMUpdatedNov 30, 2022 | 6:45 PM

Covid-19 vaccination in India. (Wikimedia Commons)

When 20-year-old Karunya Venugopalan, a student of the MSc Data Science programme at the PSG College of Technology in Coimbatore landed an internship at Goldman Sachs in Bengaluru, she was elated and started planning to go to Bengaluru for the internship.

But as everywhere it was being published and also the authorities of every state were looking for Covid-19 vaccine certificates before allowing people from other states, Karunya believed she should take the vaccine if she needed to join Goldman Sachs in Bengaluru.

She was administered the Covid-19 vaccine on 8 June, but started to have complications after 10 days. She lost her life on 10 July.

Now, in an affidavit, the Union government has told Supreme Court, which is hearing a petition, that there is no legal compulsion to get the Covid-19 vaccine.

“The concept of informed consent is inapplicable to the voluntary use of drugs such as a vaccine,” said the Union government.

It was responding to a petition filed by two families who lost their children after they were administered the Covid-19 vaccination. One of the petitioners was Karunya’s father Venugopalan Govindan.

In his petition, senior advocate Colin Gonsalves argued that neither petitioners nor their daughters were informed in advance of the risk of such severe AEFI (Adverse Event Following Immunisation) and their informed consent was not taken before administering the vaccine.

The Union government told the court, “The concept of informed consent is inapplicable to the voluntary use of a drug such as a vaccine.”

“My daughter took the vaccine in an environment where, from the caller tunes on phones to news items to advertisements by the government everywhere, it was being said that the Covid-19 vaccine was completely safe and effective, and people were being urged to take it,” Venugopalan Govindan told South First.

“Then there was a frenzy created by the media, experts, and the government — everybody — to urge people to take the vaccine. There was indirect course happening, such as when even if I have to travel to Kerala to cross the border, I have to take the vaccine, and provide vaccine certificate to the authorities,” he recounted.

Venugopalan added that if his daughter needed to go to Bengaluru for her internship, she required a vaccine certificate.

“There was indirect pressure. In that environment, when this [vaccination] was opened up for those aged 18 and above, she took the vaccine,” he said.

Venugopalan, along with Hyderabad resident Rachana Gangu, who lost her 18-year-old daughter after Covid-19 vaccination, has filed a petition in the Supreme Court seeking direction for the appointment of an expert medical board — independent of the Central government — to inquire into and investigate the deaths and to share the report of the investigation with them.

Rachana’s daughter was vaccinated with the first dose of Covishield on 29 May last year, and died within a month: on 19 June.

They are also asking for the expert medical board to prepare a protocol for early detection and timely treatment for AEFIs due to the Covid-19 vaccine, and compensation to the petitioners.

‘Government not liable for deaths’

The Union government informed the Supreme Court that it could not be held liable for the adverse effects of Covid-19 vaccines.

The Centre said that in cases where a death was found to be induced by the vaccine, the only remedy was to seek compensation by filing a suit in a civil court.

“There is no material to suggest how the state can be fastened with strict liability for the tragic death of the respective children of the petitioners which is the requirement in law to sustain a claim for compensation against the state under Article 32 of the Constitution,” it said.

The Health Ministry, which filed the affidavit on behalf of the Central government, said the vaccines in use under the immunisation programme were manufactured by third parties and successfully underwent regulatory review in India as well as other nations, and were recognised globally as safe and effective.

“Under these facts, it is most humbly submitted that holding the state directly liable to provide compensation under the narrow scope of strict liability for extremely rare deaths occurring due to AEFI (Adverse Events Following Immunisation) from the use of vaccines may not be legally sustainable,” it said.

Petitioners take government to task

“The government cheated us by not telling anything about the adverse effects. None of the advertisements or anything talked about the adverse effects, and it did not highlight the serious effect of a blood clot and deaths and so on. In that environment, we got deceived and we fell for it and we lost our daughter,” said Venugopalan.

“The doctors were completely clueless. When she was hospitalised, none of the doctors were aware that the vaccine would cause any adverse event. For a long time, they were not putting anything on the AEFI portal. AEFI is a big sham it’s not capturing every death,” said Venugopalan.

Denying the petition’s prayer for compensation, the Union government said, “If a person suffers physical injury or death from AEFI, appropriate remedies in law are open to vaccine beneficiaries per their families including approaching the civil courts for a claim of damages/compensation. Such claim for negligence is to be decided on a case-to-case basis.”

Venugopalan said: “I don’t want any other parents to go through what I go through. The country must have systems in place, that must prevent this kind of situation, which lacks clarity.”

He further said there was a need to devise systems in the country so that government could not push untested preparations on the whole population on top of a bunch of lies by the ruling class, by the media, or anybody by saying something is safe and effective and unleashed it on the whole population allowing people to die voicelessly, this should be stopped.

“There should be a system in place. The government should disclose every side effect. They should disclose all the known side effects, as they will emerge, and they should disclose in vernacular, common language, not some press release on the PIB Website. The AEFI monitoring system should be enhanced and strengthened to the extent that those sufferers have to kind in a position to file their complaint,” added Venugopalan,

Giving figures for AEFIs, the government said that it was very few when compared to the total administered doses.

Out of 219.86 crore doses of Covid-19 vaccines administered in the country till 19 November, 2022, there are 92,114 AEFIs reported, the affidavit said.

Of this, 89,332 (0.0041 percent) were minor AEFIs while only 2,782 (0.00013 percent) resulted in severe AEFI including death.

The Union government added a caveat saying that the “causation analysis” of all severe or serious AEFIs was still pending and hence, it was too early to suggest that the same was directly attributed to the vaccine.