Covid vaccine: SC seeks Centre’s response on plea for full disclosure of clinical trial data

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August 10, 2021 3:45 AM

The apex court also asked the Centre, Bharat Biotech, Serum Institute of India and others to respond to a plea seeking directions for disclosure of data on clinical trials of vaccines as also on post-vaccination cases.

Bhushan said authorities cannot coerce/ force people to take vaccines even though their clinical trial data have not been made public.Bhushan said authorities cannot coerce/ force people to take vaccines even though their clinical trial data have not been made public.

Refusing to impose an interim stay on “compulsory vaccination”, the Supreme Court on Monday decided to examine a “seminal” issue of right to personal autonomy vis-a-vis public health, in view of the “coercive measures” allegedly being undertaken by various authorities for Covid-19 vaccination in the country.

The apex court also asked the Centre, Bharat Biotech, Serum Institute of India and others to respond to a plea seeking directions for disclosure of data on clinical trials of vaccines as also on post-vaccination cases.

Observing that universal vaccination is needed to deal with the pandemic, a Bench comprising Justices L Nageswara Rao and Aniruddha Bose made it clear that it doesn’t want to create doubts in the minds of over 50 crore Indians who have already taken vaccines.

“Do you want vaccines to stop? … All your grounds are that licence was given before trial data was made public. [Fifty] crore people have taken vaccines. Won’t this petition put a doubt in the mind of people who have taken vaccines already? … We appreciate your concern. We are looking at larger public interest and looking at the opposite view. There is no way we can stop the vaccines,” Justice Rao told counsel Prashant Bhushan, appearing for Dr Jacob Puliyel, a member of the National Technical Advisory Group on Immunisation, who has sought full disclosure of data on clinical trials, efficacy and adverse effects of the Covid-19 vaccines being administered in India.

Declining to stay any order on vaccine mandates issued by the authorities for the people to avail certain facilities, the judges said, “Vaccine hesitancy is already a problem in this country. Once we entertain this petition it should not send a signal that we do not trust the efficacy of these vaccines.”

Stressing on the need to balance the risk of potential threat with public interest, the apex court said, “… You say no pandemics happened in 100 years. As it is, WHO also says there is vaccine hesitancy among public and we entertaining this PIL won’t throw a doubt in the minds of people?” the judges asked.

The judges also said the country still had four lakh active Covid-19 cases.

Though Bhushan argued that he does not want to stop vaccinations, he said vaccine hesitancy even amongst the most educated people was due to lack of data on clinical trials in the public domain.

Puliyel has also cited the instance of the Astrazenaca vaccine being banned in various nations due to side effects like blood clotting, though the vaccine continues to be administered in India under the brand name Covishield.

Citing the Helsinki declaration of the World Medical Association which mandates public disclosure of data of any vaccine before its human trials, the petitioner claimed that the huge incidence of Covid-19 in India in the past one-and-a-half years has already raised public immunity higher than it would possibly rise through vaccines.

Bhushan said authorities cannot coerce/ force people to take vaccines even though their clinical trial data have not been made public. He said barring unvaccinated people from availing essential services or entering offices is unconstitutional, as he pointed to several instances of the vaccines being mandated by authorities at various places despite the government’s official stance that the vaccination drive is a voluntary exercise.

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