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regular-article-logo Wednesday, 02 October 2024

Covid: SC seeks disclosure of clinical trial data on vaccines

The apex court declined to stay the vaccination process to avoid any panic or misgivings among the public

R. Balaji New Delhi Published 10.08.21, 02:20 AM
Supreme Court of India

Supreme Court of India File picture

The Supreme Court on Monday issued notices to the Centre and others on a petition that seeks disclosure of the clinical trial data on Covid-19 vaccines, cleared under “emergency use authorisation”, and informed consent from citizens for inoculation.

However, the apex court declined to stay the vaccination process to avoid any panic or misgivings among the public.

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The petition from Dr Jacob Puliyel, former member of the National Technical Advisory Group on Immunisation (NTAGI), claims that some people were coerced to take the jab.

It argues that the government cannot resort to arm-twisting without a public disclosure of the clinical data relating to the adverse reactions caused by the two vaccines used in India, Covishield and Covaxin.

“Our apprehension is any detailed enquiry into this will cast doubts in the minds of people,” the bench of Justices L. Nageswara Rao and Aniruddha Bose observed.

“This country is fighting a vaccine shortage. Now we are on a different tangent. Let vaccination go on — we don’t want to stop this.... India already has a serious problem of vaccine hesitancy.”

However, the court issued notices on the petition saying it would accept the argument that “personal autonomy” should have precedence over “public health”.

Besides the Union government, the apex court has sought responses from the Indian Council of Medical Research and the Central Drugs Standard Control Organisation, besides the vaccine makers Serum Institute of India and Bharat Biotech, within four weeks.

Puliyel, a Delhi-based paediatrician, has questioned the vaccines being granted emergency use authorisation — an interim approval for a drug or vaccine during a public health emergency, such as the Covid pandemic, pending final approval that can only come after the trials and data analyses are complete.

Puliyel has sought a court directive to the authorities to publish the segregated data of the clinical trials for the vaccines that are being administered to Indians.

“This (failure to disclose trial data) is a clear violation of the basic norms of scientific disclosure and the guidelines with respect to disclosure of clinical trial data, as laid down by the World Health Organisation (WHO) and followed by the Indian Council of Medical Research (ICMR),” the petition, filed through advocate Cheryl D’Souza, says.

“The disclosure of such information is essential to ascertain whether a certain section of the population is more susceptible to adverse effects, to determine what are the adverse effects in various age groups and on differing populations, etc.”

According to the petition, the Indian authorities should monitor the vaccine recipients and record all adverse events, and that such a measure in some other countries has helped identify the occurrence of blood clots and strokes in some vaccine recipients.

Many countries stopped administering the vaccine till they evaluated such occurrences, and Denmark banned the use of the AstraZeneca vaccine (branded Covishield in India), the petition says.

“Once we entertain this petition it should not send out a signal that we do not trust the efficacy of these vaccines,” the bench told advocate Prashant Bhushan, appearing for the petitioner.

Bhushan said the petitioner was not against vaccination but only wanted the government to make the clinical data public. He alleged that coercion was being used on people unwilling to take the jab.

He referred to Gauhati and Meghalaya High Courts cautioning against the adoption of coercive measures after reports said people were being threatened with the sack or closure of their businesses if they didn’t get vaccinated.

“Do you want vaccines to stop?... About 50 crore people have taken vaccines. Won’t this petition put a doubt in the mind of people who have taken vaccines already?” Justice Rao asked.

Bhushan argued that according to WHO guidelines and the Helsinki Declaration, trial data of vaccines should be made public so that prospective recipients of the jab can take an informed decision.

The court said that even the WHO had spoken of “vaccine hesitancy”, and entertaining the petition would only sow more doubts in the public’s mind.

Bhushan argued that failure to make the data public would only increase vaccine hesitancy.

Quoting the ICMR, he said two-thirds of Indians had already developed immunity from the pandemic, suggesting the urgency to take the jab had reduced.

Bhushan said various studies had indicated that the vaccines may have led to the appearance of newer Covid variants and that they were hardly effective on the “Delta variant”.

The bench said it had to hear the Centre out before passing any orders.

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