Covid vax clinical trial data can t be demanded in garb of PIL Centre to SC

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New Delhi, March 15

The Centre on Tuesday told the Supreme Court that as on March 13, over 180 crore doses of Covid-19 vaccines have been administered and "adverse event incident", which were periodically recorded were 77,314 as on March 12, or 0.004 per cent of total vaccinations, as it emphasised that segregated clinical data cannot be demanded by anyone under the garb of filing of public interest litigation.

Solicitor General Tushar Mehta and Additional Solicitor General Aishwarya Bhati made submission on behalf of the Centre before a bench comprising Justices L. Nageswara Rao and B.R. Gavai.

On the aspect of disclosure of segregated clinical trial data, the Centre said: "By the very nature of the subject matter, there is a confidentiality attached to certain parts of the clinical trial process which cannot be compromised under the law."

Mehta said it is pertinent to note that the petitioner has not shown any material to suggest that there is any legal obligation anywhere in the world to publicly disclose segregated/raw clinical data for vaccines. He added that so far as the raw or segregated data generated at trial sites is concerned, the said data is always called for and examined before grant of either emergency use approval or final approval by the statutory committee of domain experts and by the approving authority.

"The statutory authority and the domain experts, which granted the approval, have examined this raw data as required under statutory provisions. Such data cannot be demanded by anyone under the garb of filing of public interest litigation either to satisfy his curiosity or in furtherance of his attempts to create vaccine hesitancy in the country and which are, by its very nature, against public interest," the two law officers said in their submissions.

The Centre said it is relevant that there is a logical rationale in not disclosing raw data either segregated or otherwise and the citizens have a reason to rely upon the statutory system in place, the wisdom of domain experts consisting of statutory committees and the decision-making process while going for vaccination.

"Once such raw data have been repeatedly examined and scientifically evaluated by the statutory committees consisting of independent domain experts, any disclosure of raw data would lead to different people evaluating the data and irresponsibly throwing their own conclusions," they said in the submissions.

It further added such a situation would lead to vaccine hesitancy and will defeat the very object of the vaccination drive anywhere in the world.

According to the submissions over 8.91 crore doses Covaxin has been administered in the age group of 15-18 years as on March 12 and the number of adverse events following immunisation (AEFI) reported are 1,739 minor, 81 serious, and six severe. The Centre said as on March 13 2022, over 180 crore doses of Covid-19 vaccines have been administered.

The government emphasised that both vaccines – Covaxin and Covishield – generate antibodies and adverse events are also found to be minimal. "Further the efficacy, safety and immunogenicity of these vaccines, which are rolled out after an elaborate procedure by domain experts, are also accepted by the World Health Organisation which shows recognition by global experts also," added the submissions.

The Centre' s response came on a plea seeking directions for disclosure of data on clinical trials of Covid-19 vaccines and post-jab cases.

The submissions added: "This court, would not, therefore, accede to the prayer of the petitioner to exercise judicial review in issues concerning several, scientific and medical aspects which are already considered by domain experts drawn from all over the country representing various medical faculties."

Advocate Prashant Bhushan, representing petitioner Jacob Puliyel, had argued that whether to get vaccinated or not is an individual decision.

"Even, I had Covid. But, I have not taken the vaccine. I have decided not to take the vaccine, come what may."

He insisted that adverse effects of Covid vaccination are not known, and questioned why governments are issuing vaccine mandates restricting people from entering public spaces by making vaccination mandatory. "If one was infected with Covid (and got cured), that person gets better natural immunity against the infection," he said.

The top court will continue to hear arguments on March 21.


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