SC reserves verdict on plea seeking data on clinical trials of vaccination drives

A petition filed by a former member of the National Technical Advisory Group on Immunisation (NTAGI) Jacob Puliyel sought disclosure of post-vaccination data and clinical trial data.
Image used for representational purpose only. (Photo | AP)
Image used for representational purpose only. (Photo | AP)

NEW DELHI: The Supreme Court on Tuesday reserved its orders on a petition filed by a former member of the National Technical Advisory Group on Immunisation (NTAGI) Jacob Puliyel that seeks disclosure of post-vaccination data and clinical trial data. The plea also seeks a declaration that vaccine mandates, in any manner whatsoever, even by way of making it a precondition for accessing any benefits or services, is a violation of the rights of citizens.

The state of Tamil Nadu explained the vaccine mandate in the state said that it satisfies larger public interest and is necessary for the safety of every person. The government explained its stand on vaccination by saying that it is better to tread with caution and prevent harm to the public. It defended the same by referring to Tamil Nadu Public Health Act, 1939 which gives it the power to come out with such a circular.

The States of Maharashtra and Madhya Pradesh submitted that the decision to show vaccination proof fulfils the test of proportionality and is meant to create more awareness about vaccination. A bench comprising Justice L Nageswara Rao and Justice BR Gavai also heard arguments by vaccine manufacturers Serum Institute of India and Bharat Biotech Limited against data disclosure.

Serum Institute of India, the producer and marketer of the Covishield vaccine, told the court that the necessary data is with the regulator. Bharat Biotech which manufactures Covaxin while denying allegations of non-disclosure of information said that the data relating to the phase III trial has been published.

The Centre had informed the top court on Monday that all documents related to Covid-19 vaccines and their compositions are available in the public domain, and the vaccine has proved to be very effective and safe. Solicitor General Tushar Mehta, appearing for the Union government, told the bench that the administration of vaccines is being monitored on a real-time basis. "The argument of the petitioner was that they were not aware of what the vaccine is and what the ingredients are. All the documents are in the public domain. The entire composition is given, clinical particulars, therapeutic indications etc are all given in the Centre's counter. We have also given clinical trial experience and no vaccine-related adverse response is observed," he had told the apex court.

The plea filed by advocate Prashant Bhushan also seeks to disclose the post-vaccination data regarding adverse events, people who got infected with Covid, those who needed hospitalisation and those who died after such infection post-vaccination and direct the respondents to widely publicise the data collection of such adverse event through the advertisement of toll-free telephone numbers where such complaints can be registered. It has been submitted in the petitioner’s plea that “simply because vaccinations and permissions thereof deal with aspects of science does not mean they do not come under the purview of judicial review. Judicial Intervention in matters dealing with scientific procedures undertaken by domain expertise is not excluded. This should specifically be the case for vaccines for covid 19 considering they are meant to be used in universal immunisation programmes and have been introduced in the clinical trial mode under emergency use authorisation. Information related to the same should be available for public and independent scientific scrutiny.”

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