Plea Seeking Disclosure of Clinical Trials Data for Covid Vaccines Filed in SC; Urges Court to Stop Forcing Citizens to be Vaccinated Without Publication of Relevant Data

A petition has been filed in the Supreme Court seeking directions to the Central Government to make public the segregated data of clinical trials for the vaccines that are being administered in India under Emergency Use Authorisation granted by the Drugs Controller General of India (DCGI).

The plea has also urged the court to stop coercing citizens directly or indirectly to get vaccinated as it is unconstitutional, arguing that while the government had clearly stated in numerous RTIs that getting vaccinated was voluntary, there were many instances from across the country where various authorities were mandating the vaccines.

The petition, filed by Dr Jacob Puliyel, a former member of the National Technical Advisory Group on Immunisation, through advocate Prashant Bhushan has, however, clarified this was not to be understood as a challenge to the vaccination programme.

“The petitioner recognises that Covid is a public health emergency and that such an emergency may require emergency use authorisations of vaccines which may not yet have been adequately tested. However, that should not mean that all information and data of relevance as to the efficacy or side effects of the vaccines which have been given such approval, should not be collected systematically and made publicly available, especially when the vaccines are being used in a universal immunisation programme”, the plea states.

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It adds though emergency authorisation of the vaccines may be advisable in the present situation; it does not, however, mean that these vaccines can be forced upon people, especially without all relevant data being made available for independent public and scientific scrutiny.

The plea contends that the vaccines that have not been adequately tested for safety or efficacy are now licensed under Emergency Use Authorisation without the data being disclosed to the public. “This is a clear violation of the basic norms of scientific disclosure and the guidelines with respect to the 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 plea asserts.

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“In India, the manner in which the vaccines have been licensed vitiates and even precludes the possibility that the vaccines can be evaluated objectively in the future. Under these circumstances, the petitioner is forced to appeal to this court for public disclosure of trial data and post-vaccination data, as required by international medical norms”, the petition states.

The plea has urged the court to direct:

• Respondents to release the entire segregated trial data for each of the phases of trials that have been undertaken with respect to the vaccines being administered in India;
• Respondent no 2 (Drugs Controller General of India) to disclose the detailed minutes of the meetings of the Subject Expert Committee and the NTGAI about the vaccines as directed by the 59th Parliamentary Standing Committee Report and the members who constituted the committee for each approval meeting; a
•  Respondent no 2 to disclose the reasoned decision of the DCGI granting approval or rejecting an application for emergency use authorization of vaccines and the documents and reports submitted to the DCGI in support of such application;
•  Respondents to disclose the post-vaccination data regarding adverse events, vaccinees who got infected with Covid, those who needed hospitalization and those who died after such infection post-vaccination and direct the respondents to widely publicize the data collection of such adverse event through the advertisement of toll-free telephone numbers where such complaints can be registered;
• Declare 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 and is unconstitutional.

Union of India, Drugs Controller General of India, Indian Council of Medical Research, Bharat Biotech and Serum Instututite have been made respondents to the petition.

The article was originally published in The Leaflet.