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Supreme Court issues notice in plea seeking transparency in clinical trial data for vaccines being given under emergency authorization

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The Supreme Court on Monday issued notice in a plea filed by Dr Jacob Puliyel seeking transparency in clinical trial data for the vaccines being administered in India under emergency use authorization as well as seeking a stay on the vaccine mandates that are being issued by authorities in various parts of the country.

A two-judge bench of Justices L. Nageswara Rao and Aniruddha Bose has issued notice and directed the government to respond to the petition and interim application and list the matter after four weeks. The plea was filed by Dr Puliyel, who is a former member of the National Technical Advisory Group on Immunisation through advocate Cheryl D’Souza. 

The plea averred that, “vaccines that have not been adequately tested for safety or efficacy are now licensed under Emergency Use Authorisation without data being disclosed to the public.”

“This is the 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 and followed by the Indian Council of Medical Research,” it alleged. 

“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,” stated the plea. 

The plea has also sought directions to the Central Drugs Standard Control Organisation to disclose the detailed minutes of the meeting of the Subject Expert Committee and the NTGAI with regard to the vaccines as directed by the 59th Parliamentary Standing Committee Report and the members who constituted the committee for the purpose of each approval meeting. It also sought directions to the Central Drugs Standard Control Organisation to disclose the reasoned decision of the DCGI granting approval or rejecting an application for emergency use authorisation of vaccines and the documents and reports submitted to the DCGI in support of such applications. 

Also Read: Supreme Court issues notice in plea seeking transparency in clinical trial data for vaccines being given under emergency authorization

Further, it sought directions to the respondents to disclose the post vaccination data regarding adverse events, vaccines who got infected with Covid, those who needed hospitalisation and those who died after such infection post vaccination and direct the Respondents to widely publicised the data collection of such adverse event through the advertisement of toll free telephone numbers where such complaints can be registered. In addition, to 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 rights of citizens and unconstitutional. 

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