Tuesday, March 28, 2023

Supreme Court adjourns plea seeking transparency in clinical trial of vaccines used in emergency

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The Supreme Court on Thursday has adjourned its hearing 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 Justice L. Nageswara Rao and B.R. Gavai on the last hearing had observed that there is a limited scope in this plea as to whether central govt policy was in accordance with expert opinion or not. 

The Supreme Court was previously informed by the Centre that it took a decision not to make Covid Vaccination Mandatory. 

On the last hearing, appearing for the Centre Additional Solicitor General Aishwarya Bhati has submitted that data in relation to the people get vaccinated. She said, for adult, 96 percent adults have been given first dose and 80 percent adults have got the second dose. Now having achieved 96 percent coverage, the whole aspect of challenging the vaccination has paled into insignificance.

Justice L Nageswara Rao said petitioner has not challenged the vaccination but he has challenged mandatory vaccination. 

Centre has taken a decision not to make vaccination mandatory so far, Bhati replied. 

The Apex Court had earlier 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. 

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The state of Tamil Nadu had filed an affidavit stating “overarching goal of COVID-19 vaccines is to contribute significantly to the equitable protection and promotion of human well­ being among people globally. Vaccines are very important, particularly for protecting health care workers and those most-at-risk is the only way to mitigate the public health and economic impact of the pandemic.”

The Affidavit further states that

“before grant of the Emergency Use Authorization (EUA), there are rigorous assessments of laboratory and clinical trial data, including data on quality, safety, production of protective antibodies and efficacy. Safety is particularly critical aspect of this scrutiny and a risk-versus­ benefit evaluation is done in the context of a public health emergency. Full licensure is obtained when the manufacturer submits the complete data. EUA by Indian regulators is aligned with global guidelines.”

The state attributed the reduce in death count and severity of the virus to the vaccination of citizens at large.

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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. 

Also Read: Manipur High Court closes PIL against state govt order mandating Covid-19 vaccine for citizens

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. 

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.

Case Name- Jacob Puliyel Vs Union of India & Ors 

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