The Centre said on Monday that nobody is losing anything due to Covid-19 vaccines mandates in response to a plea in the Supreme Court seeking transparency in clinical trial data for vaccines being administered in India under emergency use authorization as well as seeking a stay on vaccine mandates being issued in parts of the country.
A Division Bench of Justices L. Nageswara Rao and B.R. Gavai told Senior Advocate Prashant Bhushan, appearing for the petitioner, that it might not be able to decide the issues as they have numerous situations.
Bhushan argued that an individual has to weigh the pros and cons of the vaccine, its benefits and then decide on it for himself or herself. Many people are losing their job due to vaccine mandates, he said.
Solicitor General Tushar Mehta arguing for the Centre submitted that nobody is losing anything due to vaccine mandate. He mentioned that Bhushan had filed an application to this effect.
The Bench has listed the matter for final hearing.
Earlier, 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 stated 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 reduction in death count and severity of the virus to the vaccination of citizens at large.
The plea filed by Dr Jacob Puliyel challenging the mandate of coercing citizens to take the vaccine 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.
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.