SC issues notice to Centre over public disclosure of COVID vaccine clinical trial data, post-vaccination data

New Delhi [India]: The Supreme Court on Monday issued notice to the Centre after hearing a plea filed seeking public disclosure of COVID vaccine clinical trial data and post-vaccination data, as the petitioner claims that it is mandatory and required that the government must publish these as per the International medical norms.
“We are issuing notice. We will wait for their (UOI) response. Let them (UOI) come with the reply. We will hear the matter after that. We will hear the issue, which you (petitioner) have raised,” a two-judge bench of the Apex Court, headed by Justice L Nageswara Rao and also comprising Justice Aniruddha Bose said, today. The petition was filed by Dr. Jacob Puliyel through advocate Prashant Bhushan, before the Supreme Court seeking its direction for transparency in clinical trial data for the COVID vaccines being administered in India under emergency use.
The petitioner, Dr Puliyel, also sought a stay on the COVID vaccine mandates that are being issued by authorities in various parts of the country.
The Apex Court has asked the UOI to respond to the petition filed by Dr Puliyel, and the poses the matter for further hearing after four weeks.
Prashant Bhushan told the Supreme Court that first time in history, such kind of practice took place, “without properly completing the vaccine trial.”
He also said that the Helsinki and World Health Organization (WHO) mandated that all COVID vaccine data and trials have to be made in a transparent manner, which, in this case, was not made. “The clinical trial has to be completed,” Bhushan said.
As far as the COVID vaccine mandate is concerned, “you (the government) cannot coerce people to take the vaccine,” Bhushan said, and also made it clear to the Supreme Court in his submissions that the government must clarify as to what are adverse effects, if there is any, of taking the COVID vaccine.
Bhushan said that in the interest of justice, the Supreme Court should direct the UOI to release the entire segregated trial data for each of the phases of trials that have been undertaken with respect to the COVID vaccines being administered in India.
Bhushan also sought direction from the UOI to disclose the reasoned decision of the DCGI granting approval or rejecting an application for emergency use authorization of COVID vaccines.
Bhushan also sought direction from the respondents, including the UOI, to disclose the post-vaccination data regarding adverse events, vaccines who got infected with COVID, those who needed hospitalization and those who died after such infection post-COVID vaccination.
He said that the Supreme Court should also direct the UOI to widely publicize the data collection of such adverse events.
Bhushan also sought a direction to the UOI to disclose the detailed minutes of the meetings 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.

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