Technical data

SC reserves verdict on plea requesting clinical trial data from vaccination campaigns – The New Indian Express

By Express press service

NEW DELHI: The Supreme Court on Tuesday reserved its orders on a petition filed by a former member of the National Technical Advisory Group on Immunization (NTAGI) Jacob Puliyel who seeks the disclosure of post-vaccination data and clinical trial data. Advocacy also calls for a statement that mandates for vaccinations, in any way, even making it a precondition of access to any benefit or service, is a violation of citizens’ rights.

The state of Tamil Nadu explained that the mandate of the vaccine in the state stated that it serves a wider public interest and is necessary for the safety of every person. The government explained its stance on vaccination saying it was best to proceed with caution and avoid harming the public. He defended the same by referring to the Tamil Nadu Public Health Act 1939 which gives him the power to issue such a circular.

The states of Maharashtra and Madhya Pradesh argued that the decision to present proof of vaccination satisfies the proportionality test and aims to raise awareness about vaccination. A bench consisting of Justice L Nageswara Rao and Justice BR Gavai also heard arguments from vaccine makers Serum Institute of India and Bharat Biotech Limited against releasing the data.

The Serum Institute of India, the producer and distributor of the Covishield vaccine, told the court the necessary data was with the regulator. Bharat Biotech which manufactures Covaxin while denying claims of non-disclosure of information said data from the phase III trial has been released.

The Center had informed the high court on Monday that all documents relating to Covid-19 vaccines and their compositions are available in the public domain, and that the vaccine has been found to be very effective and safe. Solicitor General Tushar Mehta, representing the Union government, told the bench that the administration of vaccines was monitored in real time. “The petitioner’s argument was that he did not know what the vaccine is and what its ingredients are. All documents are in the public domain. Full composition is given, clinical details, therapeutic indications etc. are all given in the Centre’s package insert. We have also given clinical trial experience and no vaccine-related adverse reactions are observed,” he told the Supreme Court.

The plea filed by lawyer Prashant Bhushan also seeks to disclose post-vaccination data regarding adverse events, people who were infected with Covid, those who required hospitalization and those who died after such infection after vaccination and to order respondents to disseminate the data widely. the collection of such adverse events by advertising free telephone numbers where such complaints can be registered. It was argued in the petitioner’s argument that “the mere fact that vaccinations and their authorizations deal with scientific aspects does not mean that they are not subject to judicial control. Judicial intervention in scientific proceedings undertaken by experts in the field is not excluded. This should specifically be the case for covid 19 vaccines given that they are intended for use in universal immunization programs and have been introduced into clinical trial mode under emergency use authorization. Information relating to the same should be available for public and independent scientific scrutiny.