"Coercing Citizens Directly Or Indirectly To Get Vaccinated Is Unconstitutional": Plea In Supreme Court Seeks Public Disclosure Of Vaccine Clinical Trial And Post Vaccination Data

A plea has been filed before the Supreme Court seeking public disclosure of vaccine clinical trial data and post vaccination data, as is required by International medical norms.

The plea has been filed seeking directions to make public the segregated data of the clinical trials for the vaccines that are being administered to the population in India under the Emergency Use Authorisation granted by Drugs Controller General of India( DCGI)

The plea filed by Dr Jacob Puliyel through Advocate Prashant Bhushan has sought directions for release of entire segregated trial data for each phase of trial undertaken for vaccines being administered in India. The petitioner has clarified that the present plea should not be understood as a plea challenging the present covid vaccination programme.

Further, directions have been sought to Central Drugs Standard Control Organization to disclose decision of DGCI granting approval or rejecting an application for emergency use of authorisation of vaccines and documents submitted to DGCI in support of the application.

The plea has also sought directions for disclosure of post vaccination data regarding adverse events, vacinees who got infected with covid, needed hospitalisation and those who died post vaccination. Such events should also be advertised through toll free number.

Further, the plea has sought a declaration that vaccine mandates, in any manner whatsoever, even by making it a precondition for accessing any benefits or services is violative of rights of citizens and is unconstitutional.

The petitioner avers and wishes to record the evidence in medical literature that, vaccines that have not been adequately tested for safety or efficacy are now licensed under Emergency Use Authorisation without data being disclosed to public.

This according to the petitioner, who is former member of the National Technical Advisory Group on Immunisation, is in clear violation of basic norms of scientific disclosure and guidelines for disclosure of clinical trial data as laid down by Indian Council of Medical Research.

The plea has stated that disclosure of segregated data of vaccine clinical trials with segregation made for each vaccine and each group, cannot be undermined and must be disclosed through peer reviewed scientific journals.

The plea has pointed out the following reasons to emphasise on the importance of disclosure:

* To ascertain if certain section of population is more susceptible to adverse effects.

* To determine adverse effects in various age groups and on differing populations

The petitioner has also laid emphasis on importance of vaccine recipients being carefully monitored by the authorities and public recording of all adverse events, as in other countries this observation helped identify occurrence of blood clots and strokes in recipients.

"India with its huge population and numbers vaccinated should have reported these adverse events first but due to poor follow up and poor adverse events following immunisation (AEFI) evaluation and suppression of data, these events have not been put in public domain - endangering many to suffer the same fate" the plea states

The petitioner has also prayed that no coercive mandates for use of the inadequately tested events may be issued and the courts reiterate that vaccine mandates are repugnant to right of humans to autonomy and right to self determine what may be injected into their bodies.

"Coercing citizens directly or indirectly to get vaccinated is unconstitutional and violates right to life of citizens. While the government has clearly stated in numerous RTIs that covid vaccines are voluntary, there are many instances from across the country where various authorities are mandating vaccines" the plea reads.

While acknowledging that Covid is a public health emergency, the petitioner has stated that it shouldn't mean that all data of relevance as to efficacy or side effects of vaccines which have been given approval should not be collected systematically and made publicly available, especially when they're being used in a universal immunisation programme.

Further, it has been argued that though emergency authorisation of vaccines may be advisable in present situation, it does not mean that these vaccines can be forced upon people, especially without relevant data being available for independent public and scientific scrutiny.

The plea has stated that history has shown that while vaccines can be very useful in fighting diseases and pandemics, they can also have serious unintended side effects. Therefore, before vaccines are approved they need to be property tested and studied through clinical trials and test results must he made available for scrutiny by independent scientists.

The petitioner has argued that coercing people to take vaccines on pain of losing jobs or access to essential services which has begun to happen in many parts of the country, is a clear violation of fundamental rights especially when emergency approvals have been given to vaccines without full and adequate testing and without transparency of trial and post vaccination data.

Click here to download the Petition