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.