'Covid Vaccination Voluntary, Hasn't Mandated Vaccination At This Stage': Centre Tells Supreme Court

The Central Government has submitted before the Supreme Court that it has not mandated for Covid 19 vaccines to be administered mandatorily at this stage

The Centre has stated that according to Covid-19 Vaccine Operational Guidelines", a detailed policy document providing broad vision of government regarding Covid-19 vaccination programme formulated by it, covid vaccination is voluntary.

The submissions have been made through a counter affidavit filed by the Central Government in a petition filed by Dr Jacob Puliyel, a former member of National Technical Advisory Group of Immunization, seeking directions for public disclosure of clinical trial data of COVID vaccines, and to stop the coercive mandate issued by various governments for vaccination.

The counter affidavit has been filed on behalf of the Ministry of Health and Family Welfare, and the Central Drugs Standard Control Organisation. 

Responding to the aspect of release of clinical trial data, the Centre has informed the Court that all data relating to clinical trial, approval by DCGI and vaccination data that is required to be and can be released as per law is already available in the public domain.

Further, the minutes of meetings and committee deliberations to the extent permissible are also already in the public domain.

It has been argued that neither the New Drugs and Clinical Trials Rules 2019, nor the GCP guidelines, ICMR guidelines, Declaration of Helsinki prescribe that the publication of the clinical trial study reports of each participating clinical trial sites is mandatory before approval of any new drugs including vaccine.

The Union of India has also submitted before the top Court that the decisions regarding approval of Covid 19 vaccines have been taken by expert committees consisting of domain experts based on and after verifying data and information supplied by the manufacturers and after considering its efficacy and safety.

It has been submitted that the procedure prescribed under the Drugs and Cosmetics Act, 1940 and Rules of 2019 were strictly followed while granting permission to Covaxin and Covishield vaccines.

Centre has also stated that the Post vaccination adverse data is already in the public domain and the concerned authorities are continuously monitoring and examining this data. 

The Centre has urged the Court to dismiss the present petition arguing that the petitioner has given a false picture before the Court and raised a false alarm and warning against efforts of the nation to combat an unprecedented tragedy faced by human race.

The Centre has argued that once it is placed before the Supreme Court that there is a statutory regime in place and the regime is followed, the Court, may not undertake the exercise any further as it would 'enable the petitioner and handful of others like him to create serious misgivings and misconceived doubts against the vaccination in the process of this petition itself.'

Vaccination and Adverse Event Following Immunisation Surveillance System: 

The Centre has submitted that, all cases of serious and severe AEFI (Adverse Event Following Immunisation) including reported death cases are subjected to scientific and technical review process.

This process consists of rapid reviews, analysis and causality assessment done by a team of subject experts who have been trained for doing so. Only after the causality assessment has been done that the AEFI can be attributed to the vaccine.

The affidavit states that these Adverse Event Following Immunisation are being monitored and reviewed, and the percentage of such effect having serious or severe [including deaths] in case of both Covaxin and Covishield is less than 0.01%.

It has been submitted that in all cases, the Central Government is conducting Rapid Review and Causality Assessment Of Serious And Severe AEFIS continuously.

"AEFI surveillance is a tool to identify and record all the possible adverse events following vaccination so that causality assessment can be done and adverse events actually caused by the vaccine could be identified. Therefore, mere reporting of AEFI case should not be attributed to be caused by the vaccine unless proved by the causality assessment analysis." the affidavit states.

The Centre has also informed the Court that 2116 serious and severe AEFI cases have been reported from 1,19,38,44,741 doses of COVID-19 vaccine administered till 24th Nov 2021.

A report of rapid review and analysis completed for 495 (463 Covishield & 32 Covaxin) cases has been submitted. Another report of 1356 cases (1236 Covishield, 118 Covaxin & 2 Sputnik) serious and severe AEFI cases (including 495 cases already analysed) has been presented to NEGVAC. The rapid review and analysis of balance cases is underway and will be completed soon.

About the petition:

The plea was 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 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, 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.

Case Title: Jacob Puliyel vs Union of India & Ors

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