BREAKING : Supreme Court Issues Notice On Plea For Disclosure Of Clinical Trial & Efficacy Data Of COVID Vaccines; Refuses To Halt Compulsory Vaccination Mandate
The Supreme Court on Monday issued notice on a Public Interest Litigation(PIL) seeking public disclosure of clinical trial data and post vaccination efficacy data of COVID vaccines, as is required by International medical norms, and to stop the coercive mandate issued by various governments for vaccination.The Court issued notice to the Union of India, the Indian Council of Medical...
The Supreme Court on Monday issued notice on a Public Interest Litigation(PIL) seeking public disclosure of clinical trial data and post vaccination efficacy data of COVID vaccines, as is required by International medical norms, and to stop the coercive mandate issued by various governments for vaccination.
The Court issued notice to the Union of India, the Indian Council of Medical Research (ICMR), Drug Controller of India and vaccine manufacturers Bharat Biotech Ltd and Serum Institute of India, returnable within 4 weeks.
A bench comprising Justices L Nageswara Rao and Aniruddha Bose was hearing a petition filed by Dr Jacob Puliyel, a former member of National Technical Advisory Group of Immunization.
Court-room exchange
The bench told the petitioner's counsel Advocate Prashant Bhushan that the petition raised some "relevant points" and said that it appreciated the petitioner's concerns about need for transparency in vaccine efficacy date. However, the bench expressed a concern whether an inquiry into vaccination process at this stage with throw doubts into the minds of over 50 crores of people who have taken vaccination and will add to vaccine hesitancy.
Clarifying that the petition was not an "anti-vaccine petition", Advocate Bhushan said that all that he was was seeking was disclosure of the clinical trial and post-vaccination date, as is required by the rules framed by the ICMR itself.
"It is first time in the history of India that Emergency Use Authorization has been given for vaccine without full clinical trial. The minimum I am asking is disclosure and transparency. Their own rules say this", he said.
Bhushan said that the clinical trials require to be published by the Helsinki declaration, which has been adopted by ICMR and the the WHO.
"I'm not saying that Emergency Use Authorization cannot be given. I'm saying that the data needs to be put out. And the post-vaccination data needs to be put out. I'm not asking for vaccination to be halted", Bhushan submitted.
"Yes, you are not asking for vaccination to be stopped. What we are thinking is if it will create doubts among people and lead to hesitancy", Justice Rao commented.
"It is when you don't have transparency that people will hesitate", Bhushan replied.
Won't pass any orders against vaccination now, says the bench
Bhushan also submitted that various governments have issued mandates for compulsory vaccination saying services will be denied to persons who have not taken vaccination. He referred to the judgments in Aruna Shaunbag and Common Cause cases, which recognized the legality of passive euthanasia and living wills.
However, the bench asked if personal autonomy can be pressed against a public health interest. It commented that those judgments were rendered in a different context and may not be applicable in a situation of pandemic emergency.
"You are pressing personal autonomy against public interest. It is said unless everyone is vaccinated, nobody is safe", Justice Rao observed.
Bhushan said that this is one of the most important PILs he has ever filed, and that the same has been done with considerable thought and research. He referred to the judgments passed by the High Courts of Gauhati and Meghalaya against forced vaccinations and denial of services to those who have not taken vaccines.
"We appreciate your concerns. We appreciate your concern that they have to reveal the entire data on adverse effects. But we have to to see that the situation is very grave. We are still not out of it. We still have 4 lakh cases. Our concern is that if any inquiry at this stage will throw doubts on the efficacy", Justice Rao said.
Bhushan replied by saying that transparency will not militate against public interest and will only help reduce hesitancy.
"We appreciate that you have raised some seminal issues. But we are trying to open our mind to the larger public health issue",Justice Rao said.
Though Bhushan requested for an interim relief against compulsory vaccination mandate, the bench declined, saying that it does not want to pass any such orders at this juncture.
"Let the vaccination go on and we don't want to stop this. We will examine your points", Justice Rao said.
"Once we entertain this petition it should not send a signal that we do not trust the efficacy of these vaccines", Justice Rao remarked during the hearing.
After the bench issued notice, the bench and Bhushan indulged in a bit of conversation about vaccination programs across the globe.
Bhushan said : "In 1976, the US embarked on a universal vaccination programme for swine flu and at that time it was found that people getting vaccinated develop serious neurological problems. 34 million people in the US, which was 15% of the population, were found to have developed serious neurological symptoms and it was found that this fact was kept hidden. As a consequence entire vaccination had to be stopped"
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, 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.