Supreme Court of India PIL

Jacob Puliyel, Prashant Bushan

The petitioner herein is filing the instant writ petition under Article 32 of the Constitution of India for the enforcement of fundamental rights under Article 14 and 21 of the Constitution of India, seeking a writ directing the respondents 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 the Drugs Controller General of India (DCGI). The petitioner is a former member of the National Technical Advisory Group on Immunisation (the government’s apex body on immunization). 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 the data being disclosed to the public. This is a clear violation of the basic norms of scientific disclosure and the guidelines with respect to disclosure of clinical trial data, as laid down by the World Health Organisation (WHO) and followed by the Indian Council of Medical Research (ICMR). In India, the manner in which the vaccines have been licensed vitiates and even precludes the possibility that the vaccines can be evaluated objectively in the future. Under these circumstances the petitioner is forced to appeal to this court for public disclosure of trial data and post vaccination data, as required by international medical norms.

The petitioner submits that the importance of disclosure of segregated data of vaccine clinical trials (segregated for each vaccine and for each age group) that have been undertaken with respect to the two vaccines being administered in India, cannot be undermined and must be disclosed through peer reviewed scientific journals. The disclosure of such information is essential to ascertain whether a certain section of the population is more susceptible to adverse effects, to determine what are the adverse effects in various age groups and on differing populations, etc. So far, the respondents have practiced complete secrecy in the matter and have not disclosed any data from trials for the vaccines that have been developed in India – Covaxin by the Bharatbiotech or for the Covishied manufactured at the Serum Institute, India (SII). The clinical trial information that is available for the COVISHIED vaccine is preliminary data of clinical trials that have been undertaken for the vaccine in other countries.

Besides this, it is important for the respondent authorities to carefully monitor vaccine recipients and publicly record all adverse events. In other countries, this type of observation has helped identify the occurrence of blood clots and strokes in vaccine recipients. Many countries stopped administering the vaccine till they evaluated this occurrence and countries like Denmark have completely banned use of the Astra Zeneca vaccine (branded as Covishield in India). India, with its huge population and numbers vaccinated, should have reported these adverse events first. But due to poor follow-up, poor Adverse Events Following Immunization (AEFI) evaluation and suppression of data, these events have not been put in the public domain – endangering many more to suffer the same fate. Under these circumstances the petitioner has approached this court also seeking that that all AEFI be actively solicited by notification in newspapers, and be made available in publicly accessible data base (Like the VAERS data base in the USA). Currently the website only mentions certain numbers of AEFI but details of those cases are not available for scientific scrutiny.

Further the petitioner prays that no coercive mandates for use of these inadequately tested vaccines may be issued and that the courts reiterate that vaccine mandates are repugnant to the right of humans to autonomy and right to self-determine what may be injected into their bodies. In so doing this Hon’ble Court must uphold the rights of individuals to give informed consent as the Delhi High Court did, in the Measles Rubella case. It is submitted that coercing citizens directly or indirectly to get vaccinated is unconstitutional and violates the 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 now various authorities are mandating the vaccines.

The petitioner recognises that Covid is a public health emergency and that such an emergency may require emergency use authorisations of vaccines which may not yet have been adequately tested. However, that should not mean that all information and data of relevance as to the efficacy or side effects of the vaccines which have been given such approval, should not be collected systematically and made publicly available, especially when the vaccines are being used in a universal immunisation programme. Though emergency authorisation of the vaccines may be advisable in the present situation, it does not however mean that these vaccines can be forced upon people, especially without all relevant data being available for independent public and scientific scrutiny. The present petition therefore should not be understood to be a petition challenging the present Covid vaccination programme.

For the first time in history, a universal mass vaccination programme is being undertaken in India and many other countries using vaccines which have not been fully tested for efficacy and side effects, in the manner in which vaccines are required to be tested normally, usually over a period of three years or so, so that even long term adverse effects can be examined. The problem is further compounded due to the lack of transparency in the vaccine trial data and the manner of granting approvals to the vaccines based on that data which is withheld from disclosure to the public or not available to independent researchers for scientific scrutiny.

History has shown that vaccines can be very useful instruments for fighting disease and epidemics but vaccines can also have serious unintended side effects. That is why before vaccines are approved they need to be properly tested and studied by thorough clinical trials and the test results must be available for scrutiny by independent scientists. While there may be circumstances warranting emergency approvals to vaccines which have not been fully and properly tested, there cannot be any reason whatever for trial data (that has been collected and on the basis for which approvals have been given), to be withheld from public scrutiny. This is what the WHO and ICMR guidelines also require. In such circumstances, coercing people to take the vaccines on pain of losing their jobs or access to essential services, which has begun to happen in many parts of the country, is a violation of the fundamental rights of people, especially in a situation where emergency approvals have been given to vaccines without full and adequate testing and without any transparency of the trial data and post vaccination data.
Hence this writ petition.