The Madras High Court on Friday ordered notices, returnable by March 26, to the Union Ministry of Health and Family Welfare, Drugs Controller General of India (DGCI) and Director General of Indian Council of Medical Research (ICMR) on a writ petition to declare the Covishield vaccine unsafe since it had reportedly led to adverse effects on the litigant, who had volunteered for clinical trials.
Justice Abdul Quddhose ordered issuance of notices to the CEOs of Serum Institute of India Private Limited, AstraZeneca UK and also the chairman of the ethics committee of Sri Ramachandra Institute of Higher Education and Research, a deemed to be university in Chennai, on the petition filed by Asif Riaz, a business consultant, who also sought ₹5 crore in compensation.
The petitioner’s counsel N.G.R. Prasad told the court that the 41-year-old litigant was a Master’s degree holder in management from Massey University in New Zealand and a father of two children aged 12 and seven.
The vaccine, against COVID-19, was put through clinical trials as mandated under the New Drugs and Clinical Trial Rules of 2019 after obtaining permission for human trial from DGCI. The trials were conducted in four phases. First phase was to estimate safety and tolerability of the initial administration of an investigational new drug on humans and second was to evaluate effectiveness of the drug.
Common short term side effects and risks associated with the drug were also studied in the second phase and the primary objective of the third phase was demonstration or confirmation of therapeutic benefits and to confirm the preliminary evidence accumulated in the second phase. The fourth phase or the post marketing trial of new drugs were performed after the approval of the drug.
The petitioner volunteered to participate in the Phase III trials since he wanted to help in the larger effort to find a solution to the dismal situation that prevailed across the globe due to the pandemic. The trial was conducted at Sri Ramachandra Institute and an information sheet given to him stated that the vaccine was previously tested in the UK and it was found to be safe, he said.
The participant information sheet listed out the possible reactions such as fever, chills and fatigue that might occur after vaccination but they “not even remotely close to what I experienced,” Mr. Riaz said in his affidavit and added that he underwent severe adverse reactions about 10 days after he was administered the vaccine on October 1, 2020.
He was immediately rushed to the hospital and admitted in the Intensive Care Unit. After undergoing a harrowing experience of losing consciousness due to neurological setbacks, he got discharged at his request on October 26, the petitioner said and claimed that even after three months, he often experiences trembling of hands, fear, anxiety, trepidation, panic and mood swings.
“I have lost all the projects I was working on that entitled an annual earning of over $30,000 a year prior to volunteering for the vaccine. I am feeling utterly frustrated and totally lacking in confidence. I am also feeling very guilty that my two small children who get very scared when I have extreme mood swings because of my decision to volunteer for the test vaccine,” he added.