On Friday, the Madras High Court issued notice to the Center and others, including the Serum Institute of India, on a petition from a man who administered the Covishield vaccine last year during a hearing alleging serious side effects.
The declaration that was written in the petition has came up before Justice Abdul Quddhose, said that the traumatic health issues faced by the petitioner following vaccination was a ‘serious adverse event’ as defined in the New Drugs and Clinical Trial Rules (NDCTR), 2019.
The Covishield vaccine should hence be declared ‘not safe’ he pleaded and also sought a direction to the SII to provide him a compensation of Rs five crore.
The petitioner is a 41-year old Asif Riaz who also sought an interim injunction restraining the Central government and the Drugs Controller General of India from continuing with administering Covishield vaccine, pending disposal of his petition.
He said he volunteered in the phase-III trial of the vaccine and he was inoculated on October 1 last year at Sri Ramachandra Institute of Higher Education and Research here. He experienced severe trauma due to acute neuro encephalopathy, a severe neurological disorder from October 11 to 26 and this was a serious adverse event as defined in NDCTR.
SII replied to his legal notice last December saying that his condition was not related to the trial vaccine and the firm offered no proof to support such a view. While the Director General of the Indian Council of Medical Research replied to the notice that any serious event is compensated as per the NDCTR.
Despite the request, he received an answer from the Drug Controller of India on the report of an independent committee appointing it, stating that the adverse event he went through had no relation to the vaccine.
The court ordered notice to the Union Health Secretary, DCGI, Director General of ICMR, and CEO of SII and chief of the Sri Ramachandra’s ethics panel.
The matter has been posted for March 26.