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Madras HC issues notice to SII, ICMR & India’s drug regulator on a petition against Covishield


The Madras High Court on Friday issued notices to Pune-basedSerum Institute of India(SII), Indian Council of Medical Research (ICMR), India’s drug regulator following a petition filed by a participant who had allegedly suffered serious adverse event in the Serum trial for its Covid-19 vaccine-Covishield.

“The court has admitted the case and given time to respondents to file a reply before the next date of hearing which is March 26,” Rajaram, the advocate in the case told ET.

The respondents named in the petition also include AstraZeneca and chairman of the ethics committee.

The participant in the writ petition has asked the court to grant an “interim injunction restraining the continuance of vaccine to the public” as the vaccine is “not safe” and could produce “severe adverse effect on people”.

“I submit that serious adverse reaction produced to me one after another, after taking the vaccine which prima facie proves that the vaccine is not safe and it could produce serious side effects. Therefore it is in favour of stopping the administration of vaccine to public. Hence it is prayed that the court may be pleased to grant an interim injunction restraining from continuing administering of covishield vacicne,” said the copy of the petition.

“The petitioner has also demanded compensation of Rs 5 crore “for the suffering and trauma that he and his family had to go through”.”

ET has seen the copy.

The participant has also asked for constitution of an independent expert committee to look into his case.

Along with this, the participant has also demanded compensation of Rs 5 crore “for the suffering and trauma that he and his family had to go through”.

Earlier in November the law firm representing this 40-year-old participant in the trials of Covishield – had sent a legal notice to the company and the drug regulatory authority.

The company had in response had said that it would seek 100 crore in damages for the allegations which said are “malicious” and “misconceived”.

It said that there was no correlation with the vaccine trial and the medical conduction of the participant. It said that the volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent. Inspite of specifically being made aware of the same, “he still chose to go public and malign the reputation of the company”.

Globally, the vaccine technology has been developed by AstraZeneca. It drew a contrast with SII halting India trials when an adverse event was reported in the UK, when global trials were stopped. Trials resumed after regulatory clearance.

The government also maintained that the adverse event was unrelated to the vaccine.

Concerns have been raised by various public health experts and organisations like AIDAN on the issue of Serious adverse events following immunisation of the Covid-19 vaccine. The government has so far not put the details of the investigation following SEA in the public domain.

Source

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