The Madras High Court on Friday issued notice on a petition filed by a participant in the trial for the Covishield vaccine developed by the Pune-based Serum Institute of India, alleging that he suffered serious side effects when he was given the first dose, reported Live Law.
Serum Institute of India has partnered with the British drugmaker AstraZeneca and the University of Oxford to conduct trials on its vaccine in India and for its production. It is one of the vaccines, along with Bharat Biotech’s Covaxin, approved for restricted emergency use by the Drugs Controller General of India.
The notice was issued to the Centre, Serum Institute of India, the Indian Council of Medical Research, AstraZeneca in United Kingdom and the Ethics Committee.
The petitioner, Asia Riaz, has demanded Rs 5 crores as compensation from Serum Institute for the suffering and trauma he and his family went through. He has also sought a declaration that the vaccine is not safe.
Riaz alleged that he suffered from a severe side effect from the vaccine shot and was hospitalised from October 11 to October 26. He said the effect could be categorised as a Serious Adverse Event, or SAE, under the New Drugs and Clinical Trial Rules, 2019.
After being released from the hospital, Riaz was provided a discharge summary that stated he had suffered from “acute neuro encephalopathy”, which falls under definition of a serious adverse event. This disease affects the brain. The petitioner said he has been suffering from various neurological problems, such as trembling hands and anxiety. Additionally, he said he has lost work opportunities.
In the plea, Riaz described the process of the trial, which consists of four stages, and said that the aim of Phase 1 was to estimate that safety and tolerability of the vaccine in humans. The plea stated that the participant information sheet given to the petitioner said the vaccine was safe and if there was any side effect, it would be very mild.
“I submit that I believed the assertion about the safety of the vaccine in the Participant Information Sheet and decided to volunteer to take the vaccine,” the plea said.
Riaz also alleged that the stakeholders were trying to hide the adverse effect the vaccine had on him and were “unethically and unscientifically” trying to brush the matter as inconsequential.
“There is no definitive conclusion as yet from the said vaccine study to say categorically that the vaccine is absolutely safe…I am keen that no one goes through the pain and ordeal me and my family have suffered,” the plea said. “Therefore, I submit that any move to manufacture the said vaccine commercially and distribute it to the general public as a safe vaccine is totally dishonest and goes against the WHO [World Health Organization] guidelines, as also the safety norms laid down by the 2019 Rules”.
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