The Madras High Court on Friday issued notice to the Centre on a writ petition filed by a litigant to declare Covishield vaccine of Serum Institute of India as unsafe. The litigant, a business consultant who had volunteered for the trials, claimed that he had suffered from side-effects and that he must be compensated with ₹5 crore, or any other amount as decided by the Court.

In November 2020, the litigant sent a legal notice to Serum Institute of India asking for the compensation and asked the Centre and ICMR not to give any approval to manufacture and distribute the vaccine.

However, Serum responded to the legal notice from the individual’s lawyers saying it would seek ₹100 crore as damages.

The development comes even as the Government rolls out the AstraZeneca- Oxford University vaccine in the country. Serum Institute has a production and distribution alliance with AZ on the vaccine. Globally too, the vaccine finds acceptance in many countries given its easy storage and distribution requirements.

Adverse event

The litigant said there was no adverse reaction for the first 10 days after the vaccination but on the 11th day he woke up with a very severe headache. “Even after three months of the severe side-effect, I am still not stable, as I often experience trembling of hands, fear, anxiety, trepidation, panic, mood swings, severe dent in self-confidence, and extreme problems in focusing on work,” the litigant said.

“The trauma I underwent after taking the test vaccine clearly proves that the vaccine is not safe for all, as it is made out to be. All the stakeholders are trying to hide the adverse effect that the vaccine has had on me and are unethically and unscientifically trying to brush it aside as inconsequential,” the litigant said.

The Independent Expert Committee, constituted by the Drugs Controller General of India, neither heard the litigant nor physically examined him before it submitted its report. He urged the court to constitute an expert committee to go into the issue and submit a report pending the disposal of the writ petition.

The litigant urged the court to issue a Writ of Declaration declaring that the severe side-effects and the hospitalisation of the litigant from October 11 to October 26 was a “ serious adverse event ” as defined in Rule 2(ff) read with Sub-Rule (a) of Rule 41 of The New Drugs and Clinical Trial Rules, 2019 and it was due to the administration of trial vaccine Covishield.

Other respondents in the case include the Health Secretary, DCGI, head of ICMR, Chief Executive of AZ (UK) and Chairman of the Ethics Committee at the Sri Ramachandra Higher Education and Research. The next hearing of the case will be on March 26.

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