Madras HC notice to Centre on plea to declare Serum's Covishield jab unsafe

Litigant is a Chennai-based consultant who volunteered for the trial. Claims he suffered side effects, for which he sought a compensation of Rs 5 cr

The Madras High Court today issued a notice to the Centre on a petition to declare the Serum Institute's Covishield vaccine unsafe. 

The notice was issued in response to a writ petition filed by a Chennai-based business consultant who volunteered for the trial. He claims he suffered from side effects, for which he sought a compensation of Rs 5 crore.

Legal team representing the Serum Institute said, "Allegations made in the petition are unfounded and frivolous. Serum will respond to same appropriately before the madras high court."

In November 2020, the litigant sent a legal notice to Serum Institute of India (Serum) seeking a compensation of Rs 5 crore and asked the Government and ICMR not to approve the manufacture and distribution of the vaccine.

He claimed he filed the plea when his health condition worsened after taking Serum's vaccine. In turn, Serum sent a notice asking for Rs 100 crore compensation from the litigant.

The litigant has now filed a petition, a copy of which is available with Business Standard, asking the Madras High Court to declare that the severe side effects and the hospitalisation of the Petitioner from October 11  to October 26 constituted a “serious adverse event” caused by the administration of trial vaccine. The Petitioner claimed he took the jab as a volunteer on October 1, 2020.

".....serious adverse reactions on me one after another, after taking the trial vaccine prima facie prove that the vaccine is not safe and could have serious side effects. Therefore the balance of convenience is in favour of stopping the administration of continuance of vaccines to the public. Hence it is prayed that the Hon’ble Court may be pleased to grant an ad interim injunction restraining the 1st and 2nd Respondents from continuing administering the ‘Covishield' vaccine manufactured by the 4th Respondent (Serum) to the public pending final disposal of the Writ Petition," stated in the petition.

He also stated that he took an opinion of the experts in the field and they have said the serious adverse reaction occurred to him was due to the trial vaccine that was administered to me on October 1, 2020. 

The petitioner also alleged that the Independent Expert Committee constituted by the  Drugs Controller of India neither heard him nor physically examined him before it submitted its report, said the petitioner asking the Court to form an Expert committee to go into the issue and submit its report pending l disposal of the Writ Petition.

How the story unfolded

The petitioner had signed the consent form on September 29 as a volunteer. 

Since the test for antibodies against Covid-19 was negative, Covishield study vaccine was given to him on October. 

Petitioner claims he fell sick 10 days after the shot in clinical trial (it could be the vaccine or the placebo). 

However, since follow-up tests showed he had developed antibodies for Sars-CoV-2 virus, there is a high probability that he was given the vaccine shot. 

Ten days later, on October 11, the person reported severe headache and vomited. After CT scans, Covid-19 tests and MRI scans, he was admited to the intensive care unit of a hospital. 

He was discharged after 11 days; discharge summary says he had suffered “acute encephalopathy”. The person is still disoriented and agitated.