Adverse reaction claim | Madras HC issues notice to SII, ICMR and DCGI on petition against Covishield

The Madras High Court on February 19 issued a notice on a writ petition filed by a volunteer who participated in the Serum Institute of India's (SII) clinical trial of the Oxford/AstraZeneca vaccine.

The 41-year old who took part in the Covishield clinical trial alleged in the writ petition that he had suffered a serious adverse event after receiving the first dose in the trial. The petitioner also asked the court to declare that the Covishield vaccine is not safe and consequently direct SII to pay him a compensation of Rs 5 crore.

Along with SII, the other respondents named in the petition are the Government of India, Drugs Controller General of India, Director General of ICMR, CEO of AstraZeneca, and the chairman of the Ethics Committee

"...the severe side effects and the hospitalisation of the Petitioner from 11th October to 26th October was a  serious adverse event.. and it was due to the administration of trial vaccine, Covishield manufactured by Serum Institute of India Private Limited which the Petitioner took as a volunteer on 1st October 2020 and as a follow-up to declare that Covishield vaccine is not safe and consequently direct the Respondent to pay the Petitioner a compensation and damage of Rs 5 Crores or any other amount as decided by this Hon’ble Court including the medical and legal cost for all the suffering and trauma that the Petitioner and his family went through," the writ petition said.

Moneycontrol has seen a copy of the writ petition. The next hearing of the case will be on March 26.

The participant was administered the vaccine at Chennai’s Sri Ramachandra Institute of Higher Education and Research (SRIHER), one of the trial sites, on October 1.

The participant claimed in the earlier legal notice that the vaccine administered on him on October 1 was indeed Covishield, and not a placebo, as this was established from a positive test for antibodies against COVID-19 done after he was admitted to the hospital on October 11. He was admitted 11 days after receiving the vaccination.

The volunteer said he took part in the trial on “clear assertion of the safety nature of the test vaccine in the Participant Information Sheet”.

SII, the clinical trial sponsor of the ‘Covishield’ vaccine in India, called the allegations in the notice “malicious and misconceived” and has threatened to seek damages in excess of Rs 100 crore. The company said that while it is sympathetic with the volunteer’s medical condition, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer.

SII said the volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial that he participated in.