A business consultant named Asif Riyaz has approached the Madras Hugh Court alleging serious side-effects after administration of COVISHIELD COVID-19 Vaccine.
It’s the petitioner’s claim that he has suffered acute neurological encephalopathy (altered mental state due to systemic factors) due to a vaccine dose he took in October last year as part of vaccine trials.
The petitioner has submitted that the Participant Information Sheet provided to the Petitioner revealed that the covishield 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”.
In this regard, a notice has been issued to the Government of India through the Health Secretary, Drugs Controller General of India, Director-General of ICMR, CEO of Serum Institute, CEO of Astra Zeneca UK, and Chairman of the Ethics Committee.
The Oxford/Astra Zeneca vaccine ‘Covishield’ has been produced by the Serum Institute of India (SII).
The vaccine was administered on the Petitioner on 1st October 2020, and on 11th October, the Petitioner. Post being discharged from the hospital on 26th October, the Petitioner was provided a discharge summary stating that he had suffered from “Acute Neuro Encephalopathy”.
The petitioner claims that the side-effect falls within the definition of “Serious Adverse Event (SAE)” under Rule 2(ff) read with sub-rule (a) of Rule 41 of the New Drugs and Clinical Trial Rules, 2019.
The petition also reads,
“I submit that even after three months of the severe side effect, I am not stable, as I often experience trembling of hands, fear, anxiety, trepidation, panic, mood swings, sever dent in self-confidence and extreme problems in focusing on work. I submit I have lost all the projects I was working on… prior to volunteering for the vaccine on 1st October 2020 … “, the plea further reads.
and further states,
“I submit that it is not an issue concerning me alone, it concerns public health, particularly since the Government of India is planning to vaccinate the entire Indian population. Therefore, I submit the there is an urgent need for openness and transparency…”, the petitioner states.
Accordingly, the petitioner has sought for the constitution of an expert committee to go into the issue; declare that side effects suffered by the petitioner is due to the test shot of COVISHIELD vaccine; declare COVISHEILD vaccine not safe and direct the compensation of Rs 5 crores as damages by Serum Institute.
The matter will be next heard on 26th March