With the ongoing manufacturing of the Oxford-Astrazeneca Covid-19 vaccine by the Serum Institute of India in the country, there have been a number of vaccine trials conducted on volunteers.
SII CEO Adar Poonawalla has announced that they shall be applying for emergency licensure soon and are expecting to get it by December.
Currently, the vaccine candidate for Covid-19 is in the third phase of human trials in India.
Now that about 4 crore Covishield vaccines have already been stockpiled, a trial taken participant from Chennai has filed a compensation seeking complaint against the vaccine manufactured by SII, alleging that he has suffered serious neurological and psychological symptoms after taking the experimental vaccine doses.
Chennai Volunteer Files for Hefty Compensation from SII
The Covishield vaccine developed by Oxford University and drugmaker AstraZeneca is being manufactured by SII.
For this, SII conducted vaccine trials on many voluntary individuals.
Now, a Chennai based volunteer has filed a legal notice through the Rowand Reddy law firm, alleging that the 40 year old participant has been diagnosed with “acute neuro encephalopathy”, as a side-effect of the vaccine shot he took on October 1.
The law firm has charged SII with a compensation amount of Rs 5 crore.
The notice filed by the law firm also claims that the participant experienced headaches, followed by a 7-day period in the ICU.
It highlights, “For all the trauma he is undergoing and with an uncertain future in his health, he should be given a financial compensation of Rs 5 Crores within a period of two weeks from the receipt of this notice.”
The complainant also demanded that the ongoing trials in India of the vaccine candidate be immediately halted.
What Does SII Claim in the ‘Patient Consent’ Form?
According to the ‘Informed Consent Form’ or ‘Patient Consent’ form signed by the volunteer on September 29, 2020,
“If you get sick during the course of study, we will help you get a proper treatment. In the event of trial related death or injury, you shall be provided medical management as long as required as per the opinion of the study doctor or until the time it is not established that injury or death is not due to the clinical trial, whichever is earlier.”
The law firm has sent the legal notice to other organizations too, apart from SII. They include the:
- Indian Council of Medical Research (ICMR),
- Drug Controller General of India (DCGI),
- Chief Executive Officer (CEO) of AstraZeneca,
- Professor Andrew Pollard at the Oxford Vaccine Trial,
- The Jenner Institute Laboratories University and
- Vice-chancellor of Sri Ramachandra Higher Education and Research.
Serum Institute of India’s Strong Response on the Accusation
After the vaccine trial patient’s malicious accusation on SII’s vaccine dose on Saturday, vaccine major SII showed great disapproval to the whole facade on Sunday.
SII has said in a statement,
“While Serum Institute of India is sympathetic with the volunteer’s medical condition, there’s absolutely no correlation with vaccine trial & his medical condition.
He’s falsely laying blame for his medical problems on trial.
The claim is malicious because the volunteer was specifically informed by the medical team that complications he suffered were independent of the vaccine trial he underwent.
In spite of specifically being made aware of the same, he still chose to go public & malign reputation of company.
It is evident that the intention behind spreading of such malicious information is an oblique pecuniary motive.
We will seek damages in excess of Rs 100 crores for the same and will defend such malicious claims.”
Serum Institute of India is sympathetic with volunteer’s medical condition, there's absolutely no correlation with vaccine trial & his medical condition. He's falsely laying blame for his medical problems on trial:SII's statement after a volunteer alleged he suffered side effects pic.twitter.com/3t2BAGk1aR— ANI (@ANI) November 29, 2020