The volunteer from Chennai who reportedly suffered adverse events following vaccination during the clinical trials of Covishield has alleged that authorities continued with the trials even though his family had requested them to investigate his case and halt trials until factors that led to his suffering were known.
Speaking to India Today TV over the phone, the volunteer said the vaccine trials were “not stopped at all”.
“They took in volunteers and administered them vaccine shots while I was suffering from adverse events. My wife had requested that the trials should be stopped because there was an adverse reaction,” he said.
He added that authorities should make a proper assessment of whether the adverse events following vaccination were due to the vaccine or something else.
“It is part of the protocol. My family had just asked for this investigation, as it is part of public safety protocol. People were taking the shot voluntarily and authorities owe it to them to make sure that an adverse reaction is not brushed under the carpet. That is part of public responsibility. I don’t believe the trials were ever stopped,” he said.
WHAT IS THE CASE?
Covishield is the Covid-19 vaccine candidate that is being developed by the Oxford University and drug manufacturer AstraZeneca.
In India, Phase 2/3 clinical trials of Covishield are being conducted by the Serum Institute of India.
Last week, a volunteer who had participated in the trials in Chennai claimed to have suffered serious neurological and psychological symptoms after taking the experimental shot.
He has also sued Serum Institute of India along with others and a sought compensation of Rs 5 crore.
Issuing a statement today, Serum denied the allegations and said the vaccine is safe and immunogenic.
“We would want to assure everyone that the vaccine won’t be released for mass use unless it is proven immunogenic, and safe,” the institute said.
“The incident with the Chennai volunteer though highly unfortunate was in no way induced by the vaccine and Serum Institute of India is sympathetic with the volunteer’s medical condition,” it added.
WHAT THE VOLUNTEER SAYS
Narrating the events and his experience, the Chennai volunteer told India Today TV that he took the vaccine shot on October 1. He said days later he developed a headache and can’t recollect anything that happened in the next 10 days.
“I don’t have any recollection. What I am saying now is second-hand knowledge based on what people have told me about my condition. I was not recognising anyone and I was in a state of delirium for the whole day. At the end of the day, a doctor came to my home and then an ambulance took me to the hospital. I don’t remember anything about the next 10 days. I was in the ICU. I have subconscious memory of the trauma that I went through and the pain I suffered. I was shifted to my room after 10 days,” he said.
On his present condition, he said he is “better”. “I have improved considerably and much better now. I hope I am close to 100 per cent back. But, I can’t change whatever I went through.”
BUT DIDN’T HE KNOW THERE WERE RISKS INVOLVED IN TRIALS?
Speaking about his family, the volunteer said they were not happy when he chose to volunteer for the vaccine trials saying there was no clarity on what could happen since Covishield isn’t an approved medicine yet.
“I was of the view that some people have to come forward and take the risk and get the shot because without it the trial cannot be completed. This is part of the scientific process. I was willing to take the risk but that doesn’t mean that I have to go through so much and suffer. I was aware of the fact that it was not an approved medicine and that there were certain risks. However, this extent of my trauma was not what I had signed up for,” he said while speaking to India Today TV.
WHAT ABOUT SERUM’S DEFAMATION SUIT?
Meanwhile, the Serum Institute of India has also filed a Rs 100-crore defamation case against the volunteer. Responding to the allegations made by the volunteer, Serum had on Sunday stated that they were “malicious and misconceived”.
“Taking into consideration the complexities and existing misnomers about vaccination and immunisation; the legal notice was sent (to the volunteer) therefore to safeguard the reputation of the company which is being unfairly maligned,” Serum said in a statement today.
The institute also claimed that all requisite regulatory and ethical processes and guidelines were followed diligently and strictly.
“The concerned authorities were informed and the principal investigator, DSMB and the Ethics Committee independently cleared and reckoned it as a non-related issue to the vaccine trial. Post which, we submitted all the reports and data related to the incident to the Drugs Controller General of India. It is only after we cleared all the required processes that we continued with the trials,” it added.
Responding to the legal notice from Serum, the volunteer said, “It doesn’t make sense what they have said because why would they want to threaten a participant who has been part of their trial. My objective was to help them get their product out in the market in a safe way. That is why I volunteered and took the shot. It was to help in their process. What I want is that the product should be safe. Defamation is not telling the truth. There is a public responsibility to not sell your silence to anybody. The public should know what happened. So, I wanted to be out in the public that this happened to me and I didn’t want to sell my silence to them.”
Meanwhile, his lawyer Rajaram told India Today TV that he has not received any notice from Serum so far and if there receive a notice, it will be faced legally.