Trial will continue: Centre on SII vaccine's "adverse reaction" claims
What's the story
With the coronavirus vaccine trials being conducted by Serum Institute of India (SII) being shrouded in controversy after a participant complained of an "adverse reaction," the Centre on Tuesday said there's no need to stop the process.
The government claimed there are multiple checks in place to judge such incidents and added that it has little do with compensation claims filed by participants anywhere.
Background
Context: Chennai-based volunteer said doses made him ill
A 40-year-old participant asked SII, which is producing millions of doses of the vaccine developed by Oxford University and AstraZeneca, to give Rs. 5 crore in compensation since he suffered from side-effects, including virtual neurological breakdown and impairment of cognitive functions.
The marketing professional was administered the vaccine on October 1.
He also demanded that the vaccine's testing, manufacturing, and distribution is halted.
Response
No correlation: SII said it would sue volunteer
Reacting to the claims of the participant, SII said it would seek Rs. 100 crore in damages from the participant.
On Sunday, the Pune-based firm said there was "no correlation between the vaccine trial and the medical condition of the volunteer."
The volunteer also sent the legal notice to DCGI, ICMR's Director-General, Central Drugs Standard Control Organization, AstraZeneca UK CEO, among others.
Statement
On developments, ICMR said plans won't be affected
In the first statement after the claims came to light, ICMR's Chief Dr. Balram Bhargava said that after the initial assessment conducted by the regulator, it was judged that the trials should not be stopped.
He said such incidents are expected, explaining that it is the regulator's job to ascertain whether the adverse reaction was sparked due to a health intervention or not.
What he said
Trials can't continue without consent from participants: Health Secretary
Separately, Union Health Secretary Rajesh Bhushan said candidates have to sign a consent form before they are given doses.
"This is a global practice...without the signature of the subject, he/she cannot participate in a clinical trial," he added.
He claimed due processes were followed while reporting the adverse event, adding that he can't comment on the specifics of the case.
Details
Bhushan said government is responsible for countering disinformation
Further, Bhushan stressed that the situation is extraordinary, hence, it's possible that "commercial interests dictate certain strategic actions of commercial entities."
"Governments of the day have nothing to do with it. However, the responsibility of the government is that we must educate the people about the safety, the effectiveness of the vaccine and that all disinformation is countered promptly," he added.
What she said
Meanwhile, volunteer's wife denied having ulterior motives
While SII defended its legal response, saying it wished to "safeguard the reputation of the company which is being unfairly maligned," the affected volunteer's wife said they had no ill intentions when they sent the notice.
"Our primary demand was to bring this to the notice of people. This vaccine is being called the option for India. We can't stay quiet," she told NDTV.
Impact
He has lost his creativity, claimed wife
She told the channel that her husband is better but still struggles to perform day-to-day activities. He can't do the simplest things like online payments, without her help.
"His ability to write, present things in a creative manner were his plus points. Now he is unable to do his work," she said.
The couple is concerned that the trials continued despite their complaint.
Quote
Now, they want to spread awareness about adverse reaction
"Why didn't they halt the trial when such an adverse reaction was seen? At least until they were 100% sure? How could they administer vaccine again to volunteers before informing them? Our aim is not compensation. The public ought to know about this," she added.