The Serum Institute of India has called the accusations made by a volunteer of the IBS vaccine candidate “malicious”.
On November 21, a 40-year-old Chennai volunteer from vaccine candidate Covishield filed a lawsuit against IBS. The volunteer stated that there was no adverse reaction during the first 10 days after vaccination, but on day 11, he developed symptoms of ‘Acute Encephalopathy’ that led to a decrease in his ability to reason and concentrate, memory loss and change of mind. personality. .
It had also sent a legal notice to ICMR, DCGI, AstraZeneca and the University of Oxford to stop testing, manufacturing and distributing vaccines. The legal notice states that the participant started experiencing headaches and then endured a seven-day stay in the intensive care unit (ICU).
When receiving no response, the volunteer has also presented a case. “While the Serum Institute of India is sympathetic to the volunteer’s medical condition, there is absolutely no correlation with the vaccine trial and the volunteer’s medical condition. The volunteer falsely blames the Covid vaccine trial for their medical problems.” SII said in a statement.
The company says the claim is malicious because the medical team specifically informed the volunteer that the complications he suffered were independent of the vaccine trial he underwent. Despite being specifically informed of the same, he chose to go public and smear the reputation of the company.
“It is clear that the intention behind the dissemination of such malicious information is an indirect pecuniary motive. The Serum Institute of India will seek damages in excess of Rs 100 million for it and will defend such malicious claims,” said SII.
Bioethics expert Professor Anant Bhan reacted on Twitter saying that the measure is to intimidate the volunteer. “A bad move from Serum to counterclaim. Volunteers participate in the studies mainly for altruistic reasons. In this case, healthy volunteers. If there is a problem about the serious adverse event (SAE), it is better to interact with the participant to understand their concerns Instead of trying to intimidate them, “he said.
The All India Action Against Drugs Network (AIDAN) also expressed shock. “This is a blatant attempt at intimidation,” they said.
“Rather than explain why they have been silent about the SAE reports, the Serum Institute is attempting to deflect public scrutiny from their trial. Please note that in the Serum Phase 2/3 trial, safety is one of the main endpoints in addition to immunogenicity “. AIDAN explained.
The Indian Medical Research Council has said a decision on the serious adverse event from DCGI / CDSCO is expected. AIDAN said that “given that the SAE took place in October, it is of great concern that CDSCO did not stop the trial to investigate the SAE when it was reported. The silence of the CDSCO granting permission for the trial is deafening.” .
AIDAN demanded transparency and more information from CDSCO, the regulators in India.
.
