The Serum Institute of India has called the allegations made by a volunteer of SII's vaccine candidate 'malicious'.
On November 21, a 40-year-old Chennai based volunteer of the vaccine candidate Covishield, filed a legal suit case against SII. The volunteer claimed that there was no adverse reaction for the first 10 days after the vaccination, but on the 11th day, he developed symptoms of 'Acute Encephalopathy' that led to a decline in his ability to reason and concentrate, memory loss and personality change.
He had also sent a legal notice to ICMR, DCGI, AstraZeneca and Oxford University to stop testing, manufacturing and distributing vaccine. The legal notice claims the participant began experiencing headaches and then endured a seven-day stay in the intensive care unit (ICU).
On not receiving a reply, the volunteer has also filed a case. "While the Serum Institute of India is sympathetic with the volunteer's medical condition, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer. The volunteer is falsely laying the blame for his medical problems on the Covid vaccine trial," SII said in a statement.
The company says that the claim is malicious because the volunteer was specifically informed by the medical team that the 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 and malign the reputation of the company.
"It is evident that the intention behind the spreading of such malicious information is an oblique pecuniary motive. The Serum Institute of India, will seek damages in excess of 100 crore for the same and will defend such malicious claims," SII said.
Bioethics expert Professor Anant Bhan reacted on Twitter saying that the move is to browbeat the volunteer. "A bad move by Serum to counter-sue. Volunteers participate in studies mostly out of altruistic reasons. In this case, healthy volunteers. If there is an issue about the serious adverse event (SAE), better to engage with the participant to understand their concerns. Rather than try to browbeat them," he said.
The All India Drug Action Network (AIDAN) also expressed shock. "This is a blatant attempt of intimidation," they said.
"Instead of explaining why they have been silent about the reports of the SAE, Serum Institute is attempting to divert public scrutiny of its trial. Bear in mind that in Serum's Phase 2/3 trial, safety is one of the primary endpoints in addition to immunogenicity." explained AIDAN.
The Indian Council of Medical Research has said that a decision on the serious adverse event from DCGI/CDSCO is awaited. AIDAN said that "Given that the SAE took place in October, it is of serious concern that CDSCO did not pause the trial to investigate the SAE when it was reported. The silence from the CDSCO which granted permission for the trial is deafening."
AIDAN demanded transparency and more information from the CDSCO, the regulators in India.