Coronavirus vaccine development work underway at Serum Institute of India, Pune (Photo: PTI)
After the Serum Institute of India (SII) slapped a Rs 100 crore defamation case against a Covishield coronavirus vaccine volunteer, who allegedly reported 'memory loss, ability to reason and concentrate and personality change' 10 days after being administered a shot, experts say the company's move was a "blatant attempt to intimidate" the participant.
Experts said the Serum Institute should have engaged with its coronavirus vaccine volunteer to understand his concerns if there was an issue about the serious adverse event.
The volunteer of the Oxford coronavirus vaccine in Chennai has sought a compensation of Rs 5 crore for allegedly suffering serious side effects from the shot. The man also sought that the testing, manufacturing, and distribution of the coronavirus vaccine be stopped immediately.
The 40-year-old business consultant has alleged he suffered a virtual neurological breakdown and impairment of cognitive functions and sent a legal notice to SII and others.
The Serum Institute on Sunday rejected the charges as "malicious and misconceived" and filed a defamation case against the coronavirus vaccine trial participant.
Serum's counter-sue decision was a "bad move", an expert said.
"A bad move by Serum to counter-sue. Volunteers participate in studies mostly out for altruistic reasons. In this case, healthy volunteers. If there is an issue about the serious adverse event, better to engage with the participant to understand their concerns. Rather than try to browbeat them," Bioethics expert Professor Anant Bhan said on Twitter.
All India Drug Action Network (AIDAN) also expressed shock, saying, "This is a blatant attempt of intimidation."
"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." AIDAN was quoted as saying by a report in News18.
Meanwhile, a senior ICMR official said that a preliminary assessment has not indicated any causal link between the alleged adverse events shown by the volunteer and the 'Covishield' coronavirus vaccine.
The SII has partnered with British-Swedish biopharmaceutical giant AstraZeneca for manufacturing the Oxford coronavirus vaccine candidate for Covid-19 infection.