SII says Covishield 'safe' after trial participant sends legal notice
The Serum Institute of India (SII) on Tuesday said that its COVID-19 vaccine candidate was "safe and immunogenic," in response to allegations that a trial participant developed serious side-effects after being administered the dose. The Pune-based institute also said that it has served the trial participant, a 40-year-old man, a legal notice for "maligning" its reputation. Here are more details.
Trial participant's condition 'no way induced by vaccine'
The SII said that the trial participant's side-effects were in "no way induced by the vaccine." According to ANI, the institute said, "All regulatory, ethical processes and guidelines were followed by the company. The principal investigator DSMB (Data and Safety Monitoring Board) and ethics committee stated it was a non-related issue to vaccine trial." It said the man has been served a legal notice.
Participant claimed he faced virtual neurological breakdown; demanded Rs. 5cr
The 40-year-old had participated in the vaccine's Phase III trials conducted at the SRIHER site in Chennai. In a legal notice to the SII and others, he claimed that the side-effects he faced included a virtual neurological breakdown and impairment of cognitive functions. He sought financial compensation of Rs. 5 crore and demanded that the vaccine's testing, manufacturing, and distribution be halted immediately.
Earlier, SII said it would seek Rs. 100cr in damages
The SII had said Sunday that the allegations were "malicious and misconceived" and seemed to have an oblique pecuniary motive. "The volunteer is falsely laying the blame for his medical problems on the vaccine trial," it had said, adding that he had been informed that his complications were independent of the vaccine trial. The institute said it will seek Rs. 100 crore in damages.
SII's move 'blatant attempt at intimidation,' say experts
Bioethics expert Professor Anant Bhan said on Twitter that the SII's decision to counter-sue was a "bad move." "If there is an issue about the serious adverse event, better to engage with the participant to understand their concerns," Bhan said. The All India Drug Action Network (AIDAN) has also said, "This is a blatant attempt of intimidation," demanding transparency from drug regulators.
Covishield undergoing Phase III trials
Covishield has been developed at SII with a master seed from pharma giant AstraZeneca and Oxford University. The potential vaccine is currently undergoing Phase III trials. It has shown 90% and 62% efficacy in two dosing regimens, reflecting an average efficacy of 70%. The first batch of 100 million doses—for priority groups—is expected by January, while broader access is likely by April.
