Covid vaccine ‘safe’, clinical trial volunteer incident ‘not induced by it’: Serum Institute of India

The Serum Institute of India (SII), which is the manufacturing partner of Oxford-AstraZeneca Covid-19 vaccine, today said its vaccine candidate for the virus is "safe and immunogenic".

The company also maintained that the incident with one of the volunteers during human clinical trial was "no way induced by the vaccine", reports our New Delhi correspondent.

The Bangladesh government, on November 5, signed a trilateral MoU with SII and Bangladesh's Beximco Pharmaceuticals Ltd for buying three crore doses of the vaccine.

Also read: Covid-19 Vaccines: First 3cr doses to be given for free

"We have followed all regulatory, ethical processes and guidelines. The principal investigator DSMB (Data and Safety Monitoring Board) and ethics committee stated it was non-related issue to vaccine trial," the SII said in a statement.

The company based in Pune city also said it has sent a legal notice to a man in Chennai who claimed he had developed serious side-effects during the human trial "to safeguard the reputation of the company which is being unfairly maligned."

The 40-year-old man had through a law firm served a legal notice on SII, claiming to have suffered a virtual neurological breakdown and impairment of cognitive functions during the trial, seeking Rs five crore in compensation and a halt to the trial.

The Serum Institute of India defended its legal notice to file a Rs 100-crore defamation suit against the trial volunteer, saying the notice was sent to "safeguard the reputation of the company which is being unfairly maligned."

The defence by the SII of its legal notice came after some experts expressed concern over what they see as an attempt to intimidate the trial participant. This, the experts cautioned, could discourage people from volunteering for trial participation in future.

The Indian Health authorities have said they are probing the alleged serious adverse event that happened during the trial of the vaccine candidate being developed by the SII.

Drugs Controller General of India (DCGI) has deployed an institutional ethics committee at the implementation site to investigate the event.

Any serious adverse event of the vaccine candidate trial "should be examined for their causal association or link with the vaccine or the investigational product," an official of state-owned Indian Council of Medical Research said.