Pune based pharma company developing an anti-covid vaccine, Serum Institute of India today claimed that their vaccine is "safe and immunogenic". Refuting the accusations by a trial volunteer, the firm said the Covishield has no side-effects.
The clarification comes after a Chennai based trial volunteer alleged that he suffered from adverse effects including virtual neurological breakdown, memory loss and behavioural changes after taking the vaccine shots.
Mr Adar Poonawalla in a statement has denied the claims and has filed a legal notice against the volunteer, saying it was sent to "safeguard the reputation of the company which is being unfairly maligned."
Serum Institute said in its statement said, "The COVISHIELD vaccine is safe and immunogenic. The incident with the Chennai volunteer though highly unfortunate was in no way induced by the vaccine and Serum Institute of India is sympathetic with the volunteer's medical condition.”
The company stated that it had strictly followed all regulatory and ethical processes and guidelines during the trials and had informed the concerned authorities.
The Data and Safety Monitoring Board and the Ethics Committee had "independently cleared and reckoned it as a non-related issue to the vaccine trial", it claimed.
The company said unless the vaccine is proven immunogenic, and safe, the vaccine won't be released for mass use unless it is proven immunogenic. “Taking into consideration the complexities and existing misnomers about vaccination and immunisation; the legal notice was sent therefore to safeguard the reputation of the company which is being unfairly maligned, said SII.
SII had stated that the medical team had specifically informed the volunteer that the complications he suffered were independent of the vaccine trial he underwent. The firm claimed that the volunteer is intentionally spreading malicious information and his claims are purely “oblique pecuniary motive”.
“The Serum Institute of India will seek damages over Rs 100 crore for the same and will defend such malicious claims," the vaccine manufacturer said.
Currently, the phase-3 clinical trial of Covaxin is being conducted across India involving 26,000 participants. SII is conducting the trials of AstraZeneca-Oxford's
Covid-19. The vaccine will be produced in the Biosafety Level 3 production facility of the company.
SII is developing Covid-19 vaccine - Covishield in partnership with UK's Oxford University and US pharma giant AstraZeneca.