Vaccine candidate safe and immunogenic: SII
Pune: Pune-based vaccine manufacturer Serum Institute of India (SII) said on Tuesday that its vaccine candidate for the coronavirus disease (Covid-19) is “safe and immunogenic”.
SII has said the principal investigator, data and safety monitoring board (DSMB) and the ethics committee, an internal mechanism, have independently reckoned that the issue raised by the Chennai volunteer, who alleged neurological breakdown after participating in Covishield trial, was not related to the vaccine trial.
DSMC is a monitoring body comprising independent experts, with task to evaluate study data of participants during trial.
The statement issued by SII on Tuesday states that the vaccine would not be released for mass use unless it is proven “immunogenic and safe”.
The statement comes after a volunteer from Chennai alleged that he faced a virtual neurological breakdown and impairment of cognitive functions after he took part in the “Covishield” vaccine trial. The volunteer sent a legal notice to multiple parties, including SII, which is currently mass producing Oxford University’s “Covishield” vaccine.
The 40-year-old volunteer had sought to cancel approval for its testing and also sought a Rs five crore compensation. In response, the institute defended its vaccine and stated to seek damages in excess of Rs 100 crore for the same and will defend such malicious claims.
The man had alleged that he suffered from acute encephalopathy, damage or disease that affected the brain after he was administered the vaccine and that all the tests he underwent confirmed that the setback in his health was due to the test vaccine. Defending its product, SII said that the vaccine is safe and immunogenic.
“The incident with the Chennai volunteer, though highly unfortunate, was in no way induced by the vaccine and the institute is sympathetic with the volunteer’s medical condition. However, we would like to clarify that all the requisite regulatory and ethical processes and guidelines were followed diligently and strictly. The authorities concerned were informed and the principal investigator, DSMB and the ethics committee independently cleared and reckoned it as a non-related issue to the vaccine trial,” the SII statement read.
The institute has submitted all the reports and data related to the incident to the Drugs Controller General of India (DCGI). The institute said that the vaccine would not be released for mass use unless it is proven immunogenic and safe. Taking into consideration the complexities and existing misnomers about vaccination and immunisation, the legal notice, seeking defamation amounting to Rs 100 crore, was sent therefore to safeguard the reputation of the company which is being unfairly maligned.