Won’t release vaccine for mass use, unless vaccine is proved immunogenic and safe: SII

Vaccine maker Serum Institute of India (SII) on Tuesday said that it had informed all the concerned authorities about the adverse event developed by a participant in the vaccine trial after the Covidshield Covid-19 vaccine was administered.

“The concerned authorities were informed and the principal investigator, data and safety monitoring board (DSMB) and the ethics committee independently cleared and reckoned it as a non-related issue to the vaccine trial,” SII said in a statement. “We submitted all the reports and data related to the incident to the Drugs Controller General of India (DCGI). It is only after we cleared all the required processes that we continued with the trials,” the company said.

SII has also has assured everybody that the vaccine won’t be released for mass use unless it is proved immunogenic and safe. The company claims that the Covishield vaccine was safe and immunogenic and that the incident with the Chennai volunteer though highly unfortunate was in no way induced by the vaccine. SII said all the requisite regulatory and ethical processes and guidelines were followed diligently and strictly.

Addressing the concerns related to the serious adverse event reported by a volunteer in Chennai, SII said they were sympathetic with the volunteer’s medical condition but taking into consideration the complexities and existing misnomers about vaccination and immunization, the legal notice was sent seeking damages.

The company had sought damages over Rs 100 crore, which they said was to safeguard the reputation of the company which is being unfairly maligned.

A 40-year-old resident of Chennai, participating in the Covishield Covid-19 vaccine Phase-III human trial, being conducted by SII, had sent a legal notice the company stating he had suffered an adverse event after he was administered the Covishield vaccine. N G R Prasad and R Rajaram, advocates for the complainant, said their client had participated in the trials conducted at the Sri Ramachandra Institute on October 1, 2020, and had led adverse reaction for which he had to hospitalized till October 26, 2020. The notice claims that the setback in his health was due to the test vaccine he administered and not because of any prior health condition and the trauma he went through was because of the “acute neuro encephalopathy” he suffered is an extreme side-effect of the test vaccine that he took on October 1, 2020.

The trial participant also claimed that there was no follow-up by the hospital after his discharge and even after a month of the severe adverse reaction to the vaccine, neither the DCGI Data and Safety Monitoring Committee, the ICMR, SII or AstraZeneca got in touch to find out about the severe adverse effect after vaccination or investigate the severe reaction the test vaccine had on him. This was against the protocol and guidelines set by the WHO in dealing with an Adverse Event Following Immunization/ vaccination, the participant said. He has sought compensation of Rs five crore from the company for the trauma and impact on his health.

Apart from SII, the notice has also been sent to the Indian Council for Medical Research, DCGI, CEO, AstraZeneca, Andrew Pollarad, chief investigator, Oxford Vaccine trial and vice-chancellor, Sri Ramachandra Higher Education and Research (Deemed University).