'COVISHIELD is safe': SII releases another statement after volunteer alleges side effects

After a 40-year-old volunteer sought Rs 5 crore as damage from the Serum Institute of India (SII) alleging "severe neurological and psychological symptoms" from their potential COVID-19 vaccine, the pharmaceutical company on Tuesday issued another official statement. In the statement, SII said that COVISHIELD vaccine is completely safe and immunogenic. Addressing the serious concerns reported by a volunteer, Serum Institute of India said, '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.'

Clarifying further SII said, "All the requisite regulatory and ethical processes and guidelines were followed diligently and strictly."

READ | Gold Worth Rs 1.57 Cr Seized In Chennai Airport, 3 Held

Serum Institute of India's full statement

“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. However, we would like to clarify that all the requisite regulatory and ethical processes and guidelines were followed diligently and strictly.

The concerned authorities 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. Post which we submitted all the reports and data related to the incident to the DCGI. It is only after we cleared all the required processes that we continued with the trials.

We would want to assure everyone that the vaccine won’t 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 was sent therefore to safeguard the reputation of the company which is being unfairly maligned."

READ | Chennai Man Donates Rice Bags At COVID-19 Hospital To Celebrate Parents’ Recovery

READ | Amit Shah Meets Gurumurthy & RSS Cadre as He Wraps Up Chennai Visit On Road To TN Polls

SII's COVID-19 vaccine volunteer alleges side effects

Earlier on November 29, a Chennai-based businessman claimed that he suffered from severe neurological and psychological symptoms after being administered with a dose of Oxford's COVID-19 vaccine candidate - Covishield.

The 40-year-old trial candidate has sent a legal notice to the Drugs Controller General of India (DCGI), ICMR, Central Drugs Standard Control Organisation, CEO of AstraZeneca and the Vice-Chancellor of Sri Ramachandra Higher Education and Research. The volunteer has also sought Rs 5 crore compensation and has demanded the testing, manufacturing, and distribution of the vaccine candidate be stopped immediately. 

READ | Amit Shah Likely To Meet Rajinikanth On Nov 21 Chennai Visit In Run Up To Tamil Nadu Polls