COVID-19 vaccine is safe, says Serum Institute of India on side effect claims
Pune-based Serum Institute of India's (SII) said its 'COVISHIELD' vaccine is safe and immunogenic after a volunteer claimed that he suffered neurological and psychological side effects after taking a shot of the vaccine.
Rejecting all allegations, the institute 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. "
"However, we would like to clarify that all the requisite regulatory and ethical processes and guidelines were followed diligently and strictly," the institute said.
"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," read the statement.
The Pune based institute said the vaccine will 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 was sent therefore to safeguard the reputation of the company which is being unfairly maligned," it said.
The institute is conducting clinical trials of the AstraZeneca-Oxford's Covid-19 vaccine in India.
The phase-3 clinical trial of the vaccine is currently being made across India.