Pune institute confirms safety of its vaccine, refutes Chennai volunteer’s claims  |  Photo Credit: AP
Pune: The Serum Institute of India announced that its vaccine is immunogenic and safe to use. The issue raised by the Chennai volunteer was not related to the vaccine trial, the institute clarified.
Data and Safety Monitoring Board is a body comprising of independent experts, which gave a tick to the vaccine. The vaccine will not be released for mass use until it is proven ‘immunogenic and safe’, the statement issued by the institute on December 1 said.
A Chennai volunteer faced a neurological breakdown and impairment of cognitive operations after he took part in the Covishield vaccine trial, which led to the issuance of the statement. The volunteer sent a legal notice to many people, including the institute.
The 40-year-old volunteer had looked to cancel the approval for its testing and asked for Rs 5 crore compensation. SII defended its vaccine and said that damages of more than Rs 100 crore would be claimed for the same and it would defend such harmful claims.
The man suffered from acute encephalopathy, damage or disease that affected the brain after he was given the vaccine and that all the tests he did confirm that his bad health was because of the vaccine, he alleged. The incident with the Chennai volunteer, though unfortunate, was in no way induced by the vaccine and SII is sympathetic with the volunteer’s medical condition.
The SII statement said, “We would like to clarify that all the requisite regulatory and ethical processes and guidelines were followed. The authorities concerned were informed and the principal investigator, DSMB and the ethics committee cleared and reckoned it as a non-related issue to the vaccine trial.”
SII has given all the records and data related to the issue to the Drugs Controller General of India. The vaccine will not be released for mass use unless it is proven immunogenic and safe, according to SII. The legal notice was sent to protect the reputation of the company which is being hampered.