Vaccine major Serum Institute of India on Tuesday rejected charges that it's COVID-19 vaccine candidate 'Covidshield' has serious side effects, adding that the incident with the Chennai volunteer is no way induced by the vaccine. In a press note the drug maker said, "Covishield safe & immunogenic. Incident with the Chennai volunteer no way induced by the vaccine. All regulatory & ethical processes & guidelines were followed. Principal Investigator, DSMB & Ethics Committee stated it was non-related issue to vaccine trial."
The Pune-based company also said that it has sent a legal notice to a man who claimed he had developed serious side-effects in the human trials. “The legal notice was sent to safeguard the reputation of the company which is being unfairly maligned,” news agency ANI quoted SII as saying.
In a statement, the Adar Poonawalla-led Institute also said 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,” it added.
READ MORE | 'Covidshield' vaccine trial participant alleges neuro breakdown, impaired cognitive functions
A 40-year-old man who took part in the 'Covidshield' vaccine trial in Chennai has alleged serious side effects, including a virtual neurological breakdown and impairment of cognitive functions, and has sought Rs 5 crore compensation in a legal notice to Serum Institute and others, besides seeking a halt to the trial.
Alleging that the candidate vaccine was not safe, he has also sought cancelling approval for its testing, 'manufacture and distribution', failing which legal action would be taken.
Along with SII, the man also named Indian Council of Medical Research, one of the sponsors, and Chennai-based Sri Ramachandra Institute of Higher Education and Research, which administered the vaccine to the man. The man, according to the notice, suffered acute encephalopathy, a disease that affects the brain, following vaccination and all tests confirmed that the setback in his health was because of the vaccine candidate.
Pune-based Serum Institute of India (SII) has collaborated with Oxford University and pharmaceutical company Astra Zeneca for making the COVID-19 vaccine, 'Covidshield', and is conducting trials in India.