Covishield vaccine safe and immunogenic, incident with Chennai volunteer unrelated to vaccine, says Serum Institute

World’s largest vaccine manufacturer Serum Institute of India has said that the Coronavirus vaccine candidates developed by the University of Oxford and AstraZeneca is 100 percent safe and the incident which had happened with a Chennai based volunteer was not induced from the vaccine, news agency ANI reported. The Serum institute said that it had followed all the guidelines and regulatory and ethical practice during the manufacturing of vaccine and human trials of the vaccine.

The SII also said that the Principal Investigator and the Ethics Committee monitoring the clinical trials of the vaccine had also found that the medical condition of the trial participant was unrelated to the vaccine. A Chennai based 40 year old man who had enrolled himself as a volunteer during the clinical trials of the vaccine alleged that he had suffered from serious side effects including a neurological breakdown and impairment of several of his cognitive functions due to the vaccine. The volunteer had also sought the compensation worth Rs 5 crore from the vaccine manufacturer and requested the authorities to stop the clinical trials of the vaccine.

The legal notice was sent to safeguard the reputation of the company which is being unfairly maligned: Serum Institute of India https://t.co/EWKYE5MKgm

— ANI (@ANI) December 1, 2020

In response, the Serum Institute had said that the company sympathised with the condition of the volunteer but it was unrelated to his vaccination by the Coronavirus vaccine. The company had also threatened that it would seek damages for more than Rs 100 crore from the volunteer for labelling such malicious and misconceived allegations on the company. The company had also said that the motive behind the volunteer’s move was to blame his medical problems on the vaccine trial and seek pecuniary advantage from the situation.

The man in his notice sent to the company mentioned that he had been vaccinated on October 1 and after the passage of 10 days, his medical condition suddenly worsened and he started having episodes of vomiting and severe headache afterwards. The notice also alleges that the vaccine had also impaired his cognitive senses and he faced difficulties in recognising his family members and felt disoriented.