MOSCOW (Pakistan Point News / Sputnik - 01st December, 2020) The side effects reported by a volunteer in the Indian city of Chennai during the human trials of the Covishield vaccine candidate were not caused by the medicament, the Serum Institute of India said on Tuesday.
The 40-year-old Chennai resident, who was administered the vaccine, based on AstraZeneca and Oxford University's COVID-19 vaccine, on October 1, has filed a legal notice, complaining that he began experiencing "severe headaches", "total behavioural change" and "irritation towards light and sound" 10 days after the inoculation. In late October, he was discharged from hospital after suffering from "acute encephalopathy," which he claims was "an extreme side effect of the test vaccine."
"The Covishield vaccine is safe and immunogenic. The incident with the Chennai volunteer though highly unfortunate was in no way induced by the vaccine ... 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, [Data and Safety Monitoring Board] DSMB and the Ethics Committee independently cleared and reckoned it as a non-related issue to the vaccine trial," the institute wrote on Facebook.
It added that all the reports and data related to the incident were submitted to the Indian Central Drugs Standard Control Organization's Drug Controller General.
"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," the institute added.
Trials for several COVID-19 vaccine candidates are currently underway in India. The Serum Institute of India is conducting phase 3 trials of Bharat Biotech's Covaxin and Covishield. In addition, the ZycovD vaccine pharmaceutical company Zydus Cadila and a vaccine developed by Biological E. Limited, US-based Dynavax Technologies Corp and Baylor College of Medicine are also at the trial stage. Trials for Russia's Sputnik V are set to begin this week.
