After Haryana Home Minister Anil Vij tested positive for the COVID-19 despite taking a shot of Bharat Biotech's vaccine candidate around two weeks ago during its ongoing Phase-III trail, the pharma company clarified on Saturday that its efficacy can only be determined 14 days after the second dose.
The Haryana home minister has been tested positive for novel coronavirus, around two weeks after he was administered the first trial dose of Bharat biotech vaccine candidate, COVAXIN.
"COVAXIN clinical trials are based on a two-dose schedule, given 28 days apart. The vaccine efficacy will be determined 14 days after the second dose. COVAXIN has been designed to be efficacious when subjects receive both the doses," Bharat Biotech said in a statement.
Earlier today, Vij tweeted that he has tested positive for the coronavirus and is admitted to Civil Hospital in Ambala.
"I have been tested Corona positive. I am admitted to Civil Hospital Ambala Cantt. All those who have come in close contact with me are advised to get themselves tested for corona," the Minister tweeted.
Bharat Biotech added the Phase-III trials are double-blinded and randomised, where 50 per cent of subjects will receive the vaccine and 50 per cent will receive placebo.
"As per CDSCO-DCGI guidelines for reporting adverse events, patients are required to contact the site Principle Investigator (PI) during active follow up, or when the PI determines the severity of the adverse effect; then the reports are submitted to site Ethics Committees, CDSCO-DCGI, Data Safety Monitoring Board and the sponsor," the pharma giant said.
On November 20, Vij was administered the first trial dose of Bharat Biotech's COVAXIN, a fully indigenously developed COVID-19 vaccine candidate, in Haryana.
Bharat Biotech is conducting the largest Phase-III clinical trials in India. The goal is to evaluate the efficacy of COVAXIN across India and determine its suitability to the diverse Indian population. (ANI)