NEW DELHI: After Haryana Interior Minister Anil Vij tested positive for Covid-19 despite taking an injection of the Bharat Biotech vaccine candidate about two weeks ago during his ongoing Phase III testing, the Pharmaceutical company clarified Saturday that its efficacy can only be determined 14 days after the second dose.
Haryana’s interior minister tested positive for the new coronavirus, about two weeks after he was administered the first test dose of Bharat’s biotech vaccine candidate Covaxin.
“COVAXIN clinical trials are based on a two-dose schedule, given 28 days apart. The efficacy of the vaccine will be determined 14 days after the second dose. Covaxin is designed to be effective when subjects receive both dosage, “Bharat Biotech said in a statement.
Earlier today, Vij tweeted that he tested positive for the coronavirus and is admitted to the Civil Hospital in Ambala.
“I was positive in the corona test. I am admitted to the Ambala Cantt Civil Hospital. Everyone who has been in close contact with me is recommended to take the corona test,” the minister tweeted.
Bharat Biotech added that phase III trials are double-blind and randomized, where 50 percent of subjects will receive the vaccine and 50 percent will receive placebo.
“According to CDSCO-DCGI guidelines for reporting adverse events, patients should contact the site principal investigator (PI) during active follow-up, or when the PI determines the severity of the adverse effect, then reports are submitted to the site’s ethics committees, CDSCO-DCGI, Data Safety Monitoring Board and the sponsor, “said the pharmaceutical giant.
On November 20, Vij was administered the first trial dose of Bharat Biotech’s Covaxin, a fully indigenously developed Covid-19 candidate vaccine, in Haryana.
Bharat Biotech is conducting the largest phase III clinical trials in India. The aim is to evaluate the effectiveness of COVAXIN throughout India and determine its suitability for the diverse Indian population.
Haryana’s interior minister tested positive for the new coronavirus, about two weeks after he was administered the first test dose of Bharat’s biotech vaccine candidate Covaxin.
“COVAXIN clinical trials are based on a two-dose schedule, given 28 days apart. The efficacy of the vaccine will be determined 14 days after the second dose. Covaxin is designed to be effective when subjects receive both dosage, “Bharat Biotech said in a statement.
Earlier today, Vij tweeted that he tested positive for the coronavirus and is admitted to the Civil Hospital in Ambala.
“I was positive in the corona test. I am admitted to the Ambala Cantt Civil Hospital. Everyone who has been in close contact with me is recommended to take the corona test,” the minister tweeted.
Bharat Biotech added that phase III trials are double-blind and randomized, where 50 percent of subjects will receive the vaccine and 50 percent will receive placebo.
“According to CDSCO-DCGI guidelines for reporting adverse events, patients should contact the site principal investigator (PI) during active follow-up, or when the PI determines the severity of the adverse effect, then reports are submitted to the site’s ethics committees, CDSCO-DCGI, Data Safety Monitoring Board and the sponsor, “said the pharmaceutical giant.
On November 20, Vij was administered the first trial dose of Bharat Biotech’s Covaxin, a fully indigenously developed Covid-19 candidate vaccine, in Haryana.
Bharat Biotech is conducting the largest phase III clinical trials in India. The aim is to evaluate the effectiveness of COVAXIN throughout India and determine its suitability for the diverse Indian population.
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