After Haryana Health Minister Anil Vij tested positive for COVID-19 on Saturday despite taking a shot of Bharat Biotech’s vaccine candidate around two weeks ago during its ongoing Phase III trial, the vaccine developer Bharat Biotech issued a statement saying, “Covaxin is designed to be efficacious”.
Haryana Health Minister Anil Vij has tested positive for COVID-19, around two weeks after he was administered the first trial dose of Covaxin.
Bharat Biotech said that the clinical trials are based on a 2-dose schedule, given 28 days apart, and vaccine efficacy will be determined 14 days after the second dose.
“COVAXIN has been designed to be efficacious when subjects receive both doses.
“The phase III trials are double-blinded and randomized, where 50% of subjects will receive the vaccine and 50% of subjects will receive placebo,” Bharat Biotech added.
“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,” Bharat Biotech said.
Earlier today, Vij tweeted that he has tested positive for the novel coronavirus. “I have been tested Corona positive. I am admitted in Civil Hospital Ambala Cantt. All those who have come in close contact to me are advised to get themselves tested for corona,” Vij tweeted on Saturday.
On November 20, Vij was administered the first trial dose of Covaxin in Haryana.
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