Two weeks after getting a trial dose of COVID-19 vaccine Covaxin, Haryana Health Minister Anil Vij tested positive for coronavirus on Saturday. He took to his Twitter handle to share the news. He tweeted, "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."
After the minister tested covid positive, the vaccine developer Bharat Biotech issued a statement saying, ''Covaxin is designed to be efficacious''.
"Covaxin has been designed to be efficacious when subjects receive both doses and post the 14 day period after the 2nd dose. The phase 3 trials are double-blinded and randomized, where 50% of subjects will receive the vaccine and 50% of subjects will receive placebo," Bharat Biotech, which is developing the vaccine in collaboration with ICMR, said in a statement.
The adverse reporting process, as per CDSCO-DCGI guidelines, include the patient contacting the site PI, or during active follow up. Reports are submitted to site Ethics Committees, CDSCO-DCGI, Data Safety Monitoring Board and Sponsor.
On November 20, Anil Vij was administered a dose of Covaxin at a hospital in Ambala, as part of its third phase trial. He had offered to be the first volunteer for the third phase trial of Covaxin.
"I will be administered trial dose of Coronavirus vaccine #Covaxin a Bharat Biotech product tomorrow at 11 am at Civil Hospital, Ambala Cantt under the expert supervision of a team of Doctors from PGI Rohtak and Health Department. I have volunteered to take the trial dose," Vij had tweeted on November 20.
In October, the Drugs Controller General of India (DCGI) gave permission to Bharat Biotech for conducting Phase-III clinical trial for Covaxin.