Just hours after Haryana Health minister Anil Vij, who took a trial dose of Covaxin a fortnight ago, tested positive for coronavirus on Saturday, the vaccine developer Bharat Biotech issued a statement saying, ''Covaxin is designed to be efficacious''.
The vaccine developer 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 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.
As per CDSCO-DCGI guidelines, the adverse reporting process 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.
The statement from the Bharat Biotech came after the 67-year-old minister tested positive two weeks after being given a shot of the coronavirus vaccine - Covaxin.
"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.
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.— ANIL VIJ MINISTER HARYANA (@anilvijminister) December 5, 2020
Health Ministry on Anil Vij testing Covid positive:
Meanwhile, the Union Health Ministry also clarified that Anil Vij took only the first dose of the two-dose coronavirus vaccine.
"The antibodies against the infection build up in a human being only after a specific number of days pass after the second dose of the vaccine is taken. Since, this is a two-dose vaccine. Minister in question has taken only one dose of the vaccine," the ministry said in a statement.
In the case of this vaccine, trial volunteers receive two intramuscular injections approximately 28 days apart.
Participants are randomly assigned to receive Covaxin or placebo. The trial is double-blinded, such that the investigators, the participants and the company are not aware of who is assigned to which group.
Anil Vij volunteered in Covaxin trials
On November 20, Vij had offered to be the first volunteer for the third phase trial of Covaxin, which started in the state. He was administered the trial dose of the indigenous vaccine at the Civil Hospital at Ambala Cantt.
Covaxin is being developed indigenously by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). Last month, the vaccine maker said it had successfully completed an interim analysis of Phase 1 and 2 trials and is initiating Phase 3 trials.