Haryana Health Minister Anil Vij, who got one shot of the trial dose of Bharat Biotech's COVID vaccine Covaxin a fortnight ago, on Saturday said that he has tested positive for coronavirus.
The report of Vij testing positive, despite a trial dose of the vaccine, alarmed uninformed readers with some of them wondering the vaccine was even real.
Covaxin is being developed indigenously by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). Vij had offered to be the first volunteer in the phase three trials for Covaxin. He was administered the dose on November 20 at the Civil Hospital at Ambala Cantt.
For those who are wondering how Anil Vij got infected with the virus despite the trial dose, here is an explainer:
How Covaxin trial is conducted?
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.
In the case of this vaccine, trial volunteers receive two intramuscular injections approximately 28 days apart.
Bharat Biotech's response on Vij
Covaxin clinical trials are based on a 2 dose schedule, given 28 days apart. The vaccine efficacy will be determined 14 days post the 2nd dose, the company said.
Covaxin has been designed to be efficacious when subjects receive both doses and post the 14 day period after the 2nd dose, it said. The phase 3 trials are double blinded and randomised, where 50% of subjects will receive vaccine and 50% of subjects will receive placebo, Bharat Biotech added.
Health Ministry clarifies
The Union Health Ministry also clarified that Vij took only the first dose of the two-dose 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.
Anil Vij statement
Vij said antibodies start to develop after administration of the second dose, which is given 28 days after the first shot, and there is no protection during this period.
"I was told that antibodies start to develop after the second dose, which is administered after 28 days of getting the first shot. And full antibodies are developed 14 days after the second dose is given. So, the complete cycle takes 42 days. In between there is no protection," Vij told PTI over phone from the hospital.