Hours after Haryana Home Minister Anil Vij tested positive for the Covid-19 despite taking a shot of Bharat Biotech’s vaccine candidate around two weeks ago during its ongoing Phase-III trial, the Union Health Ministry clarified on Saturday that the efficacy of the vaccine can only be determined 14 days after the second dose.
It said that the Minister has so far received the first dose only. The Hyderabad-based pharma company too echoed similar justification.
“Covaxin is a two-dose anti-coronavirus vaccine and Haryana Health Minister Anil Vij, who had volunteered for its phase-three trial, was given only the first dose,” said the Ministry.
Vij had offered to be the first volunteer in the phase three trials for Covaxin, an indigenous potential vaccine against Covid-19 being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The Ministry said, “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. This is a two-dose vaccine. The minister in question has taken only one dose of the vaccine.”
The Haryana Health Minister too 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. The 67-year-old Minister was given the first shot on November 20.
Asked about his condition, Vij said he has sore throat, fever and body ache. “But overall I am okay,” he said.
The minister said that he had gone to Panipat a few days ago where he spent two to three hours with a BJP leader, who too has tested positive for Covid-19.
“Covaxin efficacy can be determined only 14 days after second dose. Covaxin has been designed to be efficacious when subjects receive both the doses,” Bharat Biotech said in a statement.
It added that the Phase-III trials are double-blinded and randomised, where 50 per cent of subjects will receive the vaccine and 50 per cent will receive placebo. However, Vij’s claim that he received vaccine against Covid has pointed out gaps in the trial as volunteers are not told about the vaccine they are receiving.
“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,” the pharma giant said.
On November 20, Vij was administered the first trial dose of Bharat Biotech’s Covaxin, a fully indigenously developed Covid-19 vaccine candidate, in Haryana.
Bharat Biotech is conducting the largest Phase-III clinical trials in India. The goal is to evaluate the efficacy of Covaxin across India and determine its suitability to the diverse Indian population.
