Bharat Biotech on Saturday defended its COVID-19 vaccine, Covaxin, terming it safe and efficacious after Haryana Home Minister Anil Vij tested positive for the viral disease despite taking the first shot of the medication.
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 drug firm said its vaccine Covaxin is based on a two dose schedule and its efficacy is determined 14 days post the second dosage.
"COVAXIN clinical trials are based on a 2-dose schedule, given 28 days apart. The vaccine efficacy will be determined 14 days post the second dose," Bharat Biotech said in a statement.
The vaccine has been designed to be efficacious when subjects receive both doses and post the 14-day period after the second dose, it said without directly commenting on Vij who had received the first shot of the vaccine on November 20.
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.
Bharat Biotech said the phase 3 trials of the vaccine are double blinded and randomised, where 50 percent of subjects will receive the vaccine and 50 percent of subjects will receive placebo.
Covaxin is a fully indigenously developed COVID-19 vaccine, with the largest Phase 3 clinical trial conducted in India, on 26,000 subjects across 25 sites, it said The goal is to evaluate the efficacy of COVAXIN across the country, the company added.
The phase 3 trials of the vaccine is the only efficacy trial being conducted in India for COVID-19 vaccines, to determine its suitability to the diverse Indian population, Bharat Biotech said.
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