Bharat Biotech has responded to the reports of Haryana Health Minister Anil Vij testing positive for COVID-19. Vij had taken Bharat Biotech's COVID-19 vaccine candidate, Covaxin, a fortnight ago. The vaccine developer said on Saturday that the Covaxin clinical trials are based on a 2-dose routine, the two doses are administered 28 days apart.
"The vaccine efficacy will be determined 14 days post the second dose. Covaxin has been designed to be efficacious when subjects receive both doses," said Bharat Biotech in a statement. Vij was administered only the first dose of Covaxin on November 20, i.e., 15 days ago. This means he tested positive for COVID-19 before he was ever administered the second dose of the vaccine.
"Covaxin has been designed to be efficacious when subjects receive both doses and post the 14-day period after the second dose. The Phase 3 trials are double-blinded and randomised, where 50 per cent of subjects will receive the vaccine and 50 per cent of subjects will receive placebo," Bharat Biotech added.
Haryana Minister Anil Vij was administered Covaxin during the Phase 3 trials. Earlier on Saturday, he had confirmed in a tweet that he had tested positive for the COVID-19 and had been admitted to a hospital in Ambala. He wrote on the microblogging platform, "All those who have come in close contact to me are advised to get themselves tested for corona. (sic)"
Vij had volunteered to get take part in Phase 3 trials of Covaxin. He was administered the potential vaccine at the Civil Hospital in Ambala. A video of him receiving the Covaxin shot was retweeted by the Haryana Health Minister.
Covaxin is being developed with the largest Phase 3 clinical trial conducted in India, according to Bharat Biotech who are developing it in in collaboration with the Indian Council of Medical Research (ICMR). Phase 3 trials on 26,000 subjects across 25 sites across the country is currently being conducted to evaluate the efficacy of the potential vaccine.
"The Phase 3 trials of COVAXIN 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.