Responding to the resports of Haryana minister Anil Vij, who took a trial dose of Covaxin a fortnight ago, the vaccine developer on Saturday said it 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 vaccine and 50% of subjects will receive placebo," Bharat Biotech, which is developing the vaccine in collaboration with ICMR, said in a statement.
The adverse reporting process, as per CDSCO-DCGI guidelines, 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.
Earlier, Anil Vij, who was administered a dose of a coronavirus vaccine two weeks ago during phase 3 trial, said he has tested positive for COVID-19.
Vij took to Twitter to inform that he has tested positive and has been admitted to a hospital in Ambala. "All those who have come in close contact to me are advised to get themselves tested for corona."
The 67-year old senior BJP leader had volunteered to get take part in the phase three trials for Covaxin, a potential vaccine against COVID-19. He was administered the trial dose of the indigenous vaccine at the Civil Hospital at Ambala Cantt on November 20.
A video of him getting the shot was also retweeted by the minister.
Vij had claimed that he was the first volunteer in the country to take the dose in phase three trial of the vaccine. He was also stated to be the first cabinet minister of any state government who volunteered to take the trial dose of a potential vaccine against COVID-19.
Covaxin is being developed with the largest Phase 3 clinical trial conducted in India. Trial on 26,000 subjects across 25 sites is being conducted to evaluate the efficacy of Covaxin across India.
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.
Covaxin is being developed indigenously by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).