HYDERABAD: Covaxin, India’s first indigenous vaccine candidate for the Covid-19 vaccine, began phase III clinical trials on Monday in what is the country’s largest human trial of a vaccine for the dreaded coronavirus.
Trials began in Hyderabad with the first doses of the candidate vaccine administered to volunteers at the Nizam Institute of Medical Sciences (NIMS) on Monday.
The trials, which will involve 25,000 volunteers over the age of 18 at 25 centers across the country and are being conducted in partnership with the Indian Council for Medical Research (ICMR), are also the first Phase III efficacy for a Covid- 19 in the country, Bharat Biotech said on Monday.
According to the company, volunteers who are vaccinated in Phase III trials will be monitored over the next year for the onset of the Covid-19 disease.
Covaxin has already been evaluated in 1,000 subjects in phase I and II clinical trials and has shown promising safety and immunogenicity data, he added.
As part of the phase III study, volunteers will receive two intramuscular injections approximately 28 days apart and will be randomly assigned 1: 1 to receive two 6-mcg (microgram) injections of Covaxin or two placebo injections.
Being a double-blind trial, neither the researchers, the participants, nor the company will know who is assigned to which group, the company said.
Covaxin, which is a highly purified and inactivated virus vaccine, is being developed by Bharat Biotech in collaboration with ICMR-National Institute of Virology.
The vaccine is being manufactured at Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility on a vero cell manufacturing platform, the company said.
Trials began in Hyderabad with the first doses of the candidate vaccine administered to volunteers at the Nizam Institute of Medical Sciences (NIMS) on Monday.
The trials, which will involve 25,000 volunteers over the age of 18 at 25 centers across the country and are being conducted in partnership with the Indian Council for Medical Research (ICMR), are also the first Phase III efficacy for a Covid- 19 in the country, Bharat Biotech said on Monday.
According to the company, volunteers who are vaccinated in Phase III trials will be monitored over the next year for the onset of the Covid-19 disease.
Covaxin has already been evaluated in 1,000 subjects in phase I and II clinical trials and has shown promising safety and immunogenicity data, he added.
As part of the phase III study, volunteers will receive two intramuscular injections approximately 28 days apart and will be randomly assigned 1: 1 to receive two 6-mcg (microgram) injections of Covaxin or two placebo injections.
Being a double-blind trial, neither the researchers, the participants, nor the company will know who is assigned to which group, the company said.
Covaxin, which is a highly purified and inactivated virus vaccine, is being developed by Bharat Biotech in collaboration with ICMR-National Institute of Virology.
The vaccine is being manufactured at Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility on a vero cell manufacturing platform, the company said.
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