Human trials of COVAXIN, India’s first COVID-19 vaccine to begin soon: All you need to know
New Delhi, July 07: The human trials of India's first possible vaccine against COVID-19 is likely to start soon. The phase 1 trial of COVAXINE developed by Bharat Biotech, an unlisted Indian vaccine maker, is expected to begin next week.
A total of 375 people will be under observation in the first phase of clinical trials, an Indian Council for Medical Research (ICMR) spokesperson told Bloomberg. The company has set July 13 as the last date of enrollment for the first trial.
According to a report in Bloomberg, an ICMR spokesperson said that Bharat Biotech plans to enrol 375 people in the first phase of clinical trials and 750 people in the second phase. The company has set July 13 as the final date of enrollment for the trials. The company said COVAXIN has demonstrated safety and immune response in preclinical studies.
The trials of the first Indian vaccine for COVID-19 will be conducted in 12 hospitals.
The Belagavi Jeevan Sakhi Multi Speciality hospital would be among the units where the multi city clinical trial of the vaccine would be conducted. Trials would also be conducted at the AIIMS, Delhi and Hyderabad. The trial would also be conducted at the Nizam's Institute of Medical Sciences, Hyderabad.
The Drug Controller General of India has granted permission to initiate Phase I and II human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response.
During the trial researchers would examine the vaccine's efficacy with a single dose as well a double dose on the 1st and 14th day.
Several drugs have been tested for their effectiveness against COVID-19, the disease resulting from coronavirus, but they have fallen short. Gilead Sciences' remdesivir has been found to be effective in reducing the time spent in hospital by infected patients, but a cure is yet to find.