The Phase-1 human clinical trials for Covaxin, a vaccine candidate for Covid-19 developed by Hyderabad-based Bharat Biotech, have begun in Chennai's SRM Medical College Hospital and Research Centre. According to a news report in The News Minute, the first phase of the trials for the vaccine began at SRM hospital on Thursday.
Phase I of the trial will be done on healthy people, aged between 18 and 55 years, having no co-morbid conditions. Women with no pregnancy will also be selected for the trial in the first phase.
During the first phase, the volunteers will be given a controlled dose to see if the vaccine is safe and how much of the dose can be administered.
"Every week, the volunteers who have been administered the vaccine will come for a checkup here. We will test them and review their responses. This will go on for about six months. We will keep sending the results and observations to the Indian Council of Medical Research,” Dr A Sundaram, Dean (Medical Research) of SRM Medical College Hospital and Research told The News Minute.
SRM hospital in Chennai is among the 12 hospitals selected by the Indian Centre for Medical Research for the human trials of Covaxin, Covid-19 vaccine candidate developed by Bharat Biotech in collaboration with ICMR and NIV, Pune.
In phase I, the vaccine would be tested on 375 volunteers. The second phase would include around 750 volunteers from all 12 sites.
In the second phase, 750 people will be recruited and they will be between 12 and 65 years of age.
The process for conducting the clinical trials for Covaxin has also been started at Delhi's All India Insitute of Medical Sciences, Rohtak's Post-Graduate Institute of Medical Sciences and Hyderabad's Nizams Institute of Medical Sciences.
Bharat Biotech has successfully developed COVAXIN, India’s 1st vaccine candidate for COVID-19, in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India.
The Drug Controller General of India - CDSCO, Ministry of Health & Family Welfare granted permission to initiate Phase I & II human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response. Human clinical trials have already started across India in July 2020.
Expedited through national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies. Results from these studies have been promising and show extensive safety and effective immune responses.
Bharat Biotech’s track record in developing vero cell culture platform technologies has been proven in several vaccines for Polio, Rabies, Rotavirus, Japanese Encephalitis, Chikungunya and Zika.
Story Credit - www.Indiatoday.in