Indian Council of Medical Research (ICMR) to fast track clinical Trials of Covaxin, India's First indigenous covid19 vaccine (BBV152) COVAXIN, developed by Hyd-based Bharat Biotech Int Ltd (BBIL) in collaboration with ICMR & National Institute of Virology (NIV). The medicine has to get a nod from the Drugs Controller General of India (DCGI) for human clinical trials. If the phase I and II clinical trials on humans comes around as successful, then Covaxin will be registered as the 'first' indigenous COVID-19 vaccine in India. Trials to be launched by 15th August in 12 Hospitals.
As per source (PTI), the assent for human trials was provided after the company submitted data of clinical trial on animals to the DCGI, This is to be notified that the vaccine candidate was found to be successful with respect to safety and immunogenicity, as per the source. "The phase I and II trials can take around three months for completion," As per source.
What is COVAXIN?
Covaxin is a vaccine candidate that was developed by Bharat Biotech Int Ltd (BBIL) in collaboration with the National Institute of Virology (NIV) for the treatment of highly infectious and deadly disease COVID-19.
How They developed COVAXIN?
NIV isolated a strain of the covid-19 OR novel coronavirus from an asymptomatic Covid-19 patient and transferred it to BBIL, at the beginning of May 2020. BBIL further started its work of developing an 'inactivated; vaccine that happens to be a vaccine that uses the dead virus. This was implemented at Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility in Hyderabad.
As per BBIL the inactivated vaccines generally have a proven safety record. BBIL also says, "Once the vaccine is injected into a human, it has no potential to infect or replicate, since it is a killed virus. It just serves to the immune system as a dead virus and mounts an antibody response towards the virus."
What happened Next?
The pre-clinical testing on different animals such as guinea pigs and mice were held to see if the vaccine is safe before the firm approached CDSCO for approval to begin the human trials.
Where will COVAXIN clinical trials be done?
12 Hospitals have been selected by Indian Council of Medical Research (ICMR) where the clinical trial of COVAXIN will happen. ICMR also informed to the selected hospitals that it is envisaged to launch the covaxin for public health use the latest by August 15, 2020, once all clinical trials are completed, (Source - PTI).
When will COVAXIN OR covid-19 vaccine OR corona virus vaccine be available in market?
As per source, Currently there is no confirm information available that when the vaccine will be available in the market for human use, Before that human clinical trials Phase 1 and Phase 2 of the COVAXIN to be happen from July. We will keep you updated on this.