Hyderabad-based Bharat Biotech successfully developed COVAXIN COVID-19 Vaccine in collaboration with the ICMR and National Institute of Virology (NIV). The vaccine has not got a nod from the Drugs Controller General of India (DCGI) for human clinical trials.
With COVID-19 rapidly spreading across the country, the discovery of a vaccine is the only escape from the pandemic. And now it seems that August 15, 2020, might bring independence for the country from the novel coronavirus. As per the latest updates, Bharat Biotech International Limited (BBIL) and ICMR could now launch the indigenous vaccine Covaxin by August 15 for the public.
Developed by Ahmedabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research and National Institute of Virology (NIV), the medicine has not got a nod from the Drugs Controller General of India (DCGI) for human clinical trials. If the phase I and II clinical trials on humans turn out to be successful, then Covaxin will be registered as the country’s ‘first’ indigenous COVID-19 vaccine.
As per PTI, the assent for human trials was given after the company submitted data of clinical trial on animals to the DCGI, in which the vaccine candidate was found to be successful with respect to safety and immunogenicity, sources said. “The phase I and II trials will take around three months to be completed,” the source said.
Here’s everything you need to know about COVAXIN:
What is COVAXIN?
Covaxin is a vaccine candidate that was developed by BBIL in collaboration with the National Institute of Virology (NIV) for the treatment of highly infectious and deadly disease COVID-19.
How was COVAXIN COVID-19 vaccine developed?
NIV isolated a strain of the novel coronavirus from an asymptomatic Covid-19 patient and transferred it to BBIL, at the beginning of May 2020. The company then began its work of developing an ‘inactivated; vaccine that happens to be a vaccine that uses the dead virus. This was done at Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility in Hyderabad.
The company said that the inactivated vaccines generally have a proven safety record. The company in a statement said, “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.”
Next, the pre-clinical testing on animals such as guinea pigs and mice were held to see if Covaxin is safe before the firm approached CDSCO for approval to begin the human trials.
Where will COVAXIN clinical trials be done?
12 institutes have been selected by ICMR where the clinical trial of COVAXIN will take place. ICMR, in a letter to these institutes, informed that it is envisaged to launch the vaccine for public health use the latest by August 15, 2020, after completion of all clinical trials, as per news agency PTI.
These 12 institutes have also been asked by ICMR to fast track clinical trials of the vaccine as it is being considered as one of the top priority projects which are being monitored at the topmost level of the government.
When will COVID-19 vaccine COVAXIN be available in market?
According to a release, human clinical trials Phase 1 and Phase 2 of the COVAXIN will commence from July, therefore, at present no confirm information is available as to when the vaccine will be available in the market for human use.
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