India's first COVID-19 vaccine, COVAXIN, cleared for human trials
In a major development, the Drug Controller General of India (DCGI) has cleared COVAXIN, a potential COVID-19 vaccine developed in the country, for human trials.
The experimental shot is the first ever candidate from India to be approved for the clinical trial stage, which is set to begin across the country from July.
Here's all you need to know about it.
Bharat Biotech's COVAXIN candidate vaccine for COVID-19
Developed by Hyderabad-based Bharat Biotech and the Indian Council of Medical Research (ICMR), the COVAXIN candidate uses an inactivated strain of the novel coronavirus to prime the body to generate an immune response and fight off the actual virus attack.
It has reportedly shown efficacy and safety in the pre-clinical animal trials and is now set to be tested on humans across the country.
Human trials will start in July
Now, with DGCI's approval, the Phase-1 and Phase-2 clinical trial of COVAXIN will begin across the country in July (although the exact dates are not clear).
Once the trial starts, the effectiveness of the vaccine in generating a safe immune response will be assessed in dozens of healthy human volunteers.
After that, depending on the results, the candidate will move into Phase-3.
In Phase-3, it will be tested on a larger group
If the results from Phase-1, 2 trials are promising and the volunteers show sufficient neutralizing antibodies, the candidate will be tested on a much larger group as part of Phase-3.
Then, using all the data, the effectiveness and safety of the vaccine will be confirmed and reviewed, lining the shot up for emergency use approvals. The entire process could take months from now.
Proud to announce COVAXIN, said Bharat Biotech MD Krishna Ella
"We are proud to announce COVAXIN...The collaboration with ICMR and NIV was instrumental in the development of this vaccine. The proactive support and guidance from CDSCO have enabled approvals...[and] Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform (sic)."
17 candidates are already in clinical trials
The effort from Bharat Biotech and ICMR comes as the world races to get a vaccine ready to exit the ongoing COVID-19 pandemic that has killed over 5 lakh people around the world, including nearly 17,000 in India.
The global vaccine efforts have led to the development of nearly 150 candidates, of which 17 (COVAXIN not included yet) are already moving through clinical trials.
Moderna and AstraZeneca's candidates are the front-runners
Among the 17 candidates, 8 are from Chinese organizations. However, the ones from Moderna Therapeutics in the US and AstraZeneca in the UK are furthest in the testing phase and could become available by the end of this year or in early 2021.