India's second COVID-19 vaccine cleared for human trials: Details here
What's the story
India is picking up pace to develop a preventive vaccine for COVID-19, the novel coronavirus disease. Just a few days ago, Bharat Biotech's 'COVAXIN' became the first indigenously developed COVID-19 shot to be approved for clinical human trials, and now, Ahmedabad-based Zydus Cadila Healthcare is set to join the bandwagon with its own candidate. Separately, ICMR plans to launch COVAXIN by August 15.
Approval
Approved for Phase 1 and 2 of human trials
According to reports, one of Zydus Cadila's two experimental vaccines has been cleared for Phase 1, 2 of clinical human trials. The data related to the shot was examined by the Drugs Controller General of India, following which the nod to start the tests with human volunteers was given. The approval process was expedited on the suggestion of DCGI's expert committee on COVID-19.
Animal trials
Satisfactory results in pre-clinical animal trials
A senior government official told ANI that the vaccine candidate was tested on animals like mice, rabbits, guinea pigs, and was able to generate the required antibodies to fight off the virus. "Their animal trial data was inspected thoroughly and was found satisfactory. And now, DCGI has granted permission to Zydus Cadila to conduct Phase 1 & 2 clinical trial," the official added.
Details
What will happen in Phase 1, 2 trials?
In the trials, the candidate vaccine will be tested on hundreds of human volunteers to determine how safely and effectively it can generate an immune response. It is not clear when the tests will begin but an official familiar with the developments told PTI that the enrollment of subjects will start soon and the study will take around 3 months to be completed.
Phase 3
After that, Phase 3 trial will be carried out
Once the initial phases are over, the vaccine will move into the third and final stage of human trials, where it will be tested on thousands of people. After that, 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.
Vaccines
India now has 2 approved vaccines in clinical trials
With this, India has now cleared two potential vaccines for the clinical trial phase. The first one, COVAXIN by ICMR and Bharat Biotech, was approved just a few days ago and is now being fast-tracked through the tests at 12 institutes across the country. ICMR has also said it is targeting to make COVAXIN available for emergency public use by August 15.
Other candidates
18 candidates from other countries moving through human trials
From other nations, we have as many as 18 experimental vaccines that are moving through clinical trials. Of these, most (8, to be specific) are from China, but the front-runners are candidates from UK's AstraZeneca and America's Moderna Therapeutics. AstraZeneca has also partnered with the Serum Institute of India to manufacture a billion doses for India and low-to-middle income nations.