Zydus Cadila's COVID-19 vaccine found safe, going into Phase-2 trial
Indian drug company Zydus Cadila has completed early-stage human trials with its indigenously developed COVID-19 vaccine. The shot, according to a regulatory filing by the firm, was found to be safe in the study and will now be going into the second phase of clinical trials which will begin tomorrow, August 6, 2020. Here is all you need to know about it.
Vaccine doses well tolerated by volunteers in Phase 1
In the regulatory filing, Cadila Healthcare said that the doses of the vaccine administered to healthy volunteers in the Phase-1 clinical trial, which began on July 15, 2020, have been well tolerated. The safety level of the doses of the shot, officially dubbed ZyCoV-D, was endorsed by an external and independent data safety monitoring board, Reuters said in a report.
This is a major milestone: Zydus Cadila Chairman
Speaking on the development, Pankaj Patel, the Chairman of Zydus Cadila, said that this is an important milestone. "All the subjects in Phase-1 clinical trial were closely monitored in a clinical pharmacological unit for 24 hours post-dosing for safety and for 7 days thereafter, and the vaccine was found to be very safe," Patel said in a statement.
Second phase will establish efficacy of the vaccine
Now, with Phase-1 out of the way, Zydus Cadila will proceed with the second, mid-stage trial. The study will commence on August 6, 2020, and will focus on "evaluating the safety and immunogenicity of the vaccine in a larger population," Patel noted. This trial will have more than 1,000 participants and help researchers determine whether the shot generates an immune response or not.
In animal trials, ZyCoV-D was found effective
Notably, in pre-clinical animal trials involving mice, rabbits, guinea pigs, ZyCoV-D was found to be safe and effective. The shot was able to generate a high level of neutralizing antibodies in the subjects, which is what we humans also need to fight off the novel coronavirus. The results on the vaccine's effectiveness might come post Phase-2 trials, sometime in October-November.
Then, Phase-3 will begin and continue until March 2021
After Phase-2, the vaccine, if proved effective and cleared by Drug Controller General of India, will go into Phase-3 trials involving thousands of volunteers. This phase is expected to be completed by February/March 2021, following which the vaccine might become available. "We are looking at about seven or a little more than seven months for the vaccine, provided the data is encouraging," Patel had said last month.
Bharat Biotech's COVAXIN is also in Phase-2 now
Along with Cadila's shot, the COVID-19 vaccine from Bharat Biotech and the National Institute of Virology has also moved into Phase-2 clinical trials. These are the only two Indian shots that are moving through human trials at this stage. Globally, there are 24 other candidates in human trials, including those from UK's Oxford University and America's Moderna Therapeutics.