Part of phase-1 human trials over at PGIMS, Rohtak

India's first vaccine candidate against the coronavirus disease (COVID-19), Covaxin, has now been applied to 56 volunteers in the first phase of the human clinical trials at Post Graduate Institute of Medical Sciences (PGIMS), Rohtak.

Till now, only the indigenously developed vaccine prototypes by Bharat Biotech International Limited and the Zydus Cadila pharmaceutical have been approved for the human trials from the Drugs Controller General of India (DCGI).

PGIMS in Rohtak administered Covaxin to 50 volunteers in part 1 of phase-1 vaccine trials and 6 volunteers so far in part 2. Dr Savita Verma, principal investigator of the vaccine trial team at PGIMS Rohtak said the results have come out encouraging.

While Phase I trials would primarily focus on safety with the preliminary dosing in a few dozen healthy subjects, phase II trials will evaluate immunogenicity, dose levelsand adverse effects of the candidate vaccine in hundreds of people. Phase III trials then will involve more participants, including a control group, and test effectiveness of the vaccine to prevent the disease, while monitoring for unfavourable effects at the optimal dose.

Only after every step has been validated by the medical and scientific communities can a vaccine prototype be allowed for mass production and commercial release.