India’s Covid-19 vaccine Covaxin tested on 375 volunteers

NEW DELHI, Jul 19, 2020, DNA India. As announced earlier, India’s first vaccine candidate against the coronavirus disease (COVID-19), Covaxin, has now been applied to 375 volunteers in the first phase of the human clinical trials, DNA India reported.

After Russia became the first country to successfully conclude human trials for the world’s premier coronavirus vaccine, it was earlier reported that India will begin the human clinical trials for vaccines against the SARS-CoV-2, the virus that causes the dreaded COVID-19.

Covaxin has been developed by Bharat Biotech, a pharmaceutical company based in Hyderabad.

Till now, only the Bharat Biotech International Ltd and the Zydus Cadila pharmaceutical companies’ indigenously developed vaccine prototypes have got an approval for the human trials from the Drugs Controller General of India (DCGI).

For the purpose of the trials, the All India Institute of Medical Sciences (AIIMS) in Patna had selected 18 volunteers on whom the vaccine trails will be conducted. In addition to the Patna AIIMS, the Indian Council of Medical Research (ICMR) had selected the Nizam Institute of Medical Sciences in Hyderabad, the Delhi AIIMS, and nine other institutions for conducting the human clinical trials for Covaxin in phases.

The volunteers are aged anywhere between 18 to 55. In this phase, the vaccine was applied to physically fit volunteers. The subjects were kept under observation after implementing three dosages of Covaxin.

According to reports, Covaxin will be experimentally applied to a total of 1,100 volunteers in two phases. For that, the Phase-I of human clinical trials with 375 volunteers has now completed successfully.

ICMR has informed that institutions in India are developing the vaccine prototypes only after complying with every necessary rules and regulation stratified by international customs since no compromises are being made in the attempt to ahead in the race for coronavirus vaccine.

Phase I trials which test primarily for safety and preliminary dosing in a few dozen healthy subjects.

Phase II trials, following the success of Phase I trials, evaluate immunogenicity, dose levels (efficacy based on biomarkers), and adverse effects of the candidate vaccine, typically in hundreds of people. Phase III trials typically involve more participants, including a control group, and test effectiveness of the vaccine to prevent the disease (an “interventional” trial), while monitoring for adverse effects at the optimal dose.

Only after every step has been ratified by the medical community can a vaccine prototype be allowed to be released to commercial use in markets.