Interestingly, Bharat Biotech is in collaboration with a University of Wisconsin in the development of another Vaccine too.
India's drug regulatory authority on Monday gave the green signal to Bharat Biotech's COVID-19 vaccine for human trials, making it the first domestic candidate from the country as the number of COVID-19 cases in India crossed 565,000.
The vaccine, COVAXIN, has been developed by Hyderabad-based Bharat Biotech, in association with Indian Council for Medical Research (ICMR). According to the company, the Drug Controller General of India approved Bharat Biotech's application to conduct phase I and II clinical trials for Covaxin. The results are promising, show exhaustive safety and effective immune responses in laboratory studies, he added.
The company says that the formula; known as Ad5-nCoV, is now limited to use by military personnel, and can not be offered to a broader population without the approval of the Logistics Support Department, the division of the Central Military Commission which approved the military use of the vaccine.
The agency also said it would require drug companies to monitor the vaccine's performance after approval for any emerging safety problems.
According to the Reuters' report, CanSino Biologics, in an exchange filing, said China's Central Military Commission has approved the use of the vaccine by the military on June 25 for a period of one year after the vaccine was found safe in clinical trials and showed some efficacy.
"Our ongoing research and expertise in forecasting epidemics has enabled us to successfully manufacture a vaccine for the H1N1 pandemic", said Suchitra Ella, joint managing director of the company.
The FDA guidance says vaccine approval will have to undergo a full FDA licensure process that involves a large clinical trial showing people who have been vaccinated have developed protection against the coronavirus. It signed its tenth supply-and-manufacturing deal earlier this week.
Moderna, AstraZeneca, Johnson & Johnson, Merck and Sanofi all have funding from Operation Warp Speed.
Another 131 candidate vaccines listed by the World Health Organization are at the pre-clinical phase.