Covaxin, Indian Coronavirus Vaccine by Bharat Biotech Cleared for phaseIII Trials.
On October 2nd, Bharat Biotech sought permission from the Drugs Controller General of India (DCGI) to conduct phase III trials for Covaxin, the COVID-19 vaccine candidate in India.
Bharat Biotech is a Hyderabad based company and has been developing the coronavirus vaccine in collaboration with the Indian Council of Medical Research (ICMR). Their vaccine candidate, Covaxin, has been approved for phase III trial by DCGI.
In the application to the DCGI, the firm mentioned that the study would cover 28,500 subjects from the age group belonging to 18 years and above. The study will be conducted across 10 states- including Delhi, Patna, Mumbai, and Lucknow.
Besides Bharat Biotech, another vaccine candidate is undergoing Phase II human clinical trials, which is developed indigenously by Zydus Cadila Ltd.
The Serum Institute of India, Pune, has partnered with AstraZeneca for the manufacture of the Oxford COVID-19 vaccine candidate and is now conducting its Phase II and Phase III human clinical trials in India for the candidate.
Last month, Bharat Biotech reported that the vaccine candidate’s study on animal models showed that the candidate helps develop a strong immune response to the highly
contagious SARS-CoV-2 virus.Bharat Biotech put up a post on their website stating that the vaccine candidate was found to generate robust immune responses. The candidate was thus found to prevent infection and disease upon high live SARS-CoV-2 virus exposure in the primates.
Initially, Covaxin was planned to be launch by August 15 in the market. Later, government officials told a parliamentary standing committee that the release of drug as the present pandemic vaccine would not be possible until next year.
Globally, more than 100 vaccine candidates for the pandemic virus are being developed and tested in an effort to stop the pandemic. This involved hundreds of thousands and has ravaged the global economy in the process.
On Thursday, one of the volunteers for the clinical trials of the vaccine candidate developed by the University of Oxford died in Brazil. The candidate vaccine developed by the University of Oxford is seen to be a leading candidate by many. The authorities have notified that the trials would continue for this vaccine candidate.
Oxford confirmed the plan to continue testing, and they stated that there had been no concerns for safety after careful assessment.
Covaxin, Indian Coronavirus Vaccine by Bharat Biotech Cleared for phaseIII Trials.
