The phase 3 trials for coronavirus- Covaxin, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) have received a green signal.
The permission to conduct phase 3 trial was applied to the Drugs Controller General of India (DCGI) on October 2, for its COVID-19 vaccine candidate.
The application confirmed that the study would cover 28,500 subjects aged 18 years and above and would be conducted in 19 sites - including Delhi, Mumbai, Patna and Lucknow - across 10 states.
Besides, Bharat Biotech, an indigenously developed vaccine candidate by Zydus Cadila Ltd is also in Phase 2 of human clinical trials. The Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford COVID-19 vaccine candidate, is also conducting Phase 2 and 3 human clinical trials of the candidate in India.
In a report last month, Bharat Biotech had said that an animal study has shown its vaccine candidate has helped develop a strong immune response to the highly infectious coronavirus.
To summarise, the vaccine candidate was found to generate robust immune responses. Thus, preventing infection and disease in the primates upon high amounts of exposure to live SARS-CoV-2 virus," Bharat Biotech posted on its website.
Though initially the date for availability for the vaccine was August 15, the government officials later told a parliamentary standing committee that such a drug would not be possible until next year.
Globally, more than 100 vaccines are being developed and tested to try to stop the COVID-19 pandemic, which has killed hundreds of thousands and ravaged the global economy.
On Thursday, one of the volunteers part of the clinical trials of the University of Oxford's potential COVID-19 vaccine that is seen by many as the world's leading candidate died in Brazil but authorities said that the trial would continue.
Oxford confirmed the plan to keep testing, saying in a statement that after careful assessment "there have been no concerns about safety of the clinical trial."
