The phase 3 trials will be conducted in 19 sites across 10 states, including in cities such as Delhi, Mumbai, Patna and Lucknow and would seek to enroll 28,500 volunteers aged 18 years and above.
Covaxin, the coronavirus vaccine candidate jointly developed by Bharat Biotech and the Indian Council of Media Research (ICMR) in partnership with National Institute of Virology (NIV) has received approval from a panel of the Drugs Controller of India (DCGI) for Phase 3 trials, as per reports.
As per an NDTV report, the Hyderabad-based company had in an application on 2 October sought permission from the DCGI to conduct Phase 3 trials.
According to a LiveMint report, DCGI’s Subject Expert Committee recommended giving the go-ahead to the vaccine candidate after examining data from phases 1 and 2 as well as animal challenge study.
However, the approval is subject to amendment.
As per a CNBC TV18 report, the panel has suggested amendments to the criteria on how a suspected case be clinically evaluated and classified as a symptomatic case. Bharat Biotech will now be required to submit a completed protocol to the DCGI for final approval.
As per the application made by the firm, the trials would be conducted in 19 sites across 10 states, including Delhi, Mumbai, Patna and Lucknow and would seek to enroll 28,500 volunteers aged 18 years and above, as per the NDTV report. They will be given two doses of the experimental vaccine with a gap of 28 days, as per the LiveMint report.
Last month, the firm shared the results of their COVID-19 vaccine candidate safety trials in animals. The experimental shot was found safe in rhesus monkeys that were vaccinated and exposed to the SARS-CoV-2, the virus that causes the coronavirus disease (COVID-19).
“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.
It had received approval from the drug regulator for Phase I and II trials of the vaccine in June. The first phase trials have been completed on 375 healthy volunteers, as per the CNBC TV18 report. As per the LiveMint report, Phase 2 trials are currently underway and the interim data was placed before the SEC.
COVAXIN is the first indigenously-developed vaccine against coronavirus. It is an inactivated vaccine candidate, designed to produce unique elements of the SARS-CoV-2 virus, which are used by the immune system to recognise a threat if the whole virus is ever encountered in the real world.
Besides Covaxin, the vaccine candidates developed by Zydus Cadilla and by AstraZeneca with Oxford University are under different phases of clinical trials in India.
The country has so far recorded 77,06,946 cases of the coronavirus infection and 1,16,616 have succumbed to it.