Covaxin, Bharat Biotech's COVID vaccine, gets DCGI approval for phase 3 of clinical trials

India's indigeus developed COVID-19 vaccine - Covaxin - has been cleared by Drug Controller General of India (DGCI) for third phase of clinical trials. vaccine which is being developed by Hyderab-based Bharat Biotech, in collaboration with Indian Council of Medical Research (ICMR), h applied for Phase 3 trials permission on October 2. 

In its application seeking permission for third st, developers h stated that trials would cover nearly 28,500 subjects d 18 years and above and would also be conducted across 19 sites including Delhi, Mumbai, Patna and Luckw. 

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Covaxin's animal trials successful

Earlier in September, Bharat Biotech h informed that Covaxin h proved to be effective in inducing immunity against COVID-19 in animals. firm h stated that two-dose vaccination regimen of inactivated SARS-CoV-2 vaccine candidates was ministered in 20 rhesus macaques which were divided into four groups equally. results showed protective efficacy, increasing SARS-CoV-2 specific IgG and neutralizing antibodies, reducing replication of virus in nasal cavity, throat, and lung tissues of monkey.

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"To summarize, vaccine candidate was found to generate robust immune responses. Thus, preventing infection and disease in primates upon high amounts of exposure to live SARS-CoV-2 virus," statement concluded.

India's COVID vaccine candidates

Bharat Biotech got DCGA's approval in July to conduct phase I and II clinical trials to develop an indigeus vaccine for COVID-19. Covaxin is first of indigeusly developed vaccines against COVID-19 by India. Bharat Biotech has collaborated with Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV) to develop vaccine. Besides Covaxin, India has two more vaccine candidates in run. Ahmedab-based Zydus Cila's ZyCoV-D and ar one is being developed by Serum Institute of India in collaboration with Oxford University vaccine and UK's Pharmaceutical giant AstraZeneca. 

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