COVID-19: Bharat Biotech’s 'Covaxin' gets nod for Phase 3 trials
- Oct 23, 2020,
- Updated Oct 23, 2020, 12:48 AM IST
Hyderabad: The COVID-19 vaccine developed by the Bharat Biotech in collaboration with the Indian Council of Media Research named 'Covaxin' has been cleared for the third phase of clinical trials.
The Hyderabad-based vaccine maker applied to the Drugs Controller General of India (DCGI) on October 2nd seeking permission to conduct the trials for its COVID-19 vaccine candidate.
According to reports, an expert panel at the Central Drugs Standard Control Organisation (CDSCO) gave the recommendation after accessing the safety and immunogenicity data of phase 1 and 2 clinical trials and have been sent to DCGI for final approval.
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In July, the DCGI had given permission to Bharat Biotech to conduct phase 1 and 2 clinical trials of its COVID-19 vaccine.
The firm in its application said that the study would cover over 28,500 subjects aged 18 years and above and would be conducted in 19 different sites.
Earlier, Bharat Biotech said that an animal study has shown its vaccine candidate has helped develop a strong immune response to the coronavirus.
Bharat Biotech on its official site posted, “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”
Meanwhile, the Serum Institute of India is also manufacturing the Oxford COVID-19 vaccine candidate is also conducting Phase 2 and 3 human clinical trials of the candidate of India.
Globally, over 100 COVID-19 vaccine candidates are being developed and tested.
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