COVID-19 vaccine update: Bharat Biotech files for emergency use of Covaxin
After American drug maker Pfizer and Pune-based Serum Institute, Bharat Biotech is the third company to apply for emergency use authorisation for its COVID-19 vaccine to the DCGI
- Dec 7, 2020,
- Updated Dec 7, 2020 9:31 PM IST
Homegrown pharma major Bharat Biotech has sought approval from Drug Controller General of India (DCGI) for the emergency use authorisation (EUA) of its COVID-19 vaccine, Covaxin. This is India's indigenous coronavirus vaccine developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).
This is the third request received by the DCGI in the last two few days. American drug maker Pfizer and Pune-based Serum Institute of India have filed for EUA of their respective vaccine candidates.
Covaxin is an inactivated vaccine undergoing Phase 3 clinical trials with 26,000 participants in over 25 centres across India. The vaccine has already successfully completed the interim analysis from the Phase 1 and 2 clinical trials.
The vaccine, developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) high containment facility, had received the DCGI approval for Phase 1 and 2 human clinical trials, which commenced across India from July, 2020.
Homegrown pharma major Bharat Biotech has sought approval from Drug Controller General of India (DCGI) for the emergency use authorisation (EUA) of its COVID-19 vaccine, Covaxin. This is India's indigenous coronavirus vaccine developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).
This is the third request received by the DCGI in the last two few days. American drug maker Pfizer and Pune-based Serum Institute of India have filed for EUA of their respective vaccine candidates.
Covaxin is an inactivated vaccine undergoing Phase 3 clinical trials with 26,000 participants in over 25 centres across India. The vaccine has already successfully completed the interim analysis from the Phase 1 and 2 clinical trials.
The vaccine, developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) high containment facility, had received the DCGI approval for Phase 1 and 2 human clinical trials, which commenced across India from July, 2020.