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.
Serum Institute, Pfizer file for EUA
Adar Poonawalla-led Serum Institute of India (SII) announced that it has applied for an EUA for Covishield coronavirus vaccine to the DCGI. The Pune-based institute has partnered with Oxford University and British-Swedish pharmaceutical company AstraZeneca to manufacture the COVID-19 vaccine in India. According to the ICMR, the SII has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling licence it obtained from the DCGI.
Serum Institute, which is the world's largest vaccine producer by volume, is the second company to apply for the emergency authorisation after Pfizer India. Authorities will consider Pfizer India's application for an emergency use authorisation of its COVID-19 candidate this week. On December 2, the UK became the first country to approve the Pfizer-BioNTech vaccine against COVID-19 for emergency supply. On December 5, Bahrain also approved Pfizer and BioNTech's vaccine candidate, BNT162b2, for emergency use.
By Chitranjan Kumar