Bharat Biotech, developer of indigenous COVID-19 vaccine, COVAXIN has applied to the central drug regulator, DCGI, seeking emergency use authorisation for its vaccine. With this, the Hyderabad based firm, Bharat Biotech has become the third applicant after Serum Institute of India and Pfizer to apply for approval of emergency use of COVID-19 vaccine in the country.
COVAXIN is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and is currently in Phase 3 trials. The trials are being conducted at 18 sites across the country with over 22 thousand volunteers.
Emergency use approval of a drug is granted after there is sufficient evidence to suggest that the medical product is safe and effective. Final approval is granted only after completion of the trials and analysis of full data.
Pune based Serum Institute, which is also the World’s largest vaccine manufacturer has applied for approval of Oxford COVID-19 vaccine, COVISHIELD, which has been co-developed by Pharma company AstraZeneca and Oxford University. Serum Institute of India (SII) has applied for emergency approval of made-in-India covid vaccine candidate, Covishield. SII CEO Adar Poonawalla has confirmed it and said it will save countless lives.
Adar Poonawalla also thanked the Government of India and Prime minister Narendra Modi for their invaluable support. SII, the world’s largest vaccine producer by volume, had sought emergency use authorisation in the country for AstraZeneca Plc’s COVID-19 vaccine candidate.
The company applied to the Drugs Controller General of India, citing unmet medical needs due to the pandemic and in the interest of the public at large. The move comes close on the heels of Pfizer Inc applying for a similar authorisation of its coronavirus vaccine in India. (With inputs from AIR)