Bharat Biotech seeks emergency use nod for Covid vaccine

By Aakanksha Khajuria New Delhi, Dec 7 : Hyderabad-based Bharat Biotech on Monday filed an application with the Drugs Controller General of India (DCGI) for emergency use authorisation of its Covid-19 vaccine — Covaxin.
The application was filed before the apex drug regulator on Monday evening, a company source told IANS on the condition of anonymity. Covaxin, India’s indigenous Covid-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
Emergency use authorisation is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies.
The development comes a day after the Serum Institute of India, the world’s largest vaccine maker by number of doses produced, sought government approval for emergency use authorisation of its coronavirus vaccine that it is being developed in collaboration with the University of Oxford and British drugmaker AstraZeneca.
The Pune-based pharmaceutical firm was the second to do so after American firm Pfizer sought approval from the drug regulator for its vaccine, which has been cleared by the UK and Bahrain.
Covaxin is an indigenous, inactivated vaccine being developed and manufactured at Bharat Biotech’s Bio-Safety Level 3 bio containment facility. It is a highly purified and inactivated vaccine, manufactured in a vero cell manufacturing platform.