New Delhi: In a significant development, Bharat Biotech on Thursday night said its COVID vaccine — OVAXIN has now become the universal vaccine for adults, children. Issuing a statement, Bharat Biotech said the goals of developing a global vaccine against COVID-19 have been achieved and all product development for licensure has been completed.
Earlier in the day, the Hyderabad-based company had sought from the Drugs Controller General of India regular market approval for Covaxin’, which is currently only authorised for emergency use in the country.
COVAXIN is now a universal vaccine for adults and children. Our goals of developing a global vaccine against COVID-19 have been achieved and all product development for licensure has been completed: Bharat Biotech pic.twitter.com/LQ7iBxp5OI
— ANI (@ANI) January 13, 2022
In an application sent to the DCGI this week, V Krishna Mohan, Whole-Time Director at the Hyderabad-based company submitted complete information regarding chemistry, manufacturing and controls, along with pre-clinical and clinical data while seeking regular market authorisation for Covaxin.
The company, however, is yet to submit the full follow up data of clinical trila of Covaxin to DCGI, a source said.
On October 25, Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India (SII) had submitted an application to the DCGI seeking regular market authorization for Covishield which is also authorised for emergency use in the country.
The DCGI in response to the application earlier had asked for some more information following which Singh last week submitted a response along with all desired data and information to DCGI.
In addition to the successful completion of phase 2/3 clinical study in India, till now, more than 100 crore doses of Covishield vaccine have been administered to the people in India and worldwide, Singh is learnt to have stated in the response.
