Serum and Bharat Biotech had applied for the accelerated approval on December 6 and 7, respectively.
Serum Institute of India had submitted security, immunogenicity and efficacy information generated on 23,745 participants aged more or equal to 18 years or older from overseas clinical research. The general vaccine efficacy was located to be 70.42 per cent.
Further, SII was granted permission to conduct Phase-II/III clinical trials on 1,600 participants inside the nation. The firm also submitted the interim security and immunogenicity information generated from this trial and the information was located comparable with the information from the overseas clinical research.
The UK and Argentina have currently authorized the Oxford-AstraZeneca vaccine. More than 5 crore doses of the vaccine have currently been stockpiled by its manufacturer, Serum Institute of India.
As far as Bharat Biotech’s Covaxin is concerned, it is India’s very first indigenous vaccine for coronavirus. The inactivated virus vaccine is becoming created in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
The firm had generated security and immunogenicity information in a variety of animal species such as mice, rats, rabbits, Syrian hamster, and also performed challenge research on non-human primates (Rhesus macaques) and hamsters.