New Delhi: The Central Licensing Authority on Saturday granted permission to Hyderabad-based Bharat Biotech to manufacture ‘Covaxin’ for sale and distribution after the indigenous coronavirus vaccine received regulatory approval for emergency use.
“The Central Licensing Authority has granted permission to Bharat Biotech International Ltd to manufacture for sale of the pharmaceutical formulation,” a top source told IANS.
Earlier on Sunday, Drug Controller General of India (DCGI) V.G. Somani announced that Bharat Biotech’s ‘Covaxin’ has been approved for “restricted use in emergency situation”. The approval has also been given to Serum Institute of India’s ‘Covishield’ vaccine.
The Subject Expert Committee of Central Drugs Standards Control Organisation had recommended restricted use of Covaxin “in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains”. Officials say that it will be used as backup in case of spike in cases.
Covaxin has to be administered in two doses and can be stored at 2-8 degree Celsius. This is a major relief for India which has the second-highest number of infections in the world after the US.
Bharat Biotech is India’s first indigenous vaccine for coronavirus. The inactivated virus vaccine is developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
“Covaxin has generated excellent safety data with robust immune responses to multiple viral proteins that persist,” Krishna Ella, Chairman and Managing Director of the pharmaceutical firm said following the approval.