CDSCO panel on Saturday recommended granting approval for restricted emergency use of Bharat Biotech’s indigenous Covid-19 vaccine Covaxin in India. The panel met earlier today and the meeting lasted for 40 minutes. The locally-made vaccine is the second to get the expert panel's nod, after the Oxford-AstraZeneca shot was given clearance on Friday evening. Confirming the accelerated approval, the ministry said that the SEC has granted permission to Covaxin for restricted use in emergency situations "in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains".
Bharat Biotech had applied for emergency-use authorisation first on December 7. The expert panel at that time asked the firm to submit its safety and efficacy data from the ongoing phase 3 clinical trial for further consideration.Bharat Biotech’s vaccine candidate is an inactivated one which are developed by inactivating (killing) the live microorganisims that cause the disease. This destroys the pathogen’s ability to replicate, but keeps it intact so that the immune system can still recognise it and produce an immune response. There are many inactivated vaccines against Hepatitis A, Influenza, Polio, Rabies, which offer “excellent protection”, Bharat Biotech has said. Bharat Biotech had applied for emergency-use authorisation first on December 7. The development comes on a day a nationwide dry run exercise of vaccination was conducted under the supervision of the Union health ministry.