The Central Licensing Authority on Sunday granted permission to Bharat Biotech to manufacture Covaxin for sale and distribution, hours after the Drug Controller General of India (DCGI) approved the coronavirus vaccine for restricted emergency use.
The Hyderabad-based company has been asked to submit safety, efficacy and immunogenicity data from the ongoing phase I, II and III clinical trials till the completion.
"The firm should provide the protocol for rolling out for the restricted use of the vaccine in emergency situation. The firm should provide the updates prescribing information/package insert and summary of product characteristics for whole virion inactivated coronavirus vaccine (BBV152b) and also disseminate the necessary information, instructions and educational materials through their website," the DCGI said today.
"The firm should submit updated safety, efficacy and immunogenicity data from the ongoing Phase I, II and III clinical trials till the completion of trials as per requirement of New Drugs and Clinical Trials, 2019," it further stated.
The Central Licensing Authority also asked Bharat Biotech to submit risk management plan, and ongoing stability of commercial scale batches of drug substance and drug product.
READ MORE: Covaxin generated excellent safety data, says Bharat Biotech
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