The Drugs Controller General of India (DCGI) has given licensing permission to Hyderabad-based Bharat Biotech to manufacture ‘Covaxin’ for sale and distribution.
The DCGI approval document said the firm can vaccinate children above the age of 12 years during the clinical trial mode.
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.
This paves the way for the roll out of at least two vaccines in India in the coming days. ”Serum and Bharat Biotech vaccines have to be administered in two doses.
All the three vaccines have to be stored at 2-8° C,” he said. The Serum Institute of India, the world’s largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield, while Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
Prime Minister Narendra Modi termed the approval a decisive turning point in India’s fight against coronavirus.
