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. However, the DCGI has also asked the Bharat Biotech to submit updated safety, efficacy and immunogenicity data from the ongoing Phase I, II and Ill clinical trials till the completion of trials.
Bharat Biotech’s Covaxin was “safe and provides a robust immune response”, said Drugs Controller General of India VG Somani. The vaccine is yet to complete late-stage human clinical trials in India and no efficacy rate has yet been made public.
“Phase 1 and Phase 2 clinical trials were conducted on about 800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response. The Phase 3 efficacy trial was initiated in India on 25,800 volunteers and till date, approximately 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe,” Somani said.
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Covaxin has been indigenously developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
Union Health Minister Dr Harsh Vardhan had clarified yesterday that emergency approval for Covaxin is different from the one given for Serum Institute's Covishield because Covaxin's use will be in clinical trial mode. All its recipients will be tracked and monitored as if they are participating in a trial.
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