Regulator clears Bharat Biotech, Serum shots for emergency use

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.

On Sunday, Drug Controller General of India (DCGI) V.G. Somani announced that Bharat Biotech’s ‘Covaxin’ has been approved for “restricted use in an emergency situation”. The approval has also been given to Serum Institute of India’s ‘Covishield’ vaccine.

Regulator clears Bharat Biotech, Serum shots for emergency use

Bharat Biotech allowed to manufacture ‘Covaxin’; can vaccinate children above 12 during clinical trial mode

Covaxin back-up, for use if surge, under controls: AIIMS, ICMR heads

Serum, Bharat Biotech vaccines get restricted use approval from DCGI

Bharat Biotech vaccine more likely to work against newer strains like UK variant: Vardhan

Submitted all data as per guidelines, says Bharat Biotech

AIIMS डायरेक्टर ने कहा, Bharat Biotech की Corona Vaccine का हो सकता है वैकल्पिक इस्तेमाल

देश को मिली पहली स्वदेशी कोरोना वैक्सीन, भारत बायोटेक की Covaxin को मंजूरी देने की सिफारिश

कोरोना वैक्सीन को लेकर भारत का इंतजार खत्म, सीरम इंस्टीट्यूट और भारत बायोटेक के टीके को मंजूरी

भारत बायोटेक की कोवैक्सीन के इमरजेंसी इस्तेमाल को भी मिली एक्सपर्ट पैनल की मंजूरी





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