CDSCO granted restricted emergency use approval to indigenously developed Covaxin by Bharat BioTech.

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The Central Drugs Standard Control Organization’s (CDSCO) Subject Expert Committee on Saturday granted restricted emergency use of the indigenously developed vaccine “Covaxin” by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

The CDSCO had granted similar approval to the Covishield vaccine development by the Oxford and AstraZeneca.  CDSCO granted emergency use authorization after lengthy deliberation and analysis of the application submitted by the Bharat Biotech, which is Hyderabad-based pharmaceutical firm. The subject expert committee analyzed the data submitted by the Company.

A day ago, CDSCO had granted emergency use approval to Covishield, which will be mass-produced by Serum Institute of India (SII). The final decision now rests with the Drugs Controller General of India. The Subject Expert Committee noted the large sample size of Covaxin with 25800 subjects including the ones with Comorbid conditions. The vaccine demonstrated safety but the efficacy was yet to be ascertained.

India is the only nation with at least four vaccines on the final stage of trial and approval. These vaccines are Bharat Biotech’s COVAXIN, Zydus Cadila’s ZyCoV-D and Russia’s Sputnik-V and Covishield of Oxford & AstraZeneca.

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