After Pfizer and Serum Institute of India, now Hyderabad-based Bharat Biotech has applied for emergency use authorisation for their investigational vaccine candidate Covaxin to the Indian regulator on Monday.
The company is conducting a 26,000 subjects phase 3 efficacy trial in India to decide the efficacy of its candidate. This is without doubt one of the largest efficacy trials conducted in the country. The company has Phase 1 and phase 2 data in a position and would submit the interim data from large scale efficacy trials to the Drug Controller General of India (DCGI) for review.
Officials from the Central Drugs Standard Regulate Association (CDSCO), the Indian Council of Medical Research (ICMR) have been in steady touch with BBIL together with the expert committee on vaccine administration.
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First Published: Mon, December 07 2020. 21:57 IST