Bharat Biotech re-applies with DCGI for emergency approval of Covaxin
New Delhi: Hyderabad-based Bharat Biotech, which is developing the country's indigenous coronavirus vaccine in collaboration with the Indian Council of Medical Research, on Wednesday again applied to the Drug Controller General of India for the emergency use authorisation.
"The company applied for the emergency use authorisation in the evening," a company source told IANS.
Emergency Use Authorisation is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies.
Bharat Biotech had first applied for the emergency use authorisation of its vaccine on December 7 and presented its proposal, along with the interim safety and immunogenicity data of Phase 1 and 2 clinical trials.
The Central Drugs Standard Control Organisation's (CDSCO) expert panel had, however, recommended that the firm should present the safety and efficacy data from the ongoing Phase 3 clinical trial in the country for further consideration.
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