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India Biotech’s third phase trial of Corona vaccine Covaxin has been approved.

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The Drug Controller General of India (DCGI), India’s drug regulatory body, has approved the Phase III trial of Bharat Biotech’s Corona vaccine Covaxin. The trial will cover 28,500 people 18 or older. Bharat Biotech’s Corona vaccine is one of the two indigenous corona vaccines in India. Apart from this, the trial of Zydus Cadila’s indigenous vaccine is also going on in India.

Bharat Biotech vaccine is named Covaxin. Significantly, in collaboration with the Indian Council of Medical Research (ICMR), India is developing biotech covaxin vaccine indigenously. Bharat Biotech presented the Animal Challenge data along with the data for the first and second stage trials of the Corona vaccine. After discussing all the data, the Drug Controller General of India (DCGI) has approved it.
Hyderabad-based vaccine maker Bharat Biotech had on October 2 last year filed an application with the Drugs Controller General of India (DCGI) seeking permission for the Phase III vaccine trial. The company had said in its application that 28,500 people aged 18 or older would be included in this trial and this trial would be done at 19 places in 10 states of the country. This includes Delhi, Mumbai, Patna and Lucknow.
The company’s application was discussed by the Expert Committee (SECS) of the Central Drugs Standard Control Organization (CDSCO) on 5 October. The committee said after detailed deliberations that the design of the third phase of the study is, in principle, satisfactory, except without clarification on the definition of the symptom. The committee, in its recommendations, stated that the study should be initiated with the appropriate dose identified based on the safety and immunological data of the second phase trial. Thus the company should present such related figures

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