The pharma company’s immediate focus is to conduct the Phase 3 trials successfully across sites in the country.

The company’s vaccine candidate, Covaxin, has been developed in collaboration with the Indian Council of Medical Research-National Institute of Virology using inactivated Sars-Cov-2. The virus was isolated in an ICMR lab.

The price of the vaccine is yet to be determined, as the company is still looking at the cost of product development.

Bharat Biotech received approval from the Drugs Controller General of India to conduct Phase 3 clinical trial to establish the efficacy of the vaccine candidate. The company has begun site preparatory exercises for Phase 3, recruitment and dosage will begin in November.

The trial is conducted in nealy 30 sites around 14 states. About 2,000 subjects are enrolled per hospital and will provide tow doses each of the vaccine and placebo recipients.

The pharma company is looking to supply for both government and private markets. It is also in its preliminary discussions with other countries for probable supply.

Nearly Rs 350-400 crore is invested for the development of vaccines and the new manufacturing facilities, which include investments for conducting the Phase 3 clinical trials, in the next three months.

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India’s first COVID-19 vaccine COVAXIN has got the Drug Controller General of India’s approval for phase I and II of human clinical trials. The two trials are designed to test whether the vaccine is safe, rather than whether it is effective.

The experimental vaccine has been developed by Hyderabad-based Bharat Biotech, in collaboration with the ICMR (Indian Council for Medical Research) and the National Institute of Virology (NIV). This could get underway across the country in July 2020. Results are expected to be out by October 2020, following which larger clinical trials will be conducted.

The trials are among many across the world. There are around 120 vaccine programmes under way worldwide. This is the first India-made vaccine and developed from a strain of the virus that was isolated locally and weakened under laboratory conditions.

Bharat Biotech, which has delivered more than 4 billion doses of vaccines worldwide, has developed vaccines for H1N1 and rotavirus, among other diseases.

The permission to initiate clinical trials came after the company submitted results that they had generated through pre-clinical studies, demonstrating safety and effective immune responses.

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