Bharat Biotech which is developing India’s indigenous coronavirus vaccine, is planning to launch the vaccine in the second quarter of 2021, if it gets the approval from regulatory authorities.
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.
