Coronavirus: Bharat Biotech aims to launch COVAXIN by June 2021
Hyderabad-based pharmaceutical firm Bharat Biotech is expecting to launch its coronavirus vaccine candidate, COVAXIN, by June next year. COVAXIN has been developed in collaboration with the Indian Council of Medical Research's National Institute of Virology (ICMR-NIV). Bharat Biotech had on Thursday received the DCGI's (Drugs Controller General of India) approval for conducting Phase III trials for the vaccine candidate. Here are more details.
A top Bharat Biotech official told The Indian Express that the company expects to have COVAXIN ready by June 2021. Executive Director Sai Prasad said, "If we get all the approvals in place, I think during Q2 of 2021, we should get the efficacy readout from our Phase III clinical trial — April, May, June, for example. That is for the full efficacy results."
COVAXIN is an inactivated vaccine that involves injecting a "killed version" of the coronavirus, SARS-CoV-2, into a person. Prasad said that the timeline may be accelerated if the government advances COVAXIN's launch through emergency use authorization.
Prasad told the publication that the company is planning to test "25,000 to 26,000" volunteers across 12-14 states for the vaccine candidate, including Telangana, Tamil Nadu, Haryana, Maharashtra, and Bihar. "We are committed to doing all our Phase I, Phase II, and Phase III clinical trials in its entirety, but I think the government may also be considering emergency use approval," Prasad said.
Speaking to Hindustan Times, Prasad said, "The DCGI has asked us to change a few details in the protocol. These are minor procedural changes." He added, "We are currently in the process of making the necessary changes, and will hopefully re-submit the proposal to the Central Drugs Standard Control Organisation (CDSCO) in the next few days."
The Pune-based Serum Institute of India is notably in the process of recruiting and vaccinating participants for Phase III trials for the Oxford University-AstraZeneca's vaccine candidate, AZD1222, which will be sold as Covishield in India. Covishield is a front-runner and is expected to be ready by March 2021. The institute is also making potential vaccines for Novavax and Codagenix and also developing its own.
India is the world's second worst-hit in the outbreak, with 78,14,682 infections. However, only 6,80,680 are active infections and 70,16,046 patients have recovered. The death toll is 1,17,956. The government has reportedly set aside a sum of Rs. 50,000 crore to vaccinate the entire country.