India’s own Coronavirus vaccine by Bharat Biotech which was in the second stage of human clinical trials has finally received a go-ahead for the last phase. The much anticipated ICMR-backed vaccine candidate is expected to be launched for Indian population by June 2021. However, there is a catch. The company has said that the vaccine will come in the next eight months if the government does not advance Covaxin’s launch via emergency use authorisations, The Indian Express reported. Citing Sai Prasad, executive director, Bharat Biotech International, the report said that if all the approvals are in place, the company will be able to readout the complete efficacy from the third phase of clinical trials in the second quarter of next year i.e., by June 2021.
Bharat Biotech is planning to conduct the third phase of trials with more than 20,000 volunteers across 12-14 states in India. It is to note that the vaccine candidate is set to work by injecting a “killed version” of the Coronavirus strain that has been wreaking havoc for more than 10 months now. Once injected in the body, the vaccine will lead the human body to develop an immune response against the novel Coronavirus.
The report highlighted that ever since Bharat Biotech received the approval of last stage clinical trials, it has overtaken Oxford’s Covishield that was on trial by Serum Institute of India. SII is currently recruiting and vaccinating participants for phase-III clinical trials.
According to the report, the company said that Covaxin’s phase-3 trial will be much different than the earlier two phases. Prasad said that the company is intending to have everything in a manner so that logical conclusions, in terms of empirical evidence and data, can be derived along with safety and efficacy data. However, the company is in talks with the government to push for emergency use approval.
There will be 25,000 to 26,000 participants from all over the country and around 25 clinical sites where trials will be conducted. So far, the company has chosen 12-14 states for Covaxin trial and this includes Haryana, Bihar, Maharashtra, Tamil Nadu, and Telangana. Prasad said to each trial site, a multifaceted approach will be introduced.
