Coronavirus: Bharat Biotech plans to release COVID-19 vaccine Covaxin by June 2021
The approval for late-stage clinical trial puts the Hyderabad-based firm behind the Serum Institute of India (SII), which is in the process of recruiting and vaccinating participants for the third phase of the clinical trial of its candidate, Covishield.
FollowNew Delhi: Bharat Biotech, which received the approval for phase 3 clinical trial of COVID-19 vaccine Covaxin on October 22, is aiming for June 2021 launch.
Covaxin is being indigenously developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The Hyderabad-based vaccine maker will enroll 26,000 volunteers for the late-stage testing in November. The trials will be conducted at around 30 sites in the country.
A report in The Indian Express quoted Bharat Biotech International Ltd’s executive director Sai Prasad as saying that the vaccine should be ready by June 2021, “unless the government advances its launch through emergency use authorization”.
"If we get all the approvals in place, I think during Q2 of 2021, we should get the efficacy readout from our phase 3 clinical trial — April, May, June, for example. That is for the full efficacy results," Prasad added.
The approval for late-stage clinical trial puts the Hyderabad-based firm behind the Serum Institute of India (SII), which is in the process of recruiting and vaccinating participants for the third phase of the clinical trial of its candidate, Covishield.
The vaccine maker had applied to the DCGI on October 2 seeking permission to conduct phase 3 randomised double-blind placebo-controlled multi-centre trial of its Covid-19 vaccine. It was asked to submit complete safety and immunogenicity data of the phase 2 trial besides providing some clarifications before proceeding to the next stage.
India's Zydus Cadila is currently conducting mid-stage trials of its own vaccine hopeful, while Serum Institute is making potential vaccines from AstraZeneca, Novavax and Codagenix Inc, as well as developing its own.
India has the world's second-highest number of reported coronavirus cases at 7.8 million, more than a 100,000 of whom have died.
Serum Institute of India and Bharat Biotech are also expected to pursue late stage clinical trials of intranasal Covid-19 vaccines in the coming months. Of the vaccines currently in Phase 3 trials, all are administered by injection, according to the World Health Organization (WHO).
