The Hyderabad-based vaccine maker has received approval for phase 3 trials and will enroll 26,000 volunteers for the late-stage testing in November.
Covaxin, the ICMR-backed vaccine for Covid-19, is set for launch in June 2021, said Bharat Biotech. The Hyderabad-based vaccine maker has received approval for phase 3 trials and will enroll 26,000 volunteers for the late-stage testing in November. The trials will take place at 30 different locations in the country, the Indian Express reported.
According to the Indian Express report, Bharat Biotech International Ltd’s executive director Sai Prasad said the vaccine should be ready by June 2021, “unless the government advances its launch through emergency use authorization”.
On Friday, the Drugs Controller General of India (DCGI) had permitted Bharat Biotech to conduct phase 3 clinical trials of its indigenously developed Covid-19 vaccine with certain conditions. Bharat Biotech, in collaboration with the Indian Council of Medical Research (ICMR), has indigenously developed Covaxin.
On October 2, the vaccine maker had applied to the DCGI, seeking permission to conduct phase 3 randomised double-blind placebo-controlled multi-centre trial of its Covid-19 vaccine. DCGI had asked it to submit complete safety and immunogenicity data of the phase 2 trial besides providing some clarifications before proceeding to the next stage.
The potential vaccine was found to be safe without any major adverse events in the first two stages of the trials involving about 1,000 people, Sai Prasad was quoted as saying by a Reuters report. He also added that more than 90% of them developed antibodies against the novel coronavirus.
While India’s Serum Institute is making potential vaccines from AstraZeneca, Novavax and Codagenix Inc, as well as developing its own vaccine, Zydus Cadila is also conducting mid-stage trials of its own vaccine hopeful.
Serum Institute and Bharat Biotech are also likely to conduct late stage clinical trials of intranasal Covid-19 vaccines in the coming months.
All the vaccines in phase 3 trials are administered by injection, according to the World Health Organization (WHO).