Bharat Biotech has said that Covaxin, its ICMR-backed vaccine for Covid-19, is set for launch in June 2021. The Hyderabad-based vaccine maker, which has received approval for phase 3 trials, 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”.
The Drugs Controller General of India (DCGI) had on Friday permitted Bharat Biotech to conduct phase 3 clinical trials of its indigenously developed Covid-19 vaccine with certain conditions. The Covaxin vaccine is being indigenously developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
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.
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, a Reuters report quoted Sai Prasad as saying, adding that more than 90% of them developed antibodies against the novel coronavirus.
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).