India’s Bharat Biotech, which is developing a coronavirus vaccine has said that the indigenous candidate to counter the coronavirus pandemic may be ready by June 2021. There are plans to carry out testing of Covaxin with over 20,000 volunteers across 12-14 states. The Executive Director of Biotech, Sai Prasad has informed that the company expects to file for the regulatory approval of its COVID-19 vaccine candidate COVAXIN by June 2021 only if the results from its late-stage trial are positive.
The vaccine may be available early if the government decides to use it under emergency use but Bharat Biotech is not pressing for such permission. Bharat Biotech has got a go-ahead from the government for the phase-3 vaccine. Besides Bharat Biotech, Zydus Cadila is also indigenously developing coronavirus vaccine. The vaccine has got go-ahead for phase 2 trial.
The Hyderabad-based drugmaker has been planning to start a late-stage or 3rd stage trial of COVAXIN by November 2020 with over 26,000 volunteers, the approval for which came from Indian Drug Controller a few days back. The volunteers will be monitored by the firm for drug efficacy. Reportedly, the vaccine development programme of Bharat Biotech entails an investment of Rs. 400 crores, the bulk of which will go in the trials.
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, Executive Director Sai Prasad said, adding that more than 90% of them developed antibodies against the novel coronavirus. The focus now was on last-stage trials of the vaccine, developed in collaboration with the Indian Council of Medical Research, as well as seeking foreign partners, he said. “We are in active discussions with more than 10 countries that have shown an interest in COVAXIN,” he said.
Other vaccine candidates in the fray are those of Zydus Cadila, which is close to completing phase-2 trials of ZyCov-D, and of Russia’s Gamaleya Research Institute, which will soon begin phase 2/3 trials of Sputnik V in collaboration with Dr Reddy’s. The Centre had said earlier this week that three crore frontline healthcare workers will be among the first to receive the coronavirus vaccine. Minister of Health and Family Welfare Harsh Vardhan had said last month that India was likely to get the vaccine in the first quarter of 2021.
