India's first COVID-19 vaccine Covaxin to launch in Q2 2021. Phase III trial to efficacy
- 3 years ago
Covaxin, India's first vaccine against novel coronavirus, is all set launch in the second quarter of the next year if it gets the requisite approvals, a company official said, news agency PTI reported. "If we get all the approvals after establishing strong experimental evidence and data, and efficacy and safety data in our last stage of trials, we aim to launch the vaccine in Q2 of 2021," Sai Prasad, executive director, Bharat Biotech International Ltd, told the news agency.
Hyderabad-based firm has received approval from the drug regulator to conduct a Phase III clinical trial in the country. "The trial to be conducted in 25 to 30 sites across 13-14 states will provide two doses each for the vaccine and placebo recipients. About 2,000 subjects could be enrolled per hospital," Prasad said. The drugmaker begun site preparatory exercises for Phase III, recruitment and dosage will begin in November, he added. The interim results of the Phase III trial are likely to be released by April or May next year.
Covaxin has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). The coronavirus vaccine candidate has been derived from a strain of the novel coronavirus isolated by the National Institute of Virology in Pune. Bharat Biotech developed an “inactivated" vaccine at its high-containment facility at Genome Valley in Hyderabad. “Once the vaccine is injected into a human, it has no potential to infect or replicate, since it is a killed virus. It just serves to the immune system as a dead virus and mounts an antibody response towards the virus," Bharat Biotech said.
During the phase II trial, Covaxin has been tested in 12 hospitals across the country. Volunteers between the ages of 18 and 55 with no co-morbidity conditions have participated in the trial. The vaccine trial took place in Hyderabad, Rohtak, Patna, Kancheepuram, Delhi, Goa, Bhubaneswar and Lucknow among other places.
Bharat Biotech earlier released the animal study results of Covaxin. "The vaccine candidate was found to generate robust immune responses. Thus, preventing infection and disease in the primates upon high amounts of exposure to live SARS-CoV-2 virus," the drugmaker said.
The vaccine is likely to be at least 60% effective.“The benchmark for the efficacy of our anti-Covid-19 vaccine is 60%. We will be conducting the largest Phase III trial for Covaxin, and the efficacy results should be available by early April-May, 2021," Sai Prasad, executive director, Bharat Biotech International Ltd, told.
On the investment on the vaccine, Prasad said: "Our investment is about ₹350-400 crore for the development of vaccine and the new manufacturing facilities, which include our investments for conducting the Phase 3 clinical trial, in the next six months".
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