India’s first vaccine, Covaxin, against Covid-19 , is all set launch in the second quarter of the next year if it gets the requisite approvals.
“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 reporters.
Hyderabad-based firm has received approval from the drug regulator to conduct a Phase III clinical trial in the country.
Prasad said 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 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).