COVID-19 vaccine: 5 sites in 4 states ready for late-stage human clinical trials
The sites will comply with regulatory requirements and would be available to any group conducting phase III human trials
There are five sites ready for late-stage human clinical trials for several COVID-19 vaccine candidates. An additional six sites are also being set up to ensure that more healthy participants are available, The Indian Express has reported.
The companies conducting trials include University of Oxford, Zydus Cadila and Bharat Biotech.
Secretary Department of Biotechnology Renu Swarup told The Indian Express that companies would have a handy and large database of volunteers, a couple of thousands, at each site. She said there would also be trained personnel as efforts are being fast-tracked to find a vaccine against Covid-19.
Swarup confirmed that the sites have been established by the National Biopharma Mission and Grand Challenges India Programme. The latter is a collaboration between the government and the Bill and Melinda Gates Foundation to encourage innovative health and development research.
“Having trained and equipped sites for field trials in healthy populations has been a challenge for vaccine manufacturers,” The Indian Express quoted Swarup as saying. The sites that have been finalised will meet this challenge while complying with regulatory requirements and would be available to any group conducting phase III human trials, she said, according to the report.
According to The Indian Express, the sites are at INCLEN Trust International in Palwal, Haryana; KEM in Pune; the Society for Health Allied Research in Hyderabad; the National Institute of Epidemiology in Chennai; and Christian Medical College in Vellore, Tamil Nadu.