
Five sites across the country are ready for the third and final phase of human trials of the Oxford-AstraZeneca Covid-19 vaccine
New Delhi: Five sites across the country are ready for the third and final phase of human trials of the Oxford-AstraZeneca Covid-19 vaccine, Department of Biotechnology (DBT) Secretary Renu Swarup said.
This is an essential step because it is necessary to have data within the country before the vaccine is administered to Indians, Swarup said.
Covid-19 vaccineThe Serum Institute of India, the largest vaccine maker in the world, has been chosen by Oxford and its partner AstraZeneca to manufacture the vaccine once it is ready. Trials results for the first two phases were published earlier this month.
According to Swarup, the DBT is part of any Covid-19 vaccine effort in India “whether it is funding, whether it is facilitating the regulatory clearances or whether it is giving them access to different networks which exist within the country”.
“The DBT is now setting up Phase 3 clinical sites. We have already started working on them and five sites are now ready to be available for Phase 3 trials," Swarup said.
Covid-19"DBT is closely working with every manufacturer and Phase 3 trial of Serum (institute) is important because if the vaccine has to be successful and it has to be given to the Indian population we need to have the data within the country.
For that a Phase 3 trial has been proposed. Five sites are ready. Within some more weeks, they should be ready for manufacturers to take them up for clinical trial studies," the DBT secretary said.
In India, two indigenous vaccines – one by Zydus Cadila and the other by Bharat Biotech – have reached the stage of phase one of human trials.