Five Sites In India Ready For Phase 3 Human Trials Of Oxford-AstraZeneca Covid-19 Vaccine

Five sites in India are ready for the Phase 3 human trials of the Oxford-AstraZeneca Covid-19 vaccine, Department of Biotechology (DBT) secretary Renu Swaroop said on Monday (27 July), reports Times of India.

The Covid-19 vaccine candidate, AZD1222, has been developed by the University of Oxford in collaboration with pharma company AstraZeneca. Serum Institute of India (SII), which is world's largest vaccine maker by volume, has been chosen to manufacture the vaccine once it is ready.

The trial results of the first two phases of the Oxford Covid-19 vaccine were published earlier this month, which showed that the vaccine was safe and generated immune response against the SARS-CoV-2 virus, which causes the Covid-19 disease, in the patients.

The Phase 3 human trials of the Covid-19 vaccine in India is an essential step because it is necessary to have data within the country before the vaccine is administered to Indians, Swaroop was quoted as saying in the report.

Swaroop said that DBT was setting up Phase 3 clinical trial sites and that five sites were now available for the Phase 3 trials.

The SII has also sought permission from the Drug Controller General of India (DCGI) for second and third phase human trials of the Oxford vaccine.

"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," Swarup was quoted as saying.

"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.