JOIN USDCGI nod to Serum Institute of India for phase 2 and 3 human clinical trials of Oxford Covid-19 vaccine candidate
India’s drug regulator has approved the proposal of Serum Institute of India to conduct Phase II and III clinical trials of the Oxford University-AstraZeneca Covid-19 Vaccine.
“This will hasten the development of the Covid-19 vaccine,” a health ministry statement said.
The Pune-based Serum Institute of India (SII) has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for Covid-19 and had submitted its first application to the Drug Controller General of India (DCGI) on July 25 for conducting the phase 2 and 3 trials of the potential vaccine.
The trials will be conducted on 1,600 individuals aged above 18 years and across 17 selected sites that include JSS Academy of Higher Education and Research in Mysuru, AIIMS in Delhi & Jodhpur, Andhra Medical College in Vizag and B J Medical College in Pune.
“The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to phase 3 clinical trials,” a senior official said.
“As per the study design, each subject will be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the safety and immunogenicity will be assessed at predefined intervals,” the official said.
Currently, phase 2 and 3 clinical trials of the Oxford vaccine candidate is going on in the United Kingdom, phase 3 clinical trial in Brazil, and phase 1 and 2 clinical trials in South Africa.