INDIA's drugs authorities had allowed Serum Institute of India, the world's largest manufacturer of vaccines by volume, to conduct clinical trials of a vaccine candidate developed by Oxford University and AstraZeneca Plc.
"Drugs Controller General of India has given approval to Serum Institute of India, Pune to conduct Phase II+III clinical trials of Oxford University-Astra Zeneca #COVID19 vaccine (COVISHIELD) in India," the health ministry said on Twitter on Monday (3).
The development comes after an expert committee on July 31 recommended that the company be allowed to conduct these trials after it studied a revised proposal submitted by the Pune-headquartered firm.
"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.
According to the company, 1,600 people aged above 18 years will participate in the trials across 17 selected sites. Currently, phase 2 and 3 clinical trials of the Oxford vaccine candidate is going on in the UK, phase 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa.
The Serum Institute had submitted its first application to the regulator on July 25 seeking permission for conducting the phase 2 and 3 trials of the potential vaccine.
The Pune-firm has signed an agreement to manufacture the potential vaccine developed by the Oxford University in collaboration with British-Swedish company AstraZeneca.
