Oxford Vaccine gets one step Closer towards Arriving at the Indian Market! Human Vaccine Trial and other Latest Developments

India’s top drug regulator, Drugs Controller General of India (DCGI) has permitted Serum Institute of India (SII) to hold phase 2 and 3 of clinical human vaccine trails across India. 

"After a thorough evaluation, the DCGI has given approval to SII to perform phase-II, III clinical trial based on the recommendations of the Subject Expert Committee (SEC)," the official source told ANI.

"As a rapid regulatory response, the proposal was deliberated in the SEC through a virtual meeting earlier this week. And after considering the data generated on the vaccine in phase-1, 2 of the Oxford University trial, the committee recommended granting permission to conduct phase 2, 3 clinical trials of COVISHIELD (SII-ChAdOx1 nCoV-19) healthy adult subjects at risk in the country," the official said.

According to the design, each subject will be given two doses 4 weeks apart (First dose on Day 1 and Second Dose on Day 29. Subsequently, the safety and immunogenicity of the vaccine will be assessed at predefined intervals.

According to the official’s statement, the pharma firm has to submit safety data which will be evaluated by the Data Survey Monitoring Board (DSMB) and the Central Drugs Standard Control Organization (CDSCO), only after which it will be moving on to the phase-3 of the clinical trial. 

Last week, the Pune- based vaccine maker applied for seeking permission to conduct phase 2 and 3 of clinical trials for the vaccine. 

SII in collaboration with Oxford University and Astra Zeneca is manufacturing the COVISHIELD Vaccine.