OXFORD corona vaccine is on trial in India before granting marketing

INDIA has permitted human clinical trials for the vaccine developed by the iconic Oxford University for the treatment of corona patients. Serum Institute of India Ltd will conduct phase 2 and 3 human clinical trials. The approval for conducting clinical trials by the SII was granted by DCGI Dr VG Somani after thorough evaluation based on the recommendations of the Subject Expert Committee on COVID-19.

The expert panel at the Central Drugs Standard Control Organisation (CDSCO) had on Friday recommended granting permission for phase 2 and 3 clinical trials of the vaccine – Covishield on healthy adults in India. SII has a tie-up with Swedish-British firm AstraZeneca which developed the vaccine along with The University of Oxford to manufacture this vaccine for low- and middle-income countries. The firm plans to conduct its phase II/III trials on around 1,600 participants, a senior government official told The Indian Express.

The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to phase clinical trials. Currently, phase 2 and 3 clinical trials of the Oxford vaccine are going on in the UK, phase 3 clinical trials in Brazil and phase 1 and 2 clinical trials in South Africa.