APN News

  • Thursday, September, 2020| Today's Market | Current Time: 02:35:07
  • DCGI gives permission to Serum Institute of India to conduct Phase 2 and 3 human clinical trial of Corona vaccine COVISHIELD, developed by Oxford university

    Published on August 3, 2020

    Drugs Controller General of India (DCGI) has given nod to the Serum Institute of India (SII) to conduct phase 2 and 3 human clinical trials of COVID-19 vaccine developed by Oxford University.

    The approval for conducting phase 2 and 3 clinical trials by the SII was granted by DCGI Dr VG Somani late last night after a 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.

    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.

    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.

    Loading...