New Delhi: The Controller General of Indian Medicine (DCGI) has approved the Serum Institute of India (SII) by Oxford University for the second and third phase human trials of the Develop covid-19 vaccine in the country.
Officials said that Dr. VG Somani, the Drug Controller General had given this approval to SII late on Sunday night. The DCGI first discussed in-depth the recommendations of the Expert Committee (SEC) of covid-19.
According to the senior official, “SII must submit safety-related data to the Central Drugs Standard Control Organization (CDSCO) before the Phase III clinical trial, which has been evaluated by the Data Safety Monitoring Board (DSMB).”
According to the outline of this research, every person involved in the research will be given two doses at an interval of four weeks. This will be followed by an assessment of safety and immunity at fixed intervals.
Officials said that the expert panel of CDSCO has approved the second and third phase of ‘Kovishield’ on healthy adults in India after deliberating deeply on the data from the first and second phase testing.