The expert panel of CDSCO approved the second and third stage of ‘Covishield’ on healthy adults in India after deliberating deeply on the data from the first and second phase trials.
New Delhi: The Controller General of Indian Medicine (DCGI) has approved the Serum Institute of India (SII) for the second and third phase human trials of the Kovid-19 vaccine developed by Oxford University. Government officials said that this approval was given to SII by Drug Controller General of Drugs, Dr. VG Somani late on Sunday night. Earlier, he had a detailed discussion on the recommendations of the Subject Expert Committee (SEC) of Kovid-19.
Two doses will be given at the difference of four weeks
“The company will have to submit safety-related data to the Central Drugs Standard Control Organization (CDSCO) which is evaluated by the Data Safety Monitoring Board (DSMB) before the Phase III clinical trial,” a senior official said. , ‘According to the outline of this research, every person involved in the research will be given two doses at a difference of four weeks (ie the second dose will be given on the 29th day of the first dose). After this, security and immunity will be assessed at fixed intervals. ‘
Trial is still going on in Britain
Officials said that the expert panel of CDSCO 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. The second and third phase trials of this vaccine developed by Oxford are currently underway in the UK.
Selection of clinical trial sites across the country
Phase III trials are underway in Brazil and Phase I and Phase II trials are underway in South Africa. After considering SII’s application for the second and third phase of testing, the SEC on July 28 asked for some more information in this regard and asked to amend the protocol. SII submitted the revised proposal on Wednesday. The panel has also suggested that sites for clinical trials be selected from across the country.