COVISHIELD phase 2, 3 trials get DCGI nod

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News: Drugs Controller General of India(DCGI) has given approval to Serum Institute of India(SII) to conduct Phase II+III clinical trials of Oxford University AstraZeneca COVID-19 vaccine(COVISHIELD).

Facts:

  • COVISHIELD: The Oxford vaccine “AZD1222” is being called Covishield in India.
  • The Serum Institute of India(SII) has entered into a manufacturing partnership with biopharma major AstraZeneca to produce this Oxford vaccine.

Additional Facts:

  • DCGI: It is a department of the Central Drugs Standard Control Organization(CDSCO) responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids and vaccines in India.It comes under the Ministry of Health & Family Welfare.
  • Case Fatality Rate(CFR): It is the proportion of deaths from a certain disease compared to the total number of people diagnosed with the disease for a particular period.