It is the first indigenously developed Receptor Binding Domain Protein sub-unit vaccine against COVID-19.
It means it is made up of a specific part of SARS-CoV-2 – the spike protein on the virus’s surface.
The spike protein allows the virus to enter the cells in the body so that it can replicate and cause disease. However, when this protein alone is given to the body, it is not expected to be harmful as the rest of the virus is absent.
The body is expected to develop an immune response against the injected spike protein. Therefore, when the real virus attempts to infect the body, it will already have an immune response ready that will make it unlikely for the person to fall severely ill.
The vaccine is administered through an intramuscular route with two doses scheduled 28 days apart and is stored at 2 to 8 degrees Celsius.
Emergency Use Authorization (EUA)
It is a regulatory mechanism to allow the use of vaccines and medicines to prevent and/or reduce the impact of life- threatening diseases or conditions as caused by COVID-19.
About Drugs Controller General of India
S/he is the head of department of the Central Drugs Standard Control Organization (CDSO) of the Government of India.
Central Drugs Standard Control Organisation works in close collaboration with the state control administration and assist them in securing uniform enforcement of the Drug Act.
Responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India.
DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India.
Comes under the Ministry of Health & Family Welfare.
