New Delhi: The Department of Biotechnology (DBT) has readied five sites in the country for the final Phase 3 human trials of the COVID-19 vaccine developed by Oxford University researchers and partner firm AstraZeneca.
The Oxford-AstraZeneca has chosen Serum Institute of India, the largest vaccine maker in the world, to manufacture the vaccine once it is ready. Trials results for the first two phases were published earlier in July.
“DBT is closely working with every manufacturer and Phase 3 trial of Serum (institute) is important. This is an essential step because if the vaccine has to be successful and it has to be given to the Indian population, we need to have the data within the country,” DBT Secretary Renu Swarup told news agency PTI on Monday.
“For that, the Phase 3 trial has been proposed. We have already started working on Phase 3 clinical sites and five sites are now ready. Within some more weeks, they should be ready for manufacturers to take them up for clinical trial studies,” Swarup added.
On July 20, scientists had announced that the vaccine developed by Oxford University appeared safe and induced a strong immune response within the body after the first phase of “promising” human trials against the deadly disease.
The Three Phases Of Human Trials
Phase 1: A potential vaccine is given to a small number of people to test safety. It is also given to check if it stimulates the immune system.
Phase 2: The potential vaccine is administered to hundreds of people split into groups such as children and the elderly to see if it acts differently in them. The two phases focus on safety and immunogenicity in humans.
Phase 3: The vaccine candidate is administered to thousands of people.
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