Phase 3 or late-stage clinical trial of the Oxford-AstraZeneca coronavirus vaccine is reportedly set to be conducted across 5 sites in India.
Additionally, Oxford and its partner, AstraZeneca, have chosen the Serum Institute of India to manufacture the COVID-19 vaccine, following the anticipated achievement of positive trial results. The data from the Phase 1 and 2 trials has already been published earlier in July.
As per reports, the DBT (Department of Biotechnology) plays a key role in vaccine development, including funding, facilitating regulatory clearances, and providing access to various networks in the country. Moreover, the Serum Institute of India (SSI) based in Pune has sought permission from the DCGI (Drugs Controller General of India) to conduct the Phase 2 and 3 clinical trials. The institute is planning to commence the manufacturing process of the potential vaccine prior to achieving the final results, in order to ensure wide availability with sizable volumes once it receives overall approvals.
Earlier on 20th July, scientists announced high safety and efficacy of the vaccine developed by the Oxford University, as it induced a strong immune response in the Phase 1 trial. The doses of the vaccine were offered to 1,077 healthy subjects between 18-55 years of age, at 5 hospitals in the UK.
According to the results from this 1st phase, the vaccine candidate has induced a strong antibody as well as T-cell immune responses for over 56 days. The T-cells can significantly safeguard people against the virus for several years. Scientists also have discovered that the immune response could be higher after the patient receives the 2nd dose.
The Phase 1 vaccine trial was conducted among a small group of people to examine its safety as well as the stimulation of the immune system. In the 2nd phase, children and the elderly were studied to evaluate its safety and immunogenicity. The vaccine was then administered to a large number of subjects in the 3rd phase.
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