Serum Institute of India seeks DCGI permission for phase 2/3 clinical trials of Oxford's COVID 'vaccine' - (The Economic Times via NewsPoints Desk)

  • According to sources, the Serum Institute of India has submitted an application to the Drugs Controller General of India to conduct Phase II/III human trials of a COVID-19 vaccine being developed by AstraZeneca and Oxford University, as reported in The Economic Times.

  • The randomised study will enroll 1600 healthy Indian adults to determine the safety and immunogenicity of the potential vaccine.

  • Initial trial results of the vaccine conducted in the UK have shown it has an acceptable safety profile and homologous boosting increased antibody responses, the source said.

  • The firm plans to begin Phase II/III human trials in India in August.

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