SII applies to DCGI for phase 2/3 clinical trial of COVID-19 vaccine

The domestic pharma giant has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for the highly infectious disease - COVID-19.

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New Delhi: In a development related to the COVID-19 vaccine, the Serum Institute of India (SII) has applied to the Drugs Controller General of India (DCGI) for conducting the Phase 2/3 human clinical trials for a potential coronavirus vaccine.

The domestic pharma giant has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for the highly infectious disease – COVID-19. According to the official at the Health Ministry, “SII has submitted its application to the DCGI on Friday asking permission to perform the phase 2/3 human clinical trials of the potential vaccine.”

The pharmaceutical company will perform an observer-blind, randomised controlled study to determine the safety and immunogenicity of ‘Covishield’. Last week, Oxford University announced the satisfactory progress with the vaccine, making it one of the leading ones among the dozens of vaccine candidates being developed around the world.

A Lancet medical journal report has stated that a vaccine candidate developed at the University of Oxford has shown encouraging results and it appears to be “safe well-tolerated, and immunogenic”. Trials involving 1,077 people showed the injection led to them making antibodies and white blood cells that can fight coronavirus.

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“Our preliminary findings show that the candidate ChAdOx1 nCoV-19 vaccine given as a single dose was safe and tolerated, despite a higher reactogenicity profile than the control vaccine, MenACWY,” the researchers, led by Pedro M Folegatti and Katie Ewer, wrote in the study.

“No serious adverse reactions to ChAdOx1 nCoV-19 occurred. The majority of adverse events reported were mild or moderate in severity, and all were self-limiting,” the study said. The clinical trials of a potential COVID-19 vaccine on humans began in April. The Oxford vaccine — called ChAdOx1 nCoV-19 — is made from a harmless chimpanzee virus.

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