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DCGI permits phase I clinical trial of Reliance Life Sciences’ COVID-19 vaccine

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eMediNexus    05 September 2021

Reliance Life Sciences has received permission from the Drugs Controller General of India (DCGI) to conduct phase I clinical trial of an indigenous COVID-19 vaccine under some conditions, stated sources.

The phase I clinical trial will assess the safety, tolerability and immunogenicity of the SARS-CoV-2 recombinant protein subunit vaccine in healthy individuals. The company has been asked to submit the revised clinical trial protocol to evaluate immunogenicity on Day 42, rather than on Day 14, as recommended by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation. The permission to conduct the trial came after the recommendations of the SEC. The trial will be carried out at eight sites across Maharashtra… (ET Healthworld – PTI, September 4, 2021)

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