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Biological E applies for DCGI go-ahead to conduct phase-3 trial of Corbevax booster in people vaccinated with Covishield or Covaxin

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eMediNexus    13 October 2021

Biological E has asked the Drugs Controller General of India (DCGI) for permission to conduct phase-3 clinical trial of its vaccine against COVID-19, Corbevax, as a single booster dose for individuals who have received two doses of Covishield or Covaxin.

Phase 2/3 clinical trials of Corbevax, an RBD protein sub-unit vaccine, for adults 18 to 80 years of age, are currently being done and the results will likely be announced this month. 

The company has now submitted an application to seek the drug regulator’s permission for phase-3 clinical study of the vaccine as a booster dose in fully vaccinated people (who have received either Covishield or Covaxin). The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) is expected to discuss the application in its next meeting… (ET Healthworld – PTI, October 12, 2021)

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