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EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV)

February 18, 2021 / Shivaji Dound

The European Medicines Agency (EMA's) Committee for Human Medicinal Products (CHMP) has begun a moving audit of CureVac AG's COVID-19 antibodies, CVnCoV.

The survey was started on the grounds that starter research facility contemplates and early clinical preliminary outcomes recommend the immunization triggers the creation of antibodies and insusceptible cells that target SARS-CoV-2, the infection that causes COVID‑19.

The survey will successively audit information as it opens up, beginning with the preclinical and beginning stage proof presently submitted. As opposed to a customary advertising authorisation application, in which all information on a medication's or immunization's viability, security and quality and all necessary archives should be prepared toward the beginning of the assessment.

Continuous preliminaries are proceeding to assess the immunization's wellbeing, immunogenicity and viability against COVID-19. EMA will assess information from these and other clinical preliminaries as they become accessible.

The moving audit will proceed until the CHMP concludes that adequate information is accessible for a conventional showcasing authorisation application. Because of the work attempted in the moving audit, it should take less time than typical to assess such an application.

EMA will survey the immunization's consistence with the typical norms for adequacy, wellbeing and drug quality inside the moving audit measure.

About CVnCoV
CVnCoV is an mRNA vaccine which encodes the SARS-CoV-2 Spike (S) protein. The mRNA sequence is formulated in minute lipid particles to prevent it from being broken down too quickly.
When a person receives the vaccine, some of their cells will use the mRNA molecules to temporarily produce the S protein. This activates the person’s immune system, priming it to respond more quickly to a subsequent SARS-CoV-2 infection.