CureVac Initiates Rolling Submission With European Medicines Agency for COVID-19 Vaccine Candidate

Rolling submission with EMA initiated to accelerate time to potential marketing authorization of CVnCoV

15-Feb-2021 - Netherlands

CureVac N.V. announced initiation of a rolling submission with the European Medicines Agency (EMA) for CVnCoV, the company’s mRNA-based Covid-19 vaccine candidate, currently in late-stage clinical testing. The process was initiated when the first data package consisting of CVnCoV pre-clinical data was submitted to EMA and passed the technical validation.

“We are confident in the potential of our mRNA technology to contribute to the fight against the global public health emergency that is COVID-19,” said Dr. Lidia Oostvogels, Vice President Area Head Infectious Diseases at CureVac. “Working together with the EMA to initiate a rolling regulatory process is a critical step in enabling potential access to our vaccine by the many people who still need protection from this deadly disease.”

The rolling submission represents a time-optimized route to provide and review all necessary data needed for a potential market authorization during a public health emergency. Over the course of the rolling submission process, EMA will assess CVnCoV’s compliance with standards for vaccine efficacy, safety, and pharmaceutical quality on the basis of individually submitted data packages as a prerequisite for a formal market authorization application.

CVnCoV is currently being investigated in a randomized, observer blind, placebo-controlled Phase 2b/3 clinical trial called HERALD in healthy adults at a dose of 12 µg at sites in Europe and Latin America.

https://www.bionity.com/en/news/1169868/curevac-initiates-rolling-submission-with-european-medicines-agency-for-covid-19-vaccine-candidate.html