CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), today 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.
https://finance.yahoo.com/news/curevac-initiates-rolling-submission-european-103000670.html
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