Curevac -GSK. Starts EMA process in EU12 Feb 2021 11:30
EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV)
European Medicines Agency for COVID-19 Vaccine Candidate, CVnCoV
PUBLISHED
FEB 12, 2021
Rolling submission with EMA initiated to accelerate time to potential marketing authorization of CVnCoV
Submission of CVnCoV pre-clinical data package marks start of the rolling process
TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / February 12, 2021 / 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.
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.
About CVnCoVCureVac began development of its mRNA-based COVID-19 vaccine candidate in January 2020. The vaccine is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus, and formulated within Lipid Nano Particles (LNPs). Phase 1 and 2a clinical trials of CVnCoV began in June and September 2020, respectively. Phase 1 interim data reported in November 2020 showed that CVnCoV was generally well tolerated across all tested doses and induced strong antibody responses in addition to first indication of T cell activation. The quality of immune response was comparable to recovered COVID-19 patients, closely mimicking the immune response after natural COVID-19 infection. The data supported CureVac's decision to advance a 12µg dose into its current pivotal Phase 2b/3 study, the HERALD study, which started in December 2020.