Europe Reviews Another German COVID-19 Vaccine

Germany-based CureVac N.V. announced the 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.

On February 12, 2021, the EMA stated it will assess CVnCoV's compliance 'with the usual standards for effectiveness, safety, and pharmaceutical quality. While EMA cannot predict the overall timelines, it should take less time than usual to evaluate an eventual application because of the work done during the rolling review.'

The CVnCoV vaccine candidate 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.

“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, in a press release. “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 EMA initially authorized BioNTech SE's mRNA Vaccine known as Comirnaty during December 2020.