EMA to initiate rolling review of CureVac COVID vax

Feb. 12, 2021

CureVac 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.

The German-based biopharma's vaccine is currently being investigated in a randomized, observer blind, placebo-controlled phase 2b/3 clinical trial called HERALD at sites in Europe and Latin America. The pivotal study started in December 2020.

The rolling submission to the EMA offers time-optimized route to provide and review all necessary data needed for a potential market authorization during a public health emergency. The agency initiated the rolling review based on promising preliminary trial results.

CureVac went public last August, raising $213 million in an initial public offering to accelerate the development of its COVID-19 vaccine. A month prior to that, GSK announced it would collaborate with CureVac on mRNA vaccine and monoclonal antibody research programs in infectious diseases in detail worth a potential $324M