German biopharmaceutical company CureVac has announced the initiation of a rolling review with the European Medicines Agency (EMA) for its mRNA-based COVID-19 vaccine, CVnCoV.
The rolling review is a ‘time-optimised’ pathway which aims to provide and review all data needed for a potential market authorisation during a public health emergency.
CureVac’s CVnCoV is currently being investigated in a randomised, placebo-controlled Phase IIb/III clinical trial – HERALD – in healthy adults at sites in Europe and Latin America.
In Phase I, CVnCoV was found to be generally well-tolerated across all tested doses and induced strong antibody responses as well as the first indication of T cell activation.
In addition, the quality of the immune response seen in CVnCoV-vaccinated participants was comparable to recovered COVID-19 patients.
“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,” she added.
The EMA will assess CureVac’s vaccine candidate compliance with standards for vaccine efficacy, safety and pharmaceutical quality.