The candidate is currently in Phase 3 trials in Europe and Latin America, and the rolling review with the EMA is its first submission for authorization globally.
Phase 1 interim data, announced in November, 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, according to the company.
“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 review process allows the EMA to start reviewing available data from earlier stage trials, and must be followed by a formal application for Conditional Marketing Authorization.
The EU has a supply agreement with CureVac for 225 million initial doses with the option to extend with a further 180 million doses: which would make it the EU’s largest order totalling 405 million doses.
Three COVID-19 vaccines are currently authorized in the EU: Pfizer, Moderna and AstraZeneca. Novavax and Johnson & Johnson have also started the rolling review process for their vaccines.
CureVac has already set out its ambitions for both first and second generation vaccines; and modifications to adjust them to new variants of the virus. It could make a vaccine designed specifically for the South African strain available in the latter half of this year.