CureVac on track to apply for COVID-19 vaccine market authorization in Q2 2021
The German company’s mRNA vaccine candidate, CVnCoV, is currently being evaluated in the HERALD Phase 2b/3 trial in Europe and Latin America. These trials will now pinpoint efficacy against certain virus variants (UK, South Africa and Brazil strains) as well as expanding to older adults.
“Rapid distribution of new virus variants in the countries where the study is conducted supports the need for further analysis specification for the anticipated case-driven interim analysis,” says the company. “This will allow to determine efficacy of the vaccine candidate for select variants. The company has ongoing discussions with the European Medicines Agency (EMA) to potentially include an amendment related to select virus strains in the study.
“For our Phase 2a dose-confirmation trial in older adults in Peru and Panama, we have submitted a protocol amendment to include a secondary objective for vaccine efficacy. The study initially aimed to evaluate safety, reactogenicity and immunogenicity of CVnCoV in adults. Expanded trial analysis is expected to allow for collection of relevant efficacy data which includes the important group of approximately 270 participants above the age of 60, treated with 12µg of CVnCoV.”
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.
Regulatory requests and manufacture scale-up
CureVac expects data readouts from both HERALD clinical trials in the second quarter of this year; with formal marketing authorization to follow shortly after. The vaccine is already under rolling review with the European Medicines Agency in Europe (which must be followed with a formal application for conditional marketing authorisation).
CureVac has already entered into several strategic partnerships to support commercialization, manufacturing scale-up, and further development of CVnCoV.
The company signed a collaboration agreement with Bayer in January to help scale up manufacture of the vaccine. In February, CureVac and GSK agreed to jointly develop next-generation multi-valent mRNA vaccines against COVID-19. The development of new vaccine candidates is strengthened by a partnership with the UK Government and its Vaccines Taskforce, which CureVac also entered in February.