DGAP-News: CureVac's CVnCoV Phase 2b/3 Study Data Published in Preprints with The Lancet
As previously announced, the data were based on 228 adjudicated COVID-19 cases, occurring at least two weeks after administration of the second dose.
DGAP-News: CureVac / Key word(s): Study CureVac's CVnCoV Phase 2b/3 Study Data Published in Preprints with The Lancet 31.08.2021 / 13:00 The issuer is solely responsible for the content of this announcement. CureVac's CVnCoV Phase 2b/3 Study Data Published in Preprints with The Lancet TÜBINGEN, Germany/ BOSTON, USA - August 31, 2021 - CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced the publication of its pivotal Phase 2b/3 (HERALD study) primary data of CVnCoV, its first-generation COVID-19 vaccine candidate, in Preprints with The Lancet. The HERALD study enrolled approximately 40,000 participants in ten countries across Latin America and Europe, in the predefined age groups 18 to 60 and above 60. For the final analysis, COVID-19 cases were caused by 15 different virus variants. As previously announced, the data were based on 228 adjudicated COVID-19 cases, occurring at least two weeks after administration of the second dose. CVnCoV demonstrated overall vaccine efficacy of 48% against COVID-19 disease of any severity, including single non-respiratory mild symptoms. Significant protection was demonstrated among participants in the age group of 18 to 60, with an efficacy of 53% against disease of any severity and across all 15 identified strains; protection against moderate to severe disease for this age group was calculated to be 77%. In the same age group, CVnCoV provided 100% protection against hospitalization or death. CureVac is in close interaction with the European Medicines Agency (EMA) and will continue to seek regulatory approval for CVnCoV to leverage the vaccine's strengths in the large segment of the population where it provides demonstrated protection. Submission of comprehensive clinical data packages to the EMA is ongoing as part of the rolling submission initiated in February 2021 and is expected to be finalized toward the end of the third quarter of 2021. As the lack of effective vaccines is still a challenge in many parts of the world, CVnCoV has the potential to contribute to the fight against COVID-19 and the increasingly complex variant context, which warrants a vaccine that has been clinically tested in a variant-dominated environment. About CVnCoV CureVac began development of mRNA-based COVID-19 vaccine candidates in January 2020. The vaccine candidate chosen for first clinical development, CVnCoV, is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus, and formulated within Lipid Nanoparticles (LNPs). Phase 1 and 2a clinical trials of CVnCoV began in June and September 2020, respectively. Phase 1 interim data reported in November 2020 showed that CVnCoV was generally well tolerated across all tested doses and induced robust antibody responses in addition to T cell activation. The quality of the immune response was comparable to recovered COVID-19 patients, closely mimicking the immune response after natural COVID-19 infection. A pivotal Phase 2b/3, the HERALD study, with a 12µg dose of CVnCoV was initiated in December 2020. In February 2021, CureVac initiated a rolling submission with the European Medicines Agency (EMA) for CVnCoV.
CureVac Investor Relations Contact CureVac Media Contact Forward-Looking Statements
31.08.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. |
Language: | English |
Company: | CureVac |
Friedrich-Miescher-Str. 15 | |
72076 Tübingen | |
Germany | |
EQS News ID: | 1230099 |
End of News | DGAP News Service |
|
1230099 31.08.2021