Full Press Release Details
CureVac Final Data from Phase 2b/3 Trial of First-Generation COVID-19
Vaccine Candidate, CVnCoV, Demonstrates Protection in Age Group of 18 to 60
T BINGEN, Germany/ BOSTON, USA - June 30, 2021 -
CureVac N.V. (Nasdaq: CVAC), a clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger
ribonucleic acid ("mRNA"), today announced results from the final analysis of its 40,000 subject international pivotal Phase
2b/3 study (the HERALD study) of the first-generation COVID-19 vaccine candidate, CVnCoV. In the unprecedented context of 15 strains circulating
within the study population at the time of final analysis, CVnCoV demonstrated an overall vaccine efficacy of 48% (vaccine 83 vs.
145 placebo) 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% (vaccine 71 vs. 136 placebo) against disease of any severity
and across all 15 identified strains; protection against moderate to severe disease was calculated to be 77% (9 vaccine vs. 36
placebo). In the same age group, CVnCoV provided 100% protection (vaccine 0 vs. 6 placebo) against hospitalization or death. In
participants above 60 years, who represented 9% of the analysed cases, the available data did not enable a statistically significant determination
of efficacy. The data confirm the favorable safety profile of CVnCoV in all age groups. The study will continue to complete follow-up
analyses for trial participants. Available data have been communicated to the European Medicines Agency (EMA).
"In this final analysis, CVnCoV demonstrates a strong public
health value in fully protecting study participants in the age group of 18 to 60 against hospitalization or death and 77% against moderate
and severe disease - an efficacy profile, which we believe will be an important contribution to help manage the COVID-19 pandemic
and the dynamic variant spread," said Dr. Franz-Werner Haas, Chief Executive Officer of CureVac. "In the current context of
an increasingly diverse environment of COVID-19 variants, and with very little residual prevalence of the original strain, we are confident
that the HERALD study offers clinically relevant data regarding the effect of emerging variants on vaccine efficacy."
In total, 228 adjudicated COVID-19 cases (83 vaccine vs. 145
placebo) were assessed in the final analysis. In the age group of 18 to 60, across strains of higher prevalence, strain-dependent vaccine
efficacy ranged from approximately 42% to up to 67%. Out of the 228 cases, 204 were sequenced to identify the variant causing the infection.
Approximately 86% of these cases were caused by Variants of Concern (~51%) and Variants of Interest (~35%), the latter including the Lambda
strain, first identified in Peru (~21%) and B.1.621, first identified in Colombia (~14%). Approximately 3% of cases were attributable
to the original SARS-CoV-2 virus. The remaining 11% were caused by less-explored strains.
The HERALD study, enrolled approximately 40,000 participants in ten
countries in Latin America and Europe. Statistical success criteria for the final analysis were met on the basis of 228 cases, occurring
at least two weeks after administration of the second dose, including 68 additional adjudicated cases compared to the pre-defined 160
cases as per trial protocol. To identify COVID-19 strains within the trial, sequencing of virus variants has been performed on 588 COVID-19
cases, of which 204 fulfilled adjudication criteria and were included in the efficacy analysis.
Beyond CVnCoV, the company is developing second-generation COVID-19
vaccine candidates in partnership with GSK. These candidates are based on new mRNA backbones and include potential variants in multivalent
vaccine formats as well as combination vaccines for potential protection against multiple infectious diseases in single injection. Preclinical
data from the first vaccine candidate, CV2CoV, has recently been published in Nature Communications.
CureVac and GSK expect to progress the second-generation vaccine candidate into clinical testing in the third quarter of 2021, with the
goal of introducing the vaccine in 2022, subject to regulatory approval.
CureVac will host an investors and analyst webcast and conference
call on Thursday, July 1, 2021 at 2:00 p.m. CET / 8:00 a.m. EDT. The live conference call dial-in details and webcast link can be accessed
via the Investor Relations section of the CureVac website at https://www.curevac.com/en/newsroom/events/
Corresponding presentation slides will be posted shortly before the start of the webcast. A replay will be made available
on this website after the event.
CureVac will also host a virtual German speaking press conference
on Thursday, July 1, 2021 at 10:00 a.m. CET. The live conference call dial-in details and webcast link can be accessed via the Investor
Relations section of the CureVac website at https://www.curevac.com/en/newsroom/events/ Corresponding
presentation slides will be posted shortly before the start of the webcast.
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 strong antibody responses in addition to first indication
of 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 12 g 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 is a global biopharmaceutical company in the field of messenger
RNA (mRNA) technology, with more than 20 years of expertise in developing and optimizing the versatile biological molecule for medical
purposes. The principle of CureVac's proprietary technology is the use of non-chemically modified mRNA as a data carrier to instruct
the human body to produce its own proteins capable of fighting a broad range of diseases. Based on its proprietary technology, the Company
has built a deep clinical pipeline across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment
of rare diseases. CureVac had its initial public offering on the New York Nasdaq in August 2020. It is headquartered in T bingen,
Germany, and employs more than 700 people at its sites in T bingen, Frankfurt, and Boston, USA. Further information can be found
CureVac Investor Relations Contact
Dr. Sarah Fakih, Vice President Corporate Communications and Investor
CureVac, T bingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
CureVac Media Contact
Anna Kamilli, Manager Communications
CureVac, T bingen, Germany
T: +49 7071 9883-1684
Bettina J dicke-Braas, Manager Communications
CureVac, T bingen, Germany
T: 49 7071 9883-1087
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