Activities regarding CVnCoV, CureVac's mRNA-based vaccine candidate against COVID-19

The COVID-19 pandemic poses one of the greatest challenges humankind has faced this century. Developing a safe and effective vaccine to meet this challenge is the best way to save lives and to neutralize the threat posed by this dangerous virus.

At CureVac, we are driven by the strong conviction that our mRNA technology approach could deliver a new class of medicines that would bring significant and affordable benefits to human health. Based on 20 years of expertise, we aim to provide life-saving solutions for people and patients worldwide.

Our prophylactic vaccines represent a novel technology that can enable production of safe, efficacious and cost-effective vaccines not only for COVID-19, but also for a range of infectious diseases.

We are working with health authorities as well as institutions and organizations on the clinical development and production of a COVID-19-vaccine including the Coalition for Epidemic Preparedness Innovations (CEPI) or the German Federal Ministry of Education and Research (BMBF).

From the very start of this pandemic, addressing COVID-19 has been a top priority for CureVac.

Our mRNA technology instructs the human body to activate its own defense mechanism. To do that, we use messenger RNA (mRNA) that encodes the instruction manual cells needed to produce a specific protein. For our COVID-19 vaccine candidate, CVnCoV, we programmed the mRNA to serve as the instruction manual for the production of the spike protein, a key protein for the COVID-19 vaccine development. After receiving the vaccine, the body recognizes the protein as something potentially hostile and activates the immune system to produce antibodies and T cells to fight against it. In this way, we mimic the natural viral infection and activate the body’s defense system.

Use of unmodified, natural mRNA

This allows for improved induction of the viral defenses of the body, including interferon type 1.

Ability to induce immune responses at low mRNA doses

Due to targeted mRNA optimization, our vaccine is able to induce high levels of protein production within the cells.

Induction of an immune response comparable to a natural COVID-19 infection

In the Phase 1 clinical trial, antibody responses in vaccinated participants were found to be comparable to the antibody response detected in recovered COVID-19 patients.

Improved temperature stability for standard cold chain logistics

CVnCoV remains stable and within defined specifications for at least three months when stored at a standard refrigerator temperature of +5°C (+41°F) and for up to 24 hours as ready-to-use vaccine when stored at room temperature.

Please check out our mode of action video for more information on how our technology works.

Coronaviruses are a large family of ribonucleic acid (RNA) viruses causing respiratory diseases in humans, ranging from the common cold to severe diseases such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). In December 2019, an outbreak of respiratory disease caused by a novel coronavirus strain was reported in Wuhan City, Hubei Province, China. The novel coronavirus was named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2), while the disease associated with it was referred to as COVID-19 (coronavirus disease 2019). The virus spread to different parts of China and subsequently to numerous countries worldwide. On January 30, 2020, the World Health Organization (WHO) declared the outbreak under International Health Regulations a public health emergency of international concern, which represents the WHO’s highest level of alarm. On March 12, 2020, the WHO declared the outbreak a pandemic.

For more information about the coronavirus as well as the current situation, please consult the following national and international organizations and public authorities:

Clinical studies

Our pivotal Phase 2b/3 study, initiated in December 2020, assesses a 12µg dose of CVnCoV in two parts: an initial Phase 2b trial which is expected to seamlessly merge into a Phase 3 efficacy trial. Both the Phase 2b and Phase 3 trials are randomized, observer-blind, placebo-controlled studies in adults over 18 years of age or older. While the objective of the Phase 2b study is to further characterize the safety, reactogenicity and immunogenicity of CVnCoV, the Phase 3 assesses CVnCoV efficacy. Subjects will be enrolled at multiple sites and vaccinations follow a two-dose schedule on day 1 and day 29 of either CVnCoV or a placebo. In total, more than 35,000 participants will be included in the Phase 2b/3 HERALD study at multiple sites in Europe and Latin America.


Global study centers

Participate in the Phase 2b/3 clinical trial

For those interested to participate in the Phase 2b/3 clinical trial of our COVID-19 vaccine candidate CVnCoV (HERALD) please send us an email using the email button below:

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The Phase 2a trial, initiated in September 2020, is a dose-confirmation study conducted in Peru and Panama and will enroll a total of about 660 healthy participants in two distinct groups: older adults, ages 60 and above, and younger participants, ages 18 to 60. Different dose levels are being investigated with the goal of confirming safety and evaluating reactogenicity of the vaccine in older adults. In addition, the immune response after administration of CVnCoV will be assessed in a geographical environment with a high incidence of COVID-19 infection and the overall safety database will be expanded.

The aim of the Phase 1 dose-escalation study, which was initiated in June 2020, is to determine the optimal dose as well as to evaluate the safety and immune responses induced by CVnCoV in humans. The Phase 1 trial is taking place at four different study centers in Germany and Belgium and has enrolled more than 250 healthy individuals aged 18 to 60 years. Individuals are vaccinated intramuscularly with placebo or CVnCoV at escalating dose levels of 2, 4, 6, 8, 12, 16 and 20µg.

Positive data from an interim data read-out reported in November 2020 strongly supported the decision to advance a 12µg dose in the pivotal Phase 2b/3 study. The manuscript is currently available on the preprint server medRxiv.

Data from the preclinical studies showed that the vaccine candidate elicited balanced humoral and cellular immune responses, featuring high antibody titers and strong T cell activation. In addition to the positive immune response, the vaccine candidate induced favorable Th1 cytokine levels and showed protection of the lungs in a relevant disease model without any signs of disease enhancement.

The full manuscript of the preclinical data is available on the preprint server bioRxiv.

Milestones of our vaccine development against COVID-19

October 12, 2021

  • CureVac to shift focus of COVID-19 vaccine development to second-generation mRNA technology
    • COVID-19 vaccine efforts to be re-allocated to accelerate the development of second-generation program in collaboration with GSK
    • First-generation vaccine candidate, CVnCoV, to be withdrawn from regulatory review due to potential overlap with approval timelines for a second-generation candidate

June 16, 2021

  • 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
    • Unique pivotal study conducted in 10 countries in fast changing variant environment; 15 COVID-19 variant strains present for efficacy analysis; original strain almost completely absent
    • Statistical success criteria for primary endpoint met on basis of 228 adjudicated cases
    • Vaccine efficacy of 48% against COVID-19 of any severity across all age groups and 15 variants
    • Significant vaccine efficacy demonstrated in participants aged 18 to 60 and across all 15 variants:
      • Efficacy of 53% against disease of any severity
      • Efficacy of 77% against moderate and severe disease
      • Full protection against hospitalization or death
    • CureVac in ongoing dialogue with EMA; continuing regulatory submission

June 16, 2021

  • CureVac Provides Update on Phase 2b/3 Trial of First-Generation COVID-19 Vaccine Candidate, CVnCoV
    • Pivotal study conducted in 10 countries in fast changing environment of at least 29 COVID-19 variant strains; original strain almost completely absent
    • At second interim analysis, statistical success criteria not met. Favorable safety profile confirmed
    • Initial analyses show trend for age and variant dependent efficacy
    • Results communicated to EMA, study progressing to final analysis within the next few weeks

May 28, 2021

  • CureVac’s First-Generation COVID-19 Vaccine Candidate, CVnCoV, Continues Toward Phase 2b/3 Efficacy Readout in Variant-rich Environment Following DSMB Recommendation
    • Study continues to progress according to protocol following first interim analysis at 59 eligible COVID-19 cases
    • Sequencing data to be made available in parallel with efficacy data given variant-rich environment

April 19, 2021

  • CureVac Swiss AG Initiates Rolling Submission Process for mRNA-based COVID-19 Vaccine Candidate, CVnCoV, with Swissmedic
    • Rolling submission to accelerate time to marketing authorization of CVnCoV in Switzerland
    • Review process started with submission of first CVnCoV data package

March 23, 2021

  • CureVac’s COVID-19 Vaccine Candidate, CVnCoV, Demonstrates Protection Against
    SARS-CoV-2 B.1.351 Variant (South African Variant) in Preclinical Challenge Study
    • First challenge infection study in preclinical mouse model to provide evidence for protection against SARS-CoV-2 variant
    • CVnCoV induces robust antibody titers with virus variant neutralizing capacity in immunized animals
    • Full protection of immunized mice from infection and mortality during variant challenge infection

March 22, 2021

  • CureVac Expands CVnCoV Covid-19 Vaccine Candidate Clinical Trial Analyses to Include
    Phase 2b/3 Variant Specification and Efficacy Secondary Endpoint to Phase 2a
    • Impact of new SARS-CoV-2 variants supports specification of select strains for anticipated case-driven interim analysis in pivotal Phase 2b/3 study
    • Progress in Phase 2a trial in older adults in Peru and Panama enables addition of secondary vaccine efficacy endpoint
    • CureVac reaffirms intention to apply for formal market authorization in Q2 2021

March 4, 2021

  • CureVac and Novartis Sign Initial Agreement on Manufacturing of COVID-19 Vaccine Candidate, CVnCoV
    • Novartis plans to start manufacturing of the mRNA and bulk drug product of CureVac’s COVID-19 vaccine candidate, CVnCoV, in Q2 2021
    • Anticipated production of up to 50 million doses by the end of 2021 and up to a further 200 million doses in 2022 at the Novartis’ manufacturing site in Kundl, Austria
    • Further expansion of CureVac´s European manufacturing network expected to increase capacity

February 12, 2021

  • CureVac Initiates Rolling Submission With European Medicines Agency for COVID-19 Vaccine Candidate, CVnCoV
    • Rolling submission with EMA initiated to accelerate time to potential marketing authorization of CVnCoV
    • Submission of CVnCoV pre-clinical data package marks start of the rolling process

February 3, 2021

  • GSK and CureVac to develop next generation mRNA COVID-19 vaccines
    • Companies aim to develop a multi-valent candidate vaccine to address emerging variants for pandemic and endemic use
    • Development to begin immediately targeting vaccine availability in 2022, subject to regulatory approval
    • GSK will also support manufacture of up to 100 million doses of CureVac’s first generation COVID-19 vaccine CVnCoV in 2021

January 11, 2021

  • CureVac’s COVID-19 Vaccine Candidate, CVnCoV, Demonstrated Efficient Protection of Non-Human Primates During SARS-CoV-2 Challenge Infection
    • Data provided further evidence on immunogenicity and protective efficacy of CVnCoV
    • Induction of robust antibody and T cell responses at lower dose than tested in Phase 3 trial
    • Full lung protection of CVnCoV-vaccinated animals during SARS-CoV-2 challenge infection

January 7, 2021

  • CureVac and Bayer join forces on COVID-19 vaccine candidate, CVnCoV
    • Companies enter into a collaboration and services agreement
    • Bayer to support CureVac in numerous areas, including development and supply of CVnCoV
    • CureVac benefits from Bayer´s expertise and established infrastructure
    • Plan to facilitate the supply of several hundred million doses

December 21, 2020

  • CureVac and the University Medical Center Mainz Start Phase 3 Clinical Trial for COVID-19 Vaccine Candidate, CVnCoV, in Healthcare Workers:
    • Study to assess safety and immunogenicity of CVnCoV in high-risk population group
    • Study builds on observational epidemiological study

Mid-December 2020

  • CureVac commences global pivotal Phase 2b/3 trial for its COVID-19 vaccine candidate, CVnCoV:
    • First individual enrolled in Phase 2b/3 study to assess efficacy and safety of CVnCoV at 12 µg
    • Study expected to enroll more than 35,000 participants, focusing on Europe and Latin America

Mid-November 2020

  • CureVac publishes positive stability data for its COVID-19 vaccine candidate, CVnCoV:
    • Data for COVID-19 vaccine candidate support at least three months of stability at +5°C (+41°F)
    • Up to 24 hours of stability established at room temperature
    • Potential to fulfill standard vaccine cold chain requirements, with positive impact on distribution, cost and wastage
  • CureVac establishes European-based network to ramp up manufacturing of its COVID-19 vaccine candidate, CVnCoV:
    • Building an integrated European vaccine manufacturing network with experienced partners
    • Managing supply chain risk by collaborating with several partners for each manufacturing step
    • Increasing capacity to reach up to 300 million doses in 2021 and up to 600 million doses in 2022

Early November 2020

  • CureVac reports positive interim Phase 1 data for its COVID-19 vaccine candidate, CVnCoV:
    • Data show balanced immune response with strong induction of binding and neutralizing antibodies and first indications of T cell activation
    • Quality of immune response comparable to recovered COVID-19 patients, closely mimicking immune response after natural COVID-19 infection
    • CVnCoV generally well tolerated across tested dose range of 2-12µg
    • Data support 12µg dose for pivotal Phase 2b/3 clinical trial
    • On track to initiate pivotal Phase 2b/3 before end of 2020

October 23, 2020

  • CureVac reports positive preclinical data for its COVID-19 vaccine candidate CVnCoV in mice and hamsters. The full manuscript of the preclinical data is available on the pre-print server bioRxiv and was submitted for review and publication in a peer-reviewed journal.

Late September 2020

  • CureVac initiates a Phase 2a clinical trial of its COVID-19 vaccine candidate in Peru and Panama.

Early September 2020

  • CureVac receives a grant of up to 252 million euros from the German Federal Ministry of Education and Research to further its COVID-19 vaccine development and expand its production capacity.

Mid-June 2020

  • CureVac receives regulatory approval from German and Belgian authorities to initiate a Phase 1 clinical trial of its SARS-CoV-2 vaccine candidate.

Mid-May 2020

  • CureVac announces positive preclinical results at a low dose for its lead vaccine candidate against the novel coronavirus (SARS-CoV-2): Coronavirus lead vaccine candidate has generated high level of virus neutralizing titers after two 2-microgram dose vaccinations in preclinical experiments.

March 2020

  • CureVac selects the most suitable vaccine candidates from several constructs based on quality criteria and biological activity.
  • In parallel, the company coordinates the development of its program with the German Paul Ehrlich Institute (PEI) for accelerated clinical development of these vaccine candidates. CureVac is also in discussions with other European health authorities.
  • Two primary study centers have already been identified and are in preparation for clinical trials.
  • The European Commission offers up to €80 million of financial support to CureVac to scale up the development and production of a vaccine against the coronavirus in Europe.

Late January 2020

  • CureVac and CEPI extend their cooperation to develop a vaccine against the coronavirus. The cooperation includes additional initial funding of up to $8.3 million by CEPI for accelerated vaccine development, manufacturing and clinical tests.

Early January 2020

  • CureVac starts its COVID-19 vaccine program when the sequence of the novel coronavirus is published.

Frequently asked questions about our COVID-19 vaccine candidate CVnCoV

What are the requirements for the development and production of a coronavirus vaccine?

The basis is our 20 years of know-how in mRNA technology. Our mRNA-based platform allows us to react quickly and with flexibility when such outbreaks occur. We also expect to have the manufacturing capabilities to produce a significant amount of vaccine doses. Furthermore, clinical tests and the regulatory approval process are important steps on the way to develop a coronavirus vaccine.


What do you mean by vaccine platform technology?

The term “vaccine platform technology” broadly refers to a system that uses the same basic components as architecture, but can be easily adapted for use to develop therapeutics targeting different pathogens by inserting the corresponding sequences.


When could CureVac deliver a coronavirus vaccine?

We started our first clinical trials in June 2020 and have started a pivotal Phase 2b/3 clinical study in December 2020. We expect first data from an interim analysis later in the first quarter of 2021. We expect to start distributing the vaccine once regulatory approval is obtained.


What is different about your vaccine approach in contrast to traditional vaccine development?

Traditional vaccine approaches administer live or inactivated pathogens or use recombinant proteins to generate an immune response. In contrast, mRNA vaccine candidates represent an instruction manual for human cells to produce a specific protein or antigen that induces an immune response. The induced immune response is directed against the encoded protective antigen. To improve delivery of mRNA to cells, the mRNA is encapsulated.


Why are the Phase 1 rabies data relevant for the development of a coronavirus vaccine?

We investigated a rabies vaccine that was produced with the same platform that we are using for the COVID-19 vaccine. We can therefore assume that the immune responses and the safety information we gather via that study could be indicative of what will happen in clinical studies of our COVID-19 vaccine candidate. Notably, we saw that our platform has the potential to stimulate an immune response with a low dose vaccine, which is expected to allow us, after further development, to produce more vaccine doses overall and to be able to vaccinate a larger part of the population.


How many doses of coronavirus vaccine can you produce?

We are currently expanding our production capacity by multiplying our existing plant with experienced partners in Europe. With this, we are expecting to significantly increase our existing manufacturing capacity for the COVID-19 vaccine candidate and will be able to produce material for several hundred million vaccine doses per year.


Key quotes from members of our Executive Board

About CureVac

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 optimized 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, CureVac has built a deep clinical pipeline across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases. In July 2020, CureVac entered in a collaboration with GSK to jointly develop new products in prophylactic vaccines for infectious diseases based on CureVac’s second-generation mRNA technology. In February 2021, this collaboration was extended to the development of second-generation COVID-19 vaccine candidates. CureVac had its initial public offering on the New York Nasdaq in August 2020. It is headquartered in Tübingen, Germany, and employs more than 700 people at its sites in Tübingen, Frankfurt, and Boston, USA. Further information can be found at www.curevac.com.

CureVac-QueriesMedia and Investor Queries

Dr. Sarah Fakih
Vice President Corporate Communications & Investor Relations

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