CVnCoV Vaccine Description
CureVac's CVnCoV is an mRNA vaccine candidate that utilizes nucleotides without chemical modifications in the mRNA. The mRNA encodes the full-length spike protein of SARS-CoV-2 coronavirus and is formulated with lipid nanoparticles.
CureVac's proprietary technology principle is mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a wide range of diseases.
This innovative mRNA technology instructs the human body to activate its own defense mechanism. It uses the natural messenger substance mRNA that contains the construction manual needed to produce proteins. This messenger substance is programmed with information about one protein of the coronavirus and inject into the human body.
The body recognizes the protein produced by our cells as something unknown and activates its immune cells to produce antibodies and T-cells against it. This way, the natural viral infection and activate the endogenous defense system, says the company.
Traditional vaccine approaches administer live or inactivated pathogens or use recombinant protein to generate an immune response. However, the mRNA vaccine candidate delivers mRNA into a cell of the vaccine, instructing it to produce a specific protein or antigen (i.e., a foreign substance that induces an immune response). The induced immune response is directed against the encoded protective antigen. To prevent the mRNA's degradation and improve vaccine effectiveness, the mRNA is also encapsulated in a protective shell, says the U.S. CDC.
CureVac’s RNAoptimizer platform aims to optimize mRNA medicines' properties based on its 3 core pillars: protein design, mRNA optimization, and mRNA delivery.
The technology can also be adapted to avoid immune activation for protein therapy and antibodies, thereby providing potential new therapeutic modalities for patients suffering from a vast range of diseases. All the different parts of a CureVac-customized mRNA molecule create a packaged product specially optimized for different indications.
“We are very encouraged by the interim Phase 1 data. It represents a critical milestone in our COVID-19 vaccine program and strongly supports the advancement of our vaccine candidate,” said Dr. Franz-Werner Haas, CEO of CureVac, in a press statement issued on November 2, 2020. “Following further data readouts and discussion with regulatory authorities, we remain fully committed and on track to initiate a pivotal Phase 2b/3 trial before the end of 2020.”
CVnCoV Vaccine History
This phase 1 study analysis was published on November 9, 2020, which concluded by saying, 'Based on these results, the 12 μg dose is selected for further clinical investigation, including a phase 2b/3 study that will investigate the efficacy, safety, and immunogenicity of the candidate vaccine CVnCoV.'
On December 14, 2020, the company announced a large Phase 2b/3 clinical trial of its COVID-19 vaccine candidate. “The goal is to have interim results in the first quarter of 2021, which will form the basis - provided the data is good, and we are hopeful - for filing a so-called rolling submission with regulators,” Chief Executive Franz-Werner Haas told Reuters.
The company's website says, 'based on the low dosing of our rabies vaccine in humans, and we have the capacity to produce up to several hundred million doses of bulk RNA material per annum with our current GMP III facility. Beyond that, we are planning to put a new GMP IV suite into operation within two years, where we can produce 1 billion or more vaccine doses per year.'
“We are delighted to join forces with Bayer, whose expertise and infrastructure will help us make our vaccine candidate CVnCoV even more rapidly available to as many people as possible,” said Dr. Franz-Werner Haas, Chief Executive Officer of CureVac, on January 7, 2021. “Building on the positive data we have seen so far with CVnCoV, we now also have another strong partner on our side to get the vaccine to the people who need it following the receipt of the requisite regulatory approvals.”
CureVac AG is a clinical-stage biotechnology company located in Tübingen, Germany, and in Boston, Massachusetts.
CVnCoV Vaccine Indication
CVnCoV is indicated to prevent infection from the SARS-CoV-2 coronavirus, which causes COVID-19 disease.
No pediatric, oncology or pregnancy-related vaccine efficacy has been published.
CVnCoV Vaccine Dosage
The Phase 1 study evaluated the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels. The data support the decision to advance a 12µg dose in the upcoming pivotal Phase 2b/3 study, said the company.
The HERALD trial will start with an initial Phase 2b part, which is expected to merge into a Phase 3 efficacy trial seamlessly.
The 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 merge into a Phase 3 efficacy trial seamlessly. 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 Phase 2b study's objective is to characterize the safety further, reactogenicity, and immunogenicity of CVnCoV, Phase 3 assesses CVnCoV efficacy.
Subjects will be enrolled at multiple sites, and vaccinations follow a two-dose schedule on days 1 and 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.
CVnCoV Vaccine Storage Requirements
The storage of sample material and analytical testing of the CVnCoV vaccine were performed under standard conditions defined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The stability of the liquid drug product of CVnCoV was tested at the anticipated storage concentration and stored at +5°C (+41°F) as well as below -60°C (-76°F).
CVnCoV fulfilled all set release specifications at both temperatures after three months. The stability study is ongoing to evaluate the potential for a longer commercial product shelf-life.
CVnCoV Vaccine FAQs
Frequently asked questions about the COVID-19 vaccine candidate CVnCoV.
CVnCoV Vaccine News
January 11, 2021 - CureVac NV announced that preclinical data from its COVID-19 vaccine candidate CVnCoV had confirmed the induction of a pronounced immune response in non-human primates. "These data support the protective function of our COVID-19 vaccine candidate CVnCoV and complement our recently published preclinical results," said Dr. Mariola Fotin-Mleczek, Chief Technology Officer of CureVac. “The complete protection of the lungs of vaccinated animals shows the potential of CVnCoV to protect humans from the devastating effects of the virus. We are very encouraged that CVnCoV works at a low dose. The amount is even lower than the dose we are currently testing within the pivotal clinical study. "
January 7, 2021 - Bayer announced signing a collaboration and services agreement with CureVac N.V. Under the terms of the agreement, Bayer will support the further development, supply, and key territory operations of CureVa´s COVID-19 vaccine candidate CVnCoV. To this end, Bayer will contribute its expertise and established infrastructure in clinical operations, regulatory affairs, pharmacovigilance, medical information, supply chain performance, and support in selected countries.
December 21, 2020 - CureVac N.V. announced that the first participant in a clinical Phase 3 study with its COVID-19 vaccine, CVnCoV, in healthcare workers at the University Medical Center Mainz will be vaccinated on December 22, 2020. The study aims to evaluate the safety and immunogenicity of CVnCoV administered as a two-dose schedule of 12 µg. The trial follows an epidemiological, non-interventional study conducted with healthcare workers from the University Hospital in Mainz.
December 14, 2020 - The company said more than 35,000 people would take part in Europe and South America tests. "The first volunteer has been recruited," CureVac said in a statement. Dr. Franz-Werner Haas, CEO of CureVac, added: “The clinical safety and immunogenicity data achieved to date look promising, and we are hopeful that this trial will continue to demonstrate the impact of mRNA technology and our vaccine to prevent COVID-19 and to help defeat this pandemic.”
December 9, 2020 - CureVac N.V. and Fareva today announced an agreement regarding the fill & finish manufacturing of CureVac´s COVID-19 vaccine candidate, CVnCoV, at Fareva’s Pau and Val-de-Reuil-sites in France. “We are proud to contribute to the fill & finish manufacturing of this innovative vaccine candidate from CureVac. This agreement confirms Fareva’s strategy of investing significantly in the areas of sterile manufacturing, enlarging our technology offering,” said Alexandre Bastit, Vice President of EMEA Pharma Sales at Fareva.
November 23, 2020 - Germany based CureVac N.V., and Wacker Chemie AG announced that they had signed a contract to manufacture CureVac’s COVID-19 vaccine candidate CVnCoV. Under the terms of the initial agreement, WACKER will ramp up GMP (Good Manufacturing Practice) production of the mRNA drug substance for CVnCoV at its biotech site in Amsterdam in the first half of 2021. It is planned to produce more than 100 million doses of the CureVac vaccine per year at WACKER’s Amsterdam site.
November 16, 2020 - CureVac N.V. reports the European Commission announced that tomorrow it would authorize an Advanced Purchase Agreement for CureVac´s mRNA-based COVID-19 vaccine candidate, CVnCoV. Once finalized, the contract with the European Commission will provide member states of the European Union with up to 225 million doses of the vaccine and includes the option for an additional purchase of 180 million doses.
November 12, 2020 - CureVac N.V. announced that its mRNA-based COVID-19 vaccine candidate, CVnCoV, remained stable and within defined specifications for at least 3-months when stored at a standard refrigerator temperature of +5°C (+41°F) and up to 24-hours as a ready-to-use vaccine when stored at room temperature. CVnCoV fulfilled all set release specifications at both temperatures after three months. The stability study is ongoing to evaluate the potential for a longer commercial product shelf-life.
November 10, 2020 - CureVac N.V. announced detailed interim Phase 1 data, following positive topline data on November 2, 2020.
November 2, 2020 - Germany based CureVac N.V. announced positive interim data from its ongoing Phase 1 dose-escalation study evaluating the safety, reactogenicity, and immunogenicity of CVnCoV investigational SARS-CoV-2 vaccine candidate. The vaccine candidate was generally well tolerated across all tested doses (2-12µg) and induced strong binding and neutralizing antibody responses in addition to the first indication of T cell activation.
October 23, 2020 - CureVac announced data from preclinical studies of CVnCoV in mice and hamsters. The vaccine candidate elicited balanced humoral and cellular immune responses, featuring high antibody titers and excellent T cell activation. Besides, the vaccine candidate induced favorable Th1 cytokine levels. Furthermore, CVnCoV efficiently protected hamsters against a live SARS-CoV-2 viral challenge without evidence of vaccine-induced disease enhancement.
September 29, 2020 - CureVac announced today that the first participant had been dosed in a Phase 2a clinical trial of its COVID-19 vaccine candidate, CVnCoV. The dose-confirmation study, entitled CV-NCOV-002, is being conducted in Peru and Panama. It will enroll 690 healthy participants in two distinct groups: older adults ages 61 and above and younger participants 18 to 60 years old. The participants will receive two vaccinations at intervals of 28 days. Different dose levels will be investigated, starting at 6 µg, to confirm safety and evaluate the vaccine's reactogenicity in older adults.
September 4, 2020 - CureVac N.V. announced it had received notification from the German Federal Ministry of Education and Research (BMBF) that CureVac is expected to receive up to 252 million euros to support the development of its COVID-19 vaccine candidate. The grant is expected to be used to expand vaccine production rapidly.
August 20, 2020 - CureVac concluded exploratory talks outlining an Advanced Purchase Agreement for our potential mRNA-based COVID-19 vaccine. The envisaged contract with the European Commission is intended to provide all EU Member States with up to 225 million doses and an option for an additional purchase of 180 million doses, to be supplied once our mRNA-based vaccine has proven to be safe and effective against COVID-19.
August 14, 2020 - CureVac B.V. announced the pricing of its initial public offering, which produced total gross proceeds of approximately $213.3 million.
August 4, 2020 - CureVac announced that Dr. Franz-Werner Haas had been appointed Chief Executive Officer.
July 24, 2020 - CureVac B.V. filed for an initial public offering in the USA, with plans to list Nasdaq under the ticker "NVAC."
July 21, 2020 - CureVac AG announced closing its latest private financing round, raising a total of USD 640 million.
July 20, 2020 - GSK and CureVac announced a strategic collaboration agreement for the research, development, manufacturing, and commercialization of up to 5 mRNA-based vaccines and monoclonal antibodies (mAbs) targeting infectious disease pathogens. The collaboration complements GSK’s existing mRNA capabilities with CureVac’s integrated mRNA platform. However, CureVac’s existing COVID-19 mRNA vaccine research program, CVnCoV SARS-CoV-2, is reportedly not included in this agreement.
July 6, 2020 - European Investment Bank and CureVac sign a €75 million loan agreement for the development and large-scale production of vaccines, including CureVac’s vaccine candidate against SARS-CoV-2, CVnCoV. The InnovFin Infectious Diseases Finance Facility (IDFF) is a financial product dedicated to supporting the fight against infectious diseases. The joint European Commission and EIB Group initiative fall under Horizon2020, the 2014-2020 EU research and innovation program.
July 2, 2020 - Elon Musk Tweeted Tesla Inc. is building mobile molecule printers to help make the potential COVID-19 vaccine named CVnCoV developed by CureVac in Germany.
June 17, 2020 - CureVac to Initiate Phase 1 Clinical Trial of its SARS-CoV-2 Vaccine Candidate.
June 15, 2020 - The German Federal Minister for Economic Affairs and Energy, Peter Altmaier, and Dietmar Hopp announced that the Federal Republic of Germany would invest 300 million Euros in the biopharmaceutical company CureVac AG, a pioneer in the preclinical and clinical development of mRNA-based drugs.
May 14, 2020 - CureVac AG, a clinical-stage biopharmaceutical company developing a new class of transformative medicines based on optimized mRNA, announced positive pre-clinical results at a low dose for its lead vaccine candidate against the novel Coronavirus (SARS-CoV-2). The data showed a fast induction of a balanced immune response with high levels of virus-neutralizing titers (VNTs) and T-cell responses. VNTs are a major criterion supporting that the vaccine candidate can induce a strong immunologic response to neutralize SARS-CoV-2.
CVnCoV Vaccine Clinical Trials
Clinical Trial NCT04674189: COVID-19: A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Clinical Study Evaluating the Safety and Immunogenicity of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adult Health Care Workers in Mainz (Germany)
This study aims to evaluate the safety (in all participants) and reactogenicity (in a subset of participants) of CVnCoV administered as a 2-dose schedule to 2,520 adult participants 18 years of age or older. The study also aims to assess antibody responses to the receptor-binding domain (RBD) of spike (S) protein of SARS-CoV-2 after 1 and 2 doses of CVnCoV in adults 18 years or older included in a subset of participants.
Clinical Trial NCT04652102: COVID-19: A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older--Last Update Posted January 11, 2021.
This study aims to enroll 36,500 participants to:
Demonstrate the efficacy of a 2-dose schedule of CVnCoV to prevent first episodes of virologically-confirmed cases of COVID-19 of any severity in SARS-CoV-2 naïve participants.
Demonstrate the efficacy of a 2-dose schedule of CVnCoV to prevent the first episode of virologically-confirmed moderate to severe cases of COVID-19 in SARS-CoV-2 naïve participants.
Clinical Trial NCT04515147: A Phase 2 Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Vaccine CVnCoV in 674 Healthy Adults - Last Update Posted: January 12, 2021.
A Phase 2a, Partially Observer-blind, Multicenter, Controlled, Dose-confirmation Clinical Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults >60 Years of Age and 18 to 60 Years of Age.
The study design was coordinated with and approved by Peru and Panama's health authorities and ethics committees and is based on preliminary safety and immunogenicity data from CureVac’s ongoing Phase 1 CV-NCOV-001 study in healthy adult volunteers in Germany and Belgium.
Clinical Trial NCT04449276: A Phase 1 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Vaccine CVnCoV in 280 Healthy Adults - Last updated on December 22, 2020
The Phase 1 study has enrolled more than 250 healthy individuals aged 18 to 60 years. Individuals were vaccinated intramuscularly with CVnCoV at escalating dose levels of 2, 4, 6, 8, and 12µg on days 1 and 29. Per the dose level, the trial included up to 10 participants who had previously tested positive for a COVID-19 infection (seropositive) to evaluate further the safety and immunogenicity of CVnCoV in this sub-population.
A Partially Blind, Placebo-controlled, Dose-escalation, First-in-human, Clinical Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity After 1 and 2 Doses of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV Administered Intramuscularly in Healthy Adults.
In the initial part of the dose-escalation, participants will be enrolled in sentinel groups in an open manner. In the second part, participants will be enrolled in placebo-controlled groups in an observer-blind manner.