CureVac COVID-19 Vaccine (CVnCoV, CV2CoV) Description
CureVac's first-generation CVnCoV is an mRNA COVID-19 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.
CV2CoV is CureVac’s first candidate based on the advanced second-generation mRNA backbone currently developed in collaboration with GSK. Presently at a preclinical development stage, the vaccine candidate is a non-chemically modified mRNA encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 betacoronavirus and formulated within Lipid Nanoparticles (LNPs). CV2CoV was engineered with specifically optimized non-coding regions to exhibit improved mRNA translation for increased and extended protein expression than the first-generation mRNA backbone. In addition, preclinical studies in different animal models demonstrate CV2CoV’s ability to induce earlier and stronger immune responses. The first clinical trial of CV2CoV is expected to start in Q4 2021.
CureVac's proprietary technology principle is mRNA as a data carrier to instruct the human body to produce proteins capable of fighting a wide range of diseases. This innovative mRNA technology instructs the human body to activate its 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 coronavirus protein and injected into the human body.
The human 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 body copies the natural viral infection and starts the endogenous defense system, says the company. The mRNA is also encapsulated in a protective shell to prevent the mRNA's degradation and improve vaccine effectiveness, says the U.S. CDC.
CureVac’s RNAoptimizer platform aims to optimize mRNA medicines' properties based on its three core pillars: protein design, mRNA optimization, and mRNA delivery. CureVac's 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 various indications.
CVnCOV (CV07050101) vaccine's INN name zorecimeran; Drugbank Accession Number: DB15844
CureVac COVID-19 Vaccine (CVnCoV, CV2CoV) 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.' In the Phase 1 study, antibody responses in vaccinated participants were found to be comparable to the antibody response detected in recovered COVID-19 patients, said the company.
On December 14, 2020, the company announced a significant 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.
CureVac N.V. announced on February 12, 2021, the initiation of a rolling submission with the European Medicines Agency (EMA) for CVnCoV. “We are confident in the potential of our mRNA technology to contribute to the fight against the global public health emergency that is COVID-19,” commented Dr. Lidia Oostvogels, Vice President Area Head Infectious Diseases at CureVac. “Working together with the EMA to initiate a rolling regulatory process is a critical step in enabling potential access to our vaccine by the many people who still need protection from this deadly disease.”
On March 22, 2021, the company announced its Phase 2a dose-confirmation trial in older adults in Peru and Panama. In addition, CureVac has submitted a protocol amendment to include a secondary objective for vaccine efficacy. The study initially aimed to evaluate the safety, reactogenicity, and immunogenicity of CVnCoV in adults. The expanded trial analysis is expected to collect relevant efficacy data, including the important group of approximately 270 participants above 60, treated with 12µg of CVnCoV. Ulrike Gnad-Vogt, Interim Chief Development Officer of CureVac, stated in a press release.
On May 19, 2021, the UK Government announced the upcoming Cov-Boost trial, further extending current clinical research of booster vaccinations by investigating whether it is safe and effective to boost using a different vaccine from the one initially used for immunization. The initial results of the study are expected in September 2021.
CureVac N.V. announced the results of the second interim analysis of its international pivotal Phase 2b/3 study in approximately 40,000 subjects (the HERALD study) on June 16, 2021. In the unprecedented context of at least 13 variants circulating within the study population subset assessed at this interim analysis, CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. The study is continuing to the final analysis, and the totality of the data will be assessed for the most appropriate regulatory pathway.
“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, CEO of CureVac, on June 30, 2021. “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.”
The CureVac-GSK COVID-19 collaboration announced in February 2021 extends the existing strategic mRNA technology partnership both companies started in July 2020, which focuses on the development of new products based on CureVac’s second-generation mRNA technology for different targets in the field of infectious diseases.
The EMA confirmed on October 12, 2021, it had ended the rolling review of CVnCoV, CureVac AG’s COVID-19 vaccine, after the company informed the Agency that it was withdrawing from the process.
CureVac AG (Nasdaq: CVAC) is a clinical-stage biotechnology company located in Tübingen, Germany, and Boston, Massachusetts. The company is pioneering an entirely new class of drugs based on messenger RNA (mRNA). The basic principle uses this molecule as a data carrier for information, with the help of which the body itself can produce its active substances to combat various diseases. Officially founded in 2000, CureVac is the world’s first company to harness mRNA for medical purposes successfully.
CureVac COVID-19 Vaccine (CVnCoV, CV2CoV) Indication
CureVac's CVnCoV vaccine is indicated to prevent infection from the SARS-CoV-2 coronavirus, which causes COVID-19 disease.
CureVac COVID-19 Vaccine (CVnCoV, CV2CoV) Pediatric Plan
Submitted to the EMA: EMEA-002986-PIP01-21
CureVac COVID-19 Vaccine (CVnCoV, CV2CoV) Dosage
The Phase 1 study evaluated the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels. The company said the data support the decision to advance a 12µg dose in the upcoming pivotal Phase 2b/3 study. 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.
Within the study, CVnCoV and CV2CoV were tested in cynomolgus macaques immunized with a 12 µg dose of the respective candidate on day 0 and day 28.
CureVac COVID-19 Vaccine (CVnCoV, CV2CoV) 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.
CureVac COVID-19 Vaccine (CVnCoV, CV2CoV) FAQs
Updated Frequently asked questions about the CureVac COVID-19 vaccine candidate CVnCoV.
CureVac COVID-19 Vaccine (CVnCoV, CV2CoV) News
October 12, 2021 - CureVac N.V. announced the strategic decision to focus its COVID-19 vaccine development towards the development of second-generation mRNA vaccine candidates in collaboration with GSK and to withdraw its first-generation COVID-19 vaccine candidate, CVnCoV, from the current approval process with the European Medicines Agency. The companies anticipate entering clinical development in the next months, aiming to achieve regulatory approval for market readiness of an improved COVID-19 vaccine in 2022.
September 14, 2021 - CureVac N.V. announced its strategic decision to adjust the long-term footprint of the external European manufacturing network for its mRNA product pipeline. The decision was made in response to the reduced short-term peak demand for vaccines following the first wave of the COVID-19 pandemic vaccination efforts and corresponding changes in the demand of its first-generation COVID-19 vaccine candidate, CVnCoV currently under regulatory review with the European Medicines Agency (EMA). As a result, the existing contracts with WACKER to manufacture the mRNA drug substance of CVnCoV and Celonic for the manufacturing and formulation of the mRNA drug substance of CVnCoV will be terminated. CureVac’s existing agreements with Rentschler Biopharma and Novartis for mRNA production and formulation are unaffected by this adjustment and remain in place. As a result, streamlining of capacity does not limit the availability of clinical trial material for CV2CoV, the second-generation COVID-19 vaccine candidate jointly developed with GSK, expected to enter the clinic in the fourth quarter of 2021.
September 1, 2021 - KoreaBioMed reported GSK and the German biopharmaceutical company CureVac said their second-generation mRNA Covid-19 vaccine demonstrated an improved immune response than the first generation, marking higher neutralizing antibody capacity against the variant strains.
August 16, 2021 - CureVac N.V. and GSK today announced the publication of preclinical data investigating immune responses as well as the protective efficacy of CureVac’s first-generation vaccine candidate, CVnCoV, and second-generation vaccine candidate, CV2CoV, against SARS-CoV-2 challenge in non-human primates. Better activation of innate and adaptive immune responses was achieved with CV2CoV, resulting in faster response onset, higher titers of antibodies, and stronger memory B and T cell activation than the first-generation candidate, CVnCoV. In addition, higher antibody neutralizing capacity was observed with CV2CoV across all selected variants, including the Beta, Delta, and Lambda variants. During a challenge with the original SARS-CoV-2 virus, animals vaccinated with CV2CoV were better protected based on highly effective clearance of the virus in the lungs and nasal passages.
July 21, 2021 - Novartis confirmed it is prepared to deliver CureVac COVID-19 vaccines. Finance officer Harry Kirsch told reporters, "We have started the production as planned. We are planning to deliver 50 million doses this year," reported Reuters.
June 30, 2021 - CureVac N.V. 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 placeboes) against the disease of any severity and across all 15 identified strains; protection against moderate to severe disease was calculated to be 77% (9 vaccines vs. 36 placeboes). In addition, CVnCoV provided 100% protection (vaccine 0 vs. six placeboes) against hospitalization or death in the same age group. The available data did not significantly determine efficacy in participants above 60 years, who represented 9% of the analyzed cases. 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.
June 18, 2021 - The journal Nature published an article: CureVac COVID vaccine let-down spotlights mRNA design challenges.
June 16, 2021 - CurVac N.V. confirmed 134 Covid-19 cases were assessed in this interim analysis. Out of these cases, 124 were sequenced to identify the variant causing the infection. The outcome confirms that only one single case was attributable to the original SARS-CoV-2 coronavirus. “While we were hoping for a stronger interim outcome, we recognize that demonstrating high efficacy in this unprecedented broad diversity of variants is challenging. As we are continuing toward the final analysis with a minimum of 80 additional cases, the overall vaccine efficacy may change,” said Dr. Franz-Werner Haas, CEO of CureVac. “In addition, the variant-rich environment underlines the importance of developing next-generation vaccines as new virus variants continue to emerge.”
June 8, 2021 - Reuters reported the European Medicines Agency does not expect to approve CureVac's COVID-19 vaccine before August 2021.
May 26, 2021 - CureVac N.V. (Nasdaq: CVAC) announced business updates and financial results for the first quarter of 2021. A Phase 3 trial to evaluate the safety, reactogenicity, and immunogenicity of CVnCoV in adults with an elevated risk of severe COVID-19 disease due to comorbidities started in late April with the vaccination of the first participant. The multicenter trial includes people with selected comorbidities such as obesity, chronic cardiovascular disease, chronic kidney disease, chronic obstructive pulmonary disease (COPD), HIV, type 2 diabetes mellitus, and post-renal transplantation. It is currently being conducted in Belgium and is expected to enroll approximately 1,200 participants.
May 4, 2021 - Reuters reported CureVac said U.S. export restrictions on key materials make it impossible to predict its short-term supply ramp-up in Europe.
April 15, 2021 - CureVac N.V. announced business updates and financial results for the fourth quarter and full-year 2020. The company's COVID-19 vaccine candidate, CVnCoV, is in the final stage of clinical development and is believed to be well on track to provide data for conditional approval based on EMA rolling submission. Pivotal Phase 2b/3 in Europe and Latin America fully recruited with over 40,000 participants. Interim analysis for vaccine efficacy is expected in Q2 2021. The Phase 2a trial in Peru and Panama was amended to add a secondary endpoint for vaccine efficacy in the total population, focusing on participants over the age of 60.
April 8, 2021 - CureVac’s CEO Franz-Werner Haas told CNBC Thursday that the vaccine maker was close to finalizing the vaccine’s Phase 3 clinical trial recruitment. He said approval could come not long after, given the urgent need for additional effective coronavirus vaccines and the expedited regulatory approval process.
March 30, 2021 - CureVac N.V. and Celonic Group, a premium biopharmaceutical Contract Development and Manufacturing Organization specializing in developing and producing Advanced Therapy Medicinal Products and mammalian cell line-expressed bio-therapeutics, today announced their partnership for the production of CureVac’s mRNA-based COVID-19 vaccine candidate, CVnCoV. In total, Celonic will be prepared to manufacture more than 100 million doses of CVnCoV. More than 50 million doses are expected to be produced before the end of 2021. Under the terms of the initial agreement, technology and knowledge transfer are already underway.
March 23, 2021- CureVac N.V. announced the publication of preclinical data demonstrating that their COVID-19 vaccine candidate, CVnCoV, protects against challenge infections with the SARS-CoV-2 Variant of Concern B.1.351 (also referred to as the “South African” variant) and a strain of the original SARS-CoV-2 B1 lineage (BavPat1) in a transgenic mouse model. Consistent with available variant studies, the neutralization capacity of robust antibody titers was impacted by the B.1.351 variant compared to the original strain. However, vaccinated animals were fully protected from lethal challenge infections with both strains. The full manuscript of the preclinical data is available at bioRxiv.
March 22, 2021 - CureVac N.V. announced plans to expand and further specify the protocols of its ongoing late-stage clinical trials with CVnCoV, its COVID-19 vaccine candidate. CVnCoV efficacy is currently being evaluated in the pivotal HERALD Phase 2b/3 trial in Europe and Latin America. 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. For its Phase 2a dose-confirmation trial in older adults in Peru and Panama, CureVac has submitted a protocol amendment to include a secondary objective for vaccine efficacy. The study initially aimed to evaluate the safety, reactogenicity, and immunogenicity of CVnCoV in adults. The expanded trial analysis is expected to collect relevant efficacy data, including the important group of approximately 270 participants above 60, treated with 12µg of CVnCoV. This will allow determining the efficacy of the vaccine candidate for select variants. The company has ongoing discussions with the European Medicines Agency to potentially include an amendment related to select virus strains in the study.
March 4, 2021 - CureVac N.V. and Novartis AG announced that they had signed an initial agreement to manufacture CureVac’s COVID-19 vaccine candidate, CVnCoV. Following the final agreement, Novartis plans to manufacture the mRNA and bulk drug product of the CVnCoV vaccine candidate for up to 50 million doses by the end of 2021 and up to a further 200 million doses in 2022. Delivery from the manufacturing site in Kundl, Austria, is expected to start in summer 2021.
February 12, 2021 - The European Medicines Agency (EMA) human medicines committee (CHMP) announced it had started a rolling review of CVnCoV, a COVID‑19 vaccine developed by CureVac AG. The CHMP’s decision to start the rolling review is based on preliminary laboratory studies (non-clinical data) and early clinical studies in adults. These studies suggest that the vaccine triggers the production of antibodies and immune cells that target SARS-CoV-2, the virus that causes COVID‑19.
February 5, 2021 - CureVac N.V. announced that it collaborated with the UK Government to develop and manufacture potential vaccine candidates against SARS-CoV-2 variants. The collaboration aims to mitigate the current pandemic's effects and help prepare against future SARS-CoV-2 outbreaks by working on multiple variant vaccines. Under this agreement, CureVac is expected to supply 50 million doses of variant vaccines to the UK, subject to regulatory approval.
February 3, 2021 - Germany-based CureVac N.V. announced a new €150m collaboration with GSK, building on their existing relationship to develop next-generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine. GSK will also support the manufacture of up to 100 million doses of CureVac’s first-generation COVID-19 vaccine candidate CVnCoV in 2021.
February 2, 2021 - CureVac N.V. announced closing its follow-on public offering for approximately $450 million total gross proceeds.
February 1, 2021 - In a joint press briefing with German Health Minister Jens Spahn, Minister-President of North Rhine-Westphalia, Armin Laschet, and Chief Executive Officer of CureVac N.V., Franz-Werner Haas, Member of the Board of Management, Bayer AG, and President of the Bayer’s Pharmaceuticals Division, Stefan Oelrich, made the following statement: “Following discussions with the German government it has become clear that current manufacturing capacities for vaccines need to be increased, particularly for potential variants of the SARS-CoV-2 virus. Therefore, we are planning to add 160 million doses of CureVac’s vaccine in 2022 to expand further their supply network and overall capacity using the manufacturing network of Bayer. The first commercial product from this expansion may already be available towards the end of 2021. To accomplish this, we will rely on our own product supply network, including our site in Wuppertal, Germany. This includes the need to expand production capacity as well as related manufacturing expertise in Germany."
February 1, 2021 - CureVac N.V. and Rentschler Biopharma SE announced that the companies had initiated the set-up of manufacturing capabilities for CureVac´s COVID-19 vaccine, CVnCoV. From its headquarters in Laupheim, Germany, and its site in Milford, MA, USA, Rentschler Biopharma offers process development and manufacturing of biopharmaceuticals and related consulting activities, including project management and regulatory support.
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.
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.
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.
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.
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 three 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.
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.
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.
August 14, 2020 - CureVac B.V. announced its initial public offering pricing, 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 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, this agreement reportedly does not include CureVac’s existing COVID-19 mRNA vaccine research program, CVnCoV SARS-CoV-2.
July 6, 2020 - European Investment Bank and CureVac sign a €75 million loan agreement for developing and large-scale vaccine production, including CureVac’s vaccine candidate against SARS-CoV-2, CVnCoV.
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).
CVnCoV, CV2CoV Vaccine Clinical Trials
CureVac AG COVID-19 mRNA vaccine candidate tests the immunogenicity, safety, and efficacy in clinical trials.
CV2CoV is a second-generation mRNA vaccine with optimized non-coding regions and enhanced antigen expression. Here we report a head-to-head study of the immunogenicity and protective efficacy of CVnCoV and CV2CoV in nonhuman primates. CV2CoV induced substantially higher binding and neutralizing antibodies, memory B cell responses, and T cell responses as compared with CVnCoV. CV2CoV also induced more potent neutralizing antibody responses against SARS-CoV-2 variants, including B.1.351 (beta), B.1.617.2 (delta), and C.37 (lambda). While CVnCoV provided partial protection against the SARS-CoV-2 challenge, CV2CoV afforded robust protection with markedly lower viral loads in the upper and lower respiratory tract. Antibody responses correlated with protective efficacy. These data demonstrate that optimization of non-coding regions can greatly improve the immunogenicity and protective efficacy of an mRNA SARS-CoV-2 vaccine in nonhuman primates.