DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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CVnCoV
cas 2541470-90-8
An optimized, non-chemical modified mRNA encoding the prefusion-stabilized full-length spike protein of SARS-CoV-2 virus (Curevac)
zorecimeran, CureVac COVID-19 vaccine
CureVac/Bayer
GSK
NCT04674189 NCT04449276 NCT04515147 NCT04652102
EudraCT-2020-004066-19
mRNA-based vaccine
PHASE 3
| CVnCoV | Humoral and cellular responses | CD4+ T-cells, CD8+ T-cells | N/A | N/A | Rhesus macaque | [124] |
124. Rauch S, Gooch K, Hall Y, Salguero FJ, Dennis MJ, Gleeson FV. et al. mRNA vaccine CVnCoV protects non-human primates from SARS-CoV-2 challenge infection. bioRxiv. 2020. 2020 12.23.424138
The CureVac COVID-19 vaccine is a COVID-19 vaccine candidate developed by CureVac N.V. and the Coalition for Epidemic Preparedness Innovations (CEPI).[1] The vaccine showed inadequate results in its Phase III trials with only 47% efficacy.[2] The European Medicines Agency stated that: “(…) medicine developers should design studies to demonstrate a rate of efficacy of at least 50%.”[3].
The CVnCov Vaccine (or CV07050101) is in development by CureVac AG. The vaccine uses mRNA technology to create a protein associated with SARS-CoV2, and upon administration and replication, to initiate subsequent immune responses in the body. As of June 2020, the company received regulatory approval from German and Belgian Authorities to commence Phase 1 clinical trials of this vaccine (NCT04449276).
Efficacy
On 16 June 2021,[4] CureVac said its vaccine showed 47% efficacy from its Phase III trial. This was based on interim analysis of 134 COVID cases in its Phase III study conducted in Europe and Latin America. The final analysis for the trials requires a minimum of 80 additional cases.[2]
Pharmacology
CVnCoV is an mRNA vaccine that encodes the full-length, pre-fusion stabilized coronavirus spike protein, and activates the immune system against it.[5][6][7] CVnCoV technology does not interact with the human genome.[6] CVnCoV uses unmodified RNA,[8] unlike the Pfizer–BioNTech COVID-19 vaccine and Moderna COVID-19 vaccine, which both use nucleoside-modified RNA.[9]
Manufacturing
Manufacturing of mRNA vaccines can be performed rapidly in high volume,[10] including use of portable, automated printers (“RNA microfactories”) for which CureVac has a joint development partnership with Tesla.[11]
mRNA vaccines require stringent cold chain refrigeration throughout manufacturing, distribution and storage.[12][13] The CureVac technology for CVnCoV uses a non-modified, more natural mRNA less affected by hydrolysis, enabling storage at 5 °C (41 °F) and relatively simplified cold chain requirements that facilitate up to three months of storage and distribution to world regions that do not have specialized ultracold equipment.[6][10]
CureVac has a European-based network to accelerate manufacturing of CVnCoV, if proven safe and effective, for production of up to 300 million doses in 2021 and 600 million doses in 2022.[10][14] An estimated 405 million doses will be provided to EU states.[14]
Clinical trials
In November 2020, CureVac reported results of a Phase I-II clinical trial that CVnCoV (active ingredient zorecimeran) was well-tolerated, safe, and produced a robust immune response.[15][16]
In December 2020, CureVac began a Phase III clinical trial of CVnCoV with 36,500 participants.[17][18] Bayer will provide clinical trial support and international logistics for the Phase III trial, and may be involved in eventual manufacturing should the vaccine prove to be safe and effective.[19][20] In February 2021, the EU’s CHMP started a rolling review of CVnCoV.[21][22] In April 2021, the same procedure began in Switzerland.[23]
Brand names
The manufacturer currently markets the vaccine under the name CVnCoV.[24] Zorecimeran is the proposed international nonproprietary name (pINN).[25]
References
- ^ “CureVac focuses on the development of mRNA-based coronavirus vaccine to protect people worldwide”. CureVac(Press release). 15 March 2020. Retrieved 17 February 2021.
- ^ Jump up to:a b Burger, Ludwig (16 June 2021). “CureVac fails in pivotal COVID-19 vaccine trial with 47% efficacy”. Reuters. Retrieved 17 June 2021.
- ^ https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/covid-19-vaccines-studies-approval#what-is-the-level-of-efficacy-that-can-be-accepted-for-approval?-section
- ^ “CureVac Provides Update on Phase 2b/3 Trial of First-Generation COVID-19 Vaccine Candidate, CVnCoV”. 16 June 2021.
- ^ https://www.curevac.com/wp-content/uploads/2020/10/20201023-CureVac-Manuscript-draft-preclinical-data.pdf
- ^ Jump up to:a b c Schlake T, Thess A, Fotin-Mleczek M, Kallen KJ (November 2012). “Developing mRNA-vaccine technologies”. RNA Biology. 9(11): 1319–30. doi:10.4161/rna.22269. PMC 3597572. PMID 23064118.
- ^ “Understanding mRNA COVID-19 vaccines”. US Centers for Disease Control and Prevention. 18 December 2020. Retrieved 5 January 2021.
- ^ “COVID-19”. CureVac. Retrieved 21 December 2020.
- ^ Dolgin, Elie (25 November 2020). “COVID-19 vaccines poised for launch, but impact on pandemic unclear”. Nature Biotechnology: d41587–020–00022-y. doi:10.1038/d41587-020-00022-y. PMID 33239758. S2CID 227176634.
- ^ Jump up to:a b c Nawrat A (3 December 2020). “Q&A with CureVac: resolving the ultra-cold chain logistics of Covid-19 mRNA vaccines”. Pharmaceutical Technology. Retrieved 5 January 2021.
- ^ “Tesla to make molecule printers for German COVID-19 vaccine developer CureVac”. Reuters. 2 July 2020. Retrieved 19 December 2020.
- ^ Kartoglu U, Milstien J (July 2014). “Tools and approaches to ensure quality of vaccines throughout the cold chain”. Expert Review of Vaccines. 13 (7): 843–54. doi:10.1586/14760584.2014.923761. PMC 4743593. PMID 24865112.
- ^ Hanson CM, George AM, Sawadogo A, Schreiber B (April 2017). “Is freezing in the vaccine cold chain an ongoing issue? A literature review”. Vaccine. 35 (17): 2127–2133. doi:10.1016/j.vaccine.2016.09.070. PMID 28364920.
- ^ Jump up to:a b Kansteiner F (17 November 2020). “CureVac, armed with COVID-19 vaccine deal, plots ‘pandemic-scale’ Euro manufacturing expansion”. FiercePharma, Questex LLC. Retrieved 5 January2021.
- ^ “CureVac’s Covid-19 vaccine induces immune response in study”. Clinical Trials Arena. 3 November 2020. Retrieved 5 January 2021.
- ^ “CureVac’s COVID-19 vaccine triggers immune response in Phase I trial”. Reuters. 2 November 2020. Retrieved 5 January2021.
- ^ “Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older”. EU Clinical Trials Register. 19 November 2020. Retrieved 5 January 2021.
Proposed INN: zorecimeran
- ^ “A Study to Determine the Safety and Efficacy of SARS-CoV-2 mRNA Vaccine CVnCoV in Adults”. ClinicalTrials.gov. 8 December 2020. NCT04652102. Retrieved 19 December 2020.
- ^ Burger L (7 January 2021). “CureVac strikes COVID-19 vaccine alliance with Bayer”. Reuters. Retrieved 17 February 2021.
- ^ “CureVac and Bayer join forces on COVID-19 vaccine candidate CVnCoV”. CureVac (Press release). 7 January 2021. Retrieved 17 February 2021.
- ^ “EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV)”. European Medicines Agency (EMA) (Press release). 11 February 2021. Retrieved 12 February 2021.
- ^ “CureVac Initiates Rolling Submission With European Medicines Agency for COVID-19 Vaccine Candidate, CVnCoV”. CureVac(Press release).
- ^ “CureVac starts review process in Switzerland for COVID-19 vaccine hopeful”. Reuters. 19 April 2021. Retrieved 19 April 2021.
- ^ “Celonic and CureVac Announce Agreement to Manufacture over 100 Million Doses of CureVac’s COVID-19 Vaccine Candidate, CVnCoV”. CureVac (Press release). 30 March 2021. Retrieved 14 April 2021.
- ^ World Health Organization (October 2020). “International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 124 – COVID-19 (special edition)” (PDF). WHO Drug Information. 34 (3): 668–69. Archived (PDF) from the original on 27 November 2020.
External links
 | Scholia has a profile for zorecimeran (Q97154239). |
- “Zorecimeran”. Drug Information Portal. U.S. National Library of Medicine.
| Vaccine description | |
|---|---|
| Target | SARS-CoV-2 |
| Vaccine type | mRNA |
| Clinical data | |
| Other names | CVnCoV, CV07050101 |
| Routes of administration | Intramuscular |
| ATC code | None |
| Identifiers | |
| DrugBank | DB15844 |
| UNII | 5TP24STD1S |
| Part of a series on the |
| COVID-19 pandemic |
|---|
| COVID-19 (disease)SARS-CoV-2 (virus) |
| showTimeline |
| showLocations |
| showInternational response |
| showMedical response |
| showImpact |
| COVID-19 portal |
- Rego GNA, Nucci MP, Alves AH, Oliveira FA, Marti LC, Nucci LP, Mamani JB, Gamarra LF: Current Clinical Trials Protocols and the Global Effort for Immunization against SARS-CoV-2. Vaccines (Basel). 2020 Aug 25;8(3). pii: vaccines8030474. doi: 10.3390/vaccines8030474. [Article]
- Speiser DE, Bachmann MF: COVID-19: Mechanisms of Vaccination and Immunity. Vaccines (Basel). 2020 Jul 22;8(3). pii: vaccines8030404. doi: 10.3390/vaccines8030404. [Article]
- CureVac & Covid-19 [Link]
- Smart Patients [Link]
- Regulatory News [Link]
////////////zorecimeran, CVnCoV, CV07050101, CORONA VACCINE, COVID 19, VACCINE, CUREVAC, SARS-CoV-2, CV07050101, SARS-CoV-2 mRNA vaccine
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