Zorecimeran
Zorecimeran, trade-named CVnCoV is a COVID-19 vaccine candidate developed by CureVac and Coalition for Epidemic Preparedness Innovations (CEPI). Zorecimeran is an messenger RNA technology programmed with information about the coronavirus protein as an unknown pathogen, and activates the immune system against it.[1] As an mRNA vaccine, zorecimeran has established safety, and provides a minimal, harmless piece of the coronavirus spike protein to initiate an immune response against COVID-19 disease.[1][2] Zorecimeran technology does not interact with the human genome.[1]
Clinical trial progress
In November 2020, CureVac reported results of a Phases of clinical I clinical trial that zorecimeran (CVnCoV) was well-tolerated, safe, and produced a robust immune response.[3][4] In December, CureVac began a Phases of clinical research#Phase III clinical trial of zorecimeran with 36,500 participants.[5][6][6] 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.[7]
Manufacturing
Manufacturing of mRNA vaccines can be performed rapidly in high volume,[8] including use of portable, automated printers ("RNA microfactories") for which CureVac has a joint development partnership with Tesla, Inc.[9]
Cold chain
mRNA vaccines require stringent cold chain refrigeration throughout manufacturing, distribution and storage.[10][11] The CureVac technology for zorecimeran 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 freezer.[1][8]
Preorders
CureVac has a European-based network to accelerate manufacturing of zorecimeran, if proven safe and effective, for production of up to 300 million doses in 2021 and 600 million doses in 2022.[8][12] An estimated 405 million doses will be provided to EU states.[12]
References
- ↑ 1.0 1.1 1.2 1.3 Schlake, Thomas; Thess, Andreas; Fotin-Mleczek, Mariola; Kallen, Karl-Josef (2012). "Developing mRNA-vaccine technologies". RNA Biology. 9 (11): 1319–1330. doi:10.4161/rna.22269. ISSN 1547-6286. PMC 3597572. PMID 23064118.
- ↑ "Understanding mRNA COVID-19 vaccines". US Centers for Disease Control and Prevention. 18 December 2020. Retrieved 5 January 2021.
- ↑ "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 January 2021.
- ↑ "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"
- ↑ 6.0 6.1 "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.
- ↑ Ludwig Burger (6 January 2021). "CureVac strikes COVID-19 vaccine alliance with Bayer". Reuters. Retrieved 7 January 2021.
- ↑ 8.0 8.1 8.2 Allie Nawrat (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, Umit; Milstien, Julie (28 May 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. ISSN 1476-0584. PMC 4743593. PMID 24865112.
- ↑ Hanson, Celina M.; George, Anupa M.; Sawadogo, Adama; Schreiber, Benjamin (19 April 2017). "Is freezing in the vaccine cold chain an ongoing issue? A literature review". Vaccine. 35 (17): 2127–33. doi:10.1016/j.vaccine.2016.09.070. ISSN 0264-410X. PMID 28364920.
- ↑ 12.0 12.1 Fraiser Kansteiner (17 November 2020). "CureVac, armed with COVID-19 vaccine deal, plots 'pandemic-scale' Euro manufacturing expansion". FiercePharma, Questex LLC. Retrieved 5 January 2021.
External links
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