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CureVac COVID-19 vaccine

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CureVac COVID-19 vaccine
INN: zorecimeran
Vaccine description
TargetSARS-CoV-2
Vaccine typemRNA
Clinical data
Other namesCVnCoV, CV07050101
Routes of
administration
Intramuscular
ATC code
  • None
Identifiers
DrugBank

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] As of April 2021 it is currently in Phase III clinical trials.

Description

CVnCoV is an mRNA vaccine that encodes a minimal piece of the coronavirus spike protein, and activates the immune system against it.[2][3] CVnCoV technology does not interact with the human genome under normal conditions, that is, in absence of e.g. an active retrovirus infection.[2]

CVnCoV uses unmodified RNA,[4] unlike the Pfizer–BioNTech COVID-19 vaccine and Moderna COVID-19 vaccine, which both use nucleoside-modified RNA.[5]

Clinical trial progress

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.[6][7]

In December 2020, CureVac began a Phase III clinical trial of CVnCoV with 36,500 participants.[8][9] 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.[10][11] In February 2021, the CHMP started a rolling review of CVnCoV.[12][13]

Deployment

Manufacturing of mRNA vaccines can be performed rapidly in high volume,[14] including use of portable, automated printers ("RNA microfactories") for which CureVac has a joint development partnership with Tesla.[15]

mRNA vaccines require stringent cold chain refrigeration throughout manufacturing, distribution and storage.[16][17] 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.[2][14]

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.[14][18] An estimated 405 million doses will be provided to EU states.[18]

Society and culture

Names

Zorecimeran is the proposed international nonproprietary name (pINN).[19]

References

  1. ^ "CureVac focuses on the development of mRNA-based coronavirus vaccine to protect people worldwide". CureVac (Press release). 15 March 2020. Retrieved 17 February 2021. {{cite press release}}: line feed character in |title= at position 73 (help)
  2. ^ 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.
  3. ^ "Understanding mRNA COVID-19 vaccines". US Centers for Disease Control and Prevention. 18 December 2020. Retrieved 5 January 2021.
  4. ^ "COVID-19". CureVac. Retrieved 21 December 2020.
  5. ^ 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.
  6. ^ "CureVac's Covid-19 vaccine induces immune response in study". Clinical Trials Arena. 3 November 2020. Retrieved 5 January 2021.
  7. ^ "CureVac's COVID-19 vaccine triggers immune response in Phase I trial". Reuters. 2 November 2020. Retrieved 5 January 2021.
  8. ^ "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
  9. ^ "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.
  10. ^ Burger L (7 January 2021). "CureVac strikes COVID-19 vaccine alliance with Bayer". Reuters. Retrieved 17 February 2021.
  11. ^ "CureVac and Bayer join forces on COVID-19 vaccine candidate CVnCoV". CureVac (Press release). 7 January 2021. Retrieved 17 February 2021.
  12. ^ "EMA starts rolling review of CureVac's COVID-19 vaccine (CVnCoV)". European Medicines Agency (EMA) (Press release). 11 February 2021. Retrieved 12 February 2021.
  13. ^ "CureVac Initiates Rolling Submission With European Medicines Agency for COVID-19 Vaccine Candidate, CVnCoV". CureVac (Press release).
  14. ^ 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.
  15. ^ "Tesla to make molecule printers for German COVID-19 vaccine developer CureVac". Reuters. 2 July 2020. Retrieved 19 December 2020.
  16. ^ 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.
  17. ^ 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.
  18. ^ 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 January 2021.
  19. ^ 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.
  • "Zorecimeran". Drug Information Portal. U.S. National Library of Medicine.