CureVac COVID-19 vaccine

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CureVac COVID-19 vaccine
INN: zorecimeran
SARS-CoV-2
Vaccine typemRNA
Clinical data
Other namesCVnCoV
CV07050101
Routes of
administration		Intramuscular
ATC code
  • None
Legal status
Legal status
  • EU: Terminated[1]
Identifiers
DrugBank
UNII
Part of a series on the
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Scientifically accurate atomic model of the external structure of SARS-CoV-2. Each "ball" is an atom.
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The CureVac COVID-19 vaccine (abbreviated CVnCoV) was a

GlaxoSmithKline.[4]

Efficacy

On 16 June 2021,[5] CureVac said its vaccine showed 47% efficacy from its Phase IIb/III trial. Later, the final result data showed an efficacy of 48% against symptomatic disease in all age groups and, for people aged 18 to 60 years, an efficacy of 53% against symptomatic disease, 77% against moderate and severe disease and 100% against hospitalization and death, as no cases were detected in the study.[6] 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.[3]

Pharmacology

CVnCoV is an

mRNA vaccine that encodes the full-length, pre-fusion stabilized coronavirus spike protein, and activates the immune system against it.[7][8][9] CVnCoV technology does not interact with the human genome.[8] CVnCoV uses unmodified RNA,[10] unlike the Pfizer–BioNTech COVID-19 vaccine and Moderna COVID-19 vaccine, which both use nucleoside-modified RNA.[11]

Manufacturing

Manufacturing of mRNA vaccines can be performed rapidly in high volume,[12] including use of portable, automated printers ("RNA microfactories") for which CureVac has a joint development partnership with Tesla.[13]

mRNA vaccines require stringent

ultracold equipment.[8][12]

CureVac had 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.[12][16] An estimated 405 million doses would have been provided to EU states.[16]

Clinical trials

In June 2020, CureVac was launched for phase I trial with 280 participants.[17] In August, CureVac was launched for phase II trials with 674 participants.[18] In November, 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.[19][20]

In December 2020, CureVac began a Phase III clinical trial of CVnCoV with 36,500 participants.[21][22] 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.[23][24] In February 2021, the EU's CHMP started a rolling review of CVnCoV.[25][26] In April 2021, the same procedure began in Switzerland.[27]

In June 2021, CureVac announced that the vaccine's efficacy against symptomatic disease is 48%.

GlaxoSmithKline, also using unmodified mRNA, is more stable inside cells and produces higher levels of neutralizing antibodies in animals.[28][29]

Brand names

The manufacturer currently markets the vaccine under the name CVnCoV.[30] Zorecimeran is the proposed international nonproprietary name (pINN).[31]

References

  1. ^ Zimmer C (12 October 2021). "CureVac has withdrawn its Covid vaccine application to European regulators". The New York Times. Retrieved 13 October 2021.
  2. ^ "CureVac focuses on the development of mRNA-based coronavirus vaccine to protect people worldwide". CureVac (Press release). 15 March 2020. Archived from the original on 8 March 2021. Retrieved 17 February 2021.
  3. ^ a b Burger L (16 June 2021). "CureVac fails in pivotal COVID-19 vaccine trial with 47% efficacy". Reuters. Retrieved 17 June 2021.
  4. ^ Szymanska Z, Burger L (12 October 2021). "CureVac drops COVID-19 vaccine, pins hope on next-generation shots". Reuters. Retrieved 30 December 2021.
  5. ^ "CureVac Provides Update on Phase 2b/3 Trial of First-Generation COVID-19 Vaccine Candidate, CVnCoV". 16 June 2021. Archived from the original on 24 June 2021. Retrieved 17 June 2021.
  6. ^ a b "CureVac Final Data from Phase 2b/3 Trial of First-Generation COVID-19 Vaccine Candidate, CVnCoV, Demonstrates Protection in Age Group of 18 to 60". CureVac (Press release). 30 June 2021. Archived from the original on 12 October 2021. Retrieved 2 July 2021.
  7. ^ "mRNA based SARS-CoV-2 vaccine candidate CVnCoV induces high levels of virus neutralizing antibodies and mediates protection in rodents" (PDF). Archived (PDF) from the original on 4 June 2021. Retrieved 22 July 2021.
  8. ^
    PMID 23064118
    .
  9. ^ "Understanding mRNA COVID-19 vaccines". US Centers for Disease Control and Prevention. 18 December 2020. Retrieved 5 January 2021.
  10. ^ "COVID-19". CureVac. Retrieved 21 December 2020.
  11. S2CID 227176634
    .
  12. ^ 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.
  13. ^ "Tesla to make molecule printers for German COVID-19 vaccine developer CureVac". Reuters. 2 July 2020. Retrieved 19 December 2020.
  14. PMID 24865112
    .
  15. PMID 28364920
    .
  16. ^ 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.
  17. ^ "A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults". clinicaltrials.gov. United States National Library of Medicine. 26 June 2020. Retrieved 15 July 2021.
  18. ^ "A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19". clinicaltrials.gov. United States National Library of Medicine. 17 August 2020. Retrieved 12 January 2021.
  19. ^ "CureVac's Covid-19 vaccine induces immune response in study". Clinical Trials Arena. 3 November 2020. Retrieved 5 January 2021.
  20. ^ "CureVac's COVID-19 vaccine triggers immune response in Phase I trial". Reuters. 2 November 2020. Retrieved 5 January 2021.
  21. ^ "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
  22. ^ "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.
  23. ^ Burger L (7 January 2021). "CureVac strikes COVID-19 vaccine alliance with Bayer". Reuters. Retrieved 17 February 2021.
  24. ^ "CureVac and Bayer join forces on COVID-19 vaccine candidate CVnCoV". CureVac (Press release). 7 January 2021. Retrieved 17 February 2021.
  25. ^ "EMA starts rolling review of CureVac's COVID-19 vaccine (CVnCoV)". European Medicines Agency (EMA) (Press release). 11 February 2021. Retrieved 12 February 2021.
  26. ^ "CureVac Initiates Rolling Submission With European Medicines Agency for COVID-19 Vaccine Candidate, CVnCoV". CureVac (Press release).
  27. ^ "CureVac starts review process in Switzerland for COVID-19 vaccine hopeful". Reuters. 19 April 2021. Retrieved 19 April 2021.
  28. S2CID 235480198
    .
  29. ^ Cohen J (18 June 2021). "What went wrong with CureVac's highly anticipated new mRNA vaccine for COVID-19?". Science AAAS. Retrieved 6 August 2021.
  30. ^ "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.
  31. ^ 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.
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