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
Legal status
Legal status
Identifiers
DrugBank
UNII

The CureVac COVID-19 vaccine (abbreviated CVnCoV) was a COVID-19 vaccine candidate developed by CureVac N.V. and the Coalition for Epidemic Preparedness Innovations (CEPI).[2] The vaccine showed inadequate results in its Phase III trials with only 47% efficacy.[3]

Efficacy

On 16 June 2021,[4] 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.[5] 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]

The efficacy is approximately 77% against moderate and severe disease, 100% against hospitalizations and 53% in people aged 18 to 60 years.[6]

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 cold chain refrigeration throughout manufacturing, distribution and storage.[14][15] 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.[8][12]

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.[12][16] An estimated 405 million doses will be 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%.[5] The company said the high number of variants in circulation may explain the low efficacy, but some scientists attribute the result to insufficient immunogenicity due to the use of unmodified mRNA (the Pfizer–BioNTech and Moderna vaccines use uracil-modified mRNA) or the dose being too low (12 µg, compared to 30 µg for Pfizer–BioNTech and 100 µg for Moderna). Neutralizing antibody levels in CureVac recipients were about the same as those in convalescence, but much lower than those seen in recipients of Pfizer–BioNTech or Moderna. The modified mRNA induces potent antibodies and other protective immune responses and circumvents the body's inflammatory reactions. Unmodified mRNA inhibits immunogenicity by triggering the production of interferons that block the generation of T helper cells, which direct B cells to produce antibodies. CureVac attempted to evade immune detection by altering the RNA sequence in a way that does not affect the coded protein, but structural differences in the non-coding regions might have affected immunogenicity. Unmodified mRNA may have decreased tolerability, leading to the adoption of a lower dose, but studies of the Pfizer–BioNTech and Moderna vaccines found only modest gains at higher doses. A next-generation vaccine from CureVac in collaboration with 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, Carl (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. Retrieved 17 February 2021.
  3. ^ a b Burger, Ludwig (16 June 2021). "CureVac fails in pivotal COVID-19 vaccine trial with 47% efficacy". Reuters. Retrieved 17 June 2021.
  4. ^ "CureVac Provides Update on Phase 2b/3 Trial of First-Generation COVID-19 Vaccine Candidate, CVnCoV". 16 June 2021.
  5. ^ 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. Retrieved 2 July 2021.
  6. ^ Deutsch, Jillian (1 July 2021). "CureVac fails to prove coronavirus vaccine is 50 percent effective". POLITICO. Retrieved 6 August 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. ^ 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.
  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. ^ 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.
  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. ^ 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.
  15. ^ 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.
  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. ^ Dolgin, Elie (18 June 2021). "CureVac COVID vaccine let-down spotlights mRNA design challenges". Nature. 594 (7864): 483. Bibcode:2021Natur.594..483D. doi:10.1038/d41586-021-01661-0. PMID 34145413. S2CID 235480198.
  29. ^ Cohen, Jon (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

  • "Zorecimeran". Drug Information Portal. U.S. National Library of Medicine.
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