CureVac COVID-19 vaccine

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Vaccine description
Target disease SARS-CoV-2
Type ?
Clinical data
Routes of
administration
Intramuscular
Identifiers
ATC code None
DrugBank DB15844
UNII 5TP24STD1S YesY

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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 disappointing results in its Phase III trials with only 47% efficacy.[2] The EMA stated that: "(...) medicine developers should design studies to demonstrate a rate of efficacy of at least 50%."[3].

Technology

CVnCoV is an mRNA vaccine that encodes the full-length, pre-fusion stabilized coronavirus spike protein, and activates the immune system against it.[4][5][6] CVnCoV technology does not interact with the human genome.[5]

CVnCoV uses unmodified RNA,[7] unlike the Pfizer–BioNTech COVID-19 vaccine and Moderna COVID-19 vaccine, which both use nucleoside-modified RNA.[8]

Efficacy

On 16 June 2021[9], 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]

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.[10][11]

In December 2020, CureVac began a Phase III clinical trial of CVnCoV with 36,500 participants.[12][13] 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.[14][15] In February 2021, the EU's CHMP started a rolling review of CVnCoV.[16][17] In April 2021, the same procedure began in Switzerland.[18]

Deployment

Manufacturing of mRNA vaccines can be performed rapidly in high volume,[19] including use of portable, automated printers ("RNA microfactories") for which CureVac has a joint development partnership with Tesla.[20]

mRNA vaccines require stringent cold chain refrigeration throughout manufacturing, distribution and storage.[21][22] 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.[5][19]

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.[19][23] An estimated 405 million doses will be provided to EU states.[23]

Society and culture

Names

The manufacturer currently markets the vaccine under the name CVnCoV.[24] Zorecimeran is the proposed international nonproprietary name (pINN).[25]

References

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  3. 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
  4. https://www.curevac.com/wp-content/uploads/2020/10/20201023-CureVac-Manuscript-draft-preclinical-data.pdf
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  9. https://www.curevac.com/en/2021/06/16/curevac-provides-update-on-phase-2b-3-trial-of-first-generation-covid-19-vaccine-candidate-cvncov/
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External links

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