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== Description == |
== Description == |
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CVnCoV is an [[messenger RNA|mRNA technology]] programmed with information about the [[coronavirus]] protein as an unknown [[pathogen]], and activates the [[immune system]] against it.<ref name="schlake">{{cite journal | last=Schlake | first=Thomas | last2=Thess | first2=Andreas | last3=Fotin-Mleczek | first3=Mariola | last4=Kallen | first4=Karl-Josef | title=Developing mRNA-vaccine technologies | journal=RNA Biology | volume=9 | issue=11 | year=2012 | issn=1547-6286 | pmid=23064118 | pmc=3597572 | doi=10.4161/rna.22269 | pages=1319–1330}}</ref> As an mRNA vaccine, CVnCoV has established safety, and provides a minimal, harmless piece of the coronavirus [[spike protein]] to initiate an [[immune response]] against [[COVID-19 disease]].<ref name=schlake/><ref name="cdc">{{cite web |title=Understanding mRNA COVID-19 vaccines |url=https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html |publisher=US Centers for Disease Control and Prevention |access-date=5 January 2021 |date=18 December 2020}}</ref> CVnCoV technology does not interact with the [[human genome]].<ref name=schlake/> |
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==Clinical trial progress== |
==Clinical trial progress== |
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===Phase I-II=== |
===Phase I-II=== |
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In November 2020, CureVac reported results of a [[Phases of clinical research#Phase I|Phase I-II clinical trial]] that |
In November 2020, CureVac reported results of a [[Phases of clinical research#Phase I|Phase I-II clinical trial]] that CVnCoV (active ingredient zorecimeran) was well-tolerated, safe, and produced a robust immune response.<ref name="cta">{{cite web |title=CureVac’s Covid-19 vaccine induces immune response in study |url=https://www.clinicaltrialsarena.com/news/curevac-immune-response-covid/ |publisher=Clinical Trials Arena |access-date=5 January 2021 |date=3 November 2020}}</ref><ref name="reuters11-20">{{cite news |title=CureVac's COVID-19 vaccine triggers immune response in Phase I trial |url=https://www.reuters.com/article/health-coronavirus-germany-curevac/curevacs-covid-19-vaccine-triggers-immune-response-in-phase-i-trial-idUSL8N2HL72C |access-date=5 January 2021 |work=Reuters |date=2 November 2020}}</ref> |
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===Phase III=== |
===Phase III=== |
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In December 2020, CureVac began a [[Phases of clinical research#Phase III|Phase III clinical trial]] of CVnCoV with 36,500 participants.<ref name=euctr/><ref name=NCT04652102/> 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.<ref name=reuters1-21/> On February 12, 2021, CureVac announced the initiation of a rolling submission with the [[European Medicines Agency]] (EMA) for their vaccine candidate, a time-optimized process for the review of all data necessary for potential market authorization.<ref>{{Cite web|title=CureVac Initiates Rolling Submission With European Medicines Agency for COVID-19 Vaccine Candidate, CVnCoV|url=https://www.curevac.com/en/2021/02/12/curevac-initiates-rolling-submission-with-european-medicines-agency-for-covid-19-vaccine-candidate-cvncov/|url-status=live|website=CureVac Website}}</ref> |
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In December, CureVac began a [[Phases of clinical research#Phase III|Phase III clinical trial]] of ''zorecimeran'' with 36,500 participants.<ref name="euctr">{{cite web |title=Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older |url=https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-003998-22/DE |publisher=EU Clinical Trials Register |access-date=5 January 2021 |date=19 November 2020 |quote=Proposed INN: "Zorecimeran"}}</ref><ref name="NCT04652102">{{cite web |title=A Study to Determine the Safety and Efficacy of SARS-CoV-2 mRNA Vaccine CVnCoV in Adults |url=https://clinicaltrials.gov/ct2/show/NCT04652102 |website=[[ClinicalTrials.gov]] |id=NCT04652102 |date=8 December 2020 |access-date=19 December 2020}}</ref><ref name="NCT04652102">{{cite web |title=A Study to Determine the Safety and Efficacy of SARS-CoV-2 mRNA Vaccine CVnCoV in Adults |url=https://clinicaltrials.gov/ct2/show/NCT04652102 |website=[[ClinicalTrials.gov]] |id=NCT04652102 |date=8 December 2020 |access-date=19 December 2020}}</ref> 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.<ref name="reuters1-21">{{cite news |author1=Ludwig Burger |title=CureVac strikes COVID-19 vaccine alliance with Bayer |url=https://www.telegraph.co.uk/news/2020/08/01/britain-unlikely-use-russias-untrustworthy-covid-vaccine/ |access-date=7 January 2021 |agency=Reuters |date=6 January 2021}}</ref> |
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==Manufacturing== |
==Manufacturing== |
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==Cold chain== |
==Cold chain== |
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{{see also|Cold_chain#Vaccines}} |
{{see also|Cold_chain#Vaccines}} |
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mRNA vaccines require stringent [[cold chain]] refrigeration throughout manufacturing, distribution and storage.<ref name="karto">{{cite journal | last1=Kartoglu | first1=Umit | last2=Milstien | first2=Julie | title=Tools and approaches to ensure quality of vaccines throughout the cold chain | journal=Expert Review of Vaccines | volume=13 | issue=7 | date=28 May 2014 | issn=1476-0584 | pmid=24865112 | pmc=4743593 | doi=10.1586/14760584.2014.923761 | pages=843–54}}</ref><ref name="hanson">{{cite journal | last1=Hanson | first1=Celina M. | last2=George | first2=Anupa M. | last3=Sawadogo | first3=Adama | last4=Schreiber | first4=Benjamin | title=Is freezing in the vaccine cold chain an ongoing issue? A literature review | journal=Vaccine | volume=35 | issue=17 | date=19 April 2017 | issn=0264-410X | pmid=28364920 | doi=10.1016/j.vaccine.2016.09.070 | pages=2127–33 | doi-access=free }}</ref> The CureVac technology for |
mRNA vaccines require stringent [[cold chain]] refrigeration throughout manufacturing, distribution and storage.<ref name="karto">{{cite journal | last1=Kartoglu | first1=Umit | last2=Milstien | first2=Julie | title=Tools and approaches to ensure quality of vaccines throughout the cold chain | journal=Expert Review of Vaccines | volume=13 | issue=7 | date=28 May 2014 | issn=1476-0584 | pmid=24865112 | pmc=4743593 | doi=10.1586/14760584.2014.923761 | pages=843–54}}</ref><ref name="hanson">{{cite journal | last1=Hanson | first1=Celina M. | last2=George | first2=Anupa M. | last3=Sawadogo | first3=Adama | last4=Schreiber | first4=Benjamin | title=Is freezing in the vaccine cold chain an ongoing issue? A literature review | journal=Vaccine | volume=35 | issue=17 | date=19 April 2017 | issn=0264-410X | pmid=28364920 | doi=10.1016/j.vaccine.2016.09.070 | pages=2127–33 | doi-access=free }}</ref> The CureVac technology for CVnCoV uses a non-modified, more natural mRNA less affected by [[hydrolysis]], enabling storage at {{convert|5|C}} 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|ultracold equipment]].<ref name=schlake/><ref name=nawrat/> |
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==Preorders== |
==Preorders== |
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CureVac has a European-based network to accelerate manufacturing of |
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.<ref name=nawrat/><ref name="fierce">{{cite web |author1=Fraiser Kansteiner |title=CureVac, armed with COVID-19 vaccine deal, plots 'pandemic-scale' Euro manufacturing expansion |url=https://www.fiercepharma.com/manufacturing/armed-covid-19-vaccine-deal-curevac-plots-speedy-european-manufacturing-expansion |publisher=FiercePharma, Questex LLC |access-date=5 January 2021 |date=17 November 2020}}</ref> An estimated 405 million doses will be provided to EU states.<ref name=fierce/> |
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==References== |
==References== |
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Revision as of 23:53, 17 February 2021
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Submission declined on 9 February 2021 by Sulfurboy (talk).
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| Vaccine description | |
|---|---|
| Target | COVID-19 |
| Vaccine type | mRNA |
| Clinical data | |
| Other names | CVnCoV |
| Routes of administration | Intramuscular |
| Identifiers | |
| DrugBank | |
| Part of a series on the |
| COVID-19 pandemic |
|---|
 |
|
.svg){kind=small} COVID-19 portal |
Zorecimeran, also known as CVnCoV is a COVID-19 vaccine candidate developed by CureVac and Coalition for Epidemic Preparedness Innovations (CEPI).
Description
CVnCoV is an mRNA technology programmed with information about the coronavirus protein as an unknown pathogen, and activates the immune system against it.[1] As an mRNA vaccine, CVnCoV 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] CVnCoV technology does not interact with the human genome.[1]
Clinical trial progress
Phase I-II
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.[3][4]
Phase III
In December 2020, CureVac began a Phase III clinical trial of CVnCoV with 36,500 participants.[5][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] On February 12, 2021, CureVac announced the initiation of a rolling submission with the European Medicines Agency (EMA) for their vaccine candidate, a time-optimized process for the review of all data necessary for potential market authorization.[8]
Manufacturing
Manufacturing of mRNA vaccines can be performed rapidly in high volume,[9] including use of portable, automated printers ("RNA microfactories") for which CureVac has a joint development partnership with Tesla.[10]
Cold chain
mRNA vaccines require stringent cold chain refrigeration throughout manufacturing, distribution and storage.[11][12] 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.[1][9]
Preorders
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.[9][13] An estimated 405 million doses will be provided to EU states.[13]
References
- ^ a b c d 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.
- ^ Cite error: The named reference
euctrwas invoked but never defined (see the help page). - ^ Cite error: The named reference
NCT04652102was invoked but never defined (see the help page). - ^ Cite error: The named reference
reuters1-21was invoked but never defined (see the help page). - ^ "CureVac Initiates Rolling Submission With European Medicines Agency for COVID-19 Vaccine Candidate, CVnCoV". CureVac Website.
{{cite web}}: CS1 maint: url-status (link) - ^ a b c 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.
- ^ a b 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
Scholia has a profile for Zorecimeran ().
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