Redigerer Novavax COVID-19-vaksine

'''Novavax covid-19-vaksine''', kodenavn '''NVX-CoV2373''', og også kalt '''SARS-CoV-2 rS''' (''recombinant spike protein nanoparticle with Matrix-M1 adjuvant'', er en [[covid-19-vaksine]]<nowiki/>kandidat utviklet av det amerikanske konsernet [[Novavax]] og [[Coalition for Epidemic Preparedness Innovations]] (CEPI) og gjennomgår (april 2021) forsøk i India under varemerket '''Covovax'''.<ref>{{cite news |title=Hope to launch Covovax by September, says Serum Institute CEO |url=https://www.livemint.com/companies/news/hope-to-launch-covovax-by-september-says-serum-institute-ceo-11616834205232.html |access-date=28. mars 2021 |work=mint |date=27. mars 2021}}</ref> Den gis i to doser<ref name="doi 10.1126/science.abg8101" /> og er stabil til kjøleskapstemperatur (2 til 8 grader Celcius).<ref name="BBC 20210108" />

NVX-CoV2373 er blitt beskrevet både som en protein-subenhetvaksine<ref name=":1">{{cite journal | vauthors = Wadman M | title = The long shot | journal = Science | volume = 370 | issue = 6517 | pages = 649–653 | date = November 2020 | pmid = 33154120 | doi = 10.1126/science.370.6517.649 | bibcode = 2020Sci...370..649W | doi-access = free }}</ref><ref name=":2">{{cite journal| vauthors = Wadman M |date=28. desember 2020|title=Novavax launches pivotal U.S. trial of dark horse COVID-19 vaccine after manufacturing delays|url=https://www.sciencemag.org/news/2020/12/novavax-launches-pivotal-us-trial-dark-horse-covid-19-vaccine-after-manufacturing|journal=Science|doi=10.1126/science.abg3441 }}</ref><ref name="Novavax">{{cite news | vauthors = Parekh N |title=Novavax: A SARS-CoV-2 Protein Factory to Beat COVID-19. |url=https://fancycomma.com/2020/07/24/novavax-protein-subunit-covid-19-vaccine/ |access-date=24. juli 2020 |date=24. juli 2020 |archive-date=22. november 2020 |archive-url=https://web.archive.org/web/20201122040118/https://fancycomma.com/2020/07/24/novavax-protein-subunit-covid-19-vaccine/ |url-status=live }}</ref> og en viruslik partikkelvaksine,<ref>{{cite journal | vauthors = Chung YH, Beiss V, Fiering SN, Steinmetz NF | title = COVID-19 Vaccine Frontrunners and Their Nanotechnology Design | journal = ACS Nano | volume = 14 | issue = 10 | pages = 12522–12537 | date = Oktober 2020 | pmid = 33034449 | pmc = 7553041 | doi = 10.1021/acsnano.0c07197 | name-list-style = vanc }}</ref><ref>{{cite journal | vauthors = Medhi R, Srinoi P, Ngo N, Tran HV, Lee TR |date=25. september 2020 |title=Nanoparticle-Based Strategies to Combat COVID-19 |journal=ACS Applied Nano Materials |volume=3 |issue=9 |pages=8557–8580 |doi=10.1021/acsanm.0c01978 |pmc=7482545 }}</ref> og, av produsenten selv som en «rekombinant nanopartikkelvaksine».<ref name=":3">{{cite web|title=Urgent global health needs addressed by Novavax|url=https://www.novavax.com/our-unique-technology|access-date=30. januar 2021|website=Novavax}}</ref>

Vaksinen produseres ved først å sette sammen et [[Baculoviridae|baculovirus]] med et [[gen]] for et modifisert [[SARS-CoV-2]] [[spikeprotein]].  Baculoviruset injiseres så i en [[Cellekultur|kultur]] av  [[Sf9 (celler)|Sf9]] [[møll]]<nowiki></nowiki>celler, som skaper spikeproteinet og presenterer det på sine [[cellemembran]]er.  Spikeproteiner innhøstes så og settes sammen til en syntetisk [[lipid nanopartikkel]] som er om lag 50 nanometer i diameter, hver med inntil 14 spikeproteiner.<ref name=":1" /><ref name=":2" /><ref name=":3" /> I formuleringen inngår en [[saponin]]<nowiki></nowiki>basert [[adjuvant]].<ref name=":1" /><ref name=":2" /><ref name=":3" />
== Utvikling ==
I januar 2020 kunngjorde Novavax utviklingen av en vaksinekandidat, kodet NVX-CoV2373, for å etablere immunitet mot [[SARS-CoV-2]].<ref name="gilgore">{{cite news | vauthors = Gilgore S |title=Novavax is working to advance a potential coronavirus vaccine. So are competitors. |url=https://www.bizjournals.com/washington/news/2020/02/26/novavax-is-moving-forward-with-a.html |work=Washington Business Journal |access-date=6. mars 2020 |date=26. februar 2020 |archive-date=16. mars 2020 |archive-url=https://web.archive.org/web/20200316041227/https://www.bizjournals.com/washington/news/2020/02/26/novavax-is-moving-forward-with-a.html |url-status=live }}</ref> Også mange andre vaksineprodusenter satte seg dette fore.<ref name="milken">{{cite web |title=COVID-19 vaccine tracker (click on 'Vaccines' tab) |url=https://docs.google.com/spreadsheets/d/16DbPhF9OD0MHHtCR12of6yUcfiRzP_-XGkynEbnipds/htmlview?pru=AAABchldaXU*ZWdU7a75RG6u_cw8QpEBhw# |publisher=Milken Institute |access-date=12. mai 2020 |date=11. mai 2020 |lay-url=https://milkeninstitute.org/covid-19-tracker |archive-date=6. juni 2020 |archive-url=https://web.archive.org/web/20200606220149/https://docs.google.com/spreadsheets/d/16DbPhF9OD0MHHtCR12of6yUcfiRzP_-XGkynEbnipds/htmlview?pru=AAABchldaXU*ZWdU7a75RG6u_cw8QpEBhw |url-status=live }}</ref> I mars 2020 bekjentgjorde Novavax at de samarbeidet med [[Emergent BioSolutions]] for preklinisk og tidligfases utprøving på mennesker.<ref>{{cite news|url=https://www.bizjournals.com/washington/news/2020/03/10/novavax-s-coronavirus-vaccine-program-is-getting.html|title=Novavax's coronavirus vaccine program is getting some help from Emergent BioSolutions| vauthors = Gilgore S |date=10. mars 2020|work=Washington Business Journal|access-date=10. mars 2020|archive-date=9. april 2020|archive-url=https://web.archive.org/web/20200409200636/https://www.bizjournals.com/washington/news/2020/03/10/novavax-s-coronavirus-vaccine-program-is-getting.html|url-status=live}}</ref> [[Emergent BioSolutions]] skulle produsere vaksinen i stor skala i sitt anlegg i [[Baltimore]].<ref>{{cite web | vauthors = McCartney R |title=Maryland plays an outsized role in worldwide hunt for a coronavirus vaccine|url=https://www.washingtonpost.com/local/maryland-plays-an-outsized-role-in-worldwide-hunt-for-a-coronavirus-vaccine/2020/05/03/3b6f2cb8-8bd5-11ea-8ac1-bfb250876b7a_story.html|website=Washington Post|url-status=live|archive-url=https://web.archive.org/web/20200507230732/https://www.washingtonpost.com/local/maryland-plays-an-outsized-role-in-worldwide-hunt-for-a-coronavirus-vaccine/2020/05/03/3b6f2cb8-8bd5-11ea-8ac1-bfb250876b7a_story.html|archive-date=7. mai 2020|access-date=8. mai 2020}}</ref>  Det ble også foretatt forsøk i [[Storbritannia]], og der ville man eventuelt produsere minst 60 millioner doser av [[Fujifilm Diosynth Biotechnologies]] i [[Billingham]].<ref name=guardian-20210128>{{cite news |url=https://www.theguardian.com/society/2021/jan/28/novavax-covid-vaccine-shown-to-be-nearly-90-effective-in-uk-trial |title=Novavax Covid vaccine shown to be nearly 90% effective in UK trial | vauthors = Boseley S, Davis N |newspaper=The Guardian |date=28. januar 2021 |access-date=29. januar 2021}}</ref><ref name=teesidelive-20200814>{{cite news |url=https://www.gazettelive.co.uk/news/teesside-news/60m-doses-new-covid-19-18767512 |title=60m doses of new covid-19 vaccine could be made in Billingham – and be ready for mid-2021 | vauthors = Brown M |website=TeesideLive |publisher=Reach |date=14. august 2020 |access-date=29. januar 2021}}</ref> Man inngikk også avtale med [[Serum Institute of India]] for masseproduksjon for utvikling og for forsyning av lavinnkomstland.<ref>{{cite news |title=Novavax signs COVID-19 vaccine supply deal with India's Serum Institute |url=https://www.reuters.com/article/us-health-coronavirus-novavax/novavax-signs-covid-19-vaccine-supply-deal-with-indias-serum-institute-idINKCN25139A |work=Reuters |date=5. august 2020 }}</ref> Lignende produksjonsavtaler kom istand for Spania<ref>{{cite web | title = Spain, again chosen to produce the vaccine to combat COVID-19 | date = 18. september 2020 | url = https://www.thisistherealspain.com/en/latest-news/spain-again-chosen-to-produce-the-vaccine-to-combat-covid-19/ | work = This is the Real Spain | access-date = 2021-04-01 | archive-date = 2021-03-19 | archive-url = https://web.archive.org/web/20210319015957/https://www.thisistherealspain.com/en/latest-news/spain-again-chosen-to-produce-the-vaccine-to-combat-covid-19/ | url-status = yes }}</ref> og Polen, hos selskapet [[Mabion]].<ref>{{cite web | title = Novavax Deal With Mabion Boosts Poland’s Nascent Biotech Scene | date = 25. mars 2021 | url = https://www.bloomberg.com/news/articles/2021-03-03/novavax-deal-with-mabion-boosts-poland-s-nascent-biotech-scene | work = Bloomberg }}</ref>

De første studier om sikkerhet for mennesker begynte i mai 2020 i Australia.<ref name=fp>{{cite news|title=Novavax scores $384M deal, CEPI's largest ever, to fund coronavirus vaccine work| vauthors = Sagonowsky E |url=https://www.fiercepharma.com/vaccines/novavax-scores-cepi-s-largest-award-up-to-384m-to-support-covid-19-vaccine-work|work=FiercePharma|date=11. mai 2020|access-date=12. mai 2020|archive-date=16. mai 2020|archive-url=https://web.archive.org/web/20200516215744/https://www.fiercepharma.com/vaccines/novavax-scores-cepi-s-largest-award-up-to-384m-to-support-covid-19-vaccine-work|url-status=live}}</ref><ref>{{cite web|title=Novavax starts clinical trial of its coronavirus vaccine candidate|url=https://www.cnbc.com/2020/05/25/novavax-starts-phase-1-clinical-trial-of-coronavirus-vaccine-candidate.html|date=25. mai 2020 |publisher=CNBC |access-date=26. mai 2020|archive-date=26. mai 2020|archive-url=https://web.archive.org/web/20200526013622/https://www.cnbc.com/2020/05/25/novavax-starts-phase-1-clinical-trial-of-coronavirus-vaccine-candidate.html|url-status=live}}</ref>

I juli 2020 sa selskapet at det kanskje fikk $1,6 milliarder dollar fra [[Operation Warp Speed]] i USA for å aksellere utviklingen hvis de kliniske forsøkene var lovende nok.<ref name=":0">{{cite news| vauthors = Steenhuysen J |date=7. juli 2020|title=U.S. government awards Novavax $1.6 billion for coronavirus vaccine|work=Reuters|url=https://www.reuters.com/article/us-health-coronavirus-novavax-idUSKBN248182|access-date=15. september 2020|archive-date=14. september 2020|archive-url=https://web.archive.org/web/20200914213046/https://www.reuters.com/article/us-health-coronavirus-novavax-idUSKBN248182|url-status=live}}</ref> I desember 2020 innledet Novavax Fase III-utprøving i USA og Mexico.<ref>{{cite web | title=Phase 3 trial of Novavax investigational COVID-19 vaccine opens | website=National Institutes of Health (NIH) | date=28. desember 2020 | url=https://www.nih.gov/news-events/news-releases/phase-3-trial-novavax-investigational-covid-19-vaccine-opens | access-date=28. desember 2020 }}</ref>

Den 28. januar 2021 meldte Novavax foreløpige resultater for den britiske utprøving; vaksinekandidaten var over 89% effektiv.<ref name="BBC 20210108">{{cite news|date=28. januar 2021|title=New Covid vaccine shows 89% efficacy in UK trials|work=BBC News|url=https://www.bbc.com/news/uk-55850352|access-date=28 January 2021}}</ref><ref>{{cite news| vauthors = Lovelace B |date=28. januar 2020|title=Novavax says Covid vaccine is more than 89% effective|work=CNBC|url=https://www.cnbc.com/2021/01/28/covid-vaccine-novavax-says-covid-vaccine-is-more-than-89percent-effective.html}}</ref> Men interimresultater fra Sør-Afrika viste en lavere effektivitet mot [[501.V2-varianten]] av viruset: Rundt 50–60%.<ref name="doi 10.1126/science.abg8101">{{cite journal | vauthors = Wadman M, Jon C | title=Novavax vaccine delivers 89% efficacy against COVID-19 in UK—but is less potent in South Africa | journal=Science | date=28. januar 2021 | doi=10.1126/science.abg8101 | doi-access=free }}</ref><ref>{{cite web | vauthors = Facher L, Joseph A | title=Novavax says its Covid-19 vaccine is 90% effective in late-stage trial | website=[[Stat (website)|Stat]] | date=28. januar 2021 | url=https://www.statnews.com/2021/01/28/novavax-says-its-covid-19-vaccine-is-90-effective-but-far-less-so-against-one-variant/ | access-date=29. januar 2021 }}</ref> Den 12. mars 2021 meldte Novavax at deres vaksinekandidat var 96,4% effektiv mot den opprinnelige formen av [[covid-19]] og 86% effektiv mot [[Lineage B.1.1.7]]. Den var 55% effektiv mot [[501.V2-varianten]] i mennesker uten [[HIV/AIDS]]. Den var også 100% effektiv hva gjaldt særlig alvorlig sykdomsforløp.<ref>{{Cite news|last=O’Donnell|first=Carl|last2=Nadeem|first2=Dania|date=11. mars 2021|title=Novavax vaccine 96% effective against original coronavirus, 86% vs British variant in UK trial|work=Reuters|url=https://www.reuters.com/article/uk-health-coronavirus-vaccines-novavax-idUSKBN2B32ZI|access-date=23. mars 2021}}</ref>

== Godkjenning ==
Vaksinen ble nødgodkjent i Indonesia 1. november 2021.<ref>[https://www.timesnownews.com/international/article/novavax-covid-19-vaccine-gets-eua-in-indonesia-serum-institute-to-sell-it-under-covovax-brand-name/828430 "Novavax Covid-19 vaccine gets EUA in Indonesia; Serum Institute to sell it under 'Covovax' brand name"], Times Now, 1. november 2021</ref>

== Referanser==
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[[Kategori:Covid-19-vaksiner]]
[[Kategori:Koronavirus vaksinearbeid]]