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BioNTech: razlika između inačica

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=== Temelj i razvoj (2008. - 2013.) ===
=== Temelj i razvoj (2008. - 2013.) ===
BioNTech je osnovan [[2008.]] godine na temelju istraživanja [[Uğur Şahin|Uğura Şahina]], [[Özlem Türeci|Özlema Türecija]],<ref>{{Cite web|url=https://www.france24.com/en/live-news/20201113-biontech-s-founders-scientist-couple-in-global-spotlight|title=BioNTech's founders: scientist couple in global spotlight|date=2020-11-13|website=France 24|language=en|access-date=2020-12-22}}</ref> i Christoph Hubera,<ref name="browne">{{cite news|author1=Ryan Browne|title=What you need to know about BioNTech — the European company behind Pfizer's Covid-19 vaccine|url=https://www.cnbc.com/2020/11/11/biontech-the-european-company-behind-pfizers-covid-19-vaccine.html|access-date=7 December 2020|work=CNBC|date=11 November 2020}}</ref> s početnim ulaganjem od 150 milijuna [[Euro|eura]].<ref>{{Cite web|url=https://investors.biontech.de/node/6751/html#toc|title=SEC Filing {{!}} BioNTech|website=investors.biontech.de|access-date=2020-12-28}}</ref> Djelatnosti tvrtke usmjerene su na razvoj i proizvodnju tehnologija i lijekova za individualiziranu imunoterapiju raka.<ref name="SEC report" /> Andreas i Thomas Strüngmann, Michael Motschmann i Helmut Jeggle bili su suosnivači.<ref name="france24">{{cite news|title=BioNTech's founders: scientist couple in global spotlight|url=https://www.france24.com/en/live-news/20201113-biontech-s-founders-scientist-couple-in-global-spotlight|access-date=7 December 2020|work=France24|date=13 November 2020}}</ref> [[2009.]] godine dogodila se [[Akvizicija poduzeća|akvizicija]] EUFETS i JPT Peptide Technologies.<ref>{{Citation|language=en|url=https://www.biontech-imfs.de/news-events/news-post/news/eufets-becomes-biontech-innovative-manufacturing-services/|title=Eufets Becomes BioNTech Innovative Manufacturing Services|publisher=BioNTech IMFS|date=18 September 2017|access-date=11 November 2020}}</ref><ref>{{cite web|url=https://www.genomeweb.com/proteomics/theracode-acquire-jpt-peptide-technologies#.X85h3NhKhnI|title=TheraCode to Acquire JPT Peptide Technologies|date=11 May 2009|publisher=GenomeWeb|access-date=7 December 2020}}</ref> [[2013.]] godine Katalin Karikó pridružila se tvrtki BioNTech kao viša potpredsjednica.<ref>{{Cite web|url=https://forbes.hu/uzlet/hanyatatott-sorsu-magyar-szabadalom-is-kellett-a-most-bejelentett-vakcinahoz/|title=Magyar kutató, hányatatott sorsú szabadalma is kellett a most bejelentett vakcinához {{!}} Forbes.hu|date=2020-11-09|website=forbes.hu|language=hu|access-date=2020-12-22}}</ref>
BioNTech je osnovan [[2008.]] godine na temelju istraživanja [[Uğur Şahin|Uğura Şahina]], [[Özlem Türeci|Özlema Türecija]],<ref>{{Cite web|url=https://www.france24.com/en/live-news/20201113-biontech-s-founders-scientist-couple-in-global-spotlight|title=BioNTech's founders: scientist couple in global spotlight|date=2020-11-13|website=France 24|language=en|access-date=2020-12-22}}</ref> i Christoph Hubera,<ref name="browne">{{cite news|author1=Ryan Browne|title=What you need to know about BioNTech — the European company behind Pfizer's Covid-19 vaccine|url=https://www.cnbc.com/2020/11/11/biontech-the-european-company-behind-pfizers-covid-19-vaccine.html|access-date=7 December 2020|work=CNBC|date=11 November 2020}}</ref> s početnim ulaganjem od 150 milijuna [[Euro|eura]].<ref>{{Cite web|url=https://investors.biontech.de/node/6751/html#toc|title=SEC Filing {{!}} BioNTech|website=investors.biontech.de|access-date=2020-12-28}}</ref> Djelatnosti tvrtke usmjerene su na razvoj i proizvodnju tehnologija i lijekova za individualiziranu imunoterapiju raka.<ref name="SEC report" /> Andreas i Thomas Strüngmann, Michael Motschmann i Helmut Jeggle bili su suosnivači.<ref name="france24">{{cite news|title=BioNTech's founders: scientist couple in global spotlight|url=https://www.france24.com/en/live-news/20201113-biontech-s-founders-scientist-couple-in-global-spotlight|access-date=7 December 2020|work=France24|date=13 November 2020}}</ref> [[2009.]] godine dogodila se [[Akvizicija poduzeća|akvizicija]] EUFETS i JPT Peptide Technologies.<ref>{{Citation|language=en|url=https://www.biontech-imfs.de/news-events/news-post/news/eufets-becomes-biontech-innovative-manufacturing-services/|title=Eufets Becomes BioNTech Innovative Manufacturing Services|publisher=BioNTech IMFS|date=18 September 2017|access-date=11 November 2020}}</ref><ref>{{Citiranje weba|url=https://www.genomeweb.com/proteomics/theracode-acquire-jpt-peptide-technologies#.X85h3NhKhnI|title=TheraCode to Acquire JPT Peptide Technologies|date=11 May 2009|publisher=GenomeWeb|access-date=7 December 2020}}</ref> [[2013.]] godine Katalin Karikó pridružila se tvrtki BioNTech kao viša potpredsjednica.<ref>{{Cite web|url=https://forbes.hu/uzlet/hanyatatott-sorsu-magyar-szabadalom-is-kellett-a-most-bejelentett-vakcinahoz/|title=Magyar kutató, hányatatott sorsú szabadalma is kellett a most bejelentett vakcinához {{!}} Forbes.hu|date=2020-11-09|website=forbes.hu|language=hu|access-date=2020-12-22}}</ref>


=== Proširenje (2014. - 2019.) ===
=== Proširenje (2014. - 2019.) ===
Između [[2014.]] i [[2018.]] godine, BioNTech je objavio mnoge rezultate istraživanja mehanizama mRNA.<ref>{{Citation|language=en|last1=Kranz|first1=Lena M.|last2=Diken|first2=Mustafa|last3=Haas|first3=Heinrich|last4=Kreiter|first4=Sebastian|last5=Loquai|first5=Carmen|title=Systemic RNA delivery to dendritic cells exploits antiviral defence for cancer immunotherapy|newspaper=Nature|volume=534|issue=7607|date=16 June 2016|issn=1476-4687|pages=396–401|url=https://pubmed.ncbi.nlm.nih.gov/27281205/|access-date=11 November 2020|doi=10.1038/nature18300|pmid=27281205|bibcode=2016Natur.534..396K}}</ref> Programi suradnje i komercijalizacije zaključeni su s raznim tvrtkama i znanstvenim institucijama počevši od [[2015.]]<ref>{{cite web|url=https://www.fiercebiotech.com/biotech/genentech-lays-310-million-wager-biontech-s-mrna-cancer-vaccine-platform|title=Genentech lays $310M wager on BioNTech's mRNA cancer vaccine platform|date=21 September 2016|publisher=FierceBiotech|access-date=7 December 2020|author1=Nick Paul Taylor}}</ref> Tijekom tog razdoblja, BioNTech je podnio nekoliko patentnih prijava i razvio višeslojnu strategiju zaštite svog intelektualnog vlasništva na različitim tehnološkim platformama i njihovu primjenu u liječenju raka i drugih ozbiljnih bolesti.
Između [[2014.]] i [[2018.]] godine, BioNTech je objavio mnoge rezultate istraživanja mehanizama mRNA.<ref>{{Citation|language=en|last1=Kranz|first1=Lena M.|last2=Diken|first2=Mustafa|last3=Haas|first3=Heinrich|last4=Kreiter|first4=Sebastian|last5=Loquai|first5=Carmen|title=Systemic RNA delivery to dendritic cells exploits antiviral defence for cancer immunotherapy|newspaper=Nature|volume=534|issue=7607|date=16 June 2016|issn=1476-4687|pages=396–401|url=https://pubmed.ncbi.nlm.nih.gov/27281205/|access-date=11 November 2020|doi=10.1038/nature18300|pmid=27281205|bibcode=2016Natur.534..396K}}</ref> Programi suradnje i komercijalizacije zaključeni su s raznim tvrtkama i znanstvenim institucijama počevši od [[2015.]]<ref>{{Citiranje weba|url=https://www.fiercebiotech.com/biotech/genentech-lays-310-million-wager-biontech-s-mrna-cancer-vaccine-platform|title=Genentech lays $310M wager on BioNTech's mRNA cancer vaccine platform|date=21 September 2016|publisher=FierceBiotech|access-date=7 December 2020|author1=Nick Paul Taylor}}</ref> Tijekom tog razdoblja, BioNTech je podnio nekoliko patentnih prijava i razvio višeslojnu strategiju zaštite svog intelektualnog vlasništva na različitim tehnološkim platformama i njihovu primjenu u liječenju raka i drugih ozbiljnih bolesti.


U [[Rujan|rujnu]] [[2019.]] BioNTech je primio kapitalno ulaganje od 55 milijuna [[Američki dolar|američkih dolara]] od Zaklade Bill & Melinda Gates, s mogućnošću da taj iznos ulaganja naknadno udvostruči.<ref>{{Cite web|url=https://investors.biontech.de/news-releases/news-release-details/biontech-announces-new-collaboration-develop-hiv-and|title=BioNTech Announces New Collaboration to Develop HIV and Tuberculosis Programs|date=2019-09-04|publisher=BioNTech|access-date=2020-12-27}}</ref>
U [[Rujan|rujnu]] [[2019.]] BioNTech je primio kapitalno ulaganje od 55 milijuna [[Američki dolar|američkih dolara]] od Zaklade Bill & Melinda Gates, s mogućnošću da taj iznos ulaganja naknadno udvostruči.<ref>{{Cite web|url=https://investors.biontech.de/news-releases/news-release-details/biontech-announces-new-collaboration-develop-hiv-and|title=BioNTech Announces New Collaboration to Develop HIV and Tuberculosis Programs|date=2019-09-04|publisher=BioNTech|access-date=2020-12-27}}</ref>
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== Ulaganja ==
== Ulaganja ==
U [[Prosinac|prosincu]] 2019. BioNTech je dobio 50 milijuna eura financiranja od Europske investicijske banke u sklopu Plana ulaganja Europske komisije za [[Europa|Europu]].<ref name="PR December 17, 2019">{{cite web|url=https://ec.europa.eu/commission/presscorner/detail/en/IP_19_6796|title=European Investment Bank provides funding of €50 million to BioNTech as part of the Investment Plan for Europe|author=<!--Not stated-->|date=17 December 2019|language=en|publisher=[[European Commission]]|access-date=21 November 2020}}</ref>
U [[Prosinac|prosincu]] 2019. BioNTech je dobio 50 milijuna eura financiranja od Europske investicijske banke u sklopu Plana ulaganja Europske komisije za [[Europa|Europu]].<ref name="PR December 17, 2019">{{Citiranje weba|url=https://ec.europa.eu/commission/presscorner/detail/en/IP_19_6796|title=European Investment Bank provides funding of €50 million to BioNTech as part of the Investment Plan for Europe|author=<!--Not stated-->|date=17 December 2019|language=en|publisher=[[European Commission]]|access-date=21 November 2020}}</ref>


U [[Lipanj|lipnju]] 2020. godine BioNTech je dobio 250 milijuna eura od Temasek Holdings ([[Singapur]]) kupnjom običnih dionica i četverogodišnjih konvertibilnih novčanica,<ref>{{cite news|last=Burger|first=Ludwig|date=29 June 2020|title=Temasek-led investor group in $250 million vaccine bet on Germany's BioNTech|url=https://www.reuters.com/article/us-biontech-placement/temasek-led-investor-group-in-250-million-vaccine-bet-on-germanys-biontech-idUSKBN2400PS|work=[[Reuters]]|location=[[Frankfurt]]|access-date=2 August 2020}}</ref> ali i od drugih investitora privatnim plasiranjem obveznih konvertibilnih obveznica. Također je od Europske investicijske banke primila 100 milijuna eura za financiranje duga.<ref name="PR June 11, 2020">{{cite web|url=https://ec.europa.eu/commission/presscorner/detail/en/ip_20_1034|title=Investment Plan for Europe: European Investment Bank to provide BioNTech with up to €100 million in debt financing for COVID-19 vaccine development and manufacturing|author=<!--Not stated-->|date=11 June 2020|language=en|publisher=[[European Commission]]|access-date=21 November 2020}}</ref>
U [[Lipanj|lipnju]] 2020. godine BioNTech je dobio 250 milijuna eura od Temasek Holdings ([[Singapur]]) kupnjom običnih dionica i četverogodišnjih konvertibilnih novčanica,<ref>{{cite news|last=Burger|first=Ludwig|date=29 June 2020|title=Temasek-led investor group in $250 million vaccine bet on Germany's BioNTech|url=https://www.reuters.com/article/us-biontech-placement/temasek-led-investor-group-in-250-million-vaccine-bet-on-germanys-biontech-idUSKBN2400PS|work=[[Reuters]]|location=[[Frankfurt]]|access-date=2 August 2020}}</ref> ali i od drugih investitora privatnim plasiranjem obveznih konvertibilnih obveznica. Također je od Europske investicijske banke primila 100 milijuna eura za financiranje duga.<ref name="PR June 11, 2020">{{Citiranje weba|url=https://ec.europa.eu/commission/presscorner/detail/en/ip_20_1034|title=Investment Plan for Europe: European Investment Bank to provide BioNTech with up to €100 million in debt financing for COVID-19 vaccine development and manufacturing|author=<!--Not stated-->|date=11 June 2020|language=en|publisher=[[European Commission]]|access-date=21 November 2020}}</ref>


== Lokacije ==
== Lokacije ==
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[[Datoteka:Covid19_vaccine_biontech_pfizer_3.jpg|mini|Tozinameran (Pfizer-BioNTech COVID-19 cjepivo)]]
[[Datoteka:Covid19_vaccine_biontech_pfizer_3.jpg|mini|Tozinameran (Pfizer-BioNTech COVID-19 cjepivo)]]


Projekt razvoja nove mRNA tehnologije za cjepivo COVID-19 nazvan je "Projekt Lightspeed", koji je započeo sredinom [[Siječanj|siječnja]] 2020. godine, samo nekoliko dana nakon što je genetska sekvenca [[SARS-CoV-2]] prvi put objavljena u javnosti.<ref>{{cite web|url=https://biontech.de/covid-19|title=Aiming to address the global coronavirus pandemic: Project Lightspeed|date=2020|publisher=BioNTech|access-date=13 December 2020}}</ref> [[Tvrtka]] radi na razvoju tozinameran RNA cjepiva s [[Pfizer|Pfizerom]]<ref>{{cite news|last=Lovelace Jr.|first=Berkeley|date=27 July 2020|title=Pfizer and BioNTech began late-stage human trial for coronavirus vaccine Monday|url=https://www.cnbc.com/2020/07/27/pfizer-and-biontech-began-late-stage-human-trial-for-coronavirus-vaccine-monday.html|work=[[CNBC]]|access-date=2 August 2020}}</ref> i [[Fosun|Fosunom]].<ref>{{cite news|author=<!--Not stated.-->|title=BioNTech in China alliance with Fosun over coronavirus vaccine candidate|url=https://www.reuters.com/article/biontech-fosunpharma-vaccine-collaborati/biontech-in-china-alliance-with-fosun-over-coronavirus-vaccine-candidate-idUSL8N2B90UW|work=[[Reuters]]|location=[[Frankfurt]]|date=15 March 2020|access-date=2 August 2020}}</ref><ref>{{cite news|last=Burger|first=Ludwig|title=Germany approves trials of COVID-19 vaccine candidate|url=https://www.reuters.com/article/us-health-coronavirus-vaccine-biontech/germany-approves-trials-of-covid-19-vaccine-candidate-idUSKCN2241DN|work=[[Reuters]]|location=[[Berlin]]|date=22 April 2020|access-date=2 August 2020}}</ref>
Projekt razvoja nove mRNA tehnologije za cjepivo COVID-19 nazvan je "Projekt Lightspeed", koji je započeo sredinom [[Siječanj|siječnja]] 2020. godine, samo nekoliko dana nakon što je genetska sekvenca [[SARS-CoV-2]] prvi put objavljena u javnosti.<ref>{{Citiranje weba|url=https://biontech.de/covid-19|title=Aiming to address the global coronavirus pandemic: Project Lightspeed|date=2020|publisher=BioNTech|access-date=13 December 2020}}</ref> [[Tvrtka]] radi na razvoju tozinameran RNA cjepiva s [[Pfizer|Pfizerom]]<ref>{{cite news|last=Lovelace Jr.|first=Berkeley|date=27 July 2020|title=Pfizer and BioNTech began late-stage human trial for coronavirus vaccine Monday|url=https://www.cnbc.com/2020/07/27/pfizer-and-biontech-began-late-stage-human-trial-for-coronavirus-vaccine-monday.html|work=[[CNBC]]|access-date=2 August 2020}}</ref> i [[Fosun|Fosunom]].<ref>{{cite news|author=<!--Not stated.-->|title=BioNTech in China alliance with Fosun over coronavirus vaccine candidate|url=https://www.reuters.com/article/biontech-fosunpharma-vaccine-collaborati/biontech-in-china-alliance-with-fosun-over-coronavirus-vaccine-candidate-idUSL8N2B90UW|work=[[Reuters]]|location=[[Frankfurt]]|date=15 March 2020|access-date=2 August 2020}}</ref><ref>{{cite news|last=Burger|first=Ludwig|title=Germany approves trials of COVID-19 vaccine candidate|url=https://www.reuters.com/article/us-health-coronavirus-vaccine-biontech/germany-approves-trials-of-covid-19-vaccine-candidate-idUSKCN2241DN|work=[[Reuters]]|location=[[Berlin]]|date=22 April 2020|access-date=2 August 2020}}</ref>


Proizvodnju cjepiva slijedila su klinička ispitivanja čiji je uspjeh bio preduvjet za početak stavljanja na tržište. [[9. studenoga|9. studenog]] 2020. BioNTech i Pfizer objavili su da je 43.500 ljudi u 6 zemalja dobilo testno cjepivo protiv [[COVID-19]], a klinička ispitivanja imala su više od 90 posto učinkovitosti. Na temelju uspješnog testiranja zatražili su pravo distribucije cjepiva u [[SAD|Sjedinjenim Državama]], kao i u [[Europska unija|Europskoj uniji]], [[Ujedinjeno Kraljevstvo|Ujedinjenom Kraljevstvu]] i [[Japan|Japanu]].<ref>{{Cite news|date=2020-11-09|title=Covid vaccine: First 'milestone' vaccine offers 90% protection|language=en-GB|work=BBC News|url=https://www.bbc.com/news/health-54873105|access-date=2020-12-22}}</ref>
Proizvodnju cjepiva slijedila su klinička ispitivanja čiji je uspjeh bio preduvjet za početak stavljanja na tržište. [[9. studenoga|9. studenog]] 2020. BioNTech i Pfizer objavili su da je 43.500 ljudi u 6 zemalja dobilo testno cjepivo protiv [[COVID-19]], a klinička ispitivanja imala su više od 90 posto učinkovitosti. Na temelju uspješnog testiranja zatražili su pravo distribucije cjepiva u [[SAD|Sjedinjenim Državama]], kao i u [[Europska unija|Europskoj uniji]], [[Ujedinjeno Kraljevstvo|Ujedinjenom Kraljevstvu]] i [[Japan|Japanu]].<ref>{{Cite news|date=2020-11-09|title=Covid vaccine: First 'milestone' vaccine offers 90% protection|language=en-GB|work=BBC News|url=https://www.bbc.com/news/health-54873105|access-date=2020-12-22}}</ref>
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BioNTech i [[Pfizer]] potpisali su ugovore o isporuci 300 milijuna doza cjepiva protiv [[SARS-CoV-2]] za Europsku uniju,<ref>{{cite news|date=11 November 2020|title=Coronavirus: EU buys 300m doses of BioNTech-Pfizer vaccine|work=[[BBC News]]|location=[[United Kingdom]]|url=https://www.bbc.co.uk/news/world-europe-54902056|access-date=12 November 2020}}</ref> 120 milijuna doza za Japan,<ref>{{cite news|last1=Shakil|first1=Ismail|last2=Mishra|first2=Manas|date=31 July 2020|title=Pfizer, BioNTech to supply 120 million doses of coronavirus vaccine to Japan|url=https://www.reuters.com/article/us-health-coronavirus-japan-pfizer-biont/pfizer-biontech-to-supply-120-million-doses-of-coronavirus-vaccine-to-japan-idUSKCN24W1CY|work=[[Reuters]]|location=[[Bengaluru]]|access-date=3 August 2020}}</ref> 100 milijuna doza za Sjedinjene Države<ref>{{cite news|last1=Erman|first1=Michael|last2=Banerjee|first2=Ankur|date=22 July 2020|title=U.S. to pay Pfizer, BioNTech $1.95 billion for COVID-19 vaccine|url=https://www.reuters.com/article/us-health-coronavirus-usa-pfizer/u-s-to-pay-pfizer-biontech-1-95-billion-for-covid-19-vaccine-idUSKCN24N1I9|work=[[Reuters]]|access-date=2 August 2020}}</ref> i 40 milijuna doza za Ujedinjeno Kraljevstvo,<ref>{{cite news|last=Gallagher|first=James|date=20 July 2020|title=Coronavirus vaccine: UK government signs deals for 90 million doses|url=https://www.bbc.com/news/health-53469269|work=[[BBC News]]|access-date=2 August 2020}}</ref><ref>{{cite news|last=Smout|first=Alistair|date=20 July 2020|title=Britain secures 90 million possible COVID-19 vaccine doses from Pfizer/BioNTech, Valneva|url=https://www.reuters.com/article/us-health-coronavirus-britain-vaccines/britain-secures-90-million-possible-covid-19-vaccine-doses-from-pfizer-biontech-valneva-idUSKCN24L0GN|work=[[Reuters]]|location=[[London]]|access-date=2 August 2020}}</ref> ako se pokaže učinkovitim, sigurnim i licenciranim.
BioNTech i [[Pfizer]] potpisali su ugovore o isporuci 300 milijuna doza cjepiva protiv [[SARS-CoV-2]] za Europsku uniju,<ref>{{cite news|date=11 November 2020|title=Coronavirus: EU buys 300m doses of BioNTech-Pfizer vaccine|work=[[BBC News]]|location=[[United Kingdom]]|url=https://www.bbc.co.uk/news/world-europe-54902056|access-date=12 November 2020}}</ref> 120 milijuna doza za Japan,<ref>{{cite news|last1=Shakil|first1=Ismail|last2=Mishra|first2=Manas|date=31 July 2020|title=Pfizer, BioNTech to supply 120 million doses of coronavirus vaccine to Japan|url=https://www.reuters.com/article/us-health-coronavirus-japan-pfizer-biont/pfizer-biontech-to-supply-120-million-doses-of-coronavirus-vaccine-to-japan-idUSKCN24W1CY|work=[[Reuters]]|location=[[Bengaluru]]|access-date=3 August 2020}}</ref> 100 milijuna doza za Sjedinjene Države<ref>{{cite news|last1=Erman|first1=Michael|last2=Banerjee|first2=Ankur|date=22 July 2020|title=U.S. to pay Pfizer, BioNTech $1.95 billion for COVID-19 vaccine|url=https://www.reuters.com/article/us-health-coronavirus-usa-pfizer/u-s-to-pay-pfizer-biontech-1-95-billion-for-covid-19-vaccine-idUSKCN24N1I9|work=[[Reuters]]|access-date=2 August 2020}}</ref> i 40 milijuna doza za Ujedinjeno Kraljevstvo,<ref>{{cite news|last=Gallagher|first=James|date=20 July 2020|title=Coronavirus vaccine: UK government signs deals for 90 million doses|url=https://www.bbc.com/news/health-53469269|work=[[BBC News]]|access-date=2 August 2020}}</ref><ref>{{cite news|last=Smout|first=Alistair|date=20 July 2020|title=Britain secures 90 million possible COVID-19 vaccine doses from Pfizer/BioNTech, Valneva|url=https://www.reuters.com/article/us-health-coronavirus-britain-vaccines/britain-secures-90-million-possible-covid-19-vaccine-doses-from-pfizer-biontech-valneva-idUSKCN24L0GN|work=[[Reuters]]|location=[[London]]|access-date=2 August 2020}}</ref> ako se pokaže učinkovitim, sigurnim i licenciranim.


Dana [[10. studenoga]] [[2020.]] nakon pozitivne privremene analize faze III kliničkog ispitivanja u Sjedinjenim Državama, partneri BioNTech-Pfizer podnijeli su zahtjev za hitnua uporabu s FDA-om, koji bi trebao pregledati prijavu do sredine prosinca.<ref name="FDA PR 20201120">{{cite press release|title=Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate|website=U.S. [[Food and Drug Administration]] (FDA)|url=https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-advisory-committee-meeting-discuss-covid-19-vaccine|access-date=20 November 2020}} {{PD-notice}}</ref><ref name="stat11-20">{{cite web|url=https://www.statnews.com/2020/11/20/pfizer-biontech-submit-formal-application-to-fda-to-authorize-covid-19-vaccine/|title=Pfizer, BioNTech submit formal application to FDA to authorize Covid-19 vaccine|date=20 November 2020|publisher=STAT|access-date=25 November 2020|author1=Helen Branswell}}</ref> FDA je objavila dokument u kojem se objašnjava da je EUA "mehanizam koji olakšava dostupnost i upotrebu medicinskih protumjera, uključujući cjepiva, tijekom hitnih slučajeva u javnom zdravstvu, poput trenutne [[Pandemija COVID-19|pandemije COVID-19]]".<ref name="fda-eua">{{cite web|url=https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained|title=Emergency Use Authorization for Vaccines Explained|date=20 November 2020|website=U.S. [[Food and Drug Administration]]|access-date=20 November 2020}} {{PD-notice}}</ref> U studenom je Pfizer predao EUA prijavu u [[Kanada|Kanadi]].<ref name="dangerfield">{{cite news|author1=Katie Dangerfield|title=Pfizer files for emergency use of coronavirus vaccine in U.S. — what about in Canada?|url=https://globalnews.ca/news/7474273/pfizer-emergency-use-coronavirus-vaccine-canada/|access-date=25 November 2020|work=Global News|date=20 November 2020}}</ref>
Dana [[10. studenoga]] [[2020.]] nakon pozitivne privremene analize faze III kliničkog ispitivanja u Sjedinjenim Državama, partneri BioNTech-Pfizer podnijeli su zahtjev za hitnua uporabu s FDA-om, koji bi trebao pregledati prijavu do sredine prosinca.<ref name="FDA PR 20201120">{{cite press release|title=Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate|website=U.S. [[Food and Drug Administration]] (FDA)|url=https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-advisory-committee-meeting-discuss-covid-19-vaccine|access-date=20 November 2020}} {{PD-notice}}</ref><ref name="stat11-20">{{Citiranje weba|url=https://www.statnews.com/2020/11/20/pfizer-biontech-submit-formal-application-to-fda-to-authorize-covid-19-vaccine/|title=Pfizer, BioNTech submit formal application to FDA to authorize Covid-19 vaccine|date=20 November 2020|publisher=STAT|access-date=25 November 2020|author1=Helen Branswell}}</ref> FDA je objavila dokument u kojem se objašnjava da je EUA "mehanizam koji olakšava dostupnost i upotrebu medicinskih protumjera, uključujući cjepiva, tijekom hitnih slučajeva u javnom zdravstvu, poput trenutne [[Pandemija COVID-19|pandemije COVID-19]]".<ref name="fda-eua">{{Citiranje weba|url=https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained|title=Emergency Use Authorization for Vaccines Explained|date=20 November 2020|website=U.S. [[Food and Drug Administration]]|access-date=20 November 2020}} {{PD-notice}}</ref> U studenom je Pfizer predao EUA prijavu u [[Kanada|Kanadi]].<ref name="dangerfield">{{cite news|author1=Katie Dangerfield|title=Pfizer files for emergency use of coronavirus vaccine in U.S. — what about in Canada?|url=https://globalnews.ca/news/7474273/pfizer-emergency-use-coronavirus-vaccine-canada/|access-date=25 November 2020|work=Global News|date=20 November 2020}}</ref>


[[Ujedinjeno Kraljevstvo]] je [[2. prosinca]] 2020. odobrilo uvjetnu privremenu dozvolu (prema Uredbi 174 Propisa o humanim lijekovima iz [[2012.]]) za BNT162b2,<ref name="uk12-2a">{{cite web|url=https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/940728/Conditions_of_Authorisation_for_Pfizer_BioNTech_COVID-19_vaccine.pdf|title=Conditions of Authorisation for Pfizer/BioNTech COVID-19 vaccine|date=2 December 2020|language=en|publisher=Government of the United Kingdom|access-date=2 December 2020}}</ref> postavši prva država koja je odobrila mRNA cjepivo i prva zapadna država koja je odobrila [[cjepivo protiv COVID-19]] za nacionalnu upotrebu.<ref name="uk12-2">{{cite web|url=https://www.gov.uk/government/news/uk-medicines-regulator-gives-approval-for-first-uk-covid-19-vaccine|title=UK medicines regulator gives approval for first UK COVID-19 vaccine|date=2 December 2020|language=en|publisher=Government of the United Kingdom|access-date=2 December 2020}}</ref><ref>{{Cite news|date=2 December 2020|title=Covid Pfizer vaccine approved for use next week in UK|first=Michelle|last=Roberts|language=en-GB|work=[[BBC]]|url=https://www.bbc.com/news/health-55145696|access-date=2 December 2020}}</ref> BNT162b2 bio je na procjeni tijekom prosinca za status odobrenja za hitnu uporabu (EUA) u nekoliko drugih zemalja.<ref name="mueller">{{cite news|author1=Benjamin Mueller|title=U.K. Approves Pfizer coronavirus vaccine, a first in the West|url=https://www.nytimes.com/2020/12/02/world/europe/pfizer-coronavirus-vaccine-approved-uk.html|access-date=2 December 2020|work=The New York Times|date=2 December 2020}}</ref>
[[Ujedinjeno Kraljevstvo]] je [[2. prosinca]] 2020. odobrilo uvjetnu privremenu dozvolu (prema Uredbi 174 Propisa o humanim lijekovima iz [[2012.]]) za BNT162b2,<ref name="uk12-2a">{{Citiranje weba|url=https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/940728/Conditions_of_Authorisation_for_Pfizer_BioNTech_COVID-19_vaccine.pdf|title=Conditions of Authorisation for Pfizer/BioNTech COVID-19 vaccine|date=2 December 2020|language=en|publisher=Government of the United Kingdom|access-date=2 December 2020}}</ref> postavši prva država koja je odobrila mRNA cjepivo i prva zapadna država koja je odobrila [[cjepivo protiv COVID-19]] za nacionalnu upotrebu.<ref name="uk12-2">{{Citiranje weba|url=https://www.gov.uk/government/news/uk-medicines-regulator-gives-approval-for-first-uk-covid-19-vaccine|title=UK medicines regulator gives approval for first UK COVID-19 vaccine|date=2 December 2020|language=en|publisher=Government of the United Kingdom|access-date=2 December 2020}}</ref><ref>{{Cite news|date=2 December 2020|title=Covid Pfizer vaccine approved for use next week in UK|first=Michelle|last=Roberts|language=en-GB|work=[[BBC]]|url=https://www.bbc.com/news/health-55145696|access-date=2 December 2020}}</ref> BNT162b2 bio je na procjeni tijekom prosinca za status odobrenja za hitnu uporabu (EUA) u nekoliko drugih zemalja.<ref name="mueller">{{cite news|author1=Benjamin Mueller|title=U.K. Approves Pfizer coronavirus vaccine, a first in the West|url=https://www.nytimes.com/2020/12/02/world/europe/pfizer-coronavirus-vaccine-approved-uk.html|access-date=2 December 2020|work=The New York Times|date=2 December 2020}}</ref>


[[Europska agencija za lijekove]] (EMA) odobrila je jednogodišnju uvjetnu uporabu cjepiva BioNTech / Pfizer u Europskoj uniji [[21. prosinca]] 2020. Emer Cooke, direktor EMA-e, izjavio je da blagodati cjepiva daleko premašuju potencijalne rizike. Cijena doze cjepiva BioNTech / Pfizer iznosi 12 EUR (za usporedbu ovo košta više od četiri od njegovih budućih pet konkurenata: Oxford / AstraZeneca: 1,78 EUR; Johnson & Johnson: 8,50 EUR; [[Sanofi]] / GSK: 7,56 EUR; CureVac : 10 eura, ali Modernina cjepiva su skuplja i koštaju 18 eura.)<ref>{{Cite web|url=https://www.politico.eu/article/belgian-secretary-of-state-accidentally-reveals-eu-vaccine-prices/|title=Belgian secretary of state accidentally reveals EU vaccine prices|date=2020-12-17|website=POLITICO|language=en-US|access-date=2020-12-22}}</ref> Prema sporazumu, par koji proizvodi cjepivo, BioNTech i Pfizer, podliježe strožoj zakonskoj obvezi da sve stečeno iskustvo EMA-i donesu za pregled.<ref>{{Cite web|url=https://koronavirus.gov.hu/cikkek/az-europai-gyogyszerugynokseg-forgalmazasra-ajanlja-pfizerbiontech-vakcinat|title=Az Európai Gyógyszerügynökség forgalmazásra ajánlja a Pfizer/BioNTech-vakcinát|date=2020-12-21|website=koronavirus.gov.hu|language=hu|access-date=2020-12-22}}</ref>
[[Europska agencija za lijekove]] (EMA) odobrila je jednogodišnju uvjetnu uporabu cjepiva BioNTech / Pfizer u Europskoj uniji [[21. prosinca]] 2020. Emer Cooke, direktor EMA-e, izjavio je da blagodati cjepiva daleko premašuju potencijalne rizike. Cijena doze cjepiva BioNTech / Pfizer iznosi 12 EUR (za usporedbu ovo košta više od četiri od njegovih budućih pet konkurenata: Oxford / AstraZeneca: 1,78 EUR; Johnson & Johnson: 8,50 EUR; [[Sanofi]] / GSK: 7,56 EUR; CureVac : 10 eura, ali Modernina cjepiva su skuplja i koštaju 18 eura.)<ref>{{Cite web|url=https://www.politico.eu/article/belgian-secretary-of-state-accidentally-reveals-eu-vaccine-prices/|title=Belgian secretary of state accidentally reveals EU vaccine prices|date=2020-12-17|website=POLITICO|language=en-US|access-date=2020-12-22}}</ref> Prema sporazumu, par koji proizvodi cjepivo, BioNTech i Pfizer, podliježe strožoj zakonskoj obvezi da sve stečeno iskustvo EMA-i donesu za pregled.<ref>{{Cite web|url=https://koronavirus.gov.hu/cikkek/az-europai-gyogyszerugynokseg-forgalmazasra-ajanlja-pfizerbiontech-vakcinat|title=Az Európai Gyógyszerügynökség forgalmazásra ajánlja a Pfizer/BioNTech-vakcinát|date=2020-12-21|website=koronavirus.gov.hu|language=hu|access-date=2020-12-22}}</ref>

Inačica od 21. prosinac 2021. u 23:53

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  1. PREUSMJERI Predložak:Stilska dorada
  2. PREUSMJERI Predložak:Infookvir tvrtka

BioNTech SE ili BioNTech je njemačka tvrtka za biotehnologiju sa sjedištem u Mainzu koja razvija i proizvodi aktivne imunoterapije za pristupe liječenju bolesti specifične za pacijenta. Razvija farmaceutske kandidate na bazi ribonukleinske kiseline (mRNA) za uporabu kao individualizirane imunoterapije raka, kao cjepiva protiv zaraznih bolesti i kao nadomjesne terapije proteina za rijetke bolesti, a također je osmislio i staničnu terapiju, nova antitijela i imunomodulatore malih molekula kao mogućnosti liječenja raka.

Tvrtka je razvila humanu terapiju na osnovi mRNA za intravensku primjenu kako bi u klinička ispitivanja dovela individualiziranu imunoterapiju raka na osnovi mRNA i uspostavila vlastiti proizvodni postupak.[1]

Godine 2020. BioNTech je zajedno s Pfizerom razvio RNK cjepivo BNT162b2 za sprečavanje infekcija COVID-19, koje nudi 95% učinkovitost.[2] Vlada Ujedinjenog Kraljevstva odobrila je 2. prosinca 2020. privremeno odobrenje za HMR za cijepljenje BNT162b2 u Velikoj Britaniji. Bilo je to prvo mRNA cjepivo ikad odobreno. Nekoliko dana kasnije, cjepivo je također hitno odobreno u Sjedinjenim Državama,[3] Kanadi,[4] i Švicarskoj.[5] Europska komisija je 21. prosinca 2020. odobrila BioNTech / Pfizerovo cjepivo protiv koronavirusa u skladu s pozitivnom preporukom Europske agencije za lijekove (EMA).[6]

Povijest

Temelj i razvoj (2008. - 2013.)

BioNTech je osnovan 2008. godine na temelju istraživanja Uğura Şahina, Özlema Türecija,[7] i Christoph Hubera,[8] s početnim ulaganjem od 150 milijuna eura.[9] Djelatnosti tvrtke usmjerene su na razvoj i proizvodnju tehnologija i lijekova za individualiziranu imunoterapiju raka.[1] Andreas i Thomas Strüngmann, Michael Motschmann i Helmut Jeggle bili su suosnivači.[10] 2009. godine dogodila se akvizicija EUFETS i JPT Peptide Technologies.[11][12] 2013. godine Katalin Karikó pridružila se tvrtki BioNTech kao viša potpredsjednica.[13]

Proširenje (2014. - 2019.)

Između 2014. i 2018. godine, BioNTech je objavio mnoge rezultate istraživanja mehanizama mRNA.[14] Programi suradnje i komercijalizacije zaključeni su s raznim tvrtkama i znanstvenim institucijama počevši od 2015.[15] Tijekom tog razdoblja, BioNTech je podnio nekoliko patentnih prijava i razvio višeslojnu strategiju zaštite svog intelektualnog vlasništva na različitim tehnološkim platformama i njihovu primjenu u liječenju raka i drugih ozbiljnih bolesti.

U rujnu 2019. BioNTech je primio kapitalno ulaganje od 55 milijuna američkih dolara od Zaklade Bill & Melinda Gates, s mogućnošću da taj iznos ulaganja naknadno udvostruči.[16]

Od 10. listopada 2019. godine, BioNTech, sa svojim novoosnovanim sjedištem u Sjevernoj Americi u Cambridgeu, Massachusetts, javno se trguje kao američka depozitarna dionica (ADS) na Nasdaq Global Select Marketu pod oznakom BNTX.[17] BioNTech je uspio ostvariti ukupan bruto prihod od 150 milijuna dolara od IPO-a.[18]

Ulaganja

U prosincu 2019. BioNTech je dobio 50 milijuna eura financiranja od Europske investicijske banke u sklopu Plana ulaganja Europske komisije za Europu.[19]

U lipnju 2020. godine BioNTech je dobio 250 milijuna eura od Temasek Holdings (Singapur) kupnjom običnih dionica i četverogodišnjih konvertibilnih novčanica,[20] ali i od drugih investitora privatnim plasiranjem obveznih konvertibilnih obveznica. Također je od Europske investicijske banke primila 100 milijuna eura za financiranje duga.[21]

Lokacije

Mjesto osnivanja i globalnog sjedišta BioNTecha je Mainz, Njemačka. Tvrtka vodi više lokacija u gradu. Daljnja istraživačka mjesta nalaze se u San Diegu i Cambridgeu (Massachusetts) sa sjedištem u Sjevernoj Americi.

Uz to, tvrtka posjeduje GMP certificirane proizvodne pogone u Idar-Obersteinu, Martinsriedu, Neuriedu i Berlinu. U studenom 2020. tvrtka je od Novartisa u Marburgu nabavila pogone za povećanje proizvodnje cjepiva.

Razvoj cjepiva

Podrobniji članak o temi: Cjepivo protiv COVID-19
Tozinameran (Pfizer-BioNTech COVID-19 cjepivo)

Projekt razvoja nove mRNA tehnologije za cjepivo COVID-19 nazvan je "Projekt Lightspeed", koji je započeo sredinom siječnja 2020. godine, samo nekoliko dana nakon što je genetska sekvenca SARS-CoV-2 prvi put objavljena u javnosti.[22] Tvrtka radi na razvoju tozinameran RNA cjepiva s Pfizerom[23] i Fosunom.[24][25]

Proizvodnju cjepiva slijedila su klinička ispitivanja čiji je uspjeh bio preduvjet za početak stavljanja na tržište. 9. studenog 2020. BioNTech i Pfizer objavili su da je 43.500 ljudi u 6 zemalja dobilo testno cjepivo protiv COVID-19, a klinička ispitivanja imala su više od 90 posto učinkovitosti. Na temelju uspješnog testiranja zatražili su pravo distribucije cjepiva u Sjedinjenim Državama, kao i u Europskoj uniji, Ujedinjenom Kraljevstvu i Japanu.[26]

Distribucija

BioNTech i Pfizer potpisali su ugovore o isporuci 300 milijuna doza cjepiva protiv SARS-CoV-2 za Europsku uniju,[27] 120 milijuna doza za Japan,[28] 100 milijuna doza za Sjedinjene Države[29] i 40 milijuna doza za Ujedinjeno Kraljevstvo,[30][31] ako se pokaže učinkovitim, sigurnim i licenciranim.

Dana 10. studenoga 2020. nakon pozitivne privremene analize faze III kliničkog ispitivanja u Sjedinjenim Državama, partneri BioNTech-Pfizer podnijeli su zahtjev za hitnua uporabu s FDA-om, koji bi trebao pregledati prijavu do sredine prosinca.[32][33] FDA je objavila dokument u kojem se objašnjava da je EUA "mehanizam koji olakšava dostupnost i upotrebu medicinskih protumjera, uključujući cjepiva, tijekom hitnih slučajeva u javnom zdravstvu, poput trenutne pandemije COVID-19".[34] U studenom je Pfizer predao EUA prijavu u Kanadi.[35]

Ujedinjeno Kraljevstvo je 2. prosinca 2020. odobrilo uvjetnu privremenu dozvolu (prema Uredbi 174 Propisa o humanim lijekovima iz 2012.) za BNT162b2,[36] postavši prva država koja je odobrila mRNA cjepivo i prva zapadna država koja je odobrila cjepivo protiv COVID-19 za nacionalnu upotrebu.[37][38] BNT162b2 bio je na procjeni tijekom prosinca za status odobrenja za hitnu uporabu (EUA) u nekoliko drugih zemalja.[39]

Europska agencija za lijekove (EMA) odobrila je jednogodišnju uvjetnu uporabu cjepiva BioNTech / Pfizer u Europskoj uniji 21. prosinca 2020. Emer Cooke, direktor EMA-e, izjavio je da blagodati cjepiva daleko premašuju potencijalne rizike. Cijena doze cjepiva BioNTech / Pfizer iznosi 12 EUR (za usporedbu ovo košta više od četiri od njegovih budućih pet konkurenata: Oxford / AstraZeneca: 1,78 EUR; Johnson & Johnson: 8,50 EUR; Sanofi / GSK: 7,56 EUR; CureVac : 10 eura, ali Modernina cjepiva su skuplja i koštaju 18 eura.)[40] Prema sporazumu, par koji proizvodi cjepivo, BioNTech i Pfizer, podliježe strožoj zakonskoj obvezi da sve stečeno iskustvo EMA-i donesu za pregled.[41]

Nakon odobrenja, masovno cijepljenje protiv koronavirusa započelo je prvi put u Mađarskoj i Slovačkoj u Europskoj uniji 26. prosinca 2020.[42]

Vidi još

Izvori

  1. ↑ 1,0 1,1 BioNTech SE (9. rujan 2019.) (engl.), Form F-1, U.S. Securities and Exchange Commission, https://sec.report/Document/0001193125-19-241112/, pristupljeno 23. rujan 2020. 
  2. ↑ https://www.fda.gov/media/144245/download
  3. ↑ (engl.) Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/pfizer-biontech-covid-19-vaccine-frequently-asked-questions, pristupljeno 22. prosinac 2020. 
  4. ↑ (engl.) Pfizer-BioNTech COVID-19 vaccine: What you should know, https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/vaccines/pfizer-biontech.html, pristupljeno 22. prosinac 2020. 
  5. ↑ (engl.) Swissmedic grants authorisation for the first COVID-19 vaccine in Switzerland, https://www.swissmedic.ch/swissmedic/en/home/news/coronavirus-covid-19/covid-19-impfstoff_erstzulassung.html, pristupljeno 22. prosinac 2020. 
  6. ↑ "Commission approves BioNTech/Pfizer vaccine" (engl.). 21. prosinac 2020.. https://www.politico.eu/article/european-commission-approves-biontech-pfizer-vaccine/ Pristupljeno 22. prosinac 2020. 
  7. ↑ "BioNTech's founders: scientist couple in global spotlight" (engl.). 13. studeni 2020.. https://www.france24.com/en/live-news/20201113-biontech-s-founders-scientist-couple-in-global-spotlight Pristupljeno 22. prosinac 2020. 
  8. ↑ Ryan Browne (11. studeni 2020.). "What you need to know about BioNTech — the European company behind Pfizer's Covid-19 vaccine". CNBC. https://www.cnbc.com/2020/11/11/biontech-the-european-company-behind-pfizers-covid-19-vaccine.html Pristupljeno 7. prosinac 2020. 
  9. ↑ "SEC Filing | BioNTech". https://investors.biontech.de/node/6751/html#toc Pristupljeno 28. prosinac 2020. 
  10. ↑ "BioNTech's founders: scientist couple in global spotlight". France24. 13. studeni 2020.. https://www.france24.com/en/live-news/20201113-biontech-s-founders-scientist-couple-in-global-spotlight Pristupljeno 7. prosinac 2020. 
  11. ↑ (engl.) Eufets Becomes BioNTech Innovative Manufacturing Services, BioNTech IMFS, 18. rujan 2017., https://www.biontech-imfs.de/news-events/news-post/news/eufets-becomes-biontech-innovative-manufacturing-services/, pristupljeno 11. studeni 2020. 
  12. ↑ "TheraCode to Acquire JPT Peptide Technologies". GenomeWeb. 11. svibanj 2009.. https://www.genomeweb.com/proteomics/theracode-acquire-jpt-peptide-technologies#.X85h3NhKhnI Pristupljeno 7. prosinac 2020. 
  13. ↑ "Magyar kutató, hányatatott sorsú szabadalma is kellett a most bejelentett vakcinához | Forbes.hu" (mađ.). 9. studeni 2020.. https://forbes.hu/uzlet/hanyatatott-sorsu-magyar-szabadalom-is-kellett-a-most-bejelentett-vakcinahoz/ Pristupljeno 22. prosinac 2020. 
  14. ↑ Kranz, Lena M.; Diken, Mustafa; Haas, Heinrich; Kreiter, Sebastian; Loquai, Carmen (16. lipanj 2016.), "Systemic RNA delivery to dendritic cells exploits antiviral defence for cancer immunotherapy" (engl.), Nature 534 (7607): 396–401, Bibcode 2016Natur.534..396K, doi:10.1038/nature18300, ISSN 1476-4687, PMID 27281205, https://pubmed.ncbi.nlm.nih.gov/27281205/, pristupljeno 11. studeni 2020. 
  15. ↑ Nick Paul Taylor (21. rujan 2016.). "Genentech lays $310M wager on BioNTech's mRNA cancer vaccine platform". FierceBiotech. https://www.fiercebiotech.com/biotech/genentech-lays-310-million-wager-biontech-s-mrna-cancer-vaccine-platform Pristupljeno 7. prosinac 2020. 
  16. ↑ "BioNTech Announces New Collaboration to Develop HIV and Tuberculosis Programs". BioNTech. 4. rujan 2019.. https://investors.biontech.de/news-releases/news-release-details/biontech-announces-new-collaboration-develop-hiv-and Pristupljeno 27. prosinac 2020. 
  17. ↑ (engl.) BioNTech SE, Nasdaq, https://www.nasdaq.com/market-activity/stocks/bntx, pristupljeno 12. studeni 2020. 
  18. ↑ Spalding, Rebecca; Franklin, Joshua (9. listopad 2019.). "Germany's BioNTech raises $150 million in smaller-than-planned U.S. IPO amid market volatility". Reuters. https://www.reuters.com/article/us-biontech-ipo-idUSKBN1WO29B Pristupljeno 7. prosinac 2020. 
  19. ↑ "European Investment Bank provides funding of €50 million to BioNTech as part of the Investment Plan for Europe" (engl.). European Commission. 17. prosinac 2019.. https://ec.europa.eu/commission/presscorner/detail/en/IP_19_6796 Pristupljeno 21. studeni 2020. 
  20. ↑ Burger, Ludwig (29. lipanj 2020.). "Temasek-led investor group in $250 million vaccine bet on Germany's BioNTech". Reuters (Frankfurt). https://www.reuters.com/article/us-biontech-placement/temasek-led-investor-group-in-250-million-vaccine-bet-on-germanys-biontech-idUSKBN2400PS Pristupljeno 2. kolovoz 2020. 
  21. ↑ "Investment Plan for Europe: European Investment Bank to provide BioNTech with up to €100 million in debt financing for COVID-19 vaccine development and manufacturing" (engl.). European Commission. 11. lipanj 2020.. https://ec.europa.eu/commission/presscorner/detail/en/ip_20_1034 Pristupljeno 21. studeni 2020. 
  22. ↑ "Aiming to address the global coronavirus pandemic: Project Lightspeed". BioNTech. 2020. https://biontech.de/covid-19 Pristupljeno 13. prosinac 2020. 
  23. ↑ Lovelace Jr., Berkeley (27. srpanj 2020.). "Pfizer and BioNTech began late-stage human trial for coronavirus vaccine Monday". CNBC. https://www.cnbc.com/2020/07/27/pfizer-and-biontech-began-late-stage-human-trial-for-coronavirus-vaccine-monday.html Pristupljeno 2. kolovoz 2020. 
  24. ↑ "BioNTech in China alliance with Fosun over coronavirus vaccine candidate". Reuters (Frankfurt). 15. ožujak 2020.. https://www.reuters.com/article/biontech-fosunpharma-vaccine-collaborati/biontech-in-china-alliance-with-fosun-over-coronavirus-vaccine-candidate-idUSL8N2B90UW Pristupljeno 2. kolovoz 2020. 
  25. ↑ Burger, Ludwig (22. travanj 2020.). "Germany approves trials of COVID-19 vaccine candidate". Reuters (Berlin). https://www.reuters.com/article/us-health-coronavirus-vaccine-biontech/germany-approves-trials-of-covid-19-vaccine-candidate-idUSKCN2241DN Pristupljeno 2. kolovoz 2020. 
  26. ↑ "Covid vaccine: First 'milestone' vaccine offers 90% protection" (engl.). BBC News. 9. studeni 2020.. https://www.bbc.com/news/health-54873105 Pristupljeno 22. prosinac 2020. 
  27. ↑ "Coronavirus: EU buys 300m doses of BioNTech-Pfizer vaccine". BBC News (United Kingdom). 11. studeni 2020.. https://www.bbc.co.uk/news/world-europe-54902056 Pristupljeno 12. studeni 2020. 
  28. ↑ Shakil, Ismail; Mishra, Manas (31. srpanj 2020.). "Pfizer, BioNTech to supply 120 million doses of coronavirus vaccine to Japan". Reuters (Bengaluru). https://www.reuters.com/article/us-health-coronavirus-japan-pfizer-biont/pfizer-biontech-to-supply-120-million-doses-of-coronavirus-vaccine-to-japan-idUSKCN24W1CY Pristupljeno 3. kolovoz 2020. 
  29. ↑ Erman, Michael; Banerjee, Ankur (22. srpanj 2020.). "U.S. to pay Pfizer, BioNTech $1.95 billion for COVID-19 vaccine". Reuters. https://www.reuters.com/article/us-health-coronavirus-usa-pfizer/u-s-to-pay-pfizer-biontech-1-95-billion-for-covid-19-vaccine-idUSKCN24N1I9 Pristupljeno 2. kolovoz 2020. 
  30. ↑ Gallagher, James (20. srpanj 2020.). "Coronavirus vaccine: UK government signs deals for 90 million doses". BBC News. https://www.bbc.com/news/health-53469269 Pristupljeno 2. kolovoz 2020. 
  31. ↑ Smout, Alistair (20. srpanj 2020.). "Britain secures 90 million possible COVID-19 vaccine doses from Pfizer/BioNTech, Valneva". Reuters (London). https://www.reuters.com/article/us-health-coronavirus-britain-vaccines/britain-secures-90-million-possible-covid-19-vaccine-doses-from-pfizer-biontech-valneva-idUSKCN24L0GN Pristupljeno 2. kolovoz 2020. 
  32. ↑ Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate. Tiskovno izdanje. Ovaj članak sadrži tekst iz ovog izvora, koji je u javnom vlasništvu.
  33. ↑ Helen Branswell (20. studeni 2020.). "Pfizer, BioNTech submit formal application to FDA to authorize Covid-19 vaccine". STAT. https://www.statnews.com/2020/11/20/pfizer-biontech-submit-formal-application-to-fda-to-authorize-covid-19-vaccine/ Pristupljeno 25. studeni 2020. 
  34. ↑ "Emergency Use Authorization for Vaccines Explained". 20. studeni 2020.. https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained Pristupljeno 20. studeni 2020.  Ovaj članak sadrži tekst iz ovog izvora, koji je u javnom vlasništvu.
  35. ↑ Katie Dangerfield (20. studeni 2020.). "Pfizer files for emergency use of coronavirus vaccine in U.S. — what about in Canada?". Global News. https://globalnews.ca/news/7474273/pfizer-emergency-use-coronavirus-vaccine-canada/ Pristupljeno 25. studeni 2020. 
  36. ↑ "Conditions of Authorisation for Pfizer/BioNTech COVID-19 vaccine" (engl.). Government of the United Kingdom. 2. prosinac 2020.. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/940728/Conditions_of_Authorisation_for_Pfizer_BioNTech_COVID-19_vaccine.pdf Pristupljeno 2. prosinac 2020. 
  37. ↑ "UK medicines regulator gives approval for first UK COVID-19 vaccine" (engl.). Government of the United Kingdom. 2. prosinac 2020.. https://www.gov.uk/government/news/uk-medicines-regulator-gives-approval-for-first-uk-covid-19-vaccine Pristupljeno 2. prosinac 2020. 
  38. ↑ Roberts, Michelle (2. prosinac 2020.). "Covid Pfizer vaccine approved for use next week in UK" (engl.). BBC. https://www.bbc.com/news/health-55145696 Pristupljeno 2. prosinac 2020. 
  39. ↑ Benjamin Mueller (2. prosinac 2020.). "U.K. Approves Pfizer coronavirus vaccine, a first in the West". The New York Times. https://www.nytimes.com/2020/12/02/world/europe/pfizer-coronavirus-vaccine-approved-uk.html Pristupljeno 2. prosinac 2020. 
  40. ↑ "Belgian secretary of state accidentally reveals EU vaccine prices" (engl.). 17. prosinac 2020.. https://www.politico.eu/article/belgian-secretary-of-state-accidentally-reveals-eu-vaccine-prices/ Pristupljeno 22. prosinac 2020. 
  41. ↑ "Az Európai Gyógyszerügynökség forgalmazásra ajánlja a Pfizer/BioNTech-vakcinát" (mađ.). 21. prosinac 2020.. https://koronavirus.gov.hu/cikkek/az-europai-gyogyszerugynokseg-forgalmazasra-ajanlja-pfizerbiontech-vakcinat Pristupljeno 22. prosinac 2020. 
  42. ↑ Binnie, Anita Komuves, Benoit Van Overstraeten, Isla (27. prosinac 2020.). "'Window of hope': Europe begins to launch COVID-19 vaccinations" (engl.). Reuters. https://www.reuters.com/article/health-coronavirus-europe-vaccines-idUSKBN29102Y Pristupljeno 27. prosinac 2020. 
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