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Vrstica 75:
S [[klinično preskušanje|kliničnim preskušanjem]] cepiva so začeli aprila 2020, do aprila 2020 pa je bilo preskušeno že na več kot 40.000 posameznikih.<ref name="BioNTechUpdate"/> Vmesna analiza podatkov preskušanja je pokazala več kot 90-odstotno učinkovitost preprečevanja okužbe po sedmem dnevu po drugem odmerku.<ref name="palca">{{cite web |vauthors=Palca J |title=Pfizer says experimental COVID-19 vaccine is more than 90% effective |url=https://www.npr.org/sections/health-shots/2020/11/09/933006651/pfizer-says-experimental-covid-19-vaccine-is-more-than-90-effective |work=NPR |date=9. 11. 2020 |access-date=9. 11. 2020 |archive-date=9. 11. 2020 |archive-url=https://web.archive.org/web/20201109130110/https://www.npr.org/sections/health-shots/2020/11/09/933006651/pfizer-says-experimental-covid-19-vaccine-is-more-than-90-effective |url-status=live }}</ref><ref name="herper">{{cite web |vauthors=Herper M |title=Covid-19 vaccine from Pfizer and BioNTech is strongly effective, early data from large trial indicate |url=https://www.statnews.com/2020/11/09/covid-19-vaccine-from-pfizer-and-biontech-is-strongly-effective-early-data-from-large-trial-indicate/ |work=[[Stat (website)|STAT]] |access-date=9. 11. 2020 |date=9. 11. 2020 |archive-date=9. 11. 2020 |archive-url=https://web.archive.org/web/20201109114554/https://www.statnews.com/2020/11/09/covid-19-vaccine-from-pfizer-and-biontech-is-strongly-effective-early-data-from-large-trial-indicate/ |url-status=live }}</ref> Najpogostejši [[neželeni učinek|neželeni učinki]] blago do zmerno [[bolečina|bolečino]] na mestu injiciranja, utrujenost in [[glavobol]].<ref>{{cite journal | vauthors=Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Pérez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW, Hammitt LL, Türeci Ö, Nell H, Schaefer A, Ünal S, Tresnan DB, Mather S, Dormitzer PR, Şahin U, Jansen KU, Gruber WC | display-authors=6 |title=Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine |journal=N Engl J Med |volume= 383|issue= 27|pages= 2603–2615|date=december 2020 |pmid=33301246 |doi=10.1056/NEJMoa2034577 | pmc=7745181 |doi-access=free }}</ref><ref>{{cite web | title=Questions and Answers About Pfizer-BioNTech COVID-19 Vaccine | publisher=Pfizer | url=https://www.cvdvaccine-us.com/faqs | access-date=16. 12. 2020}}</ref> Poročila o hudih neželenih učinkih, kot je alergijska reakcija, so bila zelo redka, o dolgoročnih zapletih pa niso poročali (podatek za december 2020).<ref name=nhs-cvac/>
== Razvoj in financiranje ==
Pred cepivom proti covidu 19 ni bilo nobeno cepivo proti katerikoli nalezljivi bolezni proizvedeno v manj kot nekaj letih, prav tako pa ni obstajalo nobeno cepivo za preprečevanje drugih [[koronavirus]]nih okužb pri človeku.<ref name="gates2">{{Cite web|last=Gates|first=Bill |date=30. 4. 2020|title=The vaccine race explained: What you need to know about the COVID-19 vaccine|url= https://www.gatesnotes.com/Health/What-you-need-to-know-about-the-COVID-19-vaccine |url-status=live|archive-url= https://web.archive.org/web/20200514010012/https://www.gatesnotes.com/Health/What-you-need-to-know-about-the-COVID-19-vaccine |archive-date=14. 5. 2020|access-date=2. 5. 2020|publisher=The Gates Notes|name-list-style=vanc}}</ref> Nov koronavirus so odkrili decembra 2019,<ref name="who-time">{{Cite web|date=27. 4. 2020|title=World Health Organization timeline – COVID-19|url=https://www.who.int/news-room/detail/27-04-2020-who-timeline---covid-19|url-status=live|archive-url=https://web.archive.org/web/20200429012212/https://www.who.int/news-room/detail/27-04-2020-who-timeline---covid-19|archive-date=29. 4. 2020|access-date=2. 5. 2020|publisher=Svetvna zdravstvena organizacija}}</ref> z razvojem cepiva BNT162b2 pa so pričeli 10. januarja 2020, ko so objavili zaporedje genoma virusa SARS-CoV-2.<ref name="Polack">{{Cite journal|last=Polack|first=Fernando|date=10. 12. 2020|title=Safety and Efficacy of the mRNA Covid-19 Vaccine|journal=New England Journal of Medicine|volume=383|issue=27|pages=2603–2615|doi=10.1056/NEJMoa2034577|pmid=33301246|pmc=7745181|quote=development of BNT162b2 was initiated on January 10, 2020, when the SARS-CoV-2 genetic sequence was released by the Chinese Center for Disease Control and Prevention and disseminated globally by the GISAID (Global Initiative on Sharing All Influenza Data) initiative|doi-access=free}}</ref><ref name="Bohn">{{Cite journal |last=Bohn |first=Mary Kathryn |date=7. 10. 2020 |title=IFCC Interim Guidelines on Molecular Testing of SARS-CoV-2 Infection |url=https://www.degruyter.com/view/journals/cclm/ahead-of-print/article-10.1515-cclm-2020-1412/article-10.1515-cclm-2020-1412.xml |journal=Clinical Chemistry and Laboratory Medicine |volume=58 |issue=12 |pages=1993–2000 |doi=10.1515/cclm-2020-1412 |pmid=33027042 |via=|doi-access=free }}</ref><ref>{{Cite news|last=|first=|date=November 23, 2020|title=CEPI's collaborative task force to assess COVID-19 vaccines on emerging viral strains|work=BioSpectrum - Asia Edition|url=https://www.biospectrumasia.com/news/83/17161/cepis-collaborative-task-force-to-assess-covid-19-vaccines-on-emerging-viral-strains.html|url-status=live|quote=the first SARS-CoV-2 viral genomes were shared via GISAID on 10 January 2020}}</ref> Širjenje novega virusa je sprožilo mednarodni odziv v smislu priprav na izbruhe ter pohitritve razvoja potencialnih cepiv.<ref name="thanh">{{cite journal | last1=Thanh Le | first1=Tung | last2=Andreadakis | first2=Zacharias | last3=Kumar | first3=Arun | last4=Gómez Román | first4=Raúl | last5=Tollefsen | first5=Stig | last6=Saville | first6=Melanie | last7=Mayhew | first7=Stephen | display-authors=6 | title=The COVID-19 vaccine development landscape | journal=Nature Reviews Drug Discovery | date=9. 4. 2020 | volume=19 | issue=5 | pages=305–306 | issn=1474-1776 | doi=10.1038/d41573-020-00073-5 | pmid=32273591 | doi-access=free | name-list-style=vanc }}</ref><ref name="Fauci">{{cite journal|vauthors=Fauci AS, Lane HC, Redfield RR|date=March 2020|title=Covid-19: Navigating the uncharted|journal=The New England Journal of Medicine |volume=382|issue=13|pages=1268–69 |doi=10.1056/nejme2002387|pmc=7121221|pmid=32109011}}</ref>
Vrstica 101:
}}</ref>
Družba Fosun je marca 2020 vložila v podjetje [[BioNTech]] 135 milijonov dolarjev in s tem pridobila 1,58 milijona BioNTechovih delnic ter pravice za trženje cepiva BNT162b2 na Kitajskem,<ref name="fosun">{{cite news |vauthors=Burger L |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 |access-date=10. 11. 2020 |work=Reuters |date=15. 3. 2020 |archive-date=14. 11. 2020 |archive-url=https://web.archive.org/web/20201114132914/https://www.reuters.com/article/biontech-fosunpharma-vaccine-collaborati/biontech-in-china-alliance-with-fosun-over-coronavirus-vaccine-candidate-idUSL8N2B90UW |url-status=live }}</ref> v [[Hong Kong|Hong Kongu]], [[Macao|Macau]] in na [[Tajvan]]u.<ref>《[http://www.fosunpharma.com/en/news/news-details-3801.html Fosun Pharma and BioNTech form COVID-19 vaccine strategic alliance in China]》（Fosun Phrama News Content , 15. 3. 2020）</ref> Podjetje BioNTech je za razvoj cepiva proti covidu 19 pridobilo tudi denarna sredstva nemške vlade, in sicer 375 milijonov evrov,<ref>{{cite news |title=BioNTech gets $445 million in German funding for vaccine |url=https://www.bloomberg.com/news/articles/2020-09-15/biontech-gets-445-million-in-german-funding-for-covid-vaccine |access-date=10. 11. 2020 |work=Bloomberg.com |date=15. 9. 2020 |archive-date=9. 11. 2020 |archive-url=https://web.archive.org/web/20201109130431/https://www.bloomberg.com/news/articles/2020-09-15/biontech-gets-445-million-in-german-funding-for-covid-vaccine |url-status=live }}</ref> ter 100 milijonov od [[Evropska komisija|Evropske komisije]] in [[Evropska investicijska banka|Evropske investicijske banke]].<ref name="eib">{{cite web |title=Germany: Investment Plan for Europe – EIB to provide BioNTech with up to €100 million in debt financing for COVID-19 vaccine development and manufacturing |url=https://www.eib.org/en/press/all/2020-144-eib-to-provide-biontech-with-up-to-eur-100-million-in-debt-financing-for-covid-19-vaccine-development-and-manufacturing |publisher=European Investment Bank |access-date=10. 11. 2020 |date=11. 6. 2020 |archive-date=9. 11. 2020 |archive-url=https://web.archive.org/web/20201109174611/https://www.eib.org/en/press/all/2020-144-eib-to-provide-biontech-with-up-to-eur-100-million-in-debt-financing-for-covid-19-vaccine-development-and-manufacturing |url-status=live }}</ref>
===Klinična preskušanja===
Preliminarni rezultati [[klinično preskušanje|kliničnih preskušanj]] 1./2. faze so bili objavljeni oktobra 2020 in so kazali ba ugodno učinkovitost in varnost.<ref name="pmid33053279"/><ref name="mulligan">{{cite journal | vauthors = Mulligan MJ, Lyke KE, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Raabe V, Bailey R, Swanson KA, Li P, Koury K, Kalina W, Cooper D, Fontes-Garfias C, Shi PY, Türeci Ö, Tompkins KR, Walsh EE, Frenck R, Falsey AR, Dormitzer PR, Gruber WC, Şahin U, Jansen KU | display-authors = 6 | title = Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults | journal = Nature | volume = 586 | issue = 7830 | pages = 589–593 | date = October 2020 | pmid = 32785213 | doi = 10.1038/s41586-020-2639-4 | s2cid = 221126922 }}</ref> Istega meseca je [[Evropska agencija za zdravila]] (EMA) pričela s sprotnim pregledom dokumentacije cepiva BNT162b2.<ref>{{cite news |vauthors=Hannah B |date=7. 10. 2020 |title=EMA begins rolling review of BNT162b2 COVID-19 vaccine |work=European Pharmaceutical Review |url=https://www.europeanpharmaceuticalreview.com/news/129817/ema-begins-rolling-review-of-bnt162b2-covid-19-vaccine |access-date=11. 11. 2020 |archive-date=11. 11. 2020 |archive-url=https://web.archive.org/web/20201111123200/https://www.europeanpharmaceuticalreview.com/news/129817/ema-begins-rolling-review-of-bnt162b2-covid-19-vaccine/ |url-status=live }}</ref> Gre za kontinuirano klinično preskušanje, ki je prešlo v 3. fazo.<ref name="NCT04368728"/> Klinično preskušanje je randomizirano, nadzorovano s placebom in delno slepo, s ciljem ovrednotiti ustrezen odmerek, izbrati ustrezno kandidatno cepivo (izmed dveh vključenih cepiv, BNT162b1 in BNT162b2) ter ovrednotiti učinkovitost in varnost pri zdravih posameznikih.<ref name="NCT04368728"/> Tekom preskušanja so izbrali cepivo BNT162b2 za nadaljno vrednotenje pri večjem številu posameznikov in določitev. Vključenih je bilo več držav in več deset tisoč posameznikov, ki so prejeli preskušano cepivo. V kliničnem preskušanju podjetje BioNTech sodeluje s Pfizerjem in Fosunom.<ref name=herper/><ref name=fosun/>
The Phase III trial assesses the safety, efficacy, tolerability, and [[immunogenicity]] of BNT162b2 at a mid-dose level (two injections separated by 21 days) in three age groups: 12–15 years, 16–55 years or above 55 years.<ref name="NCT04368728"/> For approval in the EU, an overall vaccine efficacy of 95% was confirmed by the EMA.<ref name=":0">{{Cite web|last=|first=|date=21 December 2020|title=EMA Assessment Report|url=https://www.ema.europa.eu/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf|url-status=live|archive-url=|archive-date=|access-date=29 December 2020|website=www.ema.europa.eu}}</ref>
{| class="wikitable"
|+Vaccine Efficacy <small>–</small> <small>After Dose 1 or 2 over all ages and after Dose 2 overall and over age groups</small><ref name=":0" />
!Efficacy endpoint
!Vaccine efficacy (95% Confidence interval) [%]
|-
|After Dose 1 to before Dose 2
|52.4 (29.5, 68.4)
|-
|≥10 days after Dose 1 to before Dose 2
|86.7 (68.6, 95.4)
|-
|Dose 2 to 7 days after Dose 2
|90.5 (61.0, 98.9)
|-
| colspan="2" |≥7 Days after Dose 2 <sup>(Subjects without evidence of infection prior to 7 days after dose 2)</sup>
|-
|Overall
|'''95.0 (90.0, 97.9)'''
|-
|16 to 55 years
|95.6 (89.4, 98.6)
|-
|≥55 years
|93.7 (80.6, 98.8)
|-
|≥65 years
|94.7 (66.7, 99.9)
|}
The ongoing Phase III trial, which is scheduled to run from 2020 to 2022, is designed to assess the ability of BNT162b2 to prevent severe infection, as well as the duration of [[immune response|immune effect]].<ref name="herper" /><ref name="edwards">{{cite news|vauthors=Edwards E|date=9 November 2020|title=Pfizer's Covid-19 vaccine promising, but many questions remain|work=NBC News|url=https://www.nbcnews.com/health/health-news/pfizer-s-covid-19-vaccine-promising-many-questions-remain-n1247102|access-date=12 November 2020|archive-date=22 November 2020|archive-url=https://web.archive.org/web/20201122161113/https://www.nbcnews.com/health/health-news/pfizer-s-covid-19-vaccine-promising-many-questions-remain-n1247102|url-status=live}}</ref><ref name="bbc"/>
== Neželeni učinki ==
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