「トジナメラン」の版間の差分
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Mizuki Ayase (会話 | 投稿記録) タグ: モバイル編集 モバイルウェブ編集 改良版モバイル編集 |
m →概要 : リダイレクト先を修正 |
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{{Pathnav|[[SARSコロナウイルス2|新型コロナウイルス (SARS-CoV-2)]]|[[新型コロナウイルス感染症 (2019年)|新型コロナウイルス感染症（COVID-19）]]|COVID-19ワクチン|this=ファイザー-バイオンテック (Tozinameran)|frame=1}}
{{Infobox drug
|
| verifiedrevid =
| drug_name = ファイザー-バイオンテックCOVID‑19ワクチン Tozinameran
| INN = tozinameran
| type = vaccine
| image = Covid19 vaccine biontech pfizer 3.jpg
| alt =
| width =
| caption = ファイザー-バイオンテックCOVID-19ワクチンのバイアル<!-- A vial of the Pfizer–BioNTech COVID‑19 vaccine -->
<!-- Vaccine data -->
| target = <!-- COVID‑19 -->[[新型コロナウイルス感染症]]
| vaccine_type = mRNA
<!-- Clinical data -->
| pronounce =
| tradename = コミナティ<!-- Comirnaty --><ref name="Swiss authorization" /><ref name="Comirnaty EPAR" />
| Drugs.com =
|
|
| DailyMedID = Pfizer-BioNTech_COVID-19_Vaccine
| licence_US = <!-- FDA may use generic or brand name (generic name preferred) -->
|
| pregnancy_AU_comment = <ref>{{cite web|title=Comirnaty|url=https://www.tga.gov.au/apm-summary/comirnaty|access-date=25 January 2021|website=[[:en:Therapeutic Goods Administration|Therapeutic Goods Administration]] (TGA)}}</ref>
| pregnancy_category =
| routes_of_administration = [[筋肉内注射]]
| ATC_prefix = None <!-- scheduled to be J07BX03 in 2022 -->
| ATC_suffix =
| ATC_supplemental =
<!-- Legal status -->
| legal_AU = S4
| legal_AU_comment = <ref>{{cite web | title=Comirnaty (BNT162b2 [mRNA]) COVID‑19 Vaccine Product Information | website=[[:en:Therapeutic Goods Administration|Therapeutic Goods Administration]] (TGA) | url=https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2021-PI-01092-1 | format=PDF | accessdate=25 January 2021}}</ref><ref>{{cite report | url=https://www.tga.gov.au/sites/default/files/auspar-bnt162b2-mrna-210125.pdf | title=Australian Public Assessment Report for BNT162b2 (mRNA) | publisher=[[:en:Therapeutic Goods Administration|Therapeutic Goods Administration]] (TGA) | accessdate=25 January 2021}}</ref>
| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F -->
| legal_BR_comment =
| legal_CA = Authorized by interim order
| legal_CA_comment = <ref name= "hcreg"/><ref name="CA Pfizer-BioNTech product description" />
| legal_DE = <!-- Anlage I, II, III or Unscheduled -->
| legal_DE_comment =
| legal_NZ = <!-- Class A, B, C -->
| legal_NZ_comment =
| legal_UK = Conditional and temporary authorization to supply
| legal_UK_comment = <ref name="MHRA product information">{{cite web | title=Information for Healthcare Professionals on Pfizer/BioNTech COVID-19 vaccine | website=[[Medicines and Healthcare products Regulatory Agency]] (MHRA) | date=10 December 2020 | url=https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/information-for-healthcare-professionals-on-pfizerbiontech-covid-19-vaccine | access-date=21 December 2020}}</ref><ref>{{cite web | title=Conditions of Authorisation for Pfizer/BioNTech COVID-19 vaccine | website=[[Medicines and Healthcare products Regulatory Agency]] (MHRA) | date=31 December 2020 | url=https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/conditions-of-authorisation-for-pfizerbiontech-covid-19-vaccine | access-date=8 January 2021}}</ref>
| legal_US = Unapproved
| legal_US_comment = ([[:en:Emergency Use Authorization|Emergency Use Authorization]])<ref name="FDA PR 20201211">{{cite press release | title=FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine | publisher=U.S. [[:en:Food and Drug Administration|Food and Drug Administration]] (FDA) | date=11 December 2020 | url=https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19 | access-date=11 December 2020}} {{PD-notice}}</ref><ref name="Pfizer-BioNTech COVID-19 Vaccine FDA label">{{cite web | title=Pfizer-BioNTech COVID-19 Vaccine- rna ingredient bnt-162b2 injection, suspension | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=908ecbe7-2f1b-42dd-94bf-f917ec3c5af8 | access-date=14 December 2020}}</ref><ref name="FDAEUA">{{cite report | url=https://www.fda.gov/media/144416/download | format=PDF | title=Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Review Memorandum | website=U.S. [[:en:Food and Drug Administration|Food and Drug Administration]] (FDA) | date=14 December 2020 | accessdate=14 December 2020}} {{PD-notice}}</ref>
| legal_EU = Conditional marketing authorization granted
| legal_EU_comment = <ref name="Comirnaty EPAR" />
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->
| legal_UN_comment =
| legal_status = <!-- For countries not listed above --> {{abbr|CH|Switzerland|class=country-name}}: Rx-only{{explain|date=January 2021}}<ref name="Swiss authorization" />
<!-- Identifiers -->
| CAS_number = 2417899-77-3
| CAS_supplemental =
| PubChem =
| PubChemSubstance = 434370509
| IUPHAR_ligand =
| DrugBank = DB15696
| ChemSpiderID =
| UNII = 5085ZFP6SJ
| KEGG = D11971
| ChEBI =
| ChEMBL =
| NIAID_ChemDB =
| synonyms = BNT162b2, COVID-19 mRNA vaccine (nucleoside-modified)
<!-- Chemical and physical data -->
|legal_JP=特例承認|legal_JP_comment=<ref name="MHLW_PR_20210214">{{Cite web|title=医薬品医療機器等法に基づく新型コロナウイルスワクチンの特例承認について|url=https://www.mhlw.go.jp/stf/newpage_16734.html|website=www.mhlw.go.jp|accessdate=2021-02-19|language=ja|publisher=厚生労働省}}</ref>}}
'''ファイザー-バイオンテックCOVID‑19ワクチン'''は、[[バイオンテック]]が[[ファイザー]]と共同で開発した[[COVID-19ワクチン]]。コードネームは'''BNT162b2'''であり、商品名として'''コミナティ筋注 (Comirnaty) '''で販売される<ref name="Comirnaty EPAR">{{cite web | title=Comirnaty EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty | access-date=23 December 2020}}</ref><ref>{{Cite web|url=https://www.yomiuri.co.jp/medical/20210208-OYT1T50168/|title=ファイザー製ワクチン、１２日に承認判断…商品名「コミナティ」|accessdate=2021年2月8日|publisher=読売新聞}}</ref>。緊急使用のために厳格な規制当局により認可された最初のCOVID-19ワクチンであり<ref name="ukgov12-2">{{cite press release |title=UK medicines regulator gives approval for first UK COVID-19 vaccine |url=https://www.gov.uk/government/news/uk-medicines-regulator-gives-approval-for-first-uk-covid-19-vaccine |publisher=[[医薬品・医療製品規制庁|Medicines and Healthcare products Regulatory Agency]] (MHRA) |access-date=2 December 2020 |date=2 December 2020}}</ref><ref name="boseley">{{cite news |first1 = Sarah | last1 = Boseley |first2 = Josh | last2 = Halliday |title=UK approves Pfizer/BioNTech Covid vaccine for rollout next week |url=https://www.theguardian.com/society/2020/dec/02/pfizer-biontech-covid-vaccine-wins-licence-for-use-in-the-uk |access-date=14 December 2020 |work=The Guardian |date=2 December 2020 |name-list-style=vanc}}</ref>、通常使用が許可された最初のワクチンである<ref name="Swiss authorization">{{cite press release |title=Swissmedic grants authorisation for the first COVID-19 vaccine in Switzerland |url=https://www.bag.admin.ch/bag/en/home/das-bag/aktuell/medienmitteilungen.msg-id-81761.html |publisher=Swiss Agency for Therapeutic Products (Swissmedic) |date=19 December 2020 |access-date=19 December 2020}}</ref>。ワクチンには有効成分の'''トジナメラン (Tozinameran) '''が含まれる<ref name="CA Pfizer-BioNTech product description">{{cite web |title=Pfizer-BioNTech COVID-19 Vaccine (tozinameran) |url=https://covid-vaccine.canada.ca/pfizer-biontech-covid-19-vaccine/product-details |publisher=Health Canada |access-date=15 December 2020}}</ref>。
== 概要 ==
[[筋肉内注射]]により接種される。脂質ナノ粒子にカプセル化された[[SARSコロナウイルス2|SARS-CoV-2]]の[[スパイクタンパク質]]の変異型をコードする[[ヌクレオシド修飾メッセンジャーRNA|ヌクレオシド修飾mRNA]] (modRNA) からなる[[RNAワクチン]]である<ref name="pmid33053279">{{cite journal | vauthors = Walsh EE, Frenck RW, Falsey AR, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Mulligan MJ, Bailey R, Swanson KA, Li P, Koury K, Kalina W, Cooper D, Fontes-Garfias C, Shi PY, Türeci Ö, Tompkins KR, Lyke KE, Raabe V, Dormitzer PR, Jansen KU, Şahin U, Gruber WC | display-authors = 6 | title = Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates | journal = The New England Journal of Medicine | date = October 2020 | volume = 383 | issue = 25 | pages = 2439–50 | pmid = 33053279 | pmc = 7583697 | doi = 10.1056/NEJMoa2027906 | doi-access=free }}</ref>。予防接種には3週間間隔で2度の接種が必要である<ref name="NCT04368728"/><ref name="palca" /><ref name="herper" />。子ども、妊婦、または免疫不全の人の重度の感染を予防することができるかは、その[[
治験は2020年4月から始まり、11月までに4万人以上で試された<ref name=BioNTechUpdate>{{cite press release |title=Update on our COVID-19 vaccine development program with BNT162b2 |url=https://investors.biontech.de/static-files/53f0968a-279b-4f82-a2fc-d67dcb6e4e91 |format=PDF |publisher=[[BioNTech]] |date=2 December 2020 |access-date=12 December 2020}}</ref>。研究データの中間解析は、2回目の服薬から7日以内に感染を予防する上で90%を超える潜在的な有効性を示した<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 November 2020 |access-date=9 November 2020 |archive-date=9 November 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 November 2020 |date=9 November 2020 |archive-date=9 November 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>。最も一般的な副作用には、注射した部位の軽度から中度の痛み、倦怠感、頭痛などがある<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 December 2020}}</ref>。2020年12月現在、アレルギー反応などの深刻な副作用の報告は非常にまれであり{{efn|name=AEfrequency|According to the [[:en:British National Formulary|British National Formulary]] and [[:en:MedDRA|MedDRA]] conventions, side effects are "very common" when they occur in more than 1 in 10 instances; "common", 1 in 100 to 1 in 10; "uncommon", 1 in 1,000 to 1 in 100; "rare", 1 in 10,000 to 1 in 1,000; and "very rare" when they occur in less than 1 in 10,000 instances.<ref name=BNF>{{cite web |url= https://bnf.nice.org.uk/guidance/adverse-reactions-to-drugs.html |title= Adverse reactions to drugs |publisher= British National Formulary |access-date= 19 December 2020}}</ref>}}、長期の合併症は報告されていない<ref name="nhs-cvac" />。第III相臨床試験が進行中で、主要評価項目のモニタリングは2021年8月まで、二次評価項目のモニタリングは2023年1月まで実施される<ref name="NCT043687282">{{ClinicalTrialsGov|NCT04368728|NCT04368728: Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals}}</ref>。
2020年12月、このワクチンは世界中のいくつかの医療規制当局により、広く使用するための[[緊急使用許可]] (EUA) の評価を受けていた。第III相試験が進行中であるため、緊急承認が必要である。一次転帰の監視は2021年8月まで継続され、二次転帰の監視は2023年1月まで継続される<ref name="NCT04368728">{{ClinicalTrialsGov|NCT04368728|NCT04368728: Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals}}</ref>。イギリスは緊急時にその使用を許可した最初の国であった<ref name="nhs-cvac">{{cite web |publisher=National Health Service |url=https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/coronavirus-vaccine/ |title=Coronavirus vaccine |date=7 December 2020 |access-date=7 December 2020 |archive-date=7 December 2020 |archive-url=https://web.archive.org/web/20201207150116/https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/coronavirus-vaccine/ |url-status=live }}</ref>。他の国はその1週間以内に続いた<ref name="hcreg">{{cite web|date=9 December 2020|title=Regulatory Decision Summary - Pfizer-BioNTech COVID-19 Vaccine|url=https://covid-vaccine.canada.ca/info/regulatory-decision-summary-detailTwo.html?linkID=RDS00730|access-date=9 December 2020|publisher=[[Health Canada]] |archive-date=9 December 2020|archive-url=https://web.archive.org/web/20201209160459/https://covid-vaccine.canada.ca/info/regulatory-decision-summary-detailTwo.html?linkID=RDS00730|url-status=live}}</ref><ref>{{cite web |title=Bahrain becomes second country to approve Pfizer COVID-19 vaccine |url=https://www.aljazeera.com/news/2020/12/4/bahrain-becomes-second-country-to-approve-pfizer-covid-19-vaccine |website=[[Al Jazeera]] |access-date=5 December 2020 |archive-date=4 December 2020 |archive-url=https://web.archive.org/web/20201204211007/https://www.aljazeera.com/news/2020/12/4/bahrain-becomes-second-country-to-approve-pfizer-covid-19-vaccine |url-status=live }} <br />* {{Cite web|date=10 December 2020|title=Coronavirus: Saudi Arabia approves Pfizer COVID-19 vaccine for use|url=https://english.alarabiya.net/en/coronavirus/2020/12/10/Coronavirus-Saudi-Arabia-approves-Pfizer-COVID-19-vaccine-for-use|access-date=10 December 2020|website=Al Arabiya English|archive-date=11 December 2020|archive-url=https://web.archive.org/web/20201211155342/https://english.alarabiya.net/en/coronavirus/2020/12/10/Coronavirus-Saudi-Arabia-approves-Pfizer-COVID-19-vaccine-for-use|url-status=live}} <br />* {{cite news |author1=Daina Beth Solomon |first2 = Noe | last2 = Torres |title=Mexico approves emergency use of Pfizer's COVID-19 vaccine |url=https://www.reuters.com/article/us-health-coronavirus-mexico-idUSKBN28M019 |access-date=12 December 2020 |work=Reuters |date=11 December 2020}} <br />* {{Cite web|last=Thomas|first=Katie|date=20 November 2020|title=F.D.A. Clears Pfizer Vaccine, and Millions of Doses Will Be Shipped Right Away|url=https://www.nytimes.com/2020/12/11/health/pfizer-vaccine-authorized.html|access-date=11 December 2020|website=The New York Times|name-list-style=vanc|archive-date=12 December 2020|archive-url=https://web.archive.org/web/20201212023020/https://www.nytimes.com/2020/12/11/health/pfizer-vaccine-authorized.html|url-status=live}}<br />* {{Cite web|date=14 December 2020|title=First shipments of Pfizer-BioNTech vaccine in Singapore by end-Dec; enough vaccines for all by Q3 2021|url=https://www.straitstimes.com/singapore/health/first-shipments-of-pfizer-biontech-vaccine-in-singapore-by-end-dec-enough-vaccines|access-date=14 December 2020|website=The Straits Times}}</ref><ref name="mulla">{{cite news |author1=Yasmena Al Mulla |title=Kuwait approves emergency use of Pfizer vaccine |url=https://gulfnews.com/world/gulf/kuwait/kuwait-approves-emergency-use-of-pfizer-vaccine-1.75875294 |access-date=14 December 2020 |work=Gulf News |date=13 December 2020}}</ref>。12月20日までに、イギリスでは50万人以上が国の予防接種プログラムの一環としてワクチンを接種した<ref name=vacstat></ref>。
バイオンテックはワクチンの最初の開発者であり、ファイザーと提携して開発、[[臨床研究]]、[[臨床試験]]、物流、財務の監督、及び世界的な製造を行っている<ref>{{cite news | last=Browne | first=Ryan | title=What you need to know about BioNTech - the European company behind Pfizer's Covid-19 vaccine | website=CNBC | date=11 November 2020 | url=https://www.cnbc.com/2020/11/11/biontech-the-european-company-behind-pfizers-covid-19-vaccine.html | access-date=14 January 2021 | name-list-style=vanc }}</ref>。ただし中国では{{仮リンク|Fosun Pharma|en|Fosun Pharma}}社によりバイオンテックへの投資とともに流通・製造のライセンスが購入されている<ref name="nytimes-2020-11-09">{{cite news|title=Pfizer's early data shows vaccine is more than 90% effective|vauthors=Thomas K, Gelles D, Zimmer C|work=The New York Times|url=https://www.nytimes.com/2020/11/09/health/covid-vaccine-pfizer.html|date=9 November 2020|access-date=9 November 2020|archive-date=23 November 2020|archive-url=https://web.archive.org/web/20201123032409/https://www.nytimes.com/2020/11/09/health/covid-vaccine-pfizer.html|url-status=live}}</ref><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 November 2020 |work=Reuters |date=15 March 2020 |archive-date=14 November 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>。ドイツとトルコではバイオンテックにより流通されている<ref>{{cite web |title=Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19 |url=https://investors.biontech.de/news-releases/news-release-details/pfizer-and-biontech-celebrate-historic-first-authorization-us |publisher=Pfizer Inc. and BioNTech SE|accessdate=2021-1}}</ref>。ファイザーは2020年11月に、2020年末までに世界で5000万回の接種が可能であり、2021年には約13億回の接種が可能であると述べている<ref name=herper/>。
ファイザーは、米国、欧州連合、イギリス、日本、カナダ、ペルー、及びメキシコで認可されたワクチンを提供するために、約30億アメリカドルの事前購入契約を結んでいる<ref name="bloom11-10">{{cite news |title=Deep-freeze hurdle makes Pfizer's vaccine one for the rich |url=https://www.bloomberg.com/news/articles/2020-11-10/deep-freeze-challenge-makes-pfizer-s-shot-a-vaccine-for-the-rich |access-date=12 November 2020 |work=Bloomberg |date=10 November 2020 |quote=Vaccine goes bad five days after thawing, requires two shots; Many nations face costly ramp up of cold-chain infrastructure |archive-date=22 November 2020 |archive-url=https://web.archive.org/web/20201122105948/https://www.bloomberg.com/news/articles/2020-11-10/deep-freeze-challenge-makes-pfizer-s-shot-a-vaccine-for-the-rich |url-status=live }}</ref>。ワクチンは、接種の5日前まで-80℃～-60℃の温度で保管する必要があり<ref name="Vaccination Storage">{{cite web | title=Pfizer-BioNTech COVID-19 Vaccine Vaccination Storage & Dry Ice Safety Handling | publisher=Pfizer | url=https://www.cvdvaccine-us.com/product-storage-and-dry-ice | access-date=17 December 2020}}</ref>、接種までは2～8℃で<ref name="bloom11-10" /><ref name="Vaccination Storage">{{cite web | title=Pfizer-BioNTech COVID-19 Vaccine Vaccination Storage & Dry Ice Safety Handling | publisher=Pfizer | url=https://www.cvdvaccine-us.com/product-storage-and-dry-ice | access-date=17 December 2020}}</ref>、25℃<ref>{{Cite web|title=Information for Healthcare Professionals on Pfizer/BioNTech COVID-19 vaccine|url=https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/information-for-healthcare-professionals-on-pfizerbiontech-covid-19-vaccine|access-date=2021-01-29|website=GOV.UK}}</ref>または30℃<ref>{{cite web|title=Recommendation for an Emergency Use Listing of Tozinameran (Covid-19 Mrna Vaccine (Nucleoside Modified)) Submitted by Biontech Manufacturing Gmbh|date=26 January 2021|url=https://extranet.who.int/pqweb/sites/default/files/documents/TAG-EUL_PublicReport_BioNTech_DEC20.pdf|publisher=World Health Organization|accessdate=2021-02-20}}</ref><ref>{{cite web|title=Australian Product Information – Comirnaty (BNT162b2 [mRNA]) COVID-19 Vaccine|work=Therapeutic Goods Administration|publisher=Australian Government|url=https://www.tga.gov.au/sites/default/files/auspar-bnt162b2-mrna-210125-pi.pdf|accessdate=2021-02-20}}</ref>以下で2時間以内に使用する必要があるため、ワクチンの配布と保管は[[物流]]上の課題である。
2021年2月14日に日本国内でも特例承認され、2月17日より医療従事者から接種が始まった<ref> {{Cite web|title=コロナワクチン、国内接種開始 医師ら4万人先行（写真=共同）|url=https://www.nikkei.com/article/DGXZQODG164BB0W1A210C2000000/|website=日本経済新聞|date=2021-02-17|accessdate=2021-02-20|language=ja}}</ref>。
== 開発および資金調達 ==
COVID-19ワクチンが開発される以前、感染症用のワクチンが数年以内で作られたことはなく、コロナウイルスのヒトへの感染を予防するワクチンは存在していなかった<ref name="gates2">{{cite web | vauthors = Gates B |date=30 April 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 May 2020|access-date=2 May 2020|publisher=The Gates Notes }}</ref>。2019年12月に[[SARSコロナウイルス2|COVID-19ウイルス]]が検出された後<ref name="who-time">{{Cite web|date=27 April 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 April 2020|access-date=2 May 2020|publisher=World Health Organization}}</ref>、2020年1月10日に[[中国疾病予防管理センター]]が[[GISAID]]を介してSARS-CoV-2[[遺伝子配列]]を公開したことをきっかけに<ref name="Polack">{{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 = The New England Journal of Medicine | volume = 383 | issue = 27 | pages = 2603–2615 | date = December 2020 | pmid = 33301246 | pmc = 7745181 | doi = 10.1056/NEJMoa2034577 | 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 | vauthors = Bohn MK, Mancini N, Loh TP, Wang CB, Grimmler M, Gramegna M, Yuen KY, Mueller R, Koch D, Sethi S, Rawlinson WD, Clementi M, Erasmus R, Leportier M, Kwon GC, Menezes ME, Patru MM, Singh K, Ferrari M, Najjar O, Horvath AR, Adeli K, Lippi G | display-authors = 6 | title = IFCC Interim Guidelines on Molecular Testing of SARS-CoV-2 Infection | journal = Clinical Chemistry and Laboratory Medicine | volume = 58 | issue = 12 | pages = 1993–2000 | date = October 2020 | pmid = 33027042 | doi = 10.1515/cclm-2020-1412 | url = https://www.degruyter.com/view/journals/cclm/ahead-of-print/article-10.1515-cclm-2020-1412/article-10.1515-cclm-2020-1412.xml | doi-access = free }}</ref><ref>{{Cite news|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|quote=the first SARS-CoV-2 viral genomes were shared via GISAID on 10 January 2020}}</ref>、BNT162b2の開発が開始され、大流行に備えて予防ワクチンの開発を急ぐための国際的な緊急対応が開始された<ref name="thanh">{{cite journal | vauthors = Thanh Le T, Andreadakis Z, Kumar A, Gómez Román R, Tollefsen S, Saville M, Mayhew S | title = The COVID-19 vaccine development landscape | journal = Nature Reviews. Drug Discovery | volume = 19 | issue = 5 | pages = 305–306 | date = May 2020 | pmid = 32273591 | doi = 10.1038/d41573-020-00073-5 | doi-access = free }}</ref><ref name="Fauci">{{cite journal | vauthors = Fauci AS, Lane HC, Redfield RR | title = Covid-19 - Navigating the Uncharted | journal = The New England Journal of Medicine | volume = 382 | issue = 13 | pages = 1268–1269 | date = March 2020 | pmid = 32109011 | pmc = 7121221 | doi = 10.1056/nejme2002387 }}</ref>。
2020年1月、ドイツの[[バイオテクノロジー]]企業[[バイオンテック]]社は、すでに確立されているmRNA技術に基づいて、新しいCOVID-19ウイルスに対するワクチンを開発するためのプログラム「Project Lightspeed」を開始した<ref name="BioNTechUpdate" />。[[マインツ]]の研究室で数種類のワクチンが作成され、そのうちの20種類が[[ランゲン (ヘッセン)|ランゲン]]の{{仮リンク|パウル・エールリヒ研究所|en|Paul Ehrlich Institute}}の専門家に提示された<ref>{{cite news | vauthors = Papadopoulos C | date = 14 December 2020 | title = Chronologie - So entstand der Corona-Impfstoff von Biontech | trans-title = Chronology - That's how the Covid-vaccine of Biontech was being developed | url = https://www.swr.de/swraktuell/rheinland-pfalz/corona-impfstoff-chronologie-100.html | publisher = [[:en:Südwestrundfunk|Südwestrundfunk]] | language = de | access-date = 20 December 2020 }}</ref>。2020年4月23日にドイツで、2020年5月4日に米国で第I/II相臨床試験が開始され、4つのワクチン候補が臨床試験に入った。ワクチン候補リードの「BNT162b2」を用いた第1次ピボタル第II/III相臨床試験が7月に開始された。2020年11月18日、開発されたワクチンの95%有効性を示す第III相試験結果が発表された<ref name="BioNTechUpdate"></ref>。
2020年3月、[[バイオンテック]]はFosunから1億3,500万米ドルの出資を受け、バイオンテックの株式158万株および中国<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 November 2020 |work=Reuters |date=15 March 2020 |archive-date=14 November 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>、香港、マカオ、台湾における「BNT162b2」の将来の開発および販売権と引き換えに行われた<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 March 2020） {{Webarchive|url=https://web.archive.org/web/20200815194524/https://www.fosunpharma.com/en/news/news-details-3801.html |date=15 August 2020 }}</ref>。
2020年6月、バイオンテックは[[欧州委員会]]と[[欧州投資銀行]]から1億ユーロ（1億1900万米ドル）の融資を受けた<ref name="eib">{{cite web|date=11 June 2020|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|url-status=live|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|archive-date=9 November 2020|access-date=10 November 2020|publisher=European Investment Bank}}</ref>。2020年9月、ドイツ政府は、バイオンテックのCOVID-19ワクチン開発プログラムに対して3億7500万ユーロ（4億4500万米ドル）を融資した<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 November 2020 |work=Bloomberg.com |date=15 September 2020 |archive-date=9 November 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>。
ファイザーのCEO [[:en:Albert Bourla|Albert Bourla]]は、ワクチン開発のために米国政府の{{仮リンク|Operation Warp Speed|en|Operation Warp Speed}}からの資金提供を受けることを断念したと述べている。「私は、報告書を提出することになる官僚主義から科学者を解放したかったし、また、並行してまたは一緒にお金を使うかなどに同意したかったからである」。ファイザーは、他の国と同様に、ワクチンの最終的な流通について、米国との間で協定を結んだ<ref>{{Cite news|date=9 November 2020|title=Pfizer CEO says he would've released vaccine data before election if possible|url=https://www.axios.com/pfizer-ceo-says-he-wouldve-released-vaccine-data-before-election-if-possible-a4f0c822-bf49-4a04-ac7f-5275c8d895b4.html|access-date=11 November 2020|work=Axios|archive-date=10 November 2020|archive-url=https://web.archive.org/web/20201110214718/https://www.axios.com/pfizer-ceo-says-he-wouldve-released-vaccine-data-before-election-if-possible-a4f0c822-bf49-4a04-ac7f-5275c8d895b4.html|url-status=live}}</ref>。
=== 臨床試験 ===
{{see also|COVID-19ワクチン#2020年に開始された臨床試験}}
2020年10月に発表されたBNT162b2の[[治験#phase1trial|第I/II相臨床試験]]の予備結果は、その有効性と安全性の可能性を示唆していた<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 | bibcode = 2020Natur.586..589M | s2cid = 221126922 | doi-access = free }}</ref>。同月、[[欧州医薬品庁]]（EMA）はBNT162b2の定期的審査を開始した<ref>{{cite news |vauthors=Hannah B |date=7 October 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 November 2020 |archive-date=11 November 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>。
2020年11月時点で、BNT162b2の[[治験]]は連続[[治験#phase3trial|第III相試験]]となっている<ref name="NCT04368728" />。これは「[[ランダム化比較試験|無作為化、プラセボ対照]]、観察者盲検、用量設定、ワクチン候補選択、健康な人を対象とした有効性試験」である<ref name="NCT04368728" />。初期段階の研究では、2つのワクチン候補の安全性と用量レベルが決定され、2020年半ばに試験が拡大され、より多くの参加者を対象にBNT162b2の有効性と安全性を評価され、ファイザーとFosunの協力のもと、複数の国で試験接種を受けた参加者は数万人に到達した<ref name="herper" /><ref name="fosun" />。
第III相試験では、12～15歳、16～55歳、55歳以上の3つの年齢層を対象に、BNT162b2の安全性、有効性、忍容性、および{{仮リンク|免疫原性|en|Immunogenicity}}を中用量レベル（2回の注射を21日間隔で行う）で評価する<ref name="NCT04368728" />。EUでの承認に向けて、EMAはワクチン全体の有効性95%を確認している<ref name=":0">{{Cite web|date=21 December 2020|title=EMA Assessment Report|url=https://www.ema.europa.eu/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf|access-date=29 December 2020|website=www.ema.europa.eu}}</ref>。EMAは、2回目の投与は1回目の投与から3週間後に行うことを明確にした<ref>{{cite news | title=Clarification of Comirnaty dosage interval | website=[[:en:European Medicines Agency|European Medicines Agency]] (EMA) | date=28 January 2021 | url=https://www.ema.europa.eu/en/news/clarification-comirnaty-dosage-interval | access-date=28 January 2021}}</ref>。
{| class="wikitable"
|+ ワクチンの有効性 <small>- 1回目または2回目の投与後全体、および2回目の投与後全体を年齢層別で見る</small><ref name=":0" />
! 主要評価項目
! ワクチン有効性 (95%信頼区間) [%]
|-
|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 <small>(subjects without evidence of infection prior to 7 days after dose 2)</small>
|-
|Overall
|95.0 (90.0, 97.9)
|-
|16–55 years
|95.6 (89.4, 98.6)
|-
|≥55 years
|93.7 (80.6, 98.8)
|-
|≥65 years
|94.7 (66.7, 99.9)
|}
現在進行中の第III相試験は、2020年から2022年に実施される予定で、BNT162b2の重症感染予防能力と{{仮リンク|免疫応答|en|Immune response|label=免疫効果}}の持続期間を評価することを目的としている<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" />。
== ワクチン技術 ==
{{See also|RNAワクチン|COVID-19ワクチン#テクノロジープラットフォーム}}
BNT162b2ワクチンのバイオンテック技術は、[[SARS-CoV-2]][[コロナウイルス]]（COVID-19）の表面に見られる[[スパイクタンパク質]]の一部をコードする[[ヌクレオシド修飾メッセンジャーRNA|ヌクレオシド修飾mRNA]]（modRNA）の使用に基づいており、ウイルスタンパク質による感染に対する免疫応答{{Enlink|Immune response|英語版}}を誘発する<ref name="gaebler">{{cite journal | vauthors = Gaebler C, Nussenzweig MC | title = All eyes on a hurdle race for a SARS-CoV-2 vaccine | journal = Nature | volume = 586 | issue = 7830 | pages = 501–2 | date = October 2020 | pmid = 33077943 | doi = 10.1038/d41586-020-02926-w | bibcode = 2020Natur.586..501G | s2cid = 224808629 | doi-access=free }}</ref>。
このワクチン候補であるBNT162b2は、バイオンテックが開発した同様の技術を持つ他の3つのワクチン候補の中で最も有望なものとして選ばれた<ref name="NCT04368728" /><ref name="gaebler" /><ref name="mulligan" />。BNT162b2を選択する前に、[[バイオンテック]]と[[ファイザー]]はドイツと米国でBNT162b1の[[治験#phase1trial|第I相試験]]を実施しており、Fosunは中国で第I相試験を実施していた<ref name="pmid33053279" /><ref name="fosun11">{{Cite news|title=China's Fosun to end BioNTech's COVID-19 vaccine trial, seek approval for another|work=Reuters|url=https://www.reuters.com/article/health-coronavirus-fosunpharma-idINL4N2HQ1UU |date=3 November 2020|access-date=21 November 2020|archive-date=12 December 2020|archive-url=https://web.archive.org/web/20201212204750/https://www.reuters.com/article/health-coronavirus-fosunpharma-idINL4N2HQ1UU?edition-redirect=ca|url-status=live}}</ref>。これらの第I相試験において、BNT162b2は他の3つのバイオンテックの候補品よりも優れた安全性プロファイルを持っていることが示された<ref name="fosun11" />。
=== 配列 ===
このワクチンのmodRNA配列は4,284ヌクレオチド長である<ref name="MedNet">{{cite web |author=World Health Organization |title=Messenger RNA encoding the full-length SARS-CoV-2 spike glycoprotein |url=https://mednet-communities.net/inn/db/media/docs/11889.doc |format=DOC |work=WHO MedNet |access-date=16 December 2020}}</ref>。それを構成するものは、[[5'キャップ]]; {{仮リンク|ヘモグロビンサブユニットアルファ|en|Hemoglobin subunit alpha|label=ヒトαグロビン}}の配列に由来する[[5' 非翻訳領域|5'非翻訳領域]]; [[シグナルペプチド]]（塩基55-102）と2つのプロリン置換（K986PおよびV987P、"2P"と呼ぶ）は、スパイクに、膜融合能力を低下させ、発現を増加させ、中和抗体を刺激する融合前安定化構造の形をもたらす<ref name="pmid33053279" /><ref>{{cite journal | vauthors = Pallesen J, Wang N, Corbett KS, Wrapp D, Kirchdoerfer RN, Turner HL, Cottrell CA, Becker MM, Wang L, Shi W, Kong WP, Andres EL, Kettenbach AN, Denison MR, Chappell JD, Graham BS, Ward AB, McLellan JS | display-authors = 6 | title = Immunogenicity and structures of a rationally designed prefusion MERS-CoV spike antigen | journal = Proceedings of the National Academy of Sciences of the United States of America | volume = 114 | issue = 35 | pages = E7348–E7357 | date = August 2017 | pmid = 28807998 | pmc = 5584442 | doi = 10.1073/pnas.1707304114 }}</ref>; SARS-CoV-2の完全長スパイクタンパク質をコドン最適化した遺伝子（塩基103-3879）; 続いて、タンパク質発現の増加とmRNA安定性<ref>{{cite journal |vauthors=Orlandini von Niessen AG, Poleganov MA, Rechner C, Plaschke A, Kranz LM, Fesser S, Diken M, Löwer M, Vallazza B, Beissert T, Bukur V, Kuhn AN, Türeci Ö, Sahin U | display-authors = 6 | title = Improving mRNA-Based Therapeutic Gene Delivery by Expression-Augmenting 3' UTRs Identified by Cellular Library Screening | journal = Molecular Therapy | volume = 27 | issue = 4 | date = April 2019 | pages = 824–836 | pmid = 30638957 | pmc = 6453560 | doi = 10.1016/j.ymthe.2018.12.011 }}</ref>のために選択された''AES''および{{仮リンク|MT-RNR1|en|MT-RNR1|label=mtRNR1}}から結合された[[3' 非翻訳領域|3’非翻訳領域]]（塩基3880-4174）と、30個のアデノシン残基、10個のヌクレオチドリンカー配列、および70個の他のアデノシン残基（塩基4175-4284）からなる[[ポリアデニル化|ポリA鎖]]からなる<ref name="MedNet" />。この配列には[[ウリジン]]残基は含まれておらず、[[シュードウリジン|1-メチル-3'-シュードウリジリル]]で置換されている<ref name="MedNet" />。
=== 組成 ===
本ワクチンには、mRNA分子の他に、次の不活性成分（[[賦形剤]]、ふけいざい）が含まれている<ref name="hc12dec" /><ref name="Comirnaty product information">{{cite report |url=https://www.ema.europa.eu/en/documents/product-information/comirnaty-epar-product-information_en.pdf |title=Comirnaty: Product Information |accessdate=23 December 2020 |publisher=[[:en:European Medicines Agency|European Medicines Agency]] (EMA)}}</ref><ref name="MHRA product information"></ref>。
* [[:en:ALC-0315|ALC-0315]], (((4-Hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate))
* [[:en:ALC-0159|ALC-0159]], 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
* {{仮リンク|ジステアロイルホスファチジルコリン|en|Distearoylphosphatidylcholine|label=1,2-ジステアロイル-sn-グリセロ-3-ホスホコリン}}(DSPC)
* [[コレステロール]]
* [[リン酸水素二ナトリウム|リン酸水素二ナトリウム二水和物]]
* [[リン酸二水素カリウム]]
* [[塩化カリウム]]
* [[塩化ナトリウム]]
* [[スクロース]]
* 注射用水
このうち最初の4つは[[脂質]]である。脂質とmodRNAが一緒になって[[ナノ粒子]]を形成する。ALC-0159は[[ポリエチレングリコール]]コンジュゲート（つまり{{仮リンク|PEG化|en|PEGylation}}脂質）である<ref name="parauk">{{cite report |title=Public Assessment Report Authorisation for Temporary Supply COVID-19 mRNA Vaccine BNT162b2 (BNT162b2 RNA) concentrate for solution for injection |url=https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/944544/COVID-19_mRNA_Vaccine_BNT162b2__UKPAR___PFIZER_BIONTECH__15Dec2020.pdf |work=Regulation 174 |publisher=[[医薬品・医療製品規制庁]] (MHRA) |date=15 December 2020}}</ref>。
ワクチンは「筋肉内注射用の白色からオフホワイトの、無菌の、防腐剤不使用の凍結懸濁液」として多回投与バイアルで供給される<ref name="Pfizer-BioNTech COVID-19 Vaccine FDA label" /><ref name="FDAEUA" />。これは投与前に室温まで解凍し、通常の[[生理食塩水]]で希釈する必要がある<ref name="FDAEUA" />。
== 承認 ==
=== 迅速 ===
2020年12月2日、英国の[[医薬品・医療製品規制庁]]（MHRA）は、同ワクチンに「パンデミックなどの重要な公衆衛生上の問題に対処するための迅速な一時的規制承認」を与えた。 これは、1968年の薬事法（Medicines Act 1968{{Enlink|Medicines Act 1968|英語版}}）に基づいて許可された<ref>{{cite web |title=UK medicines regulator gives approval for first UK COVID-19 vaccine |url=https://www.gov.uk/government/news/uk-medicines-regulator-gives-approval-for-first-uk-covid-19-vaccine |date=2 December 2020 |website=[[医薬品・医療製品規制庁]] (MHRA) |access-date=2 December 2020 |archive-date=2 December 2020 |archive-url=https://web.archive.org/web/20201202101605/https://www.gov.uk/government/news/uk-medicines-regulator-gives-approval-for-first-uk-covid-19-vaccine |url-status=live }}</ref>。これは、大規模試験を経て、国内での使用が承認された初のCOVID-19ワクチンであり<ref>{{cite news |url=https://apnews.com/article/uk-authorizes-vaccine-emergency-use-ea0170c978eb281a905866e5bd78bbdf |title=Britain OKs Pfizer vaccine and will begin shots within days |work=AP |date=2 December 2020 |vauthors=Neergaard L, Kirka D |access-date=6 December 2020 |archive-date=6 December 2020 |archive-url=https://web.archive.org/web/20201206161358/https://apnews.com/article/uk-authorizes-vaccine-emergency-use-ea0170c978eb281a905866e5bd78bbdf |url-status=live }}</ref>、ヒトへの使用が承認された初の[[mRNAワクチン]]でもある<ref name="ukgov12-22">{{cite press release|title=UK medicines regulator gives approval for first UK COVID-19 vaccine|url=https://www.gov.uk/government/news/uk-medicines-regulator-gives-approval-for-first-uk-covid-19-vaccine|publisher=[[Medicines and Healthcare products Regulatory Agency]] (MHRA)|access-date=2 December 2020|date=2 December 2020}}</ref><ref name="mueller">{{cite news | vauthors = Mueller B |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>。このようにして英国は、COVID-19ワクチンの国内使用を承認した最初の[[欧米諸国]]となったが<ref name="bbcuk">{{cite news |date=2 December 2020 |title=Covid Pfizer vaccine approved for use next week in UK |vauthors=Roberts M |work=[[:en:BBC News Online|BBC News Online]] |url=https://www.bbc.com/news/health-55145696 |access-date=2 December 2020 |archive-date=2 December 2020 |archive-url=https://web.archive.org/web/20201202070718/https://www.bbc.com/news/health-55145696 |url-status=live }}</ref>、このワクチンの早期承認の決定は一部の専門家から批判を受けた<ref>{{cite news |url= https://www.theguardian.com/world/2020/dec/03/europe-us-experts-question-uk-fast-track-covid-vaccine |title=European and US experts question UK's fast-track of Covid vaccine|date=3 December 2020| vauthors = Henley J, Connolly, Jones S |website=The Guardian|access-date=9 December 2020|archive-date=9 December 2020|archive-url=https://web.archive.org/web/20201209004141/https://www.theguardian.com/world/2020/dec/03/europe-us-experts-question-uk-fast-track-covid-vaccine|url-status=live }}</ref>。
2020年12月8日、[[ファーマナ県|ファーマナ]]州出身のマーガレット・マギー・キーナン（90歳）が、英国で初めてワクチンを接種した<ref>{{Cite web|url=https://www.bbc.co.uk/news/uk-55227325|title=First patient receives Pfizer Covid-19 vaccine|date=8 December 2020|access-date=8 December 2020|via=www.bbc.co.uk|archive-date=8 December 2020|archive-url=https://web.archive.org/web/20201208070149/https://www.bbc.co.uk/news/uk-55227325|url-status=live}}</ref>。12月20日までに52万1,594人の英国居住者が{{仮リンク|イギリスでのCOVID-19ワクチン接種|en|COVID-19 vaccination in the United Kingdom|label=全国予防接種プログラム}}の一環としてワクチンを接種した。その70％は80歳以上の人であった<ref name="vacstat">{{cite web|publisher=NHS|title=COVID-19 Vaccination Statistics –Week ending Sunday 20th December 2020|date=24 December 2020|url=https://www.england.nhs.uk/statistics/wp-content/uploads/sites/2/2020/12/COVID-19-total-announced-vaccinations-24-December-2020-1.pdf|accessdate=2021-02-20}}</ref>。
英国に続いて、以下の国がファイザー-バイオンテックのCOVID-19ワクチンの使用を承認するための手続きを迅速化した。アルゼンチン<ref>{{cite web|url=https://www.lanacion.com.ar/sociedad/coronavirus-argentina-anmat-aprobo-uso-emergencia-vacuna-nid2548852|title=Coronavirus en la Argentina: La ANMAT aprobo el uso de emergencia de la vacuna Pfizer|access-date=25 December 2020|website=La Nación|language=es}}</ref>、オーストラリア<ref>{{cite press release | title=TGA provisionally approves Pfizer COVID-19 vaccine | website=[[:en:Therapeutic Goods Administration|Therapeutic Goods Administration]] | url=https://www.tga.gov.au/media-release/tga-provisionally-approves-pfizer-covid-19-vaccine | date=25 January 2021 | access-date=26 January 2021}}</ref>、バーレーン<ref>{{cite web |title=Bahrain becomes second country to approve Pfizer COVID-19 vaccine |url=https://www.aljazeera.com/news/2020/12/4/bahrain-becomes-second-country-to-approve-pfizer-covid-19-vaccine |website=Al Jazeera |access-date=5 December 2020}}</ref>、カナダ<ref name="CA Pfizer-BioNTech product description">{{cite web |title=Pfizer-BioNTech COVID-19 Vaccine (tozinameran) |url=https://covid-vaccine.canada.ca/pfizer-biontech-covid-19-vaccine/product-details |publisher=Health Canada |access-date=15 December 2020}}</ref><ref name="canlist">{{cite web|date=9 December 2020|title=Drug and vaccine authorizations for COVID-19: List of applications received|url=https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/authorization/applications.html|access-date=9 December 2020|publisher=Health Canada }}</ref>、チリ<ref name="El Pais">{{cite web |title=Chile y Ecuador se adelantan en Sudamérica y autorizan la vacuna de Pfizer |url=https://elpais.com/sociedad/2020-12-16/chile-y-ecuador-se-adelantan-en-sudamerica-y-autorizan-la-vacuna-de-pfizer.html |publisher=El Pais |access-date=17 December 2020}}</ref>、コスタリカ<ref>{{Cite news|date=23 December 2020|title=First Pfizer COVID-19 vaccines set to reach Costa Rica on Wednesday - president|work=Reuters|url=https://www.reuters.com/article/health-coronavirus-costarica-vaccine-idUSS0N2HB06S|access-date=24 December 2020}}</ref>、エクアドル<ref name="El Pais" />、香港<ref>{{cite press release | title=SFH authorises COVID-19 vaccine by Fosun Pharma/BioNTech for emergency use in Hong Kong | website=[[:en:The Government of Hong Kong|The Government of Hong Kong]] | url=https://www.info.gov.hk/gia/general/202101/25/P2021012500829.htm | date=25 January 2021 | access-date=26 January 2021}}</ref>、イラク<ref>{{Cite web|title=Iraq grants emergency approval for Pfizer COVID-19 vaccine|url=https://www.msn.com/en-ae/news/other/iraq-grants-emergency-approval-for-pfizer-covid-19-vaccine/ar-BB1cgvD6|access-date=27 December 2020|publisher=MSN}}</ref>、イスラエル<ref>{{Cite web|title=Israeli Health Minister 'pleased' as FDA approves Pfizer COVID-19 vaccine|url=https://www.jpost.com/breaking-news/fda-approves-pfizer-biontech-covid-19-vaccine-for-emergency-use-nyt-651871|access-date=28 December 2020|website=The Jerusalem Post }}</ref>、ヨルダン<ref>{{cite web|access-date=15 December 2020|title=Jordan approves Pfizer-BioNTech Covid vaccine|url=https://www.france24.com/en/live-news/20201215-jordan-approves-pfizer-biontech-covid-vaccine|date=15 December 2020|website=France 24}}</ref>、クウェート<ref>{{cite web|access-date=15 December 2020|title=Kuwait authorizes emergency use of Pfizer-BioNTech COVID-19 vaccine|url=https://arab.news/427j9|date=13 December 2020|website=Arab News}}</ref>、メキシコ<ref>{{Cite news|date=12 December 2020|title=Mexico Approves Pfizer Vaccine for Emergency Use as Covid Surges|work=Bloomberg|url=https://www.bloomberg.com/news/articles/2020-12-12/mexico-approves-pfizer-vaccine-for-emergency-use-as-covid-surges|access-date=12 December 2020}}</ref>、オマーン<ref>{{Cite news|date=15 December 2020|title=Oman issues licence to import Pfizer BioNTech Covid vaccine - TV|work=Reuters|url=https://www.reuters.com/article/health-coronavirus-oman-vaccine-int-idUSKBN28P1RA|access-date=16 December 2020}}</ref>、パナマ<ref name="panama">{{cite web|access-date=16 December 2020|title=Panama approves Pfizer's COVID-19 vaccine – health ministry|url=https://finance.yahoo.com/news/panama-approves-pfizers-covid-19-010942802.html|publisher=Yahoo! Finance}}</ref>、フィリピン<ref>{{Cite news|date=14 January 2021|title=PH authorizes Pfizer's COVID-19 vaccine for emergency use|work=CNN Philippines|url=https://cnnphilippines.com/news/2021/1/14/Pfizer-COVID-19-vaccine-Philippines-FDA-emergency-use-EUA.html}}</ref>、カタール<ref>{{cite web|access-date=24 December 2020|title=Qatar, Oman to receive Pfizer-BioNTech COVID-19 vaccine this week|url=https://www.reuters.com/article/us-health-coronavirus-vaccine-qatar/qatar-oman-to-receive-pfizer-biontech-covid-19-vaccine-this-week-idUSKBN28U0VE|publisher=Reuters}}</ref>、サウジアラビア<ref name="mulla" /><ref>{{cite web |title=Saudi Arabia to Launch Its Coronavirus Vaccination Program |url=https://www.bloomberg.com/news/articles/2020-12-15/saudi-arabia-to-launch-its-coronavirus-vaccination-program |publisher=Boomberg |access-date=17 December 2020 | language=es}}</ref>、シンガポール<ref>{{cite web | vauthors = Abdullah Z |title=Pfizer-BioNTech COVID-19 vaccine approved by Singapore, first shipment expected by end-December |url=https://www.channelnewsasia.com/news/singapore/singapore-approves-pfizer-biontech-covid-19-vaccine-phase-3-13769570 |website=CNA |access-date=16 January 2021 |date=14 December 2020}}</ref><ref>{{cite web|access-date=15 December 2020|title=Singapore approves use of Pfizer's COVID-19 vaccine|url=https://apnews.com/article/science-singapore-coronavirus-pandemic-lee-hsien-loong-coronavirus-vaccine-5bf8461b9d2d32ec08d56fcf5958317a|date=14 December 2020|website=AP News}}</ref>、アラブ首長国連邦<ref>{{Cite web|date=23 December 2020|title=Dubai approves the Pfizer-BioNTech vaccine which will be free of charge|url=https://emirateswoman.com/dubai-approves-the-pfizer-biontech-vaccine-for-free/|access-date=28 December 2020|website=Emirates Woman}}</ref>、米国<ref name="FDA PR 20201211" />。
[[世界保健機関]]（WHO）は、このワクチンの緊急使用を許可した<ref>{{cite press release | title=WHO issues its first emergency use validation for a COVID-19 vaccine and emphasizes need for equitable global access | website=[[:en:World Health Organization|World Health Organization]] (WHO) | url=https://www.who.int/news/item/31-12-2020-who-issues-its-first-emergency-use-validation-for-a-covid-19-vaccine-and-emphasizes-need-for-equitable-global-access | date=31 December 2020 | access-date=6 January 2021}}</ref>。
米国では、FDAによると、[[緊急使用許可]]（EUA）とは、「現在のCOVID-19パンデミックのような公衆衛生上の緊急事態が発生した際に、ワクチンを含む医療対策を容易に利用できるようにするための仕組み」とされている<ref name="fda-eua">{{cite web | title=Emergency Use Authorization for vaccines explained | website=U.S. [[:en:Food and Drug Administration|Food and Drug Administration]] (FDA) | date=20 November 2020 | url=https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained | access-date=20 November 2020 | archive-date=20 November 2020 | archive-url=https://web.archive.org/web/20201120184730/https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained | url-status=live }} {{PD-notice}}</ref>。EUAの発行を受けて、バイオンテックとファイザーは、安全性と有効性のデータを確定するための第III相臨床試験を継続し、米国でのワクチンの認可（承認）申請につなげることが期待されている<ref name="fda-eua" /><ref>{{cite web|title=Pfizer-BioNTech COVID-19 Vaccine EUA Letter of Authorization|publisher=U.S. [[:en:Food and Drug Administration|Food and Drug Administration]] (FDA)|date=11 December 2020|url=https://www.fda.gov/media/144412/download|format=PDF|accessdate=2021-02-20}} {{PD-notice}}</ref><ref name="EUA fact sheet">{{cite web|title=Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for Healthcare Providers|publisher=Pfizer|date=11 December 2020|url=https://www.fda.gov/media/144413/download|format=PDF|accessdate=2021-02-20}}</ref>。[[アメリカ疾病予防管理センター]]（CDC）の{{仮リンク|予防接種実施に関する諮問委員会|en|Advisory Committee on Immunization Practices}}（ACIP）は、16歳以上の人への予防接種の推奨を承認した<ref>{{cite news| vauthors = Sun LH, Stanley-Becker I |title= CDC greenlights advisory group's decision to recommend Pfizer vaccine for use|work=[[:en:The Washington Post|The Washington Post]]|url=https://www.washingtonpost.com/health/2020/12/12/covid-vaccine-cdc-approval/|access-date=14 December 2020 }}</ref><ref>{{cite journal | url=https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6950e2-H.pdf | vauthors=Oliver SE, Gargano JW, Marin M, Wallace M, Curran KG, Chamberland M, McClung N, Campos-Outcalt D, Morgan RL, Mbaeyi S, Romero JR, Talbot HK, Lee GM, Bell BP, Dooling K | display-authors=6 | title=The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine — United States, December 2020 | journal= MMWR. Morbidity and Mortality Weekly Report| date=December 2020 | volume=69 |issue=50 |pages=1922–24 |pmid=33332292 |doi=10.15585/mmwr.mm6950e2 | pmc=7745957 |doi-access=free }}</ref>。
===標準===
2020年12月19日、{{仮リンク|スイス医薬品局|en|Swissmedic}}（Swissmedic）は、ファイザー-バイオンテックCOVID-19ワクチンが安全性、有効性、品質の要件を完全に満たしているとして、申請を受けてから2ヶ月後に通常使用を承認した。これは、標準的な手続きによる初の認可となる<ref name="Swiss authorization">{{cite press release |title=Swissmedic grants authorisation for the first COVID-19 vaccine in Switzerland |url=https://www.bag.admin.ch/bag/en/home/das-bag/aktuell/medienmitteilungen.msg-id-81761.html |publisher=Swiss Agency for Therapeutic Products (Swissmedic) |date=19 December 2020 |access-date=19 December 2020}}</ref><ref>{{cite press release | title=COVID-19: Switzerland can start vaccinating vulnerable groups already in December | publisher=Federal Office of Public Health | date=19 December 2020 | url=https://www.bag.admin.ch/bag/en/home/das-bag/aktuell/medienmitteilungen.msg-id-81762.html | access-date=19 December 2020}}</ref>。12月23日、[[ルツェルン]]在住の90歳の女性が、[[スイス]]で初めてワクチンの接種を受けた<ref>{{cite news |newspaper=[[:en:Luzerner Zeitung|Luzerner Zeitung]] |date=23 December 2020 |url=https://www.luzernerzeitung.ch/zentralschweiz/luzern/coronavirus-90-jaehrige-luzernerin-als-erste-person-in-der-schweiz-gegen-corona-geimpft-ld.2079678 | vauthors = Erni S |title=90-jährige Luzernerin als erste Person in der Schweiz gegen Corona geimpft |access-date=23 December 2020}}</ref>。これは、ヨーロッパ大陸での集団予防接種の始まりとなった<ref>{{cite news |newspaper=Heidi.news |date=23 December 2020 |url=https://www.heidi.news/sante/la-piqure-de-l-espoir-pratiquee-a-lucerne | vauthors = Pralong J |title=La piqûre de l'espoir pratiquée à Lucerne |access-date=23 December 2020}}</ref>。
2020年12月21日、[[欧州医薬品庁]]（EMA）の{{仮リンク|欧州医薬品委員会|en|Committee for Medicinal Products for Human Use}}（CHMP）は、「コミナティ（Comirnaty）」というブランド名で、ファイザー-バイオンテックCOVID-19ワクチンの条件付き販売承認の付与を推奨した<ref name="Comirnaty EPAR"></ref><ref name="EU PR 20201221">{{cite press release | title=EMA recommends first COVID-19 vaccine for authorisation in the EU | website=[[:en:European Medicines Agency|European Medicines Agency]] (EMA) | date=21 December 2020 | url=https://www.ema.europa.eu/en/news/ema-recommends-first-covid-19-vaccine-authorisation-eu | access-date=21 December 2020}}</ref><ref>{{cite web | title=Comirnaty | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1528.htm | access-date=8 January 2021}}</ref>。この勧告は同日、[[欧州委員会]]によって承認された<ref name="EU PR 20201221" /><ref name="EU statement">{{cite web | title=Statement by President von der Leyen on the marketing authorisation of the BioNTech-Pfizer vaccine against COVID-19 | website=[[:en:European Commission|European Commission]] | url=https://ec.europa.eu/commission/presscorner/detail/en/statement_20_2510 | access-date=21 December 2020}}</ref>。
== 有害作用 ==
ファイザー-バイオンテックCOVID-19ワクチンの{{仮リンク|有害作用|en|Adverse effect}}プロファイルは、他の成人用ワクチンと同様である<ref name="herper" />。臨床試験において、非常に一般的{{efn|name=AEfrequency}}とみなされる副作用は（頻度の高い順に）、注射部位の痛みや腫れ、倦怠感、頭痛、筋肉痛、悪寒、関節痛、発熱である<ref name="Comirnaty product information" />。発熱は2回目の投与後によく見られる<ref name="Comirnaty product information" />。これらの影響は予測可能であり、想定されるものであり、[[ワクチン忌避]]を避けるためにも人々がこれを認識することが特に重要である<ref name="McKenna">{{cite web |url=https://www.wired.com/story/vaccines-are-here-we-have-to-talk-about-side-effects |title=Vaccines Are Here. We Have to Talk About Side Effects |work=[[:en:Wired (magazine)|Wired]] |author-link=Maryn McKenna | vauthors = McKenna M |date=17 December 2020 |access-date=23 December 2020}}</ref>。
[[アナフィラキシー|重篤なアレルギー反応]]は、ワクチン接種100万回あたり約11例で確認されている<ref name=":1">{{Cite journal|vauthors=((CDC COVID-19 Response Team)), ((Food and Drug Administration)) | date=January 2021|title=Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine — United States, December 14–23, 2020 |url=https://www.cdc.gov/mmwr/volumes/70/wr/pdfs/mm7002e1-H.pdf|journal=MMWR. Morbidity and Mortality Weekly Report|volume=70 | issue=2 | pages=46–51|doi=10.15585/mmwr.mm7002e1 | pmid=33444297| pmc=7808711| doi-access=free}}</ref><ref name="EU safety update" />。[[アメリカ疾病予防管理センター]]の報告によると、これらのアレルギー反応の71%はワクチン接種後15分以内に起こり、そのほとんど（81%）がアレルギーやアレルギー反応の既往歴のある人の間で発生した<ref name=":1" />。2020年12月9日、英国の[[医薬品・医療製品規制庁]]（MHRA）は、「重大な」アレルギー反応の既往歴がある人は、ファイザー-バイオンテックCOVID-19ワクチンを接種すべきではないと勧告した<ref name="mhra-allergy">{{cite web | vauthors = Bostock N |publisher=GP |title=MHRA warning after allergic reactions in NHS staff given COVID-19 vaccine |url=https://www.gponline.com/mhra-warning-allergic-reactions-nhs-staff-given-covid-19-vaccine/article/1702322 |date=9 December 2020 |access-date=9 December 2020 |archive-date=9 December 2020 |archive-url=https://web.archive.org/web/20201209163321/https://www.gponline.com/mhra-warning-allergic-reactions-nhs-staff-given-covid-19-vaccine/article/1702322 |url-status=live }}</ref><ref name="WP-20201209">{{cite news | vauthors = Booth W, Cunningham E |title=Britain warns against Pfizer vaccine for people with history of 'significant' allergic reactions |url=https://www.washingtonpost.com/world/pfizer-allergic-warnings-vaccine/2020/12/09/4e79ec72-3a16-11eb-aad9-8959227280c4_story.html |date=9 December 2020 |work=[[:en:The Washington Post|The Washington Post]] |access-date=9 December 2020 |archive-date=9 December 2020 |archive-url=https://web.archive.org/web/20201209195847/https://www.washingtonpost.com/world/pfizer-allergic-warnings-vaccine/2020/12/09/4e79ec72-3a16-11eb-aad9-8959227280c4_story.html |url-status=live }}</ref><ref name="cekdis20">{{cite journal | vauthors = Cabanillas B, Akdis C, Novak N | title = Allergic reactions to the first COVID-19 vaccine: a potential role of Polyethylene glycol? | journal = Allergy | date = December 2020 | pmid = 33320974 | doi = 10.1111/all.14711 | s2cid = 229284320 | doi-access = free }}</ref>。12月12日、カナダの規制当局はこれに続き、次のように指摘した。「英国の二人は、重度のアレルギー反応の既往歴があり、アドレナリン自動注射器を所持していた。彼らは両方とも治療を受け、回復している<ref name="hc12dec">{{cite web|title=Pfizer-BioNTech COVID-19 vaccine: Health Canada recommendations for people with serious allergies|url=https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/74543a-eng.php|publisher=Health Canada|date=12 December 2020|accessdate=2021-02-20}}</ref>。」
2021年1月28日、欧州連合（EU）はCOVID-19ワクチンの安全性に関する最新情報を発表し、「COVID-19の予防におけるコミナティの利点は引き続きリスクを上回り、ワクチンの使用に関して推奨される変更はない。」とした<ref name="EU safety update">{{cite web|title=COVID-19 vaccine safety update: COMIRNATY|date=28 January 2021|publisher=European Medicines Agency|url=https://www.ema.europa.eu/documents/covid-19-vaccine-safety-update/covid-19-vaccine-safety-update-comirnaty-january-2021_en.pdf|accessdate=2021-02-20}}</ref><ref>{{cite press release | title=First COVID-19 vaccine safety update published | website=[[:en:European Medicines Agency|European Medicines Agency]] (EMA) | date=28 January 2021 | url=https://www.ema.europa.eu/en/news/first-covid-19-vaccine-safety-update-published | access-date=29 January 2021}}</ref>。新たな副作用は確認されていない<ref name="EU safety update" />。
== 製造 ==
[[File:Pfizer-BioNTech COVID-19 vaccine (2020) E.jpg|thumb|ファイザーワクチンを手にした医師]]
ファイザーとバイオンテックは、米国と欧州の自社施設で、3段階の工程を経てこのワクチンを製造している。第一段階では、スパイクタンパクをコードするDNA[[プラスミド]]を[[大腸菌]]に注入して{{仮リンク|分子クローニング|en|Molecular cloning}}する。米国では、この段階は{{仮リンク|チェスターフィールド市 (ミズーリ州)|en|Chesterfield, Missouri|label=ミズーリ州チェスターフィールド}}<ref name="Gray">{{cite news|date=November 23, 2020|title=Pfizer's Chesterfield workforce playing a key role in coronavirus vaccine development|work=St. Louis Post-Dispatch|url=https://www.stltoday.com/business/local/pfizers-chesterfield-workforce-playing-a-key-role-in-coronavirus-vaccine-development/article_2eefc85c-fd51-5d2a-b137-70ca95fff123.html|vauthors=Gray B}}</ref>（[[セントルイス郡 (ミズーリ州)|セントルイス]]近郊）の小さな[[パイロットプラント]]で実施される。4日間の増殖の後、細菌を死滅させて[[溶菌|破壊]]し、その細胞の内容物を1週間半かけて精製し、目的のDNA生成物を回収する。DNAは小さな瓶に入れて冷凍保存され、出荷される。この段階でのDNAの安全かつ迅速な輸送が非常に重要であるため、ファイザーは自社のジェット機とヘリコプターを使用して支援している<ref name="Johnson">{{cite news | vauthors = Johnson CY |title=A vial, a vaccine and hopes for slowing a pandemic — how a shot comes to be |url=https://www.washingtonpost.com/health/2020/11/17/coronavirus-vaccine-manufacturing/ |access-date=21 December 2020 |work=The Washington Post |date=17 November 2020 }}</ref>。
第二段階は、米国のマサチューセッツ州[[アンドーバー (マサチューセッツ州)|アンドーバー]]<ref name="Hughes">{{cite news | vauthors = Hughes M |title=Andover's piece of the vaccine: Pfizer |url=https://www.eagletribune.com/news/merrimack_valley/andovers-piece-of-the-vaccine-pfizer/article_a648be2a-faf4-5639-9a6f-d55de285cce3.html |work=The Eagle-Tribune |date=December 20, 2020}}</ref>とドイツの工場で実施されている。そのDNAを鋳型にして、目的のmRNA鎖を[[転写 (生物学)|作成]]する。mRNAが作成および精製されると、大きなショッピングバッグほどの大きさのビニール袋に入れて凍結され、それぞれは最大500万～1000万回の投与量を収容する。袋は専用のラックに乗せてトラックに積み、次の工場に運ばれる<ref name="Johnson" />。
第三段階は、米国ミシガン州[[ポーテージ (ミシガン州)|ポーティジ]]<ref name="Shamus">{{cite news | vauthors = Shamus KJ |title= Historic journey: Pfizer prepares to deliver 6.4 million doses of COVID-19 vaccines |url= https://www.freep.com/story/news/health/2020/12/13/pfizer-covid-19-vaccines-kalamazoo-michigan/6529215002/ |work=Detroit Free Press |date=December 13, 2020}}</ref>（[[カラマズー (ミシガン州)|カラマズー]]近郊）とベルギーの[[プールス]]の工場で実施されている。この段階では、mRNAと脂質ナノ粒子を結合させ、バイアルに充填し、バイアルを箱詰めし、凍結させる<ref name="Johnson" />。[[クローダ|Croda International]]の子会社であるAvanti Polar Lipidsが必要な脂質を提供している<ref name="Mullin">{{cite news | vauthors = Mullin R |title=Pfizer, Moderna ready vaccine manufacturing networks |url=https://cen.acs.org/business/outsourcing/Pfizer-Moderna-ready-vaccine-manufacturing/98/i46 |access-date=21 December 2020 |work=Chemical & Engineering News |publisher=American Chemical Society |date=25 November 2020 |location=Washington, D.C. }}</ref>。2020年11月の時点で、製造プロセスの主要なボトルネックは、mRNAと脂質ナノ粒子の結合であった<ref name="Johnson" />。
2021年2月、ファイザーは、この配列順全体では当初、開始から終了まで平均で約110日かかり、同社はこれを60日へ短縮を進めていることを明らかにした<ref name="Weise">{{cite news |last1=Weise |first1=Elizabeth |title=Pfizer expects to cut COVID-19 vaccine production time by close to 50% as production ramps up, efficiencies increase |url=https://www.usatoday.com/story/news/health/2021/02/07/pfizer-expects-cut-covid-19-vaccine-production-time-almost-50/4423251001/ |work=USA Today |date=February 7, 2021|publisher=Gannett}}</ref>。ワクチンメーカーは通常、大規模生産を試みる前に、特定のワクチンの製造プロセスをスピードと費用対効果のため最適化するのに数年をかけている<ref name="Weise" />。COVID-19パンデミックよって示された緊急性のため、ファイザーは、もともと研究室でワクチンを製剤化していたプロセスで直ちに生産を開始し、その後、そのプロセスを安全にスピードアップおよびスケールアップする方法の特定に着手した<ref name="Weise" />。
2020年9月、バイオンテックは、ドイツの[[マールブルク|マールブルグ]]にある製造施設を[[ノバルティス]]から買収し、ワクチンの生産能力を拡大する契約を結んだことを発表した<ref>{{Cite web|title=BioNTech to Acquire GMP Manufacturing Site to Expand COVID-19 Vaccine Production Capacity in First Half 2021 {{!}} BioNTech|url=https://investors.biontech.de/news-releases/news-release-details/biontech-acquire-gmp-manufacturing-site-expand-covid-19-vaccine/|access-date=2021-02-05|website=investors.biontech.de|language=en}}</ref>。同施設が完全に稼働すれば、年間最大7億5000万回、月産6000万回以上のワクチンを生産することになる。現在、ファイザーは米国と欧州で少なくとも4つの製造施設を運営し、この施設は欧州で3番目のバイオンテック施設となる。
== 先行発注と物流 ==
ファイザーは11月9日のプレスリリースで、2020年末までに5,000万用量が投与可能で、2021年までに世界で約13億用量が提供される可能性があることを示した<ref name="herper" />。2021年2月、バイオンテックは、2021年に20億用量を製造するために、生産量を50％以上増やすと発表した<ref>{{Cite web|title=Statement on Manufacturing {{!}} BioNTech|url=https://investors.biontech.de/news-releases/news-release-details/statement-manufacturing/|access-date=2021-02-05|website=investors.biontech.de|language=en}}</ref>。
2020年7月、ワクチン開発プログラム{{仮リンク|Operation Warp Speed|en|Operation Warp Speed}}は、ワクチンが安全で効果的であることが示された場合、米国で使用する1億用量のCOVID-19ワクチンを製造するために、ファイザーに19億5,000万米ドルの先行発注を行った<ref name="nytimes-2020-11-09">{{cite news|title=Pfizer's early data shows vaccine is more than 90% effective|vauthors=Thomas K, Gelles D, Zimmer C|work=The New York Times|url=https://www.nytimes.com/2020/11/09/health/covid-vaccine-pfizer.html|date=9 November 2020|access-date=9 November 2020|archive-date=23 November 2020|archive-url=https://web.archive.org/web/20201123032409/https://www.nytimes.com/2020/11/09/health/covid-vaccine-pfizer.html|url-status=live}}</ref><ref name="pbio">{{Cite news|date=22 July 2020|title=U.S. to pay Pfizer, BioNTech $1.95 bln for millions of COVID-19 vaccine doses|work=Reuters|url=https://www.reuters.com/article/us-health-coronavirus-usa-pfizer-idUSKCN24N1I9|access-date=22 July 2020|vauthors=Erman M, Ankur B|archive-date=22 July 2020|archive-url=https://web.archive.org/web/20200722171010/https://www.reuters.com/article/us-health-coronavirus-usa-pfizer-idUSKCN24N1I9|url-status=live}}</ref><ref>{{cite web|date=22 July 2020|title=U.S. Government Engages Pfizer to Produce Millions of Doses of COVID-19 Vaccine|url=https://www.hhs.gov/about/news/2020/07/22/us-government-engages-pfizer-produce-millions-doses-covid-19-vaccine.html|access-date=23 July 2020|publisher=US Department of Health and Human Services|archive-date=22 July 2020|archive-url=https://web.archive.org/web/20200722152445/https://www.hhs.gov/about/news/2020/07/22/us-government-engages-pfizer-produce-millions-doses-covid-19-vaccine.html|url-status=live}}</ref><ref name="yahoo">{{cite news |vauthors=Nazaryan A |title=So is Pfizer part of Operation Warp Speed or not? Yes and no |url=https://news.yahoo.com/so-is-pfizer-part-of-operation-warp-speed-or-not-well-its-a-little-complicated-175429888.html |access-date=9 November 2020 |work=Yahoo! |date=9 November 2020 |archive-date=10 November 2020 |archive-url=https://web.archive.org/web/20201110052209/https://news.yahoo.com/so-is-pfizer-part-of-operation-warp-speed-or-not-well-its-a-little-complicated-175429888.html |url-status=live }}</ref>。2020年12月中旬までに、ファイザーは、欧州連合に3億用量<ref>{{cite news |vauthors=Pleitgen F |title=EU agrees to buy 300 million doses of the Pfizer/BioNTech Covid-19 vaccine |url=https://www.cnn.com/2020/11/11/europe/eu-authorizes-contract-biontech-pfizer-vaccine-intl/index.html |access-date=26 November 2020 |work=CNN |date=11 November 2020 |archive-date=24 November 2020 |archive-url=https://web.archive.org/web/20201124175829/https://www.cnn.com/2020/11/11/europe/eu-authorizes-contract-biontech-pfizer-vaccine-intl/index.html |url-status=live }}</ref>、日本に1億2,000万用量<ref>{{Cite web|date=1 August 2020|title=Japan and Pfizer reach COVID-19 vaccine deal to treat 60 million people|url=https://www.japantimes.co.jp/news/2020/08/01/national/science-health/pfizer-coronavirus-vaccine-deal/|access-date=21 November 2020|website=The Japan Times|archive-date=10 November 2020|archive-url=https://web.archive.org/web/20201110142029/https://www.japantimes.co.jp/news/2020/08/01/national/science-health/pfizer-coronavirus-vaccine-deal/|url-status=live}}</ref>、英国に4,000万用量（2021年以前に1,000万用量）<ref name="bbc" />、カナダに2,000万用量<ref name="cbc">{{cite news |vauthors=Tasker JP |title=Trudeau says promising new Pfizer vaccine could be 'light at the end of the tunnel' |url=https://www.cbc.ca/news/politics/trudeau-pfizer-vaccine-1.5795160 |access-date=9 November 2020 |work=CBC News |date=9 November 2020 |archive-date=9 November 2020 |archive-url=https://web.archive.org/web/20201109170721/https://www.cbc.ca/news/politics/trudeau-pfizer-vaccine-1.5795160 |url-status=live }}</ref>、シンガポールに不特定多数の用量<ref>{{cite web |title=Pfizer and BioNTech to Supply Singapore with their BNT162b2 mRNA-based Vaccine Candidate to Combat COVID-19 |url=https://www.pfizer.com.sg/pfizer-and-biontech-supply-singapore-vaccine-candidate-combat-covid-19 |website=www.pfizer.com.sg |publisher=Pfizer Singapore |access-date=1 February 2021 |date=14 December 2020}}</ref>、メキシコに3,440万用量を供給する契約を結んでいた<ref>{{Cite web| vauthors = de Salud S |title=233. Firma secretario de Salud convenio con Pfizer para fabricación y suministro de vacuna COVID-19|url=http://www.gob.mx/salud/prensa/233-firma-secretario-de-salud-convenio-con-pfizer-para-fabricacion-y-suministro-de-vacuna-covid-19?idiom=es|access-date=17 December 2020|website=gob.mx|language=es }}</ref>。また、Fosunは、[[香港]]と[[マカオ]]に1,000万用量を供給する契約を結んでいる<ref>{{Cite web|date=27 August 2020|title=Fosun Pharma to supply Covid-19 vaccine to Hong Kong, Macau once approved|url=https://www.scmp.com/business/companies/article/3099003/shanghais-fosun-pharma-track-bring-german-partners-covid-19|access-date=21 November 2020|website=South China Morning Post|archive-date=20 November 2020|archive-url=https://web.archive.org/web/20201120223224/https://www.scmp.com/business/companies/article/3099003/shanghais-fosun-pharma-track-bring-german-partners-covid-19|url-status=live| vauthors = Ng E }}</ref>。香港政府は、2021年の第1四半期までに100万用量の最初のバッチを受け取ると述べている<ref>{{cite news | vauthors = Ting V, Lau C, Wong O |title=Hong Kong buys 15 million Covid-19 vaccine doses from Sinovac, Pfizer |url=https://www.scmp.com/news/hong-kong/health-environment/article/3113509/hong-kong-fourth-wave-carrie-lam-update-progress |access-date=18 December 2020 |work=South China Morning Post |date=11 December 2020 }}</ref>。
バイオンテックとFosunは、規制当局の承認を条件に、2021年に中国本土に1億用量を供給することで合意した。最初の供給は、ドイツにあるバイオンテックの生産施設から行われる<ref>{{cite press release |title=BioNTech and Fosun Pharma to Supply China with mRNA-based COVID-19 Vaccine |date=16 December 2020|url=https://investors.biontech.de/news-releases/news-release-details/biontech-and-fosun-pharma-supply-china-mrna-based-covid-19 |publisher=BioNTech |access-date=16 December 2020}}</ref>。
ワクチンは2.25mlのバイアルで供給される（0.45mlの冷凍ワクチンに1.8mlの希釈液を加えたもの）<ref name="EUA fact sheet" />。バイアルのラベルによると、1本のバイアルには0.3ml用量が5回分入っているが、余ったワクチンは1回分あるいは2回分の追加用量に使用することができる<ref name="EUA fact sheet" /><ref name="Pfizer-BioNTech COVID-19 Vaccine FAQ">{{cite web|date=11 December 2020|title=Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions|url=https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/pfizer-biontech-covid-19-vaccine-frequently-asked-questions|access-date=29 December 2020|website=U.S. [[:en:Food and Drug Administration|Food and Drug Administration]]}} {{PD-notice}}</ref>。追加用量を得るためには{{仮リンク|低デッドスペースシリンジ|en|Low dead space syringe}}（無駄を減らした注射器）を使用することが望ましく、バイアル内の部分的な用量は廃棄する必要がある<ref name="EUA fact sheet" /><ref name="EU dose">{{cite web | title=Extra dose from vials of Comirnaty COVID-19 vaccine | website=[[:en:European Medicines Agency|European Medicines Agency]] (EMA) | date=8 January 2021 | url=https://www.ema.europa.eu/en/news/extra-dose-vials-comirnaty-covid-19-vaccine | access-date=8 January 2021}}</ref>。{{仮リンク|イタリア医薬品庁|en|Italian Medicines Agency}}は、単一バイアル内に残っている過剰用量の使用を公式に認めている<ref>{{Cite web|title=AIFA, possibile ottenere almeno 6 dosi da ogni flaconcino del vaccino BioNTech/Pfizer|url=https://aifa.gov.it/-/aifa-possibile-ottenere-almeno-6-dosi-da-ogni-flaconcino-del-vaccino-biontech-pfizer|access-date=29 December 2020|website=aifa.gov.it|language=it-IT}}</ref>。2021年1月8日現在、1バイアルには6用量分が含まれている<ref name="Comirnaty product information" /><ref>{{cite web | title=Global information about Comirnaty | website=Comirnaty IE | date=8 January 2021 | url=https://www.comirnatyeducation.ie/ | access-date=16 January 2021}}</ref><ref>{{cite web|title=Comirnaty Package Insert|publisher=BioNTech Manufacturing GmbH|url=https://www.comirnatyeducation.ie/files/Approved_SmPC_V2.pdf|accessdate=2021-02-20}}</ref><ref name="EU dose" />。米国では、バイアルは通常の注射器を伴う場合は5用量分、低デッドスペースシリンジを伴う場合は6用量分としてカウントされる<ref>{{cite news|date=22 January 2021|title=Biden wants to squeeze an extra shot of vaccine out of every Pfizer vial. It won't be easy.|website=[[:en:The Washington Post|The Washington Post]]|url=https://www.washingtonpost.com/business/2021/01/22/pfizer-vaccine-doses-syringes/|access-date=29 January 2021|vauthors=Rowland C}}</ref>。[[File:Ultracold storage (cropped).jpg|thumb|ファイザーワクチンの温度は、有効性を確保するために、およそ-80～-60℃の間に保つ必要がある。]]
ファイザーと先行発注契約を結んでいる開発途上国（エクアドルやペルーなど）の物流は、依然として不明瞭である<ref name="bloom11-10" />。高所得国でさえ、解凍後5日以内に劣化し、3週間間隔で2回接種する必要があるワクチンを超低温で{{仮リンク|超低温冷凍庫|en|ULT freezer|label=輸送し保管}}するための[[コールドチェーン]]の能力は限られている<ref name="bloom11-10" />。このワクチンは、同様の[[モデルナCOVID-19ワクチン|モデルナワクチン]]よりもはるかに低い-80～-60℃の超低温で保管し輸送する必要がある<ref name="Vaccination Storage" /><ref name="bbc" /><ref name="bloom11-10" /><ref>{{cite news|vauthors=Kollewe J|title=Pfizer and BioNTech's vaccine poses global logistics challenge|url=https://www.theguardian.com/business/2020/nov/10/pfizer-and-biontechs-vaccine-poses-global-logistics-challenge|work=[[:en:The Guardian|The Guardian]]|access-date=10 November 2020|archive-date=10 November 2020|archive-url=https://web.archive.org/web/20201110184815/https://www.theguardian.com/business/2020/nov/10/pfizer-and-biontechs-vaccine-poses-global-logistics-challenge|url-status=live}}</ref><ref>{{cite news|vauthors=Newey S|date=8 September 2020|title=Daunting task of distribution exposed as it emerges some vaccines must be 'deep frozen' at −70C|url=https://www.telegraph.co.uk/global-health/science-and-disease/boost-oxford-covid-vaccine-emerges-rivals-must-deep-frozen/|work=The Telegraph|access-date=10 November 2020|archive-date=9 November 2020|archive-url=https://web.archive.org/web/20201109121506/https://www.telegraph.co.uk/global-health/science-and-disease/boost-oxford-covid-vaccine-emerges-rivals-must-deep-frozen/|url-status=live}}</ref>。[[インドネシア]]の[[:en:Bio Farma|Bio Farma]] Honesti Basyirのトップは、必要なコールドチェーンの能力を持っていなかったことを考えると、ワクチンの購入は、世界で4番目に人口の多い国にとって問題外であると述べた。同様に、インドの既存のコールドチェーンネットワークは、ワクチンの要件をはるかに超える2～8℃の温度しか取り扱えない<ref>{{cite news|url=https://fortune.com/2020/12/05/china-covid-19-vaccines-approval-sinovac-sinopharm/|title=How China's COVID-19 could fill the gaps left by Pfizer, Moderna, AstraZeneca|work=Fortune|date=5 December 2020|access-date=5 December 2020|archive-date=12 December 2020|archive-url=https://web.archive.org/web/20201212204815/https://fortune.com/2020/12/05/china-covid-19-vaccines-approval-sinovac-sinopharm/|url-status=live}}</ref><ref>{{cite news|url=https://jakartaglobe.id/business/pfizers-vaccine-is-out-of-the-question-as-indonesia-lacks-refrigerators-state-pharma-boss|title=Pfizer's Vaccine Is Out of the Question as Indonesia Lacks Refrigerators: State Pharma Boss|work=Jakarta Globe|date=22 November 2020|access-date=5 December 2020|archive-date=7 December 2020|archive-url=https://web.archive.org/web/20201207124956/https://jakartaglobe.id/business/pfizers-vaccine-is-out-of-the-question-as-indonesia-lacks-refrigerators-state-pharma-boss/|url-status=live}}</ref>。
2021年1月、ファイザーとバイオンテックは、3月から2021年末までの間に、アフリカ全土の医療従事者向けにCOVID-19ワクチン5,000万用量を1回あたり10米ドルの割引価格で供給することを提案した<ref>{{Cite news|date=4 January 2021|title=Pfizer Has Offered South Africa Discounted Covid-19 Vaccines|work=Bloomberg|url=https://www.bloomberg.com/news/articles/2021-01-04/pfizer-has-offered-south-africa-discounted-covid-19-vaccines|access-date=5 January 2021}}</ref>。
== 社会文化 ==
=== 名称 ===
BNT162b2は開発および試験中のコードネームであり<ref name="pmid33053279" /><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 |pmc=7745181 |doi=10.1056/NEJMoa2034577 }}</ref>、tozinameranは提案された[[国際一般名]]（pINN）であり<ref name="INN">{{cite journal|author=World Health Organization|date=2020|title=International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 124 – COVID-19 (special edition)|url=https://www.who.int/medicines/publications/druginformation/issues/WHO_DI_34-3_PL124-SpecialEdition.pdf|journal=WHO Drug Information|volume=34|issue=3|page=666|accessdate=23 November 2020|archivedate=27 November 2020|archiveurl=https://web.archive.org/web/20201127075410/https://www.who.int/medicines/publications/druginformation/issues/WHO_DI_34-3_PL124-SpecialEdition.pdf|url-status=live}}</ref>、コミナティはブランド名である<ref name="Swiss authorization" /><ref name="Comirnaty EPAR" />。バイオンテックによると、コミナティという名称は 「COVID-19、mRNA、コミュニティ、および免疫という用語の組み合わせを表している」という<ref>{{cite press release | publisher=BioNTech | title=Pfizer and BioNTech Receive Authorization in the European Union for COVID-19 Vaccine | via=GlobeNewswire | date=21 December 2020 | url=http://www.globenewswire.com/news-release/2020/12/21/2148959/0/en/Pfizer-and-BioNTech-Receive-Authorization-in-the-European-Union-for-COVID-19-Vaccine.html | access-date=26 December 2020}}</ref><ref>{{cite web | vauthors = Bulik BS | title=The inside story behind Pfizer and BioNTech's new vaccine brand name, Comirnaty | website=FiercePharma | date=23 December 2020 | url=https://www.fiercepharma.com/marketing/pfizer-biontech-select-comirnaty-as-brand-name-for-covid-19-vaccine | access-date=25 December 2020 }}</ref>。
このワクチンはまた「COVID-19 mRNAワクチン（ヌクレオシド修飾）という一般名があり<ref name="Comirnaty EPAR" />、ファイザー-バイオンテックCOVID-19ワクチンという名称でパッケージに入って流通することもある<ref>{{cite web | title=Comirnaty COVID-19 mRNA Vaccine | url=https://www.comirnatyglobal.com/ | access-date=31 December 2020 | website=Comirnaty Global }}</ref>。」
== 脚注 ==
{{脚注ヘルプ}}
=== 注釈 ===
{{Notelist}}
=== 出典 ===
{{Reflist|3}}
== 外部リンク ==
53 ⟶ 227行目:
* {{cite web | url = https://druginfo.nlm.nih.gov/drugportal/name/tozinameran | publisher = U.S. National Library of Medicine | work = Drug Information Portal | title = Tozinameran |accessdate=2021-1}}
* [https://www.cvdvaccine.com/ Global Information About Pfizer–BioNTech COVID‑19 Vaccine (also known as BNT162b2)] Pfizer
*[https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf Comirnaty assessment report] [[European Medicines Agency]] Committee for Medicinal Products for Human Use
* [https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-09/C4591001_Clinical_Protocol.pdf A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID‑19 in Healthy Individuals] Pfizer clinical protocol
* {{cite web | title=Reverse Engineering the source code of the BioNTech/Pfizer SARS-CoV-2 Vaccine | url=https://berthub.eu/articles/posts/reverse-engineering-source-code-of-the-biontech-pfizer-vaccine/ |accessdate=2021-1}}
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