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強生2019冠狀病毒病疫苗：修订间差异

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{{Medical}}
{{noteTA
|T = zh-cn:强生2019冠状病毒病疫苗; zh-hk:強生2019冠狀病毒病疫苗; zh-mo:強生2019冠狀病毒病疫苗; zh-tw:嬌生嚴重特殊傳染性肺炎疫苗; zh-sg:强生2019冠状病毒疾病疫苗; zh-my:强生2019冠状病毒病疫苗;
|1 = zh-hans:强生; zh-hk:強生; zh-mo:強生; zh-tw:嬌生; zh-sg:强生; zh-my:强生;
|G1=ME
|G2=地名
}}
{{Infobox drug
| Verifiedfields =
| verifiedrevid =
| drug_name = 强生2019冠状病毒病疫苗
| INN =
| type = vaccine
| image = Johnson & Johnson COVID-19 vaccine developed by Janssen.jpg
| alt =
| caption = 一瓶强生2019冠状病毒病疫苗


<!-- Vaccine data -->
{{Infobox drug|Verifiedfields=|legal_status=<!-- For countries not listed above -->
| target = 严重急性呼吸系统综合征冠状病毒2（SARS-CoV-2）
| vaccine_type = viral


<!-- Clinical data -->
<!-- Identifiers -->|legal_DE_comment=|legal_NZ=<!-- Class A, B, C -->|legal_NZ_comment=|legal_UK=<!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM -->|legal_UK_comment=|legal_US=Unapproved|legal_US_comment=({{link-en|Emergency Use Authorization}})<ref name="FDA PR 20210227">{{cite press release |title=FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine |website=U.S. [[Food and Drug Administration]] (FDA) |date=27 February 2021 |url=https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine |access-date=27 February 2021}}</ref><ref name="Janssen COVID-19 Vaccine FDA label"/><ref name="FDA EUA">{{cite web | url=https://www.fda.gov/media/146303/download | format=PDF | title=FDA Letter of Authorization |quote=...letter is in response to a request from Janssen Biotech, Inc. that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA)... | date=27 February 2021}}</ref><ref name="FDA Janssen COVID-19 Vaccine">{{cite web|date=19 March 2021|title=Janssen COVID-19 Vaccine|url=https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/janssen-covid-19-vaccine|access-date=7 April 2021|website=U.S. [[Food and Drug Administration]] (FDA)}} {{PD-notice}}</ref>|legal_EU=Conditional marketing authorization granted|legal_EU_comment=<ref name="COVID-19 Vaccine Janssen EPAR">{{cite web |title=COVID-19 Vaccine Janssen EPAR |url=https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-janssen |website=[[European Medicines Agency]] (EMA) | date=5 March 2021 | access-date=16 March 2021}}</ref>|legal_UN=<!-- N I, II, III, IV / P I, II, III, IV -->|legal_UN_comment=|CAS_number=|legal_CA_comment=<ref name="CA authorization">{{cite web | title=Regulatory Decision Summary – Janssen COVID-19 Vaccine – Health Canada | website=[[加拿大衛生部]] | date=5 March 2021 | url=https://covid-vaccine.canada.ca/info/regulatory-decision-summary-detailTwo.html?linkID=RDS00779 | access-date=5 March 2021}}</ref><ref>{{cite web | title=Janssen COVID-19 Vaccine monograph | publisher=Janssen | url=https://covid-vaccine.canada.ca/info/pdf/janssen-covid-19-vaccine-pm-en.pdf | date=5 March 2021 }}</ref>|PubChem=|IUPHAR_ligand=|DrugBank=DB15857|ChemSpiderID=|UNII=JT2NS6183B|KEGG=|ChEBI_Ref=|ChEBI=|ChEMBL_Ref=|ChEMBL=|NIAID_ChemDB=|PDB_ligand=|legal_DE=<!-- Anlage I, II, III or Unscheduled -->|legal_CA=Schedule D; Authorized by interim order|verifiedrevid=|licence_EU=|drug_name=|INN=|type=vaccine|image=Johnson & Johnson COVID-19 vaccine developed by Janssen.jpg|alt=|caption=一瓶強生2019冠狀病毒病疫苗
| pronounce =
| tradename = 杨森2019冠状病毒病疫苗（Janssen COVID-19 Vaccine）<ref name="Janssen COVID-19 Vaccine FDA label" /><ref>{{cite web | title=Janssen COVID-19 Emergency Use Authorization (EUA) Official Website | website=Janssen | date=2021-02-28 | url=https://www.janssencovid19vaccine.com/hcp.html | access-date=2021-02-28 }}</ref>、COVID-19 Vaccine Janssen<ref name="Janssen CMA application" />
| Drugs.com =
| MedlinePlus =
| licence_EU =
| DailyMedID = Janssen_COVID-19_Vaccine
| licence_US =
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_AU_comment =
| pregnancy_category =
| routes_of_administration = [[肌肉注射]]
| class =
| ATCvet =
| ATC_prefix = <!-- scheduled to be J07BX03 in 2022 -->
| ATC_suffix =
| ATC_supplemental =


<!-- Legal status -->
<!-- Vaccine data -->|target=[[严重急性呼吸系统综合征冠状病毒2]]|vaccine_type=viral
| legal_status = 欧盟<ref name="COVID-19 Vaccine Janssen EPAR">{{cite web |title=COVID-19 Vaccine Janssen EPAR |url=https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-janssen |website=European Medicines Agency (EMA) | date=2021-03-05| access-date=2021-03-16}}</ref>、加拿大<ref name="CA authorization">{{cite web | title=Regulatory Decision Summary – Janssen COVID-19 Vaccine – Health Canada | website=[[加拿大卫生部]] | date=2021-03-05 | url=https://covid-vaccine.canada.ca/info/regulatory-decision-summary-detailTwo.html?linkID=RDS00779 | access-date=2021-03-05}}</ref><ref>{{cite web | title=Janssen COVID-19 Vaccine monograph | publisher=Janssen | url=https://covid-vaccine.canada.ca/info/pdf/janssen-covid-19-vaccine-pm-en.pdf | date=2021-03-05 }}</ref>、美国<ref name="FDA PR 20210227">{{cite press release |title=FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine |website=U.S. Food and Drug Administration (FDA) |date=2021-02-27|url=https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine |access-date=2021-02-27}}</ref><ref name="Janssen COVID-19 Vaccine FDA label"/><ref name="FDA EUA">{{cite web |title=Janssen COVID-19 Vaccine EUA Letter of Authorization |url=https://www.fda.gov/media/146303/download |website=[[美国食品药品监督管理局]] |accessdate=2021-04-11}}</ref>


<!-- Identifiers -->
<!-- Clinical data -->|pronounce=|tradename=Janssen COVID-19 Vaccine,<ref name="Janssen COVID-19 Vaccine FDA label" /><ref>{{cite web | title=Janssen COVID-19 Emergency Use Authorization (EUA) Official Website | website=Janssen | date=28 February 2021 | url=https://www.janssencovid19vaccine.com/hcp.html | access-date=28 February 2021}}</ref> COVID-19 Vaccine Janssen<ref name="Janssen CMA application" />|Drugs.com=|MedlinePlus=|DailyMedID=Janssen_COVID-19_Vaccine|legal_BR_comment=|licence_US=|pregnancy_AU=<!-- A / B1 / B2 / B3 / C / D / X -->|pregnancy_AU_comment=|pregnancy_category=|routes_of_administration=[[肌肉注射]]|ATCvet=|ATC_prefix=None<!-- scheduled to be J07BX03 in 2022 -->|ATC_suffix=|ATC_supplemental=<!-- Legal status -->|legal_AU=<!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled -->|legal_AU_comment=|legal_BR=<!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F -->|synonyms={{ubl|
| CAS_number =
| Ad26.COV2.S<ref name="J&J Protocol" /><ref name="J&J ENSEMBLE 2 Protocol" /><ref name="jnj">{{cite press release |url= https://www.jnj.com/johnson-johnson-initiates-pivotal-global-phase-3-clinical-trial-of-janssens-covid-19-vaccine-candidate |title= Johnson & Johnson Initiates Pivotal Global Phase 3 Clinical Trial of Janssen's COVID-19 Vaccine Candidate |access-date= 23 September 2020 |website=Johnson & Johnson }}</ref>
| CAS_supplemental =
| PubChem =
| IUPHAR_ligand =
| DrugBank = DB15857
| ChemSpiderID =
| UNII = JT2NS6183B
| KEGG =
| ChEBI_Ref =
| ChEBI =
| ChEMBL_Ref =
| ChEMBL =
| NIAID_ChemDB =
| PDB_ligand =
| synonyms = {{ubl|
| Ad26.COV2.S<ref name="J&J Protocol" /><ref name="J&J ENSEMBLE 2 Protocol" /><ref name="jnj">{{cite press release |url= https://www.jnj.com/johnson-johnson-initiates-pivotal-global-phase-3-clinical-trial-of-janssens-covid-19-vaccine-candidate |title= Johnson & Johnson Initiates Pivotal Global Phase 3 Clinical Trial of Janssen's COVID-19 Vaccine Candidate |access-date= 2020-09-23|website=Johnson & Johnson }}</ref>
| JNJ-78436735<ref name="J&J Protocol" /><ref name="J&J ENSEMBLE 2 Protocol" /><ref name="jnj" />
| JNJ-78436735<ref name="J&J Protocol" /><ref name="J&J ENSEMBLE 2 Protocol" /><ref name="jnj" />
| Ad26COVS1<ref name="J&J Protocol" /><ref name="J&J ENSEMBLE 2 Protocol" />
| Ad26COVS1<ref name="J&J Protocol" /><ref name="J&J ENSEMBLE 2 Protocol" />
| VAC31518<ref name="J&J Protocol">{{cite web |title=A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older ENSEMBLE Protocol VAC31518COV3001; Phase 3 |url=https://www.jnj.com/coronavirus/ensemble-1-study-protocol | format=PDF |publisher=[[杨森制药]]}}</ref><ref name="J&J ENSEMBLE 2 Protocol">{{cite web | url=https://www.jnj.com/coronavirus/ensemble-2-study-protocol | format=PDF | title=A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older ENSEMBLE 2 Protocol VAC31518COV3009; Phase 3 | publisher=[[杨森制药]] }}</ref>
| VAC31518<ref name="J&J Protocol">{{cite web |title=A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older ENSEMBLE Protocol VAC31518COV3001; Phase 3 |url=https://www.jnj.com/coronavirus/ensemble-1-study-protocol | format=PDF |publisher=Janssen Vaccines & Prevention}}</ref><ref name="J&J ENSEMBLE 2 Protocol">{{cite web | url=https://www.jnj.com/coronavirus/ensemble-2-study-protocol | format=PDF | title=A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older ENSEMBLE 2 Protocol VAC31518COV3009; Phase 3 | publisher=Janssen Vaccines & Prevention }}</ref>
}}
}}
<!-- Chemical and physical data -->

}}
<!-- Chemical and physical data -->}}

{{2019冠狀病毒病疫情邊欄}}
{{2019冠狀病毒病疫情邊欄}}


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它是一种基于人类[[腺病毒]]的{{link-en|病毒载体疫苗|Viral vector vaccine}}，人类[[腺病毒]]经过改造後會含有能產生[[严重急性呼吸系统综合征冠状病毒2]]病毒{{link-en|尖峰蛋白|spike protein}}的[[基因]]<ref name="Janssen CMA application">{{Cite press release|accessdate=16 February 2021}}</ref>。人体的[[免疫系统]]会对这种尖峰蛋白产生反应並产生[[抗体]]<ref>{{Cite web|title=COVID Vaccines: Does it Matter Which One You Get?|url=https://healthblog.uofmhealth.org/wellness-prevention/covid-vaccines-does-it-matter-which-one-you-get|accessdate=30 March 2021|date=8 March 2021|work={{link-en|Michigan Medicine}}}}</ref>。人類只需注射一剂该疫苗，且該疫苗无需冷冻保存 <ref name="Fact sheet">{{Cite web|title=Fact Sheet for Healthcare Providers Administering Vaccine and EUA|url=https://www.fda.gov/media/146304/download|accessdate=13 April 2021|format=PDF|publisher=Janssen}}</ref><ref name=":3">{{Cite web|title=Johnson & Johnson's Janssen COVID-19 Vaccine Information|url=https://www.cdc.gov/vaccines/covid-19/info-by-product/janssen/index.html|accessdate=30 March 2021|date=23 March 2021|publisher=[[美国疾病控制与预防中心]] (CDC)}}</ref>。
它是一种基于人类[[腺病毒]]的{{link-en|病毒载体疫苗|Viral vector vaccine}}，人类[[腺病毒]]经过改造後會含有能產生[[严重急性呼吸系统综合征冠状病毒2]]病毒{{link-en|尖峰蛋白|spike protein}}的[[基因]]<ref name="Janssen CMA application">{{Cite press release|accessdate=16 February 2021}}</ref>。人体的[[免疫系统]]会对这种尖峰蛋白产生反应並产生[[抗体]]<ref>{{Cite web|title=COVID Vaccines: Does it Matter Which One You Get?|url=https://healthblog.uofmhealth.org/wellness-prevention/covid-vaccines-does-it-matter-which-one-you-get|accessdate=30 March 2021|date=8 March 2021|work={{link-en|Michigan Medicine}}}}</ref>。人類只需注射一剂该疫苗，且該疫苗无需冷冻保存 <ref name="Fact sheet">{{Cite web|title=Fact Sheet for Healthcare Providers Administering Vaccine and EUA|url=https://www.fda.gov/media/146304/download|accessdate=13 April 2021|format=PDF|publisher=Janssen}}</ref><ref name=":3">{{Cite web|title=Johnson & Johnson's Janssen COVID-19 Vaccine Information|url=https://www.cdc.gov/vaccines/covid-19/info-by-product/janssen/index.html|accessdate=30 March 2021|date=23 March 2021|publisher=[[美国疾病控制与预防中心]] (CDC)}}</ref>。


该疫苗的[[臨床試驗]]于2020年6月开始，三期试验涉及约4.3万人。2021年1月29日，杨森公司宣布，在疫苗接种28天后，该疫苗预防[[2019冠狀病毒病]]的有效率为66%，预防重症[[2019冠狀病毒病]]的有效率为85%<ref>{{Cite news|date=29 January 2021|title=Johnson & Johnson single-shot vaccine 85% effective against severe COVID-19 disease|work=ABC News|url=https://abcnews.go.com/Health/johnson-johnson-single-shot-vaccine-85-effective-severe/story?id=75557358}}</ref><ref>{{Cite news|date=29 January 2021|title=Covid vaccine: Single dose Covid vaccine 66% effective|work=BBC News|url=https://www.bbc.com/news/health-55857530|accessdate=29 January 2021}}</ref><ref>{{Cite web|title=J&J's Covid vaccine is 66% effective, a weapon but not a knockout punch|url=https://www.statnews.com/2021/01/29/jj-one-dose-covid-vaccine-is-66-effective-a-weapon-but-not-a-knockout-punch/|accessdate=29 January 2021|date=29 January 2021|work={{link-en|Stat (website)}}}}</ref>，预防[[2019冠狀病毒病]]引起的住院或死亡的有效率为100%<ref name="Janssen COVID-19 Vaccine FDA label">{{Cite web|title=Janssen COVID-19 Vaccine – ad26.cov2.s injection, suspension|url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14a822ff-f353-49f9-a7f2-21424b201e3b|accessdate=27 February 2021|work=DailyMed|publisher=U.S. National Institutes of Health}}</ref>。
该疫苗的[[臨床試驗]]于2020年6月开始，三期试验涉及约4.3万人<ref name="FDA PR 20210227" />。2021年1月29日，杨森公司宣布，在疫苗接种28天后，该疫苗预防[[2019冠狀病毒病]]的有效率为66%，预防重症[[2019冠狀病毒病]]的有效率为85%<ref>{{Cite news|date=29 January 2021|title=Johnson & Johnson single-shot vaccine 85% effective against severe COVID-19 disease|work=ABC News|url=https://abcnews.go.com/Health/johnson-johnson-single-shot-vaccine-85-effective-severe/story?id=75557358}}</ref><ref>{{Cite news|date=29 January 2021|title=Covid vaccine: Single dose Covid vaccine 66% effective|work=BBC News|url=https://www.bbc.com/news/health-55857530|accessdate=29 January 2021}}</ref><ref>{{Cite web|title=J&J's Covid vaccine is 66% effective, a weapon but not a knockout punch|url=https://www.statnews.com/2021/01/29/jj-one-dose-covid-vaccine-is-66-effective-a-weapon-but-not-a-knockout-punch/|accessdate=29 January 2021|date=29 January 2021|work={{link-en|Stat (website)}}}}</ref>，预防[[2019冠狀病毒病]]引起的住院或死亡的有效率为100%<ref name="Janssen COVID-19 Vaccine FDA label">{{Cite web|title=Janssen COVID-19 Vaccine – ad26.cov2.s injection, suspension|url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14a822ff-f353-49f9-a7f2-21424b201e3b|accessdate=27 February 2021|work=DailyMed|publisher=U.S. National Institutes of Health}}</ref>。


该疫苗於2021年2月27日获得[[美国食品药品监督管理局]]的{{link-en|紧急使用授权|Emergency Use Authorization}}，2021年3月11日獲得[[欧洲药品管理局]]的{{link-en|有条件上市授权|Marketing authorisation}}<ref>{{Cite press release|accessdate=11 March 2021}}</ref><ref name="EU COVID-19 Vaccine Janssen">{{Cite web|title=COVID-19 Vaccine Janssen|url=https://ec.europa.eu/health/documents/community-register/html/h1525.htm|accessdate=16 March 2021|work=Union Register of medicinal products}}</ref><ref name=":1">{{Cite press release|website=[[Centers for Disease Control and Prevention]] (CDC)|accessdate=1 March 2021}}</ref>。
该疫苗於2021年2月27日获得[[美国食品药品监督管理局]]的{{link-en|紧急使用授权|Emergency Use Authorization}}，2021年3月11日獲得[[欧洲药品管理局]]的{{link-en|有条件上市授权|Marketing authorisation}}<ref>{{Cite press release|accessdate=11 March 2021}}</ref><ref name="EU COVID-19 Vaccine Janssen">{{Cite web|title=COVID-19 Vaccine Janssen|url=https://ec.europa.eu/health/documents/community-register/html/h1525.htm|accessdate=16 March 2021|work=Union Register of medicinal products}}</ref><ref name=":1">{{Cite press release|website=[[Centers for Disease Control and Prevention]] (CDC)|accessdate=1 March 2021}}</ref>。


==疫苗简介==
2021年4月13日，[[美国疾病控制与预防中心]]和[[美国食品药品监督管理局]]宣布，他们将调查6例极其罕见的在注射疫苗後出現的{{link-en|脑静脉窦血栓|Cerebral venous sinus thrombosis}}形成病例，並建議暂停接種强生疫苗。6名病例中有一名妇女已经死亡，另有一名妇女緊急住院。<ref name="CDC/FDA">{{Cite press release|accessdate=13 April 2021}}</ref><ref name=":6">{{Cite news|author=Weiland|first=Noah|author2=LaFraniere|first2=Sharon|last3=Zimmer|first3=Carl|date=13 April 2021|title=Johnson & Johnson Vaccinations Halt Across Country After Rare Clotting Cases Emerge|work=The New York Times|url=https://www.nytimes.com/2021/04/13/us/politics/johnson-johnson-vaccine-blood-clots-fda-cdc.html|accessdate=13 April 2021}}</ref><ref name=":5">{{Cite news|author=Erman|first=Michael|first2=Manas|author2=Mishra|date=13 April 2021|title=U.S. pauses use of J&J vaccine over rare blood clots, rollout delayed in Europe|publisher=Reuters|url=https://www.reuters.com/article/us-health-coronavirus-johnson-johnson-va-idUSKBN2C01BC|accessdate=13 April 2021}}</ref><ref name=":7">{{Cite news|first=Jacqueline|author=Howard|title=CDC and FDA recommend US pause use of Johnson & Johnson's Covid-19 vaccine over blood clot concerns|url=https://www.cnn.com/2021/04/13/health/johnson-vaccine-pause-cdc-fda/index.html|accessdate=13 April 2021|publisher=CNN}}</ref>
强生2019冠状病毒病疫苗采用与[[加马列亚2019冠状病毒病疫苗|卫星V疫苗]]、[[牛津－阿斯利康2019冠状病毒病疫苗|阿斯利康疫苗]]相似的技术。疫苗采用人类[[腺病毒]]为载体，与卫星V疫苗更为相似，但根据一期临床试验，其效果可能较差<ref>{{cite news |title=Russia's Sputnik V vaccine looks good in early analysis |url=https://arstechnica.com/science/2021/02/russias-sputnik-v-vaccine-looks-good-in-early-analysis/ |work=Ars Technica |date=2021-02-03 }}</ref>。疫苗由无复制能力的重组腺病毒26型（Ad26）载体组成，该载体包含[[严重急性呼吸系统综合症冠状病毒2]]刺突（S）蛋白<ref name="FDA VRBPAC brief" /><ref name="J&J Protocol" />。


[[美国国家过敏和传染病研究所]]疫苗研究中心和[[德州大学奥斯汀分校]]的研究人员开发了刺突蛋白的稳定版本，其中包括两个突变，其中普通氨基酸被[[脯氨酸]]取代<ref name="C&EN092920">{{cite news |title =The tiny tweak behind COVID-19 vaccines|work=Chemical & Engineering News|url=https://cen.acs.org/pharmaceuticals/vaccines/tiny-tweak-behind-COVID-19/98/i38|access-date=2021-03-01| date=2020-09-29}}</ref><ref name="2020-NatGeo">{{cite news| vauthors = Kramer J |date=2020-12-31|title=They spent 12 years solving a puzzle. It yielded the first COVID-19 vaccines.|work=National Geographic|url=https://www.nationalgeographic.com/science/article/these-scientists-spent-twelve-years-solving-puzzle-yielded-coronavirus-vaccines}}</ref><ref name="Nature073020">{{cite journal | vauthors=Mercado NB, Zahn R, Wegmann F, Loos C, Chandrashekar A, Yu J, Liu J, Peter L, McMahan K, Tostanoski LH, He X, Martinez DR, Rutten L, Bos R, van Manen D, Vellinga J, Custers J, Langedijk JP, Kwaks T, Bakkers MJ, Zuijdgeest D, Rosendahl Huber SK, Atyeo C, Fischinger S, Burke JS, Feldman J, Hauser BM, Caradonna TM, Bondzie EA, Dagotto G, Gebre MS, Hoffman E, Jacob-Dolan C, Kirilova M, Li Z, Lin Z, Mahrokhian SH, Maxfield LF, Nampanya F, Nityanandam R, Nkolola JP, Patel S, Ventura JD, Verrington K, Wan H, Pessaint L, Van Ry A, Blade K, Strasbaugh A, Cabus M, Brown R, Cook A, Zouantchangadou S, Teow E, Andersen H, Lewis MG, Cai Y, Chen B, Schmidt AG, Reeves RK, Baric RS, Lauffenburger DA, Alter G, Stoffels P, Mammen M, Van Hoof J, Schuitemaker H, Barouch DH | display-authors=6 |title = Single-shot Ad26 vaccine protects against SARS-CoV-2 in rhesus macaques |journal=Nature | date=2020-10|bibcode=2020Natur.586..583M |volume=586 |issue=7830 |pages=583–88 | doi=10.1038/s41586-020-2607-z | title-link=doi | pmid=32731257 }}</ref>。该疫苗的非活性成分为：[[柠檬酸一水合物]]、[[柠檬酸三钠二水合物]]、[[乙醇]]、2-羟丙基-β-环糊精（HBCD）（羟丙基βdex）[[聚山梨酸酯80]]、[[氯化钠]]、[[氢氧化钠]]和[[盐酸]]<ref name="FDA VRBPAC brief" /><ref name="Janssen COVID-19 Vaccine FDA label" />。
==参考文献==

疫苗可在冰箱中保存数月时间<ref name="JohnsonMcGinley">{{cite news|url=https://www.washingtonpost.com/health/2021/02/04/jj-vaccine-fda/|newspaper=The Washington Post|date=2021-02-04|title=Johnson & Johnson seeks emergency FDA authorization for single-shot coronavirus vaccine | vauthors = Johnson CY, McGinley L }}</ref><ref name=":0">{{Cite web| vauthors = Weintraub K |title=One-dose J&J COVID-19 vaccine meets criteria as safe and effective, FDA report finds|url=https://www.usatoday.com/story/news/health/2021/02/24/fda-finds-one-dose-j-j-covid-vaccine-meets-criteria-safe-effective/4535542001/|access-date=2021-02-05|website=USA Today }}</ref><ref>{{Cite web| vauthors = Mole B |date=2021-01-29|title=COVID variants throw J&J vaccine a curveball, lowering efficacy to 66%|url=https://arstechnica.com/science/2021/01/covid-variants-throw-jj-vaccine-a-curveball-lowering-efficacy-to-66/|access-date=2021-01-26|website=Ars Technica }}</ref>。与[[辉瑞－BioNTech 2019冠状病毒病疫苗|辉瑞疫苗]]、[[莫德纳2019冠状病毒病疫苗|莫德纳疫苗]]不同的是，强生疫苗采用单针接种程序，且无需冷冻运输<ref name="Chander">{{cite news | vauthors = Chander V |title=J&J files COVID-19 vaccine application with U.S. FDA |url=https://www.reuters.com/article/us-health-coronavirus-vaccines-johnson-j-idINKBN2A430V |access-date=2021-02-04 |publisher=Reuters |date=2021-02-04 }}</ref><ref name="Fact sheet" />。每瓶疫苗含五剂<ref name=":3" />。

==不良反应==
该疫苗主要的不良反应包括注射部位的疼痛、头痛、疲劳、肌肉酸痛和恶心<ref name="FDA PR 20210227" /><ref name="FDA Janssen COVID-19 Vaccine" />。这些不良反应大多数在接种疫苗后1至2天内发生，轻度至中度的不良反应则持续1至2天<ref name="FDA Janssen COVID-19 Vaccine">{{cite web | title=Janssen COVID-19 Vaccine | website=U.S. Food and Drug Administration | date=2021-03-19| url=https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/janssen-covid-19-vaccine | access-date=2021-04-07}} {{PD-notice}}</ref><ref>{{cite web | title=Information about the J&J/Janssen COVID-19 Vaccine | website=Centers for Disease Control and Prevention (CDC) | date=2021-03-31| url=https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/janssen.html | access-date=2021-04-07}} {{PD-notice}}</ref>。

==研发历史==
[[File:Ad26.COV2.S production facility.jpg|缩略图|强生与{{le|新兴生物科技公司|Emergent BioSolutions}}（Emergent BioSolutions）合作开设的疫苗生产场所]]
[[2019冠状病毒病疫情]]期间，强生公司与[[美国卫生及公共服务部]]{{le|应急管理办公室|Office of the Assistant Secretary for Preparedness and Response}}{{le|生物医学高级研究与发展局|Biomedical Advanced Research and Development Authority}}合作，以非盈利性原则研发疫苗<ref name="Vecchione_2020">{{cite web|url=https://njbiz.com/jj-collaborates-accelerate-covid-19-vaccine-development/|title=J&J collaborates to accelerate COVID-19 vaccine development| vauthors = Vecchione A |date=2020-03-13|website=NJBIZ|access-date=2020-04-22}}</ref><ref>{{cite web|url=https://www.wspa.com/news/prisma-health-collaborates-with-ethicon-inc-to-make-distribute-vesper-ventilator-expansion-splitter-device/|title=Prisma Health collaborates with Ethicon Inc. to make, distribute VESper Ventilator Expansion Splitter Device|date=2020-04-06|website=WSPA 7News|access-date=2020-04-22}}</ref>。强生公司表示，其疫苗项目将“处于非营利水平”，因为该公司将其视为“以最快最好的方式找到世界上所有合作，来实现这一目标”<ref>{{cite web|url=https://news.sky.com/story/coronavirus-johnson-johnson-vows-to-make-not-for-profit-vaccine-11966292|title=Coronavirus: Johnson & Johnson vows to make 'not-for-profit' vaccine|website=Sky News|access-date=2020-04-22}}</ref>。

杨森疫苗公司则与[[贝斯以色列女执事医疗中心]]合作，根据用于生产{{le|埃博拉疫苗|Ebola vaccine}}的相同技术，负责开发候选疫苗<ref name="Globe 20200312" /><ref>{{cite news | title=A Beth Israel researcher helped create a COVID-19 vaccine that awaits approval. It could be a 'game changer' | website=The Boston Globe | date=2021-01-16| url=https://www.bostonglobe.com/2021/01/16/nation/beth-israel-researcher-awaits-approval-covid-19-vaccine-he-helped-create/ | access-date=2021-02-28}}</ref><ref>{{cite web | title=FDA grants third COVID-19 vaccine, developed in part at BIDMC, emergency use authorization | website=Beth Israel Deaconess Medical Center (BIDMC) | date=2021-02-27 | url=https://www.bidmc.org/about-bidmc/news/2021/01/data-shows-bidmc-vaccine-collab-met-co-primary-endpoints |first=Jacqueline |last=Mitchell |first2=Chloe |last2=Meck |access-date=2021-02-28}}</ref>。

临床前试验表明，该疫苗可有效保护[[仓鼠]]和[[恒河猕猴]]免受SARS-CoV-2侵害<ref name=":4">{{cite journal | vauthors = Calvo Fernández E, Zhu LY | title = Racing to immunity: Journey to a COVID-19 vaccine and lessons for the future | journal = British Journal of Clinical Pharmacology | volume = n/a | issue = n/a | date = 2020-12| pmid = 33289156 | pmc = 7753785 | doi = 10.1111/bcp.14686 }}</ref>。

===一、二期临床试验===
2020年6月，强生公司和[[美国国家过敏和传染病研究所]]确认，计划于2020年9月开始该疫苗的临床试验，并可能进行一、二a期人类临床试验。试验工作从7月下半月开始加速发展<ref>{{cite web| vauthors = Coleman J |date=10 June 2020|title=Final testing stage for potential coronavirus vaccine set to begin in July|url=https://thehill.com/policy/healthcare/501999-final-testing-stage-for-coronavirus-vaccine-could-begin-in-july-report|access-date=2020-06-11|website=TheHill}}</ref><ref>{{cite web|title=Moderna, AstraZeneca and J&J coronavirus shots rev up for NIH tests beginning in July: WSJ|url=https://www.fiercepharma.com/vaccines/nih-preps-late-stage-studies-moderna-az-and-j-j-coronavirus-vaccines-wsj|access-date=2020-06-11|website=FiercePharma}}</ref><ref>{{cite web|title=Johnson & Johnson to start human testing of COVID-19 vaccine next week|url=https://www.fiercepharma.com/vaccines/j-j-to-start-human-testing-covid-19-vaccine-next-week-exec|access-date=2020-07-20|website=FiercePharma}}</ref>。

一、二a期试验自2020年7月15日招募首位受试者开始，并在比利时和美国招募了研究参与者<ref name="phase1-2a_clinicaltrialsgov">{{cite web |title=A Study of Ad26.COV2.S in Adults (COVID-19)|url=https://clinicaltrials.gov/ct2/show/NCT04436276 |access-date=2021-02-19|website=ClinicalTrials.gov}}</ref>。一、二a期试验的中期结果确定了疫苗的安全性、反应原性和免疫原性。根据报告，注射一剂疫苗后的29天内，可确保90%的参与者具有中和病毒所需的足够抗体。在57天后，所有参与者全部具有抗体<ref name="NEJM">{{cite journal |vauthors=Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, de Groot AM, Stoop J, Tete S, Van Damme W, Leroux-Roels I, Berghmans PJ, Kimmel M, Van Damme P, de Hoon J, Smith W, Stephenson KE, De Rosa SC, Cohen KW, McElrath MJ, Cormier E, Scheper G, Barouch DH, Hendriks J, Struyf F, Douoguih M, Van Hoof J, Schuitemaker H |display-authors=6 |date=13 January 2021 |title=Interim Results of a Phase 1-2a Trial of Ad26.COV2.S Covid-19 Vaccine |journal=New England Journal of Medicine |volume= |issue= |pages= |pmid=33440088 |pmc=7821985}}</ref><ref name="phase1-2a">{{cite press release |title=Johnson & Johnson COVID-19 Vaccine Candidate Interim Phase 1/2a Data Published in New England Journal of Medicine |url=https://www.jnj.com/johnson-johnson-covid-19-vaccine-candidate-interim-phase-1-2a-data-published-in-new-england-journal-of-medicine |access-date=2021-01-16 |website=Johnson & Johnson}}</ref>。

===三期临床试验===
三期临床试验命名为“ENSEMBLE”，于2020年9月开始招募，并于2020年12月17日完成招募。此次临床试验是随机、双盲、[[安慰剂对照]]的试验，旨在与18岁及以上成年人的安慰剂相比，评估单剂量疫苗的安全性和有效性。研究参与者在第一天接受疫苗的单次肌肉注射，剂量为5×10{{sup|10}}病毒颗粒<ref>{{cite web |title=Fourth large-scale COVID-19 vaccine trial begins in the United States|url=https://www.nih.gov/news-events/news-releases/fourth-large-scale-covid-19-vaccine-trial-begins-united-states|access-date=2021-01-30|website=National Institutes of Health }}</ref>。但因一名志愿者出现不良反应，试验于10月12日暂停。试验在11天后恢复<ref>{{cite news |author1=Katherine J. Wu |author2=Carl Zimmer |author3=Sharon LaFraniere |author4=Noah Weiland |title=Two Companies Restart Virus Trials in U.S. After Safety Pauses |url=https://www.nytimes.com/2020/10/23/health/covid-vaccine-astrazeneca-johnson-and-johnson.html |accessdate=2021-02-26 |work=[[纽约时报]] |date=2020-10-23}}</ref>。2021年1月29日，杨森从此次临床试验数据的中期分析中公布安全性和有效性数据。该数据表明，该疫苗在所有志愿者中预防接种后28天内，重度COVID-19疾病预防有效率为66%。中期分析则是基于阿根廷、巴西、智利、哥伦比亚、墨西哥、秘鲁、南非和美国的43783名成年志愿者中的468例COVID-19征候病例。在疫苗试验组中，没有与COVID-19相关的死亡个案，而在安慰剂组中，有5例与COVID-19相关的死亡个案。在试验期间，所有参与者未观察到过敏反应<ref name="jnj_29Jan2021">{{cite press release |title=Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial|url=https://www.jnj.com/johnson-johnson-announces-single-shot-janssen-covid-19-vaccine-candidate-met-primary-endpoints-in-interim-analysis-of-its-phase-3-ensemble-trial|access-date=2021-02-01|website=Johnson & Johnson }}</ref>。

第二次三期临床试验于2020年11月12日开始招募。第二次三期临床试验与第一次的不同之处在于，其研究参与者将分别接受两次肌内注射，分别在第1天和第57天<ref name="ensemble2">{{cite web |title=A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults (ENSEMBLE 2)|url=https://clinicaltrials.gov/ct2/show/NCT04614948 |access-date=2021-01-30|website=ClinicalTrials.gov}}</ref>。

==生产==
2020年4月，强生公司与Catalent建立合作关系，以在Catalent位于[[印第安纳州]][[布卢明顿 (印第安纳州)|布卢明顿]]的工厂大规模生产疫苗<ref>{{cite web| vauthors = Vecchione A |date=29 April 2020|title=Catalent to lead US manufacturing for J&J's lead COVID-19 vaccine candidate|url=https://njbiz.com/catalent-lead-us-manufacturing-jjs-lead-covid-19-vaccine-candidate/|access-date=2020-11-13|website=NJBIZ}}</ref>。2020年7月，合作关系扩大到包括Catalent在[[意大利]][[阿纳尼]]的工厂<ref>{{cite web|title=J&J expands COVID-19 vaccine pact with Catalent for finishing work at Italian facility|url=https://www.fiercepharma.com/manufacturing/j-j-expands-covid-19-vaccine-pact-catalent-for-finishing-work-at-italian-facility|access-date=2020-11-13|website=FiercePharma}}</ref>。

2020年7月，强生承诺向美国提供多达3亿剂疫苗，其中1亿剂为前期供应，另外还包括2,000万剂作为后期选择。此次交易总价值超过10亿美元，由生物医学高级研究与开发局和[[美国国防部]]资助<ref>{{cite press release|date=5 August 2020|title=HHS, DOD Collaborate With Johnson & Johnson to Produce Millions of COVID-19 Investigational Vaccine Doses|url=https://www.hhs.gov/about/news/2020/08/05/hhs-dod-collaborate-with-johnson-and-johnson-to-produce-millions-of-covid-19-investigational-vaccine-doses.html|access-date=2020-08-06|website=HHS.gov}}</ref><ref name="Aug2020USGov">{{cite press release|title=Johnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 Vaccine |url=https://www.jnj.com/johnson-johnson-announces-agreement-with-u-s-government-for-100-million-doses-of-investigational-covid-19-vaccine|access-date=2020-08-06|website=Johnson & Johnson}}</ref>。同年8月5日，双方确认交易<ref>{{cite web|url=https://www.voanews.com/covid-19-pandemic/us-pay-johnson-and-johnson-1-billion-covid-19-vaccine|title=US to Pay Johnson and Johnson $1 Billion for COVID-19 Vaccine|access-date=2020-08-05|website=Voice of America}}</ref>。

2020年9月，Grand River无菌制造公司与强生公司达成协议，将在[[密歇根州]][[大急流城 (密歇根州)|大急流城]]的工厂支持疫苗的制造，包括技术转让以及灌装和精加工制造<ref name="contract">{{Cite web|url=https://www.contractpharma.com/contents/view_online-exclusives/2020-11-03/ramping-up-covid-19-vaccine-fill-and-finish-capacity/|title=Ramping Up COVID-19 Vaccine Fill and Finish Capacity|website=Contract Pharma|date=2020-11-03}}</ref>。

2020年12月，强生公司与西班牙Reig Jofre制药公司达成协议，将在Reig Jofre的巴塞罗那工厂生产疫苗<ref>{{Cite news|url=https://www.reuters.com/article/us-reig-jofre-johnson-johnson-vaccine-idUSKBN28P0V2|title=Spain's Reig Jofre to manufacture J&J's COVID-19 vaccine, shares soar| vauthors = Faus J, Allen N |date=2020-12-15|publisher=Reuters }}</ref>。一旦欧洲药品管理局在2021年3月之前批准该疫苗，强生公司可能会从2021年4月开始，向[[欧洲联盟成员国|欧盟各成员国]]提供疫苗<ref name="Francesco">{{Cite news|url=https://www.reuters.com/article/us-health-coronavirus-vaccine-eu-johnson-idUSKBN29I1EM|title=J&J COVID-19 vaccine could be available in Europe in April: source | vauthors = Guarascio F |date=2021-01-13|publisher=Reuters }}</ref><ref>{{cite news |title=EMA expected to approve Johnson & Johnson vaccine by March – CEO of Janssen Italy to paper |url=https://www.reuters.com/article/us-health-coronavirus-italy-vaccine-idUSKBN2AA0JG |access-date=2021-02-13 |publisher=Reuters |date=2021-02-10}}</ref>。从2021年第二季度开始，该工厂将每年生产5000万剂疫苗<ref>{{cite news |last1=Staff |first1=Reuters |title=Spain's Reig Jofre to have capacity for 50 million COVID-19 vaccine doses a year |url=https://www.reuters.com/article/us-health-coronavirus-reig-jofre-vaccine-idUSKBN27T0UY |accessdate=2021-04-15 |work=Reuters |date=2020-11-13 |language=en}}</ref>。

2020年8月，强生与美国联邦政府签署了一项价值10亿美元的合同，同意在疫苗获得美国食品和药物管理局的批准或紧急使用授权后，向美国提供1亿剂疫苗<ref name="Aug2020USGov"/>。根据与美国政府达成的协议，强生的目标是到2021年2月底生产1200万剂，到2021年4月底生产超过6000万剂，到2021年6月底生产超过1亿剂。然而，强生公司在2021年1月承认，由于生产方面的延迟，可能会阻止其履行2月底之前交付给美国的1200万剂的合同<ref>{{cite news|url=https://www.nytimes.com/2021/01/13/health/covid-vaccine-johnson-johnson.html| title=Johnson & Johnson Expects Vaccine Results Soon but Lags in Production| work=The New York Times| date=2021-01-13| vauthors = Zimmer C, LaFraniere S, Weiland N }}</ref>。2021年2月，强生公司高管在美国国会作证。但强生公司表示，该公司可以在3月底之前向美国政府交付2千万剂，在2021年上半年交付1亿剂<ref>{{cite web | vauthors = Owermohle S | title=Johnson & Johnson says it can provide 20M vaccine doses by late March | website=Politico | date=2021-02-22| url=https://www.politico.com/news/2021/02/22/johnson-johnson-vaccine-march-470994 | access-date=2021-04-01 }}</ref>。

2021年2月，[[赛诺菲]]与强生公司达成一项协议，要求赛诺菲在法国Marcy-l'Étoile工厂提供支持和基础设施。一旦赛诺菲获得授权，赛诺菲每月可生产约1200万剂强生疫苗<ref>{{cite news | title=France's Sanofi to help Johnson & Johnson manufacture COVID-19 vaccine | website=Reuters | date=2021-02-22 | url=https://www.reuters.com/article/us-health-coronavirus-johnson-johnson-sa-idUSKBN2AM126 | access-date=2021-04-01 }}</ref>。

2021年3月，[[默克公司]]和强生公司达成一项交易，要求默克公司在美国的两个工厂生产强生疫苗，以根据《[[国防生产法]]》的规定帮助扩大疫苗的生产能力<ref>{{cite press release | title=Biden Administration Announces Historic Manufacturing Collaboration Between Merck and Johnson & Johnson to Expand Production of COVID-19 Vaccines | website=HHS | date=2021-03-02 | url=https://www.hhs.gov/about/news/2021/03/02/biden-administration-announces-historic-manufacturing-collaboration-between-merck-johnson-johnson-expand-production-covid-19-vaccines.html | access-date=2021-03-04}}</ref>。同月，在[[巴尔的摩]]{{le|新兴生物科技公司|Emergent BioSolutions}}运营的一家工厂发生人为失误，由于员工弄混药剂成分，导致多达1500万剂强生疫苗变质及报废<ref>{{Cite news| vauthors = LaFraniere S, Weiland N |date=2021-03-31|title=Factory Mix-Up Ruins Up to 15 Million Vaccine Doses From Johnson & Johnson|work=The New York Times|url=https://www.nytimes.com/2021/03/31/us/politics/johnson-johnson-coronavirus-vaccine.html|access-date=2021-04-01 }}</ref>。强生公司3月31日向媒体证实，这家工厂生产的某批次强生疫苗“质量不达标”，涉事疫苗处于试生产阶段，该厂所产强生疫苗尚未获美国食品和药物管理局批准投用于美国市场<ref>{{cite news |title=一个疏忽，1500万剂疫苗报废 |url=https://finance.sina.com.cn/jjxw/2021-04-01/doc-ikmxzfmk0633276.shtml |accessdate=2021-04-15 |work=参考消息 |date=2021-04-01}}</ref>。

==获批与供应==
===欧盟===
2020年12月1日开始，该候选疫苗的临床试验已经由[[欧洲药品管理局]]人用药品委员会进行“滚动审查”，以加快对预期的有条件销售许可申请<ref name="Francesco"/><ref name=":2">{{cite press release|url=https://www.jnj.com/our-company/johnson-johnson-announces-initiation-of-rolling-submission-for-its-single-dose-janssen-covid-19-vaccine-candidate-with-the-european-medicines-agency|title=Johnson & Johnson Announces Initiation of Rolling Submission for its Single-dose Janssen COVID-19 Vaccine Candidate with the European Medicines Agency|publisher=Johnson & Johnson|date=2020-12-01}}</ref>。2021年2月16日，杨森向欧洲药品管理局申请该疫苗的有条件销售许可<ref name="Janssen CMA application">{{cite press release| title=EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen | publisher=European Medicines Agency (EMA) | date=2021-02-16| url=https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-covid-19-vaccine-janssen | access-date=2021-02-16}}</ref>。2021年3月11日，欧盟委员会批准疫苗上市<ref name="COVID-19 Vaccine Janssen EPAR" /><ref name="EU COVID-19 Vaccine Janssen">{{cite web | title=COVID-19 Vaccine Janssen | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1525.htm | access-date=2021-03-16}}</ref>。该疫苗计划于4月下半月开始发货，杨森亦承诺到2021年将向欧盟运送至少2亿剂疫苗<ref>{{cite news | vauthors = Muvija M, Aripaka P | title=Europe clears J&J's single-shot COVID-19 vaccine as roll-out falters | website=Reuters | date=2021-03-11 | url=https://www.reuters.com/article/us-health-coronavirus-eu-johnson-johnson-idUSKBN2B31SW | access-date=2021-03-16}}</ref>。

2021年4月9日，欧洲药品管理局表示，在发现4起接种强生疫苗后出现与低血小板有关的严重罕见血栓案例，其中一人死亡。欧洲药品管理局表示当局正在审查接种强生疫苗后出现的血栓案例<ref>{{cite news |last1=廖慧婷 |first1=文 / |title=欧洲药管局：正审查强生疫苗与血栓个案是否有关 |url=https://www.zaobao.com.sg/realtime/world/story20210409-1138225 |accessdate=2021-04-18 |work=联合早报 |date=2021-04-09 }}</ref>。4月13日，强生宣布將延後在歐洲推出疫苗<ref>{{cite news |title=嬌生疫苗6人接種後出現血栓 暫緩於歐洲推出 |url=https://www.cna.com.tw/news/firstnews/202104140031.aspx |accessdate=2021-04-18 |work=中央通讯社 |date=2021-04-14 |language=zh-TW}}</ref>。

2021年4月14日，瑞典卫生局宣布，将暂缓开始使用强生疫苗接种的打算。法国表示将继续为55岁以上的人接种强生疫苗<ref>{{cite news |last1=廖慧婷 |first1=文 / |title=瑞典暂停强生疫苗接种计划 欧洲监管机构加速审查该疫苗 |url=https://www.zaobao.com.sg/realtime/world/story20210414-1139423 |accessdate=2021-04-18 |work=联合早报 |date=2021-04-14}}</ref>。

===美国===
2021年2月4日，杨森生物技术公司向[[美国食品药品监督管理局]]申请紧急使用授权。美国食药监局宣布，疫苗和相关生物产品咨询委员会将于2月26日开会审议该申请<ref name="JohnsonMcGinley"/><ref name="Chander"/><ref>{{cite press release|title=FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.'s COVID-19 Vaccine Candidate |url=https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-advisory-committee-meeting-discuss-janssen-biotech-incs |publisher=U.S. Food and Drug Administration (FDA) |access-date=2021-02-04 |date=2021-02-04}}</ref><ref>{{cite web | title=Vaccines and Related Biological Products Advisory Committee February 26, 2021 Meeting Announcement | publisher=U.S. Food and Drug Administration (FDA) | url=https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-february-26-2021-meeting-announcement | access-date=2021-02-19}}</ref>。强生公司宣布，计划在获得紧急使用授权后立即发货<ref name="jnj_29Jan2021" />。2月24日，在疫苗和相关生物产品咨询委员会召开会议之前，发布了杨森和美国食药监局的简报文件。美国食药监局文件建议授予疫苗的紧急使用授权，其结论是疫苗的临床试验结果和安全性数据与美国食药监局针对COVID-19疫苗的紧急使用授权指南一致<ref>{{cite report|title=Janssen Biotech, Inc. COVID-19 Vaccine Ad26.COV2.S VRBPAC Briefing Document|publisher=Janssen Biotech |url=https://www.fda.gov/media/146219/download | format=PDF}}</ref><ref>{{cite report|title=Janssen Biotech, Inc. COVID-19 Vaccine Ad26.COV2.S VRBPAC Briefing Document Addendum|publisher=Janssen Biotech |url=https://www.fda.gov/media/146218/download | format=PDF}}</ref><ref name="FDA VRBPAC brief">{{cite report|title=FDA Briefing Document Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19|publisher=U.S. Food and Drug Administration (FDA) |url=https://www.fda.gov/media/146217/download | format=PDF | lay-url=https://www.statnews.com/2021/02/24/new-data-shed-light-on-efficacy-of-jjs-single-dose-vaccine-against-covid-19/}} {{PD-notice}}</ref><ref>{{cite web | vauthors = Christensen J |url=https://www.cnn.com/2021/02/24/health/johnson-vaccine-fda-analysis/index.html|title=FDA says Johnson & Johnson Covid-19 vaccine meets requirements for emergency use authorization|publisher=CNN|date=2021-02-24 }}</ref>。2月26日，疫苗和相关生物产品咨询委员会成员就此进行投票，最终以22票（全票赞成）的结果，建议为该疫苗授予紧急使用授权<ref>{{cite web | vauthors = Lovelace Jr B |date=2021-02-26|title=FDA panel unanimously recommends third Covid vaccine as J&J wins key vote in path to emergency use|url=https://www.cnbc.com/2021/02/26/johnson-and-johnson-covid-vaccine-fda-panel-recommends-emergency-use.html }}</ref>。翌日，美国食药监局授予疫苗的紧急使用授权<ref name="FDA PR 20210227" /><ref name="FDA EUA" /><ref>{{cite news|url=https://www.washingtonpost.com/health/2021/02/27/johnson-and-johnson-covid-vaccine-fda/|newspaper=The Washington Post|date=2021-02-27|title=FDA authorizes Johnson & Johnson's single-shot coronavirus vaccine, adding to the nation's arsenal against the pandemic | vauthors = McGinley L, Johnson CY }}</ref>。2月28日，[[美国疾病控制和预防中心]]免疫实践咨询委员会（ACIP）建议为18岁以上的人群使用该疫苗<ref>{{cite news | vauthors = Feuer W | title=CDC panel recommends use of J&J's single-shot Covid vaccine, clearing way for distribution | website=CNBC | date=2021-02-28 | url=https://www.cnbc.com/2021/02/28/cdc-panel-recommends-use-of-jjs-single-shot-covid-vaccine.html | access-date=2021-02-28 }}</ref><ref name=":1">{{cite press release | title=Media Statement from CDC Director Rochelle P. Walensky, MD, MPH, on Signing the Advisory Committee on Immunization Practices' Recommendation to Use Janssen's COVID-19 Vaccine in People 18 and Older| website=Centers for Disease Control and Prevention (CDC) | date=2021-02-28 | url=https://www.cdc.gov/media/releases/2021/s0228-JJ-vaccine.html | access-date=2021-03-01}}</ref>。

2021年4月初，美国国内多地发生了接种该款疫苗后出现头晕、呼吸急促等不良反应状况。其后佐治亚州、科罗拉多州以及北卡罗来纳州的部分地区已宣布暂停接种强生疫苗<ref>{{cite news |title=不良反应频现，美国多地暂停接种强生疫苗 |url=https://www.yicai.com/news/101016850.html |accessdate=2021-04-18 |work=央视新闻客户端 |date=2021-04-11}}</ref>。

2021年4月13日，[[美国疾病控制与预防中心]]和[[美国食品药品监督管理局]]宣布，他们将调查6例极其罕见的在注射疫苗後出現的{{link-en|脑静脉窦血栓|Cerebral venous sinus thrombosis}}形成病例，並建議暂停接種强生疫苗。6名病例中有一名妇女已经死亡，另有一名妇女緊急住院。<ref name=":6">{{Cite news|author=Weiland|first=Noah|author2=LaFraniere|first2=Sharon|last3=Zimmer|first3=Carl|date=13 April 2021|title=Johnson & Johnson Vaccinations Halt Across Country After Rare Clotting Cases Emerge|work=The New York Times|url=https://www.nytimes.com/2021/04/13/us/politics/johnson-johnson-vaccine-blood-clots-fda-cdc.html|accessdate=2021-04-13}}</ref><ref name=":5">{{Cite news|author=Erman|first=Michael|first2=Manas|author2=Mishra|date=2021-04-13|title=U.S. pauses use of J&J vaccine over rare blood clots, rollout delayed in Europe|publisher=Reuters|url=https://www.reuters.com/article/us-health-coronavirus-johnson-johnson-va-idUSKBN2C01BC|accessdate=2021-04-13}}</ref><ref name=":7">{{Cite news|first=Jacqueline|author=Howard|title=CDC and FDA recommend US pause use of Johnson & Johnson's Covid-19 vaccine over blood clot concerns|url=https://www.cnn.com/2021/04/13/health/johnson-vaccine-pause-cdc-fda/index.html|accessdate=2021-04-13|publisher=CNN}}</ref>

===其他国家和地区===
2021年2月11日，[[圣文森特和格林纳丁斯]]政府授予强生疫苗的紧急使用授权<ref>{{Cite web|title=Public Health (Emergency Authorisation of COVID-19 Vaccine) Rules, 2021 |url=https://www.gov.vc/images/pdf_documents/SRO-Public_Health_Emergency_Authorisation_of_Covid-19_Vaccine.pdf |date=2021-02-11|access-date=2021-02-12|website=Government of Saint Vincent and the Grenadines}}</ref>。

2020年12月，强生与{{le|GAVI|GAVI}}疫苗联盟原则上签署了一项协议，以支持[[COVAX]]计划。2021年2月19日，强生公司向世界卫生组织提交其“紧急使用清单”的正式请求和数据包；而参加COVAX的要求则是EUL。强生公司预计到2022年将为COVAX提供多达5亿剂的疫苗<ref>[https://www.prnewswire.com/news-releases/johnson--johnson-announces-submission-to-world-health-organization-for-emergency-use-listing-of-investigational-single-shot-janssen-covid-19-vaccine-candidate-301231645.html Johnson & Johnson Announces Submission to World Health Organization for Emergency Use Listing of Investigational Single-Shot Janssen COVID-19 Vaccine Candidate], Johnson & Johnson (2021-02-19).</ref><ref name=":0" /><ref>{{Cite web| vauthors = Heeb G |title=Johnson & Johnson Applies For Emergency Use Vaccine Approval At W.H.O.|url=https://www.forbes.com/sites/ginaheeb/2021/02/19/johnson--johnson-applies-for-emergency-use-vaccine-approval-at-who/|access-date=2021-02-25|website=Forbes }}</ref>。

2021年2月25日，巴林授权疫苗的紧急使用<ref name="bahrain">{{cite news |title=Bahrain first to approve Johnson & Johnson COVID-19 vaccine for emergency use |website=Reuters |date=25 February 2021 |url=https://www.reuters.com/article/health-coronavirus-bahrain-idUSS8N2I4021 |first=Lisa |last=Barrington |access-date=2021-02-25}}</ref><ref name="abcnews.go.com">{{cite news | title=Bahrain becomes 1st nation to grant J&J shot emergency use | website=ABC News | date=2021-02-25 | url=https://abcnews.go.com/International/wireStory/bahrain-1st-nation-grant-jj-shot-emergency-76112143 | access-date=2021-02-25}}</ref>。

2021年2月26日，韩国食品及药品安全处开始审查强生公司的疫苗批准申请<ref>{{cite news |url=https://www.reuters.com/article/us-health-coronavirus-southkorea-vaccine/south-korea-launches-review-of-johnson-johnsons-covid-19-vaccine-idUSKBN2AR03K |first=Cynthia |last=Kim |first2=Sangmi |last2=Cha |title=South Korea launches review of Johnson & Johnson's COVID-19 vaccine |work=Reuters |date=2021-02-26}}</ref>。

2020年11月下旬，强生公司向[[加拿大卫生部]]提交滚动审核申请，以批准其疫苗<ref>{{cite news |first=Terry |last=Haig |url=https://www.rcinet.ca/en/2021/02/01/another-vaccine-submits-a-bid-for-health-canada-approval/ |title=Novavax submits its vaccine for Health Canada approval |work=Radio Canada International |date=2021-02-01}}</ref>。加拿大政府已与强生公司签订了供应1000万剂疫苗的订单，强生亦拥有再购买2800万剂疫苗的权利。2021年3月5日，该疫苗成为第四个获得加拿大卫生部批准使用的疫苗<ref>{{Cite web|url=https://www.cbc.ca/news/politics/johnson-johnson-covid19-vaccine-approved-1.5937900|title=Johnson & Johnson COVID-19 vaccine becomes 4th to receive Health Canada approval|website=CBC}}</ref>。

2021年2月，该疫苗在南非获得紧急授权<ref>{{cite web|title=SA is the first country to roll out Johnson & Johnson vaccine – what you need to know about the jab|url=https://www.businessinsider.co.za/covid-19-vaccine-johnson-johnson-what-we-know-2020-12| date=17 February 2021 |access-date=4 March 2021|website=BusinessInsider}}</ref><ref>{{cite news | vauthors = Browdie B | title=South Africa to be first to use Johnson Johnson Covid-19 vaccine | website=Quartz | date=20 February 2021 | url=https://qz.com/africa/1973285/south-africa-to-be-first-to-use-johnson-johnson-covid-19-vaccine/ | access-date=4 March 2021 }}</ref><ref name="WSJ 20210217">{{cite news|url=https://www.wsj.com/articles/south-africa-rolls-out-j-j-covid-19-vaccine-to-healthcare-workers-11613564630 |newspaper= The Wall Street Journal|date=2021-02-17 | vauthors = Steinhauser G |title=South Africa Rolls Out J&J Covid-19 Vaccine to Healthcare Workers }}</ref>。同年4月，南非暂停使用该疫苗<ref name="iolTurner13042021">{{cite web | last=Turner | first=Kelly-Jane | title=This is why SA is suspending its J&J vaccine roll-out | website=IOL | date=2021-04-13 | url=https://www.iol.co.za/news/politics/this-is-why-sa-is-suspending-its-j-and-j-vaccine-roll-out-84618c38-ab59-490e-af76-ff732fe43912 | access-date=2021-04-14}}</ref>。

2021年3月底，该疫苗在哥伦比亚获得紧急授权<ref name=Colombia>{{cite news| vauthors = Acosta LJ |location=Bogotá|title=Colombia grants emergency use for J&J coronavirus vaccine |url=https://www.reuters.com/article/health-coronavirus-colombia/colombia-grants-emergency-use-for-jj-coronavirus-vaccine-idUSL1N2LO01O |access-date=2021-03-25 |work=Reuters |date=2021-03-25 }}</ref>。

2021年4月，澳大利亚政府表示，将不会购买强生疫苗，并强调“目前不打算再购买任何腺病毒疫苗”<ref name=AbcAusApril132021>{{cite news| last = Lowrey |first=Tom |title=Johnson & Johnson's one-dose COVID-19 vaccine won't be coming to Australia due to AstraZeneca similarities |url=https://www.abc.net.au/news/2021-04-13/johnson-johnson-covid-19-vaccine-australia/100064454|work=ABC News|date=2021-04-13 }}</ref><ref>{{cite news | last=Karp|first=Paul | title=Australia won't buy Johnson & Johnson's one-dose Covid vaccine due to AstraZeneca similarities | work=The Guardian | date=2021-04-12 | url=http://www.theguardian.com/society/2021/apr/13/australia-wont-buy-johnson-johnsons-one-dose-covid-vaccine-due-to-astrazeneca-similarities | access-date=2021-04-12}}</ref>。

==争议==
{{le|美國天主教主教團|United States Conference of Catholic Bishops}}表示，對強生疫苗表达「道德關切」。美國天主教主教會議和新奧爾良等多個教區先後發聲明，指強生使用流產[[胎兒]]的細胞生產疫苗，已經受「道德污染」，注射疫苗等同在道德上妥協，呼籲信徒在有選擇情況下，應盡量接種其他疫苗<ref name=bbccn>{{cite news |title=在疫情最嚴重的美國，民眾選擇新冠疫苗的標凖 |url=https://www.bbc.com/zhongwen/trad/world-56473782 |accessdate=2021-04-19 |work=BBC News 中文 |date=2021-03-21 |language=zh-hant}}</ref><ref name=am730>{{cite news |title=新冠疫苗｜美天主教籲杯葛 強生：疫苗無流產胎兒組織細胞 - 新聞 |url=https://www.am730.com.hk/news/%E6%96%B0%E8%81%9E/%E6%96%B0%E5%86%A0%E7%96%AB%E8%8B%97%EF%BD%9C%E7%BE%8E%E5%A4%A9%E4%B8%BB%E6%95%99%E7%B1%B2%E6%9D%AF%E8%91%9B-%E5%BC%B7%E7%94%9F%EF%BC%9A%E7%96%AB%E8%8B%97%E7%84%A1%E6%B5%81%E7%94%A2%E8%83%8E%E5%85%92%E7%B5%84%E7%B9%94%E7%B4%B0%E8%83%9E-258444 |accessdate=2021-04-19 |work=am730 |date=2021-03-05 |language=zh-hk}}</ref><ref name=cnn-us-bishops>{{cite news |title=Some US bishops discourage Catholics from getting Johnson & Johnson vaccine if others are available |url=https://www.cnn.com/2021/03/03/health/bishops-catholics-johnson-and-johnson-vaccine/index.html |access-date=2021-03-03 |publisher=CNN |date=2021-03-03}}</ref><ref name=nebraska-med>{{Cite web|title=You asked, we answered: Do the COVID-19 vaccines contain aborted fetal cells? {{!}} Nebraska Medicine Omaha, NE|url=https://www.nebraskamed.com/COVID/you-asked-we-answered-do-the-covid-19-vaccines-contain-aborted-fetal-cells|access-date=2021-03-24|website=www.nebraskamed.com}}</ref>。教宗[[方濟各_(教宗)|方濟各]]则认为這類疫苗「在道德上是可以接受的」<ref name=cnn-us-bishops /><ref name=VaticanNote>{{Cite web|title=Note on the morality of using some anti-Covid-19 vaccines (21 December 2020)|url=https://www.vatican.va/roman_curia/congregations/cfaith/documents/rc_con_cfaith_doc_20201221_nota-vaccini-anticovid_en.html|access-date=2021-03-24|website=www.vatican.va}}</ref><ref name=bbccn/>。另外美国康涅狄格州哈特福德大主教（Archbishop of Hartford）和其他當地神職人員在一份聲明中宣佈，所有居民「應該憑良心自由地接種目前可用的疫苗……為了自己的健康和公共利益」<ref name=bbccn/>。而強生公司其後發表聲明，否認有關說法，指疫苗中沒有流產胎兒組織細胞<ref name=am730/>。

==参考资料==
{{reflist|30em}}
{{reflist|30em}}

==外部链接==
* {{cite web | title=Janssen COVID-19 Vaccine (Johnson & Johnson) | publisher=[[美国疾病预防控制中心]]| url=https://www.cdc.gov/vaccines/covid-19/info-by-product/janssen/index.html }}
* {{cite web | title=强生公司的杨森COVID-19疫苗概述 | publisher=[[美国疾病预防控制中心]]| url=https://chinese.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/janssen.html }}


{{COVID-19}}
{{COVID-19}}

2021年4月20日 (二) 15:09的版本

维基百科中的醫學内容仅供参考，並不能視作專業意見。如需獲取醫療幫助或意見，请咨询专业人士。詳見醫學聲明。
强生2019冠状病毒病疫苗
一瓶强生2019冠状病毒病疫苗
疫苗说明
目標严重急性呼吸系统综合征冠状病毒2（SARS-CoV-2）
种类類毒素
臨床資料
商品名（英语：Drug nomenclature）杨森2019冠状病毒病疫苗（Janssen COVID-19 Vaccine）[1][2]、COVID-19 Vaccine Janssen[3]
其他名稱
核准狀況
给药途径肌肉注射
法律規範狀態
法律規範
识别信息
DrugBank
UNII
系列条目索引
2019冠状病毒病疫情
科學準確的 SARS-CoV-2 外部結構原子模型。 每個“球”都是一個原子。
科學準確的 SARS-CoV-2 外部結構原子模型。 每個“球”都是一個原子。
各地
國際反應
醫療反應

疫苗

变异株
高關注變異株(VOC)

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反应与影响
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2019冠狀病毒病主题

強生2019冠狀病毒病疫苗（Johnson & Johnson COVID-19 vaccine）是由位於荷兰莱顿的杨森疫苗（英语：Janssen Vaccines）[12]及其比利时母公司同時也是美国強生公司的子公司杨森制药[13]研发的2019冠状病毒病疫苗[14][15]。

它是一种基于人类腺病毒的病毒载体疫苗，人类腺病毒经过改造後會含有能產生严重急性呼吸系统综合征冠状病毒2病毒尖峰蛋白（英语：spike protein）的基因[3]。人体的免疫系统会对这种尖峰蛋白产生反应並产生抗体[16]。人類只需注射一剂该疫苗，且該疫苗无需冷冻保存 [17][18]。

该疫苗的臨床試驗于2020年6月开始，三期试验涉及约4.3万人[10]。2021年1月29日，杨森公司宣布，在疫苗接种28天后，该疫苗预防2019冠狀病毒病的有效率为66%，预防重症2019冠狀病毒病的有效率为85%[19][20][21]，预防2019冠狀病毒病引起的住院或死亡的有效率为100%[1]。

该疫苗於2021年2月27日获得美国食品药品监督管理局的紧急使用授权（英语：Emergency Use Authorization），2021年3月11日獲得欧洲药品管理局的有条件上市授权（英语：Marketing authorisation）[22][23][24]。

疫苗简介

强生2019冠状病毒病疫苗采用与卫星V疫苗、阿斯利康疫苗相似的技术。疫苗采用人类腺病毒为载体，与卫星V疫苗更为相似，但根据一期临床试验，其效果可能较差[25]。疫苗由无复制能力的重组腺病毒26型（Ad26）载体组成，该载体包含严重急性呼吸系统综合症冠状病毒2刺突（S）蛋白[26][4]。

美国国家过敏和传染病研究所疫苗研究中心和德州大学奥斯汀分校的研究人员开发了刺突蛋白的稳定版本，其中包括两个突变，其中普通氨基酸被脯氨酸取代[27][28][29]。该疫苗的非活性成分为：柠檬酸一水合物、柠檬酸三钠二水合物、乙醇、2-羟丙基-β-环糊精（HBCD）（羟丙基βdex）聚山梨酸酯80、氯化钠、氢氧化钠和盐酸[26][1]。

疫苗可在冰箱中保存数月时间[30][31][32]。与辉瑞疫苗、莫德纳疫苗不同的是，强生疫苗采用单针接种程序，且无需冷冻运输[33][17]。每瓶疫苗含五剂[18]。

不良反应

该疫苗主要的不良反应包括注射部位的疼痛、头痛、疲劳、肌肉酸痛和恶心[10][34]。这些不良反应大多数在接种疫苗后1至2天内发生，轻度至中度的不良反应则持续1至2天[34][35]。

研发历史

强生与新兴生物科技公司（英语：Emergent BioSolutions）（Emergent BioSolutions）合作开设的疫苗生产场所

2019冠状病毒病疫情期间，强生公司与美国卫生及公共服务部应急管理办公室（英语：Office of the Assistant Secretary for Preparedness and Response）生物医学高级研究与发展局（英语：Biomedical Advanced Research and Development Authority）合作，以非盈利性原则研发疫苗[36][37]。强生公司表示，其疫苗项目将“处于非营利水平”，因为该公司将其视为“以最快最好的方式找到世界上所有合作，来实现这一目标”[38]。

杨森疫苗公司则与贝斯以色列女执事医疗中心合作，根据用于生产埃博拉疫苗（英语：Ebola vaccine）的相同技术，负责开发候选疫苗[15][39][40]。

临床前试验表明，该疫苗可有效保护仓鼠和恒河猕猴免受SARS-CoV-2侵害[41]。

一、二期临床试验

2020年6月，强生公司和美国国家过敏和传染病研究所确认，计划于2020年9月开始该疫苗的临床试验，并可能进行一、二a期人类临床试验。试验工作从7月下半月开始加速发展[42][43][44]。

一、二a期试验自2020年7月15日招募首位受试者开始，并在比利时和美国招募了研究参与者[45]。一、二a期试验的中期结果确定了疫苗的安全性、反应原性和免疫原性。根据报告，注射一剂疫苗后的29天内，可确保90%的参与者具有中和病毒所需的足够抗体。在57天后，所有参与者全部具有抗体[46][47]。

三期临床试验

三期临床试验命名为“ENSEMBLE”，于2020年9月开始招募，并于2020年12月17日完成招募。此次临床试验是随机、双盲、安慰剂对照的试验，旨在与18岁及以上成年人的安慰剂相比，评估单剂量疫苗的安全性和有效性。研究参与者在第一天接受疫苗的单次肌肉注射，剂量为5×1010病毒颗粒[48]。但因一名志愿者出现不良反应，试验于10月12日暂停。试验在11天后恢复[49]。2021年1月29日，杨森从此次临床试验数据的中期分析中公布安全性和有效性数据。该数据表明，该疫苗在所有志愿者中预防接种后28天内，重度COVID-19疾病预防有效率为66%。中期分析则是基于阿根廷、巴西、智利、哥伦比亚、墨西哥、秘鲁、南非和美国的43783名成年志愿者中的468例COVID-19征候病例。在疫苗试验组中，没有与COVID-19相关的死亡个案，而在安慰剂组中，有5例与COVID-19相关的死亡个案。在试验期间，所有参与者未观察到过敏反应[50]。

第二次三期临床试验于2020年11月12日开始招募。第二次三期临床试验与第一次的不同之处在于，其研究参与者将分别接受两次肌内注射，分别在第1天和第57天[51]。

生产

2020年4月，强生公司与Catalent建立合作关系，以在Catalent位于印第安纳州布卢明顿的工厂大规模生产疫苗[52]。2020年7月，合作关系扩大到包括Catalent在意大利阿纳尼的工厂[53]。

2020年7月，强生承诺向美国提供多达3亿剂疫苗，其中1亿剂为前期供应，另外还包括2,000万剂作为后期选择。此次交易总价值超过10亿美元，由生物医学高级研究与开发局和美国国防部资助[54][55]。同年8月5日，双方确认交易[56]。

2020年9月，Grand River无菌制造公司与强生公司达成协议，将在密歇根州大急流城的工厂支持疫苗的制造，包括技术转让以及灌装和精加工制造[57]。

2020年12月，强生公司与西班牙Reig Jofre制药公司达成协议，将在Reig Jofre的巴塞罗那工厂生产疫苗[58]。一旦欧洲药品管理局在2021年3月之前批准该疫苗，强生公司可能会从2021年4月开始，向欧盟各成员国提供疫苗[59][60]。从2021年第二季度开始，该工厂将每年生产5000万剂疫苗[61]。

2020年8月，强生与美国联邦政府签署了一项价值10亿美元的合同，同意在疫苗获得美国食品和药物管理局的批准或紧急使用授权后，向美国提供1亿剂疫苗[55]。根据与美国政府达成的协议，强生的目标是到2021年2月底生产1200万剂，到2021年4月底生产超过6000万剂，到2021年6月底生产超过1亿剂。然而，强生公司在2021年1月承认，由于生产方面的延迟，可能会阻止其履行2月底之前交付给美国的1200万剂的合同[62]。2021年2月，强生公司高管在美国国会作证。但强生公司表示，该公司可以在3月底之前向美国政府交付2千万剂，在2021年上半年交付1亿剂[63]。

2021年2月，赛诺菲与强生公司达成一项协议，要求赛诺菲在法国Marcy-l'Étoile工厂提供支持和基础设施。一旦赛诺菲获得授权，赛诺菲每月可生产约1200万剂强生疫苗[64]。

2021年3月，默克公司和强生公司达成一项交易，要求默克公司在美国的两个工厂生产强生疫苗，以根据《国防生产法》的规定帮助扩大疫苗的生产能力[65]。同月，在巴尔的摩新兴生物科技公司（英语：Emergent BioSolutions）运营的一家工厂发生人为失误，由于员工弄混药剂成分，导致多达1500万剂强生疫苗变质及报废[66]。强生公司3月31日向媒体证实，这家工厂生产的某批次强生疫苗“质量不达标”，涉事疫苗处于试生产阶段，该厂所产强生疫苗尚未获美国食品和药物管理局批准投用于美国市场[67]。

获批与供应

欧盟

2020年12月1日开始，该候选疫苗的临床试验已经由欧洲药品管理局人用药品委员会进行“滚动审查”，以加快对预期的有条件销售许可申请[59][68]。2021年2月16日，杨森向欧洲药品管理局申请该疫苗的有条件销售许可[3]。2021年3月11日，欧盟委员会批准疫苗上市[7][23]。该疫苗计划于4月下半月开始发货，杨森亦承诺到2021年将向欧盟运送至少2亿剂疫苗[69]。

2021年4月9日，欧洲药品管理局表示，在发现4起接种强生疫苗后出现与低血小板有关的严重罕见血栓案例，其中一人死亡。欧洲药品管理局表示当局正在审查接种强生疫苗后出现的血栓案例[70]。4月13日，强生宣布將延後在歐洲推出疫苗[71]。

2021年4月14日，瑞典卫生局宣布，将暂缓开始使用强生疫苗接种的打算。法国表示将继续为55岁以上的人接种强生疫苗[72]。

美国

2021年2月4日，杨森生物技术公司向美国食品药品监督管理局申请紧急使用授权。美国食药监局宣布，疫苗和相关生物产品咨询委员会将于2月26日开会审议该申请[30][33][73][74]。强生公司宣布，计划在获得紧急使用授权后立即发货[50]。2月24日，在疫苗和相关生物产品咨询委员会召开会议之前，发布了杨森和美国食药监局的简报文件。美国食药监局文件建议授予疫苗的紧急使用授权，其结论是疫苗的临床试验结果和安全性数据与美国食药监局针对COVID-19疫苗的紧急使用授权指南一致[75][76][26][77]。2月26日，疫苗和相关生物产品咨询委员会成员就此进行投票，最终以22票（全票赞成）的结果，建议为该疫苗授予紧急使用授权[78]。翌日，美国食药监局授予疫苗的紧急使用授权[10][11][79]。2月28日，美国疾病控制和预防中心免疫实践咨询委员会（ACIP）建议为18岁以上的人群使用该疫苗[80][24]。

2021年4月初，美国国内多地发生了接种该款疫苗后出现头晕、呼吸急促等不良反应状况。其后佐治亚州、科罗拉多州以及北卡罗来纳州的部分地区已宣布暂停接种强生疫苗[81]。

2021年4月13日，美国疾病控制与预防中心和美国食品药品监督管理局宣布，他们将调查6例极其罕见的在注射疫苗後出現的脑静脉窦血栓（英语：Cerebral venous sinus thrombosis）形成病例，並建議暂停接種强生疫苗。6名病例中有一名妇女已经死亡，另有一名妇女緊急住院。[82][83][84]

其他国家和地区

2021年2月11日，圣文森特和格林纳丁斯政府授予强生疫苗的紧急使用授权[85]。

2020年12月，强生与GAVI（英语：GAVI）疫苗联盟原则上签署了一项协议，以支持COVAX计划。2021年2月19日，强生公司向世界卫生组织提交其“紧急使用清单”的正式请求和数据包；而参加COVAX的要求则是EUL。强生公司预计到2022年将为COVAX提供多达5亿剂的疫苗[86][31][87]。

2021年2月25日，巴林授权疫苗的紧急使用[88][89]。

2021年2月26日，韩国食品及药品安全处开始审查强生公司的疫苗批准申请[90]。

2020年11月下旬，强生公司向加拿大卫生部提交滚动审核申请，以批准其疫苗[91]。加拿大政府已与强生公司签订了供应1000万剂疫苗的订单，强生亦拥有再购买2800万剂疫苗的权利。2021年3月5日，该疫苗成为第四个获得加拿大卫生部批准使用的疫苗[92]。

2021年2月，该疫苗在南非获得紧急授权[93][94][95]。同年4月，南非暂停使用该疫苗[96]。

2021年3月底，该疫苗在哥伦比亚获得紧急授权[97]。

2021年4月，澳大利亚政府表示，将不会购买强生疫苗，并强调“目前不打算再购买任何腺病毒疫苗”[98][99]。

争议

美國天主教主教團（英语：United States Conference of Catholic Bishops）表示，對強生疫苗表达「道德關切」。美國天主教主教會議和新奧爾良等多個教區先後發聲明，指強生使用流產胎兒的細胞生產疫苗，已經受「道德污染」，注射疫苗等同在道德上妥協，呼籲信徒在有選擇情況下，應盡量接種其他疫苗[100][101][102][103]。教宗方濟各则认为這類疫苗「在道德上是可以接受的」[102][104][100]。另外美国康涅狄格州哈特福德大主教（Archbishop of Hartford）和其他當地神職人員在一份聲明中宣佈，所有居民「應該憑良心自由地接種目前可用的疫苗……為了自己的健康和公共利益」[100]。而強生公司其後發表聲明，否認有關說法，指疫苗中沒有流產胎兒組織細胞[101]。

参考资料

  1. ^ 1.0 1.1 1.2 1.3 Janssen COVID-19 Vaccine – ad26.cov2.s injection, suspension. DailyMed. U.S. National Institutes of Health. [27 February 2021]. 
  2. ^ Janssen COVID-19 Emergency Use Authorization (EUA) Official Website. Janssen. 2021-02-28 [2021-02-28]. 
  3. ^ 3.0 3.1 3.2 (新闻稿).  缺少或|title=为空 (帮助) 引用错误：带有name属性“Janssen CMA application”的<ref>标签用不同内容定义了多次
  4. ^ 4.0 4.1 4.2 4.3 4.4 A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older ENSEMBLE Protocol VAC31518COV3001; Phase 3 (PDF). Janssen Vaccines & Prevention. 
  5. ^ 5.0 5.1 5.2 5.3 A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older ENSEMBLE 2 Protocol VAC31518COV3009; Phase 3 (PDF). Janssen Vaccines & Prevention. 
  6. ^ 6.0 6.1 Johnson & Johnson Initiates Pivotal Global Phase 3 Clinical Trial of Janssen's COVID-19 Vaccine Candidate. Johnson & Johnson (新闻稿). [2020-09-23]. 
  7. ^ 7.0 7.1 COVID-19 Vaccine Janssen EPAR. European Medicines Agency (EMA). 2021-03-05 [2021-03-16]. 
  8. ^ Regulatory Decision Summary – Janssen COVID-19 Vaccine – Health Canada. 加拿大卫生部. 2021-03-05 [2021-03-05]. 
  9. ^ Janssen COVID-19 Vaccine monograph (PDF). Janssen. 2021-03-05. 
  10. ^ 10.0 10.1 10.2 10.3 FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine. U.S. Food and Drug Administration (FDA) (新闻稿). 2021-02-27 [2021-02-27]. 
  11. ^ 11.0 11.1 Janssen COVID-19 Vaccine EUA Letter of Authorization. 美国食品药品监督管理局. [2021-04-11]. 
  12. ^ Leiden developed Covid-19 vaccine submitted to EMA for approval. 16 February 2021. 
  13. ^ Clinical trial COVID-19 vaccine candidate underway. Janssen Belgium. [13 March 2021]. 
  14. ^ EMA recommends Johnson & Johnson Covid vaccine for approval; Developed in Leiden. NL Times. 
  15. ^ 15.0 15.1 Beth Israel is working with Johnson & Johnson on a coronavirus vaccine. The Boston Globe. 12 March 2020. 
  16. ^ COVID Vaccines: Does it Matter Which One You Get?. Michigan Medicine（英语：Michigan Medicine）. 8 March 2021 [30 March 2021]. 
  17. ^ 17.0 17.1 Fact Sheet for Healthcare Providers Administering Vaccine and EUA (PDF). Janssen. [13 April 2021]. 
  18. ^ 18.0 18.1 Johnson & Johnson's Janssen COVID-19 Vaccine Information. 美国疾病控制与预防中心 (CDC). 23 March 2021 [30 March 2021]. 
  19. ^ Johnson & Johnson single-shot vaccine 85% effective against severe COVID-19 disease. ABC News. 29 January 2021. 
  20. ^ Covid vaccine: Single dose Covid vaccine 66% effective. BBC News. 29 January 2021 [29 January 2021]. 
  21. ^ J&J's Covid vaccine is 66% effective, a weapon but not a knockout punch. Stat (website)（英语：Stat (website)）. 29 January 2021 [29 January 2021]. 
  22. ^ (新闻稿).  缺少或|title=为空 (帮助)
  23. ^ 23.0 23.1 COVID-19 Vaccine Janssen. Union Register of medicinal products. [16 March 2021].  引用错误：带有name属性“EU COVID-19 Vaccine Janssen”的<ref>标签用不同内容定义了多次
  24. ^ 24.0 24.1 Centers for Disease Control and Prevention (CDC) (新闻稿).  缺少或|title=为空 (帮助) 引用错误：带有name属性“:1”的<ref>标签用不同内容定义了多次
  25. ^ Russia's Sputnik V vaccine looks good in early analysis. Ars Technica. 2021-02-03. 
  26. ^ 26.0 26.1 26.2 FDA Briefing Document Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19 (PDF) (报告). U.S. Food and Drug Administration (FDA). 简明摘要.  公有领域 本文含有此來源中屬於公有领域的内容。
  27. ^ The tiny tweak behind COVID-19 vaccines. Chemical & Engineering News. 2020-09-29 [2021-03-01]. 
  28. ^ Kramer J. They spent 12 years solving a puzzle. It yielded the first COVID-19 vaccines.. National Geographic. 2020-12-31. 
  29. ^ Mercado NB, Zahn R, Wegmann F, Loos C, Chandrashekar A, Yu J, et al. Single-shot Ad26 vaccine protects against SARS-CoV-2 in rhesus macaques. Nature. 2020-10, 586 (7830): 583–88. Bibcode:2020Natur.586..583M. PMID 32731257. doi:10.1038/s41586-020-2607-z. 
  30. ^ 30.0 30.1 Johnson CY, McGinley L. Johnson & Johnson seeks emergency FDA authorization for single-shot coronavirus vaccine. The Washington Post. 2021-02-04. 
  31. ^ 31.0 31.1 Weintraub K. One-dose J&J COVID-19 vaccine meets criteria as safe and effective, FDA report finds. USA Today. [2021-02-05]. 
  32. ^ Mole B. COVID variants throw J&J vaccine a curveball, lowering efficacy to 66%. Ars Technica. 2021-01-29 [2021-01-26]. 
  33. ^ 33.0 33.1 Chander V. J&J files COVID-19 vaccine application with U.S. FDA. Reuters. 2021-02-04 [2021-02-04]. 
  34. ^ 34.0 34.1 Janssen COVID-19 Vaccine. U.S. Food and Drug Administration. 2021-03-19 [2021-04-07].  公有领域 本文含有此來源中屬於公有领域的内容。
  35. ^ Information about the J&J/Janssen COVID-19 Vaccine. Centers for Disease Control and Prevention (CDC). 2021-03-31 [2021-04-07].  公有领域 本文含有此來源中屬於公有领域的内容。
  36. ^ Vecchione A. J&J collaborates to accelerate COVID-19 vaccine development. NJBIZ. 2020-03-13 [2020-04-22]. 
  37. ^ Prisma Health collaborates with Ethicon Inc. to make, distribute VESper Ventilator Expansion Splitter Device. WSPA 7News. 2020-04-06 [2020-04-22]. 
  38. ^ Coronavirus: Johnson & Johnson vows to make 'not-for-profit' vaccine. Sky News. [2020-04-22]. 
  39. ^ A Beth Israel researcher helped create a COVID-19 vaccine that awaits approval. It could be a 'game changer'. The Boston Globe. 2021-01-16 [2021-02-28]. 
  40. ^ Mitchell, Jacqueline; Meck, Chloe. FDA grants third COVID-19 vaccine, developed in part at BIDMC, emergency use authorization. Beth Israel Deaconess Medical Center (BIDMC). 2021-02-27 [2021-02-28]. 
  41. ^ Calvo Fernández E, Zhu LY. Racing to immunity: Journey to a COVID-19 vaccine and lessons for the future. British Journal of Clinical Pharmacology. 2020-12, n/a (n/a). PMC 7753785 可免费查阅. PMID 33289156. doi:10.1111/bcp.14686. 
  42. ^ Coleman J. Final testing stage for potential coronavirus vaccine set to begin in July. TheHill. 10 June 2020 [2020-06-11]. 
  43. ^ Moderna, AstraZeneca and J&J coronavirus shots rev up for NIH tests beginning in July: WSJ. FiercePharma. [2020-06-11]. 
  44. ^ Johnson & Johnson to start human testing of COVID-19 vaccine next week. FiercePharma. [2020-07-20]. 
  45. ^ A Study of Ad26.COV2.S in Adults (COVID-19). ClinicalTrials.gov. [2021-02-19]. 
  46. ^ Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, de Groot AM, et al. Interim Results of a Phase 1-2a Trial of Ad26.COV2.S Covid-19 Vaccine. New England Journal of Medicine. 13 January 2021. PMC 7821985 可免费查阅. PMID 33440088. 
  47. ^ Johnson & Johnson COVID-19 Vaccine Candidate Interim Phase 1/2a Data Published in New England Journal of Medicine. Johnson & Johnson (新闻稿). [2021-01-16]. 
  48. ^ Fourth large-scale COVID-19 vaccine trial begins in the United States. National Institutes of Health. [2021-01-30]. 
  49. ^ Katherine J. Wu; Carl Zimmer; Sharon LaFraniere; Noah Weiland. Two Companies Restart Virus Trials in U.S. After Safety Pauses. 纽约时报. 2020-10-23 [2021-02-26]. 
  50. ^ 50.0 50.1 Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial. Johnson & Johnson (新闻稿). [2021-02-01]. 
  51. ^ A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults (ENSEMBLE 2). ClinicalTrials.gov. [2021-01-30]. 
  52. ^ Vecchione A. Catalent to lead US manufacturing for J&J's lead COVID-19 vaccine candidate. NJBIZ. 29 April 2020 [2020-11-13]. 
  53. ^ J&J expands COVID-19 vaccine pact with Catalent for finishing work at Italian facility. FiercePharma. [2020-11-13]. 
  54. ^ HHS, DOD Collaborate With Johnson & Johnson to Produce Millions of COVID-19 Investigational Vaccine Doses. HHS.gov (新闻稿). 5 August 2020 [2020-08-06]. 
  55. ^ 55.0 55.1 Johnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 Vaccine. Johnson & Johnson (新闻稿). [2020-08-06]. 
  56. ^ US to Pay Johnson and Johnson $1 Billion for COVID-19 Vaccine. Voice of America. [2020-08-05]. 
  57. ^ Ramping Up COVID-19 Vaccine Fill and Finish Capacity. Contract Pharma. 2020-11-03. 
  58. ^ Faus J, Allen N. Spain's Reig Jofre to manufacture J&J's COVID-19 vaccine, shares soar. Reuters. 2020-12-15. 
  59. ^ 59.0 59.1 Guarascio F. J&J COVID-19 vaccine could be available in Europe in April: source. Reuters. 2021-01-13. 
  60. ^ EMA expected to approve Johnson & Johnson vaccine by March – CEO of Janssen Italy to paper. Reuters. 2021-02-10 [2021-02-13]. 
  61. ^ Staff, Reuters. Spain's Reig Jofre to have capacity for 50 million COVID-19 vaccine doses a year. Reuters. 2020-11-13 [2021-04-15] （英语）. 
  62. ^ Zimmer C, LaFraniere S, Weiland N. Johnson & Johnson Expects Vaccine Results Soon but Lags in Production. The New York Times. 2021-01-13. 
  63. ^ Owermohle S. Johnson & Johnson says it can provide 20M vaccine doses by late March. Politico. 2021-02-22 [2021-04-01]. 
  64. ^ France's Sanofi to help Johnson & Johnson manufacture COVID-19 vaccine. Reuters. 2021-02-22 [2021-04-01]. 
  65. ^ Biden Administration Announces Historic Manufacturing Collaboration Between Merck and Johnson & Johnson to Expand Production of COVID-19 Vaccines. HHS (新闻稿). 2021-03-02 [2021-03-04]. 
  66. ^ LaFraniere S, Weiland N. Factory Mix-Up Ruins Up to 15 Million Vaccine Doses From Johnson & Johnson. The New York Times. 2021-03-31 [2021-04-01]. 
  67. ^ 一个疏忽，1500万剂疫苗报废. 参考消息. 2021-04-01 [2021-04-15]. 
  68. ^ Johnson & Johnson Announces Initiation of Rolling Submission for its Single-dose Janssen COVID-19 Vaccine Candidate with the European Medicines Agency (新闻稿). Johnson & Johnson. 2020-12-01. 
  69. ^ Muvija M, Aripaka P. Europe clears J&J's single-shot COVID-19 vaccine as roll-out falters. Reuters. 2021-03-11 [2021-03-16]. 
  70. ^ 廖慧婷, 文 /. 欧洲药管局：正审查强生疫苗与血栓个案是否有关. 联合早报. 2021-04-09 [2021-04-18]. 
  71. ^ 嬌生疫苗6人接種後出現血栓 暫緩於歐洲推出. 中央通讯社. 2021-04-14 [2021-04-18] （中文（臺灣））. 
  72. ^ 廖慧婷, 文 /. 瑞典暂停强生疫苗接种计划 欧洲监管机构加速审查该疫苗. 联合早报. 2021-04-14 [2021-04-18]. 
  73. ^ FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.'s COVID-19 Vaccine Candidate (新闻稿). U.S. Food and Drug Administration (FDA). 2021-02-04 [2021-02-04]. 
  74. ^ Vaccines and Related Biological Products Advisory Committee February 26, 2021 Meeting Announcement. U.S. Food and Drug Administration (FDA). [2021-02-19]. 
  75. ^ Janssen Biotech, Inc. COVID-19 Vaccine Ad26.COV2.S VRBPAC Briefing Document (PDF) (报告). Janssen Biotech. 
  76. ^ Janssen Biotech, Inc. COVID-19 Vaccine Ad26.COV2.S VRBPAC Briefing Document Addendum (PDF) (报告). Janssen Biotech. 
  77. ^ Christensen J. FDA says Johnson & Johnson Covid-19 vaccine meets requirements for emergency use authorization. CNN. 2021-02-24. 
  78. ^ Lovelace Jr B. FDA panel unanimously recommends third Covid vaccine as J&J wins key vote in path to emergency use. 2021-02-26. 
  79. ^ McGinley L, Johnson CY. FDA authorizes Johnson & Johnson's single-shot coronavirus vaccine, adding to the nation's arsenal against the pandemic. The Washington Post. 2021-02-27. 
  80. ^ Feuer W. CDC panel recommends use of J&J's single-shot Covid vaccine, clearing way for distribution. CNBC. 2021-02-28 [2021-02-28]. 
  81. ^ 不良反应频现，美国多地暂停接种强生疫苗. 央视新闻客户端. 2021-04-11 [2021-04-18]. 
  82. ^ Weiland, Noah; LaFraniere, Sharon; Zimmer, Carl. Johnson & Johnson Vaccinations Halt Across Country After Rare Clotting Cases Emerge. The New York Times. 13 April 2021 [2021-04-13]. 
  83. ^ Erman, Michael; Mishra, Manas. U.S. pauses use of J&J vaccine over rare blood clots, rollout delayed in Europe. Reuters. 2021-04-13 [2021-04-13]. 
  84. ^ Howard, Jacqueline. CDC and FDA recommend US pause use of Johnson & Johnson's Covid-19 vaccine over blood clot concerns. CNN. [2021-04-13]. 
  85. ^ Public Health (Emergency Authorisation of COVID-19 Vaccine) Rules, 2021 (PDF). Government of Saint Vincent and the Grenadines. 2021-02-11 [2021-02-12]. 
  86. ^ Johnson & Johnson Announces Submission to World Health Organization for Emergency Use Listing of Investigational Single-Shot Janssen COVID-19 Vaccine Candidate, Johnson & Johnson (2021-02-19).
  87. ^ Heeb G. Johnson & Johnson Applies For Emergency Use Vaccine Approval At W.H.O.. Forbes. [2021-02-25]. 
  88. ^ Barrington, Lisa. Bahrain first to approve Johnson & Johnson COVID-19 vaccine for emergency use. Reuters. 25 February 2021 [2021-02-25]. 
  89. ^ Bahrain becomes 1st nation to grant J&J shot emergency use. ABC News. 2021-02-25 [2021-02-25]. 
  90. ^ Kim, Cynthia; Cha, Sangmi. South Korea launches review of Johnson & Johnson's COVID-19 vaccine. Reuters. 2021-02-26. 
  91. ^ Haig, Terry. Novavax submits its vaccine for Health Canada approval. Radio Canada International. 2021-02-01. 
  92. ^ Johnson & Johnson COVID-19 vaccine becomes 4th to receive Health Canada approval. CBC. 
  93. ^ SA is the first country to roll out Johnson & Johnson vaccine – what you need to know about the jab. BusinessInsider. 17 February 2021 [4 March 2021]. 
  94. ^ Browdie B. South Africa to be first to use Johnson Johnson Covid-19 vaccine. Quartz. 20 February 2021 [4 March 2021]. 
  95. ^ Steinhauser G. South Africa Rolls Out J&J Covid-19 Vaccine to Healthcare Workers. The Wall Street Journal. 2021-02-17. 
  96. ^ Turner, Kelly-Jane. This is why SA is suspending its J&J vaccine roll-out. IOL. 2021-04-13 [2021-04-14]. 
  97. ^ Acosta LJ. Colombia grants emergency use for J&J coronavirus vaccine. Reuters (Bogotá). 2021-03-25 [2021-03-25]. 
  98. ^ Lowrey, Tom. Johnson & Johnson's one-dose COVID-19 vaccine won't be coming to Australia due to AstraZeneca similarities. ABC News. 2021-04-13. 
  99. ^ Karp, Paul. Australia won't buy Johnson & Johnson's one-dose Covid vaccine due to AstraZeneca similarities. The Guardian. 2021-04-12 [2021-04-12]. 
  100. ^ 100.0 100.1 100.2 在疫情最嚴重的美國，民眾選擇新冠疫苗的標凖. BBC News 中文. 2021-03-21 [2021-04-19] （中文（繁體））. 
  101. ^ 101.0 101.1 新冠疫苗｜美天主教籲杯葛 強生：疫苗無流產胎兒組織細胞 - 新聞. am730. 2021-03-05 [2021-04-19] （中文（香港））. 
  102. ^ 102.0 102.1 Some US bishops discourage Catholics from getting Johnson & Johnson vaccine if others are available. CNN. 2021-03-03 [2021-03-03]. 
  103. ^ You asked, we answered: Do the COVID-19 vaccines contain aborted fetal cells? | Nebraska Medicine Omaha, NE. www.nebraskamed.com. [2021-03-24]. 
  104. ^ Note on the morality of using some anti-Covid-19 vaccines (21 December 2020). www.vatican.va. [2021-03-24]. 

外部链接

SARS-CoV-2（病毒株）· COVID-19（疾病）· 全球大流行（世界卫生组织定級）
取自“https://zh.wikipedia.org/w/index.php?title=強生2019冠狀病毒病疫苗&oldid=65288506”