Editing Smallpox vaccine (section)

==== MVA-BN ====
{{anchor|Imvamune}}{{anchor|Imvanex}}{{anchor|Jynneos}}
MVA-BN (also known as: '''Imvanex''' in the European Union; '''Imvamune''' in Canada; and '''Jynneos'''<ref name="NIAID Supply">{{cite web | title=Smallpox Vaccine Supply & Strength | website=[[National Institute of Allergy and Infectious Diseases]] (NIAID) | date=26 September 2019 | url=https://www.niaid.nih.gov/diseases-conditions/smallpox-vaccine | archive-url=https://web.archive.org/web/20191017060706/https://www.niaid.nih.gov/diseases-conditions/smallpox-vaccine | archive-date=17 October 2019 | url-status=live | access-date=16 October 2019}}</ref><ref>{{cite journal | vauthors = Greenberg RN, Hay CM, Stapleton JT, Marbury TC, Wagner E, Kreitmeir E, Röesch S, von Krempelhuber A, Young P, Nichols R, Meyer TP, Schmidt D, Weigl J, Virgin G, Arndtz-Wiedemann N, Chaplin P | title = A Randomized, Double-Blind, Placebo-Controlled Phase II Trial Investigating the Safety and Immunogenicity of Modified Vaccinia Ankara Smallpox Vaccine (MVA-BN) in 56-80-Year-Old Subjects | journal = PLOS ONE | volume = 11 | issue = 6 | pages = e0157335 | date = 2016 | pmid = 27327616 | pmc = 4915701 | doi = 10.1371/journal.pone.0157335 | doi-access = free | title-link = doi | bibcode = 2016PLoSO..1157335G }}</ref>) is a vaccine manufactured by [[Bavarian Nordic]] by growing MVA in cell culture. Unlike replicating vaccines, MVA-BN is administered by injection via the subcutaneous route and does not result in a vaccine "take."<ref>{{cite web |title=Summary Basis for Regulatory Action Template |url=https://www.fda.gov/media/131802/download |publisher=U.S. Food & Drug Administration |access-date=8 October 2021 |archive-date=8 October 2021 |archive-url=https://web.archive.org/web/20211008212419/https://www.fda.gov/media/131802/download |url-status=live }}</ref> A "take" or "major cutaneous reaction" is a pustular lesion or an area of definite induration or congestion surrounding a central lesion, which can be a scab or an ulcer.<ref>{{cite web |title=Vaccine "Take" Evaluation |url=https://www.cdc.gov/smallpox/clinicians/vaccination-take-evaluation4.html |publisher=U.S. [[Centers for Disease Control and Prevention]] (CDC) |access-date=9 January 2022 |archive-date=26 January 2022 |archive-url=https://web.archive.org/web/20220126003741/https://www.cdc.gov/smallpox/clinicians/vaccination-take-evaluation4.html |url-status=live }}</ref>

MVA-BN can also be administered [[Intradermal injection|intradermally]] to increase the number of available doses.<ref>{{cite web |date=13 October 2022 |title=Monkeypox in the U.S. |url=https://www.cdc.gov/poxvirus/monkeypox/interim-considerations/jynneos-vaccine.html |access-date=19 October 2022 |website=U.S. [[Centers for Disease Control and Prevention]] (CDC) |archive-date=19 October 2022 |archive-url=https://web.archive.org/web/20221019033901/https://www.cdc.gov/poxvirus/monkeypox/interim-considerations/jynneos-vaccine.html |url-status=live }}</ref> It is safer for immunocompromised patients and those who are at risk from a ''vaccinia'' infection.{{cn|date=July 2023}} MVA-BN has been approved in the European Union,<ref name="Imvanex EPAR">{{cite web |url=https://www.ema.europa.eu/en/medicines/human/EPAR/imvanex |title=Imvanex EPAR |date=16 August 2013 |access-date=2 October 2014 |publisher=[[European Medicines Agency]] (EMA) |archive-date=27 April 2022 |archive-url=https://web.archive.org/web/20220427235228/https://www.ema.europa.eu/en/medicines/human/EPAR/imvanex |url-status=live }}</ref> Canada,<ref>{{cite web | title=Smallpox and monkeypox vaccine: Canadian Immunization Guide | website=Public Health Agency of Canada | date=16 June 2022 | url=https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-21-smallpox-vaccine.html | access-date=8 July 2022 | archive-date=20 July 2020 | archive-url=https://web.archive.org/web/20200720171112/https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-21-smallpox-vaccine.html | url-status=live }}</ref><ref>{{cite web | title=Register of Innovative Drugs | website=[[Health Canada]] | date=June 2020 | url=https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/drug-products/applications-submissions/register-innovative-drugs/reg-innov-dr-eng.pdf | access-date=24 June 2020 | archive-date=26 June 2020 | archive-url=https://web.archive.org/web/20200626124518/https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/drug-products/applications-submissions/register-innovative-drugs/reg-innov-dr-eng.pdf | url-status=live }}</ref><ref name="Health Canada">{{cite web|url=http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php |title=Products for Human Use. Submission #144762 |work=Register of Innovative Drugs |access-date=30 October 2014 |publisher=[[Health Canada]] |url-status=dead |archive-url=https://web.archive.org/web/20140617224429/http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/regist/reg_innov_dr-eng.php |archive-date=17 June 2014 }}</ref> and the United States.<ref>{{cite web | title=Jynneos | website=U.S. [[Food and Drug Administration]] (FDA) | date=24 September 2019 | url=https://www.fda.gov/vaccines-blood-biologics/jynneos | archive-url=https://web.archive.org/web/20191017060019/https://www.fda.gov/vaccines-blood-biologics/jynneos | archive-date=17 October 2019 | url-status=live | access-date=16 October 2019 | id=STN 125678}} {{PD-notice}}</ref><ref>{{cite press release | title=FDA approves first live, non-replicating vaccine to prevent smallpox and monkeypox | website=U.S. [[Food and Drug Administration]] (FDA) | date=24 September 2019 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-live-non-replicating-vaccine-prevent-smallpox-and-monkeypox | archive-url=https://web.archive.org/web/20191017055501/https://www.fda.gov/news-events/press-announcements/fda-approves-first-live-non-replicating-vaccine-prevent-smallpox-and-monkeypox | archive-date=17 October 2019 | url-status=live | access-date=17 October 2019}} {{PD-notice}}</ref> Clinical trials have found that MVA-BN is safer and just as immunogenic as ACAM2000.<ref>{{cite web |url=http://id.bavarian-nordic.com/pipeline/clinical-trials.aspx |title=Infectious Diseases: Clinical Trials |access-date=30 October 2014 |publisher=Bavarian Nordic |archive-url=https://web.archive.org/web/20160426132236/http://id.bavarian-nordic.com/pipeline/clinical-trials.aspx |archive-date=26 April 2016 |url-status=dead }}</ref><ref name="Clinicaltrials.gov-NIAID">{{cite web |url=http://www.clinicaltrials.gov/ct2/show/study/NCT01827371 |title=Phase II Trial to Assess Safety and Immunogenicity of Imvamune |access-date=30 October 2014 |publisher=[[U.S. National Institutes of Health]] |work=ClinicalTrials.gov |archive-date=13 March 2022 |archive-url=https://web.archive.org/web/20220313044946/https://clinicaltrials.gov/ct2/show/study/NCT01827371 |url-status=live }}</ref><ref>{{cite journal | vauthors = Pittman PR, Hahn M, Lee HS, Koca C, Samy N, Schmidt D, Hornung J, Weidenthaler H, Heery CR, Meyer TP, Silbernagl G, Maclennan J, Chaplin P | title = Phase 3 Efficacy Trial of Modified Vaccinia Ankara as a Vaccine against Smallpox | journal = The New England Journal of Medicine | volume = 381 | issue = 20 | pages = 1897–1908 | date = November 2019 | pmid = 31722150 | doi = 10.1056/NEJMoa1817307 | doi-access = free | title-link = doi }}</ref> This vaccine has also been approved for use against [[mpox]].<ref>{{cite web |date=19 May 2023 |title=Jynneos Vaccine Effectiveness |url=https://www.cdc.gov/poxvirus/mpox/cases-data/JYNNEOS-vaccine-effectiveness.html |access-date=24 May 2023 |website=U.S. [[Centers for Disease Control and Prevention]] (CDC) |archive-date=24 May 2023 |archive-url=https://web.archive.org/web/20230524073420/https://www.cdc.gov/poxvirus/mpox/cases-data/JYNNEOS-vaccine-effectiveness.html |url-status=live }}</ref><ref>{{cite web |date=19 August 2022 |title=Considerations on posology for the use of the vaccine Jynneos/ Imvanex (MVA-BN) against monkeypox |url=https://www.ema.europa.eu/en/documents/other/considerations-posology-use-vaccine-jynneos/imvanex-mva-bn-against-monkeypox_en.pdf |access-date=28 May 2023 |website=European Medicines Agency |archive-date=28 May 2023 |archive-url=https://web.archive.org/web/20230528112802/https://www.ema.europa.eu/en/documents/other/considerations-posology-use-vaccine-jynneos/imvanex-mva-bn-against-monkeypox_en.pdf |url-status=live }}</ref><ref>{{cite web |title=Protecting you from mpox (monkeypox): information on the smallpox vaccination |url=https://www.gov.uk/government/publications/monkeypox-vaccination-resources/protecting-you-from-monkeypox-information-on-the-smallpox-vaccination |access-date=28 May 2023 |website=GOV.UK |archive-date=28 May 2023 |archive-url=https://web.archive.org/web/20230528112802/https://www.gov.uk/government/publicationsMentioned/monkeypox-vaccination-resources/protecting-you-from-monkeypox-information-on-the-smallpox-vaccination |url-status=live }}</ref>