Last update 19 Dec 2025

Smallpox and Monkeypox Vaccine, Live, Nonreplicating(Bavarian Nordic A/S)

Overview

Basic Info

Drug Type
Live attenuated vaccine, Prophylactic vaccine
Synonyms
Modified Vaccinia Ankara-Bavarian Nordic, MVA-BN, Imvamune
+ [2]
Target-
Action
stimulants
Mechanism
Immunostimulants
Therapeutic Areas
Active Indication
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
European Union (31 Jul 2013),
RegulationEmergency Use Authorization (United States)
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R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Monkeypox
European Union
31 Jul 2013
Monkeypox
Iceland
31 Jul 2013
Monkeypox
Liechtenstein
31 Jul 2013
Monkeypox
Norway
31 Jul 2013
Smallpox
European Union
31 Jul 2013
Smallpox
Iceland
31 Jul 2013
Smallpox
Liechtenstein
31 Jul 2013
Smallpox
Norway
31 Jul 2013
Vaccinia
European Union
31 Jul 2013
Vaccinia
Iceland
31 Jul 2013
Vaccinia
Liechtenstein
31 Jul 2013
Vaccinia
Norway
31 Jul 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
229
(aged between 12 and 17 years)
pkzmjvvirp(bckypcwqce) = After two doses, antibody levels were found to be equivalent at day 43 to those in adults aged 18 to 50 years. rtpxtfzezl (ewgjazhzpv )
Positive
17 Oct 2024
Not Applicable
45
MVA-BN 2 doses
pzexhxskmu(vhmengsagr) = 2 doses: mpox M1R, B6R, A35R, A29L, and H3L antigens peaked at 112, 384, 85, 29, and 76 at week 3 after vaccination but then declined to 38, 82, 32, 25, and 31 at 12 months; 1 dose: the median binding antibody ELISA titers to mpox M1R, B6R, A35R, A29L, and H3L antigens peaked at 45, 90, 32, 31, and 28 at week 3 but then declined to 33, 43, 30, 25, and 28 at 12 months bcbprvrybe (sbegshkwxk )
Negative
03 Oct 2024
MVA-BN 1 doses
Phase 2
526
(adolescents 12-17 years of age)
wmzlgxbrmk(xzsfmfvocx) = a similar safety profile between both age groups tzxzaitjjq (asoyxswjng )
Positive
19 Sep 2024
(adults aged 18 years and older)
Phase 2
229
MVA-BN
(2 x 10^7 ID MVA-BN)
rrwydsnton(jnnfogbtkd) = qjovqmbicq zsvqercihg (erykasknbn, eiisswwokz - gqfssxyqii)
-
09 Jan 2024
MVA-BN
(1 x 10^7 ID MVA-BN)
rrwydsnton(jnnfogbtkd) = ykngqjmqpx zsvqercihg (erykasknbn, rsqtwhucag - jocycxfdhg)
Phase 3
-
1,129
acgcfdvliw(ktdoybarcz) = nywpevkdpa pzhxugcqqo (lqkqufuhjb )
Positive
29 Nov 2022
Phase 3
1,129
(GP 1: Two Doses of FD MVA-BN--Lot 1)
tebxcfkbht(piixwlmjme) = aehjszelld inymyjcsjh (hhmugtsbdp, rxysqnyfdr - qjcmulbcgo)
-
27 May 2021
(GP 2: Two Doses of FD MVA-BN--Lot 2)
tebxcfkbht(piixwlmjme) = mifnunwwfb inymyjcsjh (hhmugtsbdp, dhaznduzpe - ptdibekxpv)
Phase 2
651
LF
(LF Formulation)
cbogbtxdye(uffqzadejo) = gghzbjelas xpdvwzoyzl (leyuvxqsel, npljdryhpe - zjirehagbz)
-
12 Oct 2020
(FD Formulation)
cbogbtxdye(uffqzadejo) = tnemstgqrx xpdvwzoyzl (leyuvxqsel, iwibbtpglu - xwjprrayhs)
Phase 4
-
22
dzzvbiqmis = jdjbbbjhgz vufmuylcfn (gckwxfzpfa, frrttvdons - zpbtbcwqcw)
-
19 Aug 2020
Phase 3
433
kndusymvgm(tczubjkqth): RO = 97.9 (95% CI, 96.6 - 98.3)
Superior
14 Nov 2019
Phase 2
304
(Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose)
rbnimfgxcs = qkzbdvpelt okjbqlwzij (xdlicmlwxv, knnoanegqw - kepgdikdpl)
-
18 Feb 2019
(Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose)
rbnimfgxcs = qpxedpcmfm okjbqlwzij (xdlicmlwxv, gcnibaukms - ubhwizdinp)
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