Delving into the Latest Updates on Smallpox vaccine(Bavarian Nordic A/S) with Synapse

Overview

Basic Info

Drug Type

Live attenuated vaccine, Prophylactic vaccine

Synonyms

MVA, MVA-BN, Modified Vaccinia Ankara-Bavarian Nordic

+ [11]

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious Diseases

Active Indication

MonkeypoxSmallpoxVaccinia

Inactive Indication

Dermatitis, AtopicHIV InfectionsRhinitis, Allergic, Seasonal

Originator Organization

Bavarian Nordic A/S

Active Organization

Bavarian Nordic A/S

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

EU (31 Jul 2013),

MonkeypoxSmallpoxVaccinia

RegulationEmergency Use Authorization (US)

Login to view timeline

This is a prospective observational phase IV study of a novel, replication-deficient smallpox vaccine that has been recently been approved by FDA. The purpose of this study is to determine if there are any abnormalities detected by electrocardiographic testing and/or blood tests within 35 days of receiving the second dose of smallpox vaccine either alone or co-administered with other vaccines that may/may not be suggestive of myopericarditis.

Start Date01 Mar 2029

Sponsor / Collaborator

Womack Army Medical Center

[+1]

NCT05745987 / RecruitingPhase 4IIT

SMART (Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: a Cluster Randomized Controlled Trial)

A cluster randomized controlled trial to determine if smallpox vaccine reduces secondary cases and symptom severity in persons exposed to mpox.

Start Date17 Sep 2024

Sponsor / Collaborator

McMaster University

NCT06366672 / RecruitingEarly Phase 1IIT

Evaluating the Durability of the Human Immune Response to the JYNNEOS Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) Vaccine

This study is designed to evaluate the magnitude and duration of the human adaptive immune response to the JYNNEOS Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine in the blood, lung mucosa, skin and bone marrow.

Start Date10 Jun 2024

Sponsor / Collaborator

Washington University School of Medicine

100 Clinical Results associated with Smallpox vaccine(Bavarian Nordic A/S)

Login to view more data

100 Translational Medicine associated with Smallpox vaccine(Bavarian Nordic A/S)

Login to view more data

100 Patents (Medical) associated with Smallpox vaccine(Bavarian Nordic A/S)

Login to view more data

1,453

Literatures (Medical) associated with Smallpox vaccine(Bavarian Nordic A/S)

31 Dec 2024·Human Vaccines & Immunotherapeutics

Equivalence of freeze-dried and liquid-frozen formulations of MVA-BN as smallpox and mpox vaccine

Article

Author: Maclennan, Jane ; Vidojkovic, Sanja ; Kreusel, Christian ; Gruenert, Robert ; Weidenthaler, Heinz ; Chaplin, Paul John ; Roesch, Siegfried ; Meyer, Thomas P.H. ; Chen, Liddy M. ; Reichhardt, Daniela ; Schmidt, Darja ; Greenberg, Richard N.

31 Dec 2024·Expert Review of Vaccines

Immunogenicity and safety of ebolavirus vaccines in healthy adults: a systematic review and meta-analysis of randomized controlled trials

Review

Author: Miao, Mingsan ; Zhang, Liang ; Yin, Juntao ; Wang, Chaoyang ; Qin, Changjiang

BACKGROUNDThis review aimed to systematically evaluate the immunogenicity and safety of the candidate Ebola virus vaccine (EVV).METHODSWe searched five databases for randomized controlled trials (RCTs) evaluating the effects of EVV on healthy adults. The primary outcomes were relative risk (RR) of sero-conversion or sero-response of EVV in healthy adults between the groups that received EVV and the controls.RESULTSTwenty-nine RCTs (n = 23573) were included. There was a significant difference in RR of sero-conversion of EVV (RR 13.18; 95% CI 11.28-15.41; I² = 33%; P < 0.01) between the two groups. There was a significant difference in RR of adverse events (AEs) of EVV (RR 1.49; 95% CI 1.27-1.74; I² = 88%; P < 0.01), although no difference in RR of serious AE (SAE) between the two groups. Subgroup analysis showed that there was no significant difference in RR of AEs for DNAEBO, EBOV-GP, MVA, and rVSVN4CT1 vaccines, compared with controls.CONCLUSIONSThe DNAEBO, EBOV-GP, MVA, and rVSVN4CT1 vaccines are likely to be safe and immunogenic, tending to support the vaccination against Ebola disease. These findings should provide much-needed evidence for public health policy makers to develop preventive measures based on disease prevalence features and socio-economic conditions.

31 Dec 2024·Human Vaccines & Immunotherapeutics

Knowledge about, attitudes toward and acceptance and predictors of intention to receive the mpox vaccine among cancer patients in China: A cross-sectional survey

Article

Author: Yu, Chao-Qin ; Xu, Xiao-Wan ; Zhang, Qing-Mei ; Liu, Yi-Qun ; Ding, Jie ; Hong, Jing ; Liu, Xing-Chen

This study aimed to investigate the knowledge about, attitudes toward, and acceptance and predictors of receiving the mpox vaccine among Chinese cancer patients. Patients were selected using a convenience sampling method. A web-based self-report questionnaire was developed to assess cancer patients' knowledge, attitudes, and acceptance regarding the mpox vaccine. Multivariate logistic regression analysis was used to determine predictors of acceptance of the mpox vaccine. A total of 805 cancer patients were included in this study, with a vaccine hesitancy rate of 27.08%. Approximately 66% of the patients' information about mpox and the vaccine came from the mass media, and there was a significant bias in the hesitant group's knowledge about mpox and the vaccine. Multivariable logistic regression analysis suggested that retirement; chemotherapy; the belief that the mpox vaccine could prevent disease, that vaccination should be compulsory when appropriate and that the mpox vaccine prevents mpox and reduces complications; the willingness to pay for the mpox vaccine; the willingness to recommend that friends and family receive the mpox vaccine; and the belief that the mpox vaccine should be distributed fairly and equitably were factors that promoted vaccination. The belief that mpox worsens tumor prognosis was a driving factor for vaccine hesitancy. This study investigated the knowledge of cancer patients about mpox and the vaccine, evaluated the acceptance and hesitancy rates of the mpox vaccine and examined the predictors of vaccination intention. We suggest that the government scientifically promote the vaccine and develop policies such as free vaccination and personalized vaccination to increase the awareness and acceptance rate of the mpox vaccine.

295

News (Medical) associated with Smallpox vaccine(Bavarian Nordic A/S)

29 Oct 2024

·www.globenewswire.com

First Children Vaccinated in New Clinical Study Seeking to Expand the Indication for Bavarian Nordic’s Mpox Vaccine

Clinical study in children 2-11 years of age follows the recent EMA and WHO approvals of the MVA-BN mpox vaccine for adolescents 12-17 of age. COPENHAGEN, Denmark, October 29, 2024 – Bavarian Nordic A/S (OMX: BAVA) announced today the initiation of a clinical study of the MVA-BN® mpox/smallpox vaccine in children 2 to 11 years of age. The first children have now been vaccinated in the study, which is currently enrolling in the Democratic Republic of Congo (DRC) with plans also to include sites in Uganda. A total of 460 individuals are expected to participate in the study, which will compare the safety and immunogenicity of the vaccine between children aged 2 to 11 years of age to adults. The study (NCT06549530) is partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI). Results from this study could support an extension of the current approval of MVA-BN to include children from 2 years of age and older. Last month, the WHO prequalified the vaccine for adolescents 12 to 17 years of age, adopting the recent approval from the European Medicines Agency (EMA) for this age group. Paul Chaplin, President & CEO of Bavarian Nordic, said: “Children remain highly vulnerable to mpox infections in the ongoing outbreak in Africa, highlighting the importance and urgency to broaden the access to effective vaccines that can be safely administered to this young population. Following the recent approval of MVA-BN for adolescents, we are pleased to initiate this study, which could provide additional data to further extend the indication to also include children, and we thank CEPI and our partners in Africa for their support of this important work.” Dr Nicole Lurie, Executive Director of Preparedness and Response at CEPI, said: “The findings of this study will be crucial in shaping mpox vaccine strategies that could protect children and bring an end to this devastating and widespread outbreak, while also providing pivotal vaccine guidance in local endemic populations to tackle mpox outbreaks that could strike in the future.” While this study represents the first investigation of MVA-BN as an mpox/smallpox vaccine for younger children, a recombinant version of MVA-BN (Mvabea®) was approved by EMA in 2020 as part of a prime-boost vaccine regimen1 for the prevention of disease caused by Ebola virus in individuals 1 year of age and older. Clinical studies supporting this approval encompassed more than 3,300 individuals across Europe, USA, and Africa including over 800 children and adolescents 1 to 17 years of age in Africa2. The safety profile of Mvabea in children 1 to 17 years of age was generally similar to that observed in adults. About the mpox vaccineMVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is the only non-replicating mpox vaccine approved in the U.S., Switzerland, Singapore and Mexico (marketed as JYNNEOS®), Canada (marketed as IMVAMUNE®), and the EU/EAA and United Kingdom (marketed as IMVANEX®). Originally developed as a smallpox vaccine in collaboration with the U.S. government to ensure the supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines, MVA-BN has been indicated for use in the general population (from 12 years old) in individuals considered at risk for smallpox or mpox infection. About Bavarian NordicBavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. For more information, visit www.bavarian-nordic.com. Forward-looking statements This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. ContactsEurope: Rolf Sass Sørensen, Vice President Investor Relations, rss@bavarian-nordic.com, Tel: +45 61 77 47 43US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600 1 Mvabea® was licensed in 2014 to Johnson & Johnson as part of a prime-boost vaccine regimen. 2 https://www.ema.europa.eu/en/documents/assessment-report/mvabea-epar-public-assessment-report_en.pdf Attachment 2024-10-29-en

Drug ApprovalVaccineClinical Study

17 Oct 2024

·www.biospace.com

Bavarian Nordic’s Jynneos Elicits ‘Robust’ Mpox Antibody Response in Adolescents: Study

iStock, Anne Czichos The mpox vaccine induced an antibody response in adolescents aged 12 to 17 years that matched that in adults, suggesting the shot can be used to protect the highly susceptible group. Bavarian Nordic ’s mpox vaccine Jynneos is safe to use in adolescents and can induce an antibody response that matches its effect in adults , according to the interim findings of a study funded by the National Institutes of Health. The results, which were unveiled Wednesday at the 2024 IDWeek conference in Los Angeles, come from a Phase II trial that administered Jynneos to more than 300 adolescents aged 12 to 17 years and compared the vaccine’s safety and efficacy to that in over 200 adults 18 to 50 years. Data were sparse with the NIH only revealing that Jynneos “generated antibody levels in adolescents equivalent to those observed in adults” two weeks after the second dose. “The vaccine was well tolerated through study day 210,” according to the NIH, which pointed out that side effects arose at similar frequencies between study groups. Mary Healy, associated professor of pediatrics infectious diseases at Baylor College of Medicine and who presented the study at IDWeek, called the results “an important milestone for people living in areas with mpox” while noting that the vaccine continues to be “an important solution” to protect vulnerable populations from the virus, particularly adolescents. Wednesday’s findings come just days after the World Health Organization prequalified the use of Jynneos for adolescents aged 12 to 17. According to the global health authority, this move will make the vaccine available for an age group of patients that are considered particularly vulnerable to the virus. The European Medicines Agency in September 2024 allowed the use of Jynneos in adolescents . The FDA has yet to grant a similar approval. Adding to the NIH’s most recent data on Jynneos, several studies in recent months have helped improve the industry’s understanding of the vaccine, not just regarding its efficacy and safety but also the durability of its effects and acceptable dosing. In April 2024, another NIH study found that even a dose-sparing regimen of Jynneos—where patients are given just one-fifths of its standard dose—can elicit an antibody response similar to that of the standard dose , though this effect waned much sooner. Earlier this month, another study showed that even at its approved dose, antibody titers appear to decline after six to 12 months , raising concerns about weakening protective immunity in patients that were vaccinated in during the 2022 outbreak. In August 2024, the WHO declared the mpox outbreak a public health emergency of international concern. Though cases were largely concentrated in the Democratic Republic of Congo and in Africa at the time, WHO Director-General Tedros Adhanom Ghebreyesus flagged “the emergency of a new clade of mpox” which appears to be a more aggressive and deadlier version of the virus. For Bavarian Nordic, the WHO’s declaration represents a promising windfall opportunity . In an August 2024 investor note, Jefferies analyst Peter Welford estimated that the company is looking at $600 million to $1 billion in revenue into 2025, if it can deliver its promised 10 million doses.

VaccineClinical ResultPhase 2

17 Oct 2024

·www.pharmaceutical-technology.com

Bavarian Nordic’s mpox vaccine equally effective in teens as adults

The NIH study team says the data supports the safety and quality of the vaccine’s immune response in adolescents. Image credit: Shutterstock/Halfpoint. A clinical trial by the US National Institutes of Health (NIH) has shown that Bavarian Nordic ’s mpox vaccine induced an antibody response in adolescents equivalent to that of adults. The interim results, presented at the Infectious Diseases Society of America’s IDWeek2024 conference in Los Angeles, could provide backing to aid the vaccine’s extended use in those under 18 years of age in the US and other areas where mpox cases have occurred. “[The interim data] would support an application to expand licensure of the vaccine to people in that age group,” an NIH’s National Institute of Allergy and Infectious Diseases (NIAID) spokesperson confirmed to Pharmaceutical Technology . Bavarian Nordic won an European Medicines Agency (EMA) approval for MVA-BN’s use in adolescents in September this year, whilst in the US it is still only approved in adults under the brand name Jynneos. During the 2022–2023 mpox outbreak, though, the FDA did grant the vaccine an emergency use authorisation for both pre- and post-exposure use in adolescents. The NIH stated that whilst several countries have approved the vaccine for the prevention of mpox and smallpox in adults, there is “insufficient data available to support licensure for people younger than 18 years,” as per a 16 October press release. See Also: Intercept’s liver disease drug Ocaliva faces FDA approval delay Avadel wins FDA approval for narcolepsy drug Lumryz in children The NIAID-sponsored Phase II study (NCT05512949) was conducted in the US in individuals aged between 12 and 17 years. After two doses, antibody levels were found to be equivalent at day 43 to those in adults aged 18 to 50 years. The overall frequency of adverse events was comparable between the study groups, with the vaccine well tolerated through day 210 of the study. Dizziness was reported more often in the adolescent group, but the NIH stated this is also seen in many other vaccines given to a younger age group. The randomised mid-stage study enrolled 229 healthy adolescents, some of whom have a human immunodeficiency virus (HIV) infection. People with compromised immune systems and those who are pregnant are being adversely affected by the Clade II mpox outbreak in Africa, with a large portion of those testing positive in the continent under the age of 18 years old. Whilst mpox cases have steadily increased in areas of Africa over the past decade, the number of cases reported so far this year has already exceeded last year’s total, with more than 24,000 confirmed or suspected mpox cases because Clade I and Clade II, including over 600 deaths. Even though the NIH study team says the data supports the safety and quality of the immune response in adolescents, the authors reiterated the need for further evaluation in younger children. Bavarian Nordic is gearing up for its own Phase II clinical trial (NCT06549530) to assess the immunogenicity and safety of MVA-BN in children between two and 12 years of age. The company has previously said it aims “to further extend the indication of the vaccine into younger populations”. The trial, partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), is expected to start this month. In September, Bavarian Nordic said it would prioritise the production of two million mpox vaccines by the end of this year to help fight the disease in Africa. The Swiss biotech has already shipped 250,000 doses of the vaccine to the Democratic Republic of Congo, considered the epicentre of the outbreak. Note: The third paragraph of this article was amended on 18 October to include response from the NIAID spokesperson.

VaccinePhase 2Drug ApprovalClinical Result

100 Deals associated with Smallpox vaccine(Bavarian Nordic A/S)

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
-	Smallpox vaccine(Bavarian Nordic A/S)	J07BX	DB15483

R&D Status

Approved

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Monkeypox	IS	Bavarian Nordic A/S	31 Jul 2013
Monkeypox	LI	Bavarian Nordic A/S	31 Jul 2013
Monkeypox	EU	Bavarian Nordic A/S	31 Jul 2013
Monkeypox	NO	Bavarian Nordic A/S	31 Jul 2013
Smallpox	NO	Bavarian Nordic A/S	31 Jul 2013
Smallpox	EU	Bavarian Nordic A/S	31 Jul 2013
Smallpox	LI	Bavarian Nordic A/S	31 Jul 2013
Smallpox	IS	Bavarian Nordic A/S	31 Jul 2013
Vaccinia	LI	Bavarian Nordic A/S	31 Jul 2013
Vaccinia	EU	Bavarian Nordic A/S	31 Jul 2013
Vaccinia	NO	Bavarian Nordic A/S	31 Jul 2013
Vaccinia	IS	Bavarian Nordic A/S	31 Jul 2013

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Monkeypox	Phase 3	CG	Bavarian Nordic A/S	23 Feb 2017
Vaccinia	Phase 2	KR	Bavarian Nordic A/S	01 Mar 2015
Dermatitis, Atopic	Phase 2	MX	Bavarian Nordic A/S	01 Jul 2006
Dermatitis, Atopic	Phase 2	US	Bavarian Nordic A/S	01 Jul 2006
HIV Infections	Phase 2	PR	Bavarian Nordic A/S	01 Jun 2006
HIV Infections	Phase 2	US	Bavarian Nordic A/S	01 Jun 2006
Rhinitis, Allergic, Seasonal	Phase 1	DE	Bavarian Nordic A/S	01 Apr 2004

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05512949 (NEWS) Manual	Phase 2	Monkeypox	229	MVA-BN (aged between 12 and 17 years)	vtpyefkyqe(jygnqcwvfu) = After two doses, antibody levels were found to be equivalent at day 43 to those in adults aged 18 to 50 years. trhgvawlat (lebmuruvlg ) View more	Positive	17 Oct 2024
Literature Manual	Not Applicable	Monkeypox	45	MVA-BN 2 doses	cnmeohpxup(znarefprkh) = 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 seagaudovn (smubwxwkjc )	Negative	03 Oct 2024
				MVA-BN 1 doses
NCT05740982 (NEWS) Manual	Phase 2	Hemorrhagic Fever, Ebola	526	IMVANEX (adolescents 12-17 years of age)	(ifhqrwlytp) = a similar safety profile between both age groups evnxxfekvc (ilqjgeepmi ) View more	Positive	19 Sep 2024
				IMVANEX (adults aged 18 years and older)
NCT03699124 (Pubmed) Manual	Phase 3	-	1,129	MVA-BN	(ngmlbcavjf) = mojctuerzq acojhzdqau (liewjbpwnz ) View more	Positive	29 Nov 2022
NCT03699124 (CTgov)	Phase 3	Smallpox	1,129	FD MVA-BN (GP 1: Two Doses of FD MVA-BN--Lot 1)	qnttcikith(scmvhnerek) = ypsnltrstc btzojvengw (fvciadijov, ooiqzszwdx - befrepiykb) View more	-	27 May 2021
				FD MVA-BN (GP 2: Two Doses of FD MVA-BN--Lot 2)	qnttcikith(scmvhnerek) = pyyxtnqpot btzojvengw (fvciadijov, mrwsslpfmv - gppwodliso) View more
NCT01668537 (CTgov)	Phase 2	Smallpox	651	LF (LF Formulation)	yiawkjslnx(ujqugwueex) = gnojzmaedq uujzenlqdx (znannqxkzc, fwdadrdwun - eoryzwiheg) View more	-	12 Oct 2020
				MVA-BN (FD Formulation)	yiawkjslnx(ujqugwueex) = itzpjrxnqd uujzenlqdx (znannqxkzc, qcxcskwgsw - jiwroccwvn) View more
NCT03472014 (CTgov)	Phase 4	-	22	MVA-BN	imnkpjoruh(usyypbvquy) = upantzdsrk elyyfoxcxu (qngiicctes, ievqldlsbj - uvzjnkbioo) View more	-	19 Aug 2020
NCT01913353 (Pubmed \| Br Dent J) Manual	Phase 3	Smallpox	433	modified vaccinia Ankara+ACAM2000	hzisxaixxl(ukqiwaghhm): RO = 97.9 (95% CI, 96.6 - 98.3) View more	Superior	14 Nov 2019
				ACAM2000
NCT00686582 (CTgov)	Phase 2	Smallpox	304	IMVAMUNE (Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose)	hxateszbhd(qtxzyuaqtu) = krlqtskhgb jgvowlfzvu (heotentlul, vvvxtlsoow - utppspahrf) View more	-	18 Feb 2019
				IMVAMUNE (Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose)	hxateszbhd(qtxzyuaqtu) = lfoordqhwo jgvowlfzvu (heotentlul, kqxyftdwio - sxmmwsekvm) View more
NCT00857493 (CTgov)	Phase 2	Smallpox	120	IMVAMUNE (Group 1)	pciyieflfr(ufkulzkobc) = bmexysnppp clsoidsfvk (kvipkndggr, jqtsvvwbaq - kdzgiuyuci) View more	-	10 Jan 2019
				IMVAMUNE (Group 2)	pciyieflfr(ufkulzkobc) = lfzyqrjtkr clsoidsfvk (kvipkndggr, vjmybomkbt - vemmehjlyc) View more