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 / Not yet 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 Date01 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)

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

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

1,427

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

15 Nov 2108·Psychiatria DanubinaQ4 · MEDICINE

NON-SUICIDAL SELF-INJURY AMONG UNIVERSITY STUDENTS IN TURKEY: THE EFFECT OF GENDER AND CHILDHOOD ABUSE

Q4 · MEDICINE

Article

Author: Idig-Camuroglu, Meltem ; Gölge, Z Belma

BACKGROUND:

The purpose of this study was to explore the effect of gender and childhood abuse on non-suicidal self-injurious (NSSI) behaviors among university students in Turkey.

SUBJECTS AND METHODS:

In this study convenience sampling technique was used, the sample consisted of 1000 young adults who were from the eight universities in two big cities; Istanbul and Ankara. Besides with demographic questionnaire, Inventory of Statements about Self-Injury and Childhood Trauma Questionnaire were used.

RESULTS:

The prevalence of NSSI was 28.5% and the most prevalent three self-injurious behaviors were wound picking, banging/hitting and pinching self. There was not a gender difference in NSSI behavior frequency but in the type of behavior; males had significantly higher percentages of hitting and burning behavior. Examining the intrapsychic and interpersonal functions of NSSI, "affect regulation" and "toughness" functions were the most used ones among the participants. In terms of gender differences, "revenge" function was used by females more than males. Self-injurers had higher childhood abuse scores on sexual, physical, and emotional abuse and neglect subscales than non self-injurers, and males were significantly more abused than females.

CONCLUSIONS:

Accepting childhood abuse as an important predictor of NSSI behavior, screening and assessment of abused children and adolescents can help to prevent the onset of the behavior.

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 ; Qin, Changjiang ; Wang, Chaoyang ; Zhang, Liang ; Yin, Juntao

BACKGROUND:

This review aimed to systematically evaluate the immunogenicity and safety of the candidate Ebola virus vaccine (EVV).

METHODS:

We 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.

RESULTS:

Twenty-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.

CONCLUSIONS:

The 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.

01 Feb 2024·EClinicalMedicine

Immunogenicity and reactogenicity of modified vaccinia Ankara pre-exposure vaccination against mpox according to previous smallpox vaccine exposure and HIV infection: prospective cohort study

Article

Author: Corso, Rita ; Rosati, Silvia ; Giancola, Maria Letizia ; Camici, Marta ; Cannone, Fabio ; Nappo, Alessandra ; Sarmati, Loredana ; Mazzotta, Stefania ; Scanzano, Pietro ; Caterini, Luciano ; Matusali, Giulia ; Siddu, Andrea ; Plazzi, Maria Maddalena ; Cimaglia, Claudia ; Lapa, Daniele ; Notari, Stefania ; Junea, Angela ; Grassi, Germana ; Faccendini, Paolo ; Preziosi, Gianni ; D'Ettorre, Gabriella ; Pinnetti, Carmela ; Gagliardini, Roberta ; Tartaglia, Eleonora ; Possi, Adriano ; Lepri, Alessandro Cozzi ; Natalini, Giorgia ; Maggi, Fabrizio ; Girardi, Enrico ; Nicastri, Emanuele ; Agrati, Chiara ; Bettini, Aurora ; Lamonaca, Alessandra ; Fontana, Carla ; Cruciani, Stefania ; Gili, Simona ; Passacantilli, Sara ; Caputi, Priscilla ; Rubino, Marika ; Del Duca, Giulia ; Faraglia, Francesca ; De Ponte, Chiara ; Meschi, Silvia ; Vescovo, Maurizio ; Mondillo, Vanessa ; Masone, Erminia ; Lanini, Simone ; Mazzotta, Valentina ; Piselli, Pierluca ; Vaia, Francesco ; Cimini, Eleonora ; Di Giambenedetto, Simona ; Latini, Alessandra ; Stingone, Christof ; Paulicelli, Jessica ; Montagnari, Giulia ; Antinori, Andrea ; Coppola, Luigi ; Barca, Alessandra ; Faticoni, Augusto ; Marocco, Raffaella ; Tamburrini, Enrica ; Marchili, Mauro ; Vita, Serena ; Aguglia, Camilla ; Mondi, Annalisa ; Marani, Alessandra ; Vergori, Alessandra ; Fusto, Marisa ; Kontogiannis, Dimitra ; Farinacci, Damiano ; Anzalone, Enza ; Lichtner, Miriam ; Iannella, Maria Rosaria ; Scorzolini, Laura ; Giannico, Giuseppina ; De Marco, Nicola ; Cristofanelli, Flavia ; Oliva, Alessandra ; Colavita, Francesca ; Gallì, Paola ; Tomassi, Virginia ; Gebremeskel, Saba ; Parisi, Alfredo ; Mastrorosa, Ilaria ; Casetti, Rita ; Ridolfi, Marco ; Mastroianni, Claudio

Background:

Pre-exposure vaccination with MVA-BN has been widely used against mpox to contain the 2022 outbreak. Many countries have defined prioritized strategies, administering a single dose to those historically vaccinated for smallpox, to achieve quickly adequate coverage in front of low supplies. Using epidemiological models, real-life effectiveness was estimated at approximately 36%-86%, but no clinical trials were performed. Few data on MVA-BN immunogenicity are currently available, and there are no established correlates of protection. Immunological response in PLWH in the context of the 2022 outbreak was also poorly described.

Methods:

Blood samples were collected from participants eligible for pre-exposure MVA-BN vaccination before (T1) receiving a full course of vaccine (single-dose for vaccine-experienced or smallpox-primed and two-dose for smallpox vaccine-naïve or smallpox non-primed) and one month after the last dose (T2 and T3, respectively). MPXV-specific IgGs were measured by in-house immunofluorescence assay, using 1:20 as screening dilution, MPXV-specific nAbs by 50% plaque reduction neutralization test (PRNT₅₀, starting dilution 1:10), and IFN-γ-producing specific T cells to MVA-BN vaccine, by ELISpot assay. Paired or unpaired t-test and Wilcoxon or Mann-Whitney test were used to analyse IgG and nAbs, and T-cell response, as appropriate. The probability of IgG and nAb response in vaccine-experienced vs. vaccine-naïve was estimated in participants not reactive at T1. The McNemar test was used to evaluate vaccination's effect on humoral response both overall and by smallpox vaccination history. In participants who were not reactive at T1, the proportion of becoming responders one month after full-cycle completion by exposure groups was compared by logistic regression and then analysed by HIV status strata (interaction test). The response was also examined in continuous, and the Average Treatment Effect (ATE) of the difference from baseline to schedule completion according to previous smallpox vaccination was estimated after weighting for HIV using a linear regression model. Self-reports of adverse effects following immunization (AEFIs) were prospectively collected after the first MVA-BN dose (T1). Systemic (S-AEFIs: fatigue, myalgia, headache, GI effects, chills) and local (L-AEFIs: redness, swelling, pain) AEFIs were graded as absent (grade 0), mild (1), moderate (2), or severe (3). The maximum level of severity for S-AEFIs and L-AEFIs ever experienced over the 30 days post-dose by vaccination exposure groups were analysed using a univariable multinomial logistic regression model and after adjusting for HIV status; for each of the symptoms, we also compared the mean duration by exposure group using an unpaired t-test.

Findings:

Among the 164 participants included, 90 (54.8%) were smallpox vaccine-experienced. Median age was 49 years (IQR 41-55). Among the 76 (46%) PLWH, 76% had a CD4 count >500 cells/μL. There was evidence that both the IgG and nAbs titers increased after administration of the MVA-BN vaccine. However, there was no evidence for a difference in the potential mean change in humoral response from baseline to the completion of a full cycle when comparing primed vs. non-primed participants. Similarly, there was no evidence for a difference in the seroconversion rate after full cycle vaccination in the subset of participants not reactive for nAbs at T1 (p = 1.00 by Fisher's exact test). In this same analysis and for the nAbs outcome, there was some evidence of negative effect modification by HIV (interaction p-value = 0.17) as primed people living with HIV (PLWH) showed a lower probability of seroconversion vs. non-primed, and the opposite was seen in PLWoH. When evaluating the response in continuous, we observed an increase in T-cell response after MVA-BN vaccination in both primed and non-primed. There was evidence for a larger increase when using the 2-dose vs. one-dose strategy with a mean difference of -2.01 log₂ (p ≤ 0.0001), after controlling for HIV. No evidence for a difference in the risk of developing any AEFIs of any grade were observed by exposure group, except for the lower risk of grade 2 (moderate) fatigue, induration and local pain which was lower in primed vs. non-primed [OR 0.26 (0.08-0.92), p = 0.037; OR 0.30 (0.10-0.88), p = 0.029 and OR 0.19 (0.05-0.73), p = 0.015, respectively]. No evidence for a difference in symptom duration was also detected between the groups.

Interpretation:

The evaluation of the humoral and cellular response one month after the completion of the vaccination cycle suggested that MVA-BN is immunogenic and that the administration of a two-dose schedule is preferable regardless of the previous smallpox vaccination history, especially in PLWH, to maximize nAbs response. MVA-BN was safe as well tolerated, with grade 2 reactogenicity higher after the first administration in vaccine-naïve than in vaccine-experienced individuals, but with no evidence for a difference in the duration of these adverse effects. Further studies are needed to evaluate the long-term duration of immunity and to establish specific correlates of protection.

Funding:

The study was supported by the National Institute for Infectious Disease Lazzaro Spallanzani IRCCS "Advanced grant 5 × 1000, 2021" and by the Italian Ministry of Health "Ricerca Corrente Linea 2".

236

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

22 Aug 2024

·www.globenewswire.com

Bavarian Nordic Announces First Half 2024 Results

COPENHAGEN, Denmark, August 22, 2024 – Bavarian Nordic A/S (OMX: BAVA) announced today its interim financial results and business progress for the first half of 2024 and released its financial calendar for 2025. Revenue for the first half was DKK 2,259 million, and the operating profit (EBITDA) was DKK 441 million.Revenue from travel health increased by 15% to DKK 1,119 million and revenue from public preparedness was DKK 1,024 million, which is in line with the Company’s expectations. Other revenue was DKK 116 million.Revenues from Rabipur/RabAvert and Encepur have reached levels exceeding the original expectations at the time of acquisition, thus triggering a sales milestone of DKK 186 million to GSK, payable in the third quarter of 2024.Bavarian Nordic confirms its new guidance for the full year at the upper end of the range, with aggregated revenue of approximately DKK 5,300 million and EBITDA of approximately DKK 1,350 million. The public preparedness revenue included in the new guidance is now largely all secured by contracts. DKK millionQ2 2024Q2 2023H1 2024H1 20232024 GuidanceRevenue1,4271,9872,2593,239~5,300EBITDA4206904411,171~1,350 Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: “We are pleased to report strong developments for Bavarian Nordic during the first half of 2024. Unfortunately, mpox is again making global headlines as a result of the record number of cases reported in Africa. The situation has urged the African CDC and the WHO to declare public health emergencies and Bavarian Nordic is working closely with all stakeholders to ensure the equitable access to our mpox vaccine. Importantly, we have built a strong partnership with the Africa Centers of Disease Control (CDC), both on exploring supply, but also expanding our manufacturing network to include Africa. We are also working with the WHO on a regulatory path to ensure access to all countries, while in parallel seeking approval for use in adolescents and also conducting clinical studies in Africa to further expand the use to children. A recent order for MVA-BN was secured by an undisclosed European country, and this was anticipated as part of the 2024 guidance and as such, has no impact on the remaining vaccine capacity. Indeed, in response to recent events the company plans to ramp-up vaccine manufacturing to ensure the continued equitable access to our mpox vaccine. Consequently, we have the capacity to manufacture 10 million doses by the end of 2025, in addition to our current orders, and could already supply up to 2 million doses this year. Bavarian Nordic is prepared to work with the international community to play our role in protecting and saving lives around the World and to contain the latest outbreak.” Highlights from the period In April, Bavarian Nordic launched its mpox vaccine in the U.S., thereby expanding access to JYNNEOS® for at-risk populations.In April, Bavarian Nordic initiated a rolling BLA submission for its chikungunya vaccine candidate to the U.S. Food and Drug Administration (FDA). The submission was completed in June, and in August, the FDA accepted the BLA with priority review.In April, Bavarian Nordic was awarded a contract valued at EUR 65 million for the supply of smallpox vaccines to the rescEU stockpile in 2025.In May, Bavarian Nordic announced the departure of EVP and Chief Medical Officer Laurence de Moerlooze. A search process to identify the next Chief Medical Officer has been initiated.In May, Bavarian Nordic received funding from CEPI to advance a clinical trial of the mpox vaccine in an African population, potentially supporting expansion of the current regulatory approvals to include children 2 years of age and older, as well as potentially supporting approval of the vaccine in Africa.In May, Bavarian Nordic submitted a supplemental BLA seeking FDA approval of a freeze-dried formulation of the MVA-BN smallpox and mpox vaccine.In June, Bavarian Nordic submitted a Marketing Authorization Application (MAA) for its chikungunya vaccine candidate to the European Medicines Agency (EMA). The MAA was accepted in July, marking the start of the centralized review procedure under accelerated assessment.In June, Bavarian Nordic announced a donation of mpox vaccines to support the public health response in Africa led by a consortium of global partners, including Gavi, WHO and UNICEF. Events after the reporting date In July, Bavarian Nordic announced the conversion of its existing undrawn DKK 1 billion revolving credit facility into a sustainability-linked loan (SLL).In July, Bavarian Nordic received positive opinion from EMA’s Committee for Medicinal Products for Human Use (CHMP), recommending approval of a type II variation for IMVANEX® (MVA-BN) smallpox and mpox vaccine, including real-world effectiveness data from the use of the vaccine during the global 2022 mpox outbreak in the marketing authorization.In August, Bavarian Nordic received a new order from the U.S. government valued at USD 156.8 million, primarily for the manufacture of additional bulk product for JYNNEOS® smallpox/mpox vaccine. The bulk product will be manufactured and invoiced in 2024.In August, Bavarian Nordic received a new order for 175,420 doses of the Company’s mpox vaccine from the European Health Emergency Preparedness and Response Authority (HERA) for donation to the Africa CDC. Bavarian Nordic will also donate 40,000 doses to this initiative.In August, Bavarian Nordic submitted clinical data to the EMA to support an extension of the IMVANEX® (MVA-BN®) smallpox and mpox vaccine indication to include adolescents 12 to 17 years of age. Pending review, approval of the extension could occur during fourth quarter of 2024.In August, Bavarian Nordic received a new order to supply 440,000 doses of smallpox and mpox vaccines to a non-disclosed European country. The order was anticipated as part of the 2024 guidance and has no impact on the remaining 2024/25 capacity for our smallpox and mpox vaccine. Financial calendar 2025 2024 Annual Report March 5, 2025Annual General Meeting April 9, 2025Three-month report (Q1) May 9, 2025Half-year report (Q2) August 22, 2025Nine-month report (Q3) November 14, 2025 Conference call and webcastThe management of Bavarian Nordic will host an investor/analyst call today at 2 pm CEST (8 am EDT) to present the interim results followed by a Q&A session. A listen-only version of the call and presentation slides can be accessed via https://bit.ly/bavaQ22024. To join the Q&A session, please register in advance via https://bit.ly/bavaQ22024reg. 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 Company Announcement no. 25 / 2024 About Bavarian NordicBavarian Nordic is a fully integrated vaccine company with a mission to protect and save lives through innovative vaccines. We are a global leader in smallpox and mpox vaccines, supplied to governments to enhance public health preparedness and have a strong portfolio of vaccines for travelers and endemic diseases. 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. Attachment Interim Report H1 2024

VaccineDrug ApprovalFinancial Statement

22 Aug 2024

·firstwordpharma.com

Orders for Bavarian Nordic’s mpox jab pick up as cases increase in Africa

August has been a busy month for Bavarian Nordic and its mpox vaccine. Both US and European health officials purchased hundreds of thousands of new doses of the jab, just days before the World Health Organization (WHO) declared that an outbreak of the infectious disease in the Democratic Republic of the Congo (DRC) constitutes a public health emergency of international concern. In its latest update, the drugmaker disclosed in its second-quarter earnings report Thursday that an unnamed European country has put in its order for 440,000 doses of the vaccine. “Unfortunately, mpox is again making global headlines as a result of the record number of cases reported in Africa,” said Paul Chaplin, Bavarian Nordic’s chief executive. He added that the company is “working with all stakeholders to ensure the equitable access to our mpox vaccine” and is establishing manufacturing capabilities in Africa. Bavarian Nordic is also conducting clinical studies in the region to expand the use of its vaccine to children.Separately, the firm is engaging with the WHO regarding a regulatory path so all countries can access the jab.Manufacturing ramp-upThe US Department of Health and Human Services was the first to put in its order this month, signing a deal with Bavarian Nordic worth $156.8 million for an undisclosed number of doses. The mpox vaccine is approved as Jynneos in the country, where it was commercially launched in April. The company also received an order from the European Health Emergency Preparedness and Response Authority (HERA) for 175,420 doses. Those vials will be given to the Africa Centres for Disease Control and Prevention, on top of which Bavarian Nordic will donate an additional 40,000 doses. Despite increasing demand for the vaccine, Bavarian Nordic leadership projected confidence that each order — as well as subsequent requests — would be filled, noting plans to ramp-up manufacturing. By the end of 2025, the company expects to have the capacity to manufacture 10 million doses, in addition to its current orders. The drugmaker added that it’s capable of supplying 2 million doses this year. “Bavarian Nordic is prepared to work with the international community to play our role in protecting and saving lives around the world and to contain the latest outbreak,” Chaplin commented.

Drug ApprovalVaccine

21 Aug 2024

·www.globenewswire.com

Bavarian Nordic Receives 440,000 Dose Contract to Supply Smallpox and Mpox Vaccines for Undisclosed European Country

The order was anticipated as part of the 2024 guidance and has no impact on the remaining 2024/25 capacity for the Company’s smallpox and mpox vaccine. COPENHAGEN, Denmark, August 21, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced the award of a contract of 440,000 doses to supply its MVA-BN® smallpox/mpox vaccine to an undisclosed European country. Paul Chaplin, President & CEO of Bavarian Nordic, said: “Since the last mpox outbreak in 2022/23 Bavarian Nordic has established a strong strategic partnership with a number of authorities that have recognized the need to improve their preparedness against smallpox and mpox. Importantly, the latest order was planned as part of our original guidance for this year, and as such, will not impact the remaining capacity that is available to support governments and organizations to address the current WHO declared Public Health Emergency of International Concern for mpox. Bavarian Nordic can still supply up to 10 million doses of our smallpox and mpox vaccine by the end of next year, with 2 million doses of this capacity available during the remaining part of this year.” All vaccines under this contract will be delivered in 2024, bringing the total value of secured contracts in the Public Preparedness business close to DKK 3,000 million, representing the upper end of the revenue guidance for this business in 2024. Hence, Bavarian Nordic is now able to confirm its new guidance for the year at the upper end of the range, with aggregated revenue of approximately DKK 5,300 million and EBITDA of approximately DKK 1,350 million. The total revenue of approximately DKK 5,300 million consists of approximately DKK 3,000 million from Public Preparedness, approximately DKK 2,100 million from Travel Health and approximately DKK 200 million from contract work. About the smallpox/mpox vaccineMVA-BN or Modified Vaccinia Ankara-Bavarian Nordic (marketed under the brand names JYNNEOS®, IMVANEX® and IMVAMUNE®) is a non-replicating smallpox and mpox vaccine. The vaccine is approved by the FDA, EC, Health Canada, MHRA and Swissmedic and has also obtained emergency use authorization in other territories for use during the mpox outbreak. The vaccine was originally developed in collaboration with the U.S. government to ensure supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines. About Bavarian NordicBavarian Nordic is a fully integrated vaccine company with a mission to protect and save lives through innovative vaccines. We are a global leader in smallpox and mpox vaccines, supplied to governments to enhance public health preparedness and have a strong portfolio of vaccines for travelers and endemic diseases. 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 Company Announcement no. 24 / 2024 Attachment 2024-24-en

VaccineDrug ApprovalAccelerated Approval

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

External Link

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

R&D Status

Approved

10 top approved records.

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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dermatitis, Atopic	Phase 2	US	Bavarian Nordic A/S	01 Jul 2006
Dermatitis, Atopic	Phase 2	MX	Bavarian Nordic A/S	01 Jul 2006
HIV Infections	Phase 2	US	Bavarian Nordic A/S	01 Jun 2006
HIV Infections	Phase 2	PR	Bavarian Nordic A/S	01 Jun 2006
Rhinitis, Allergic, Seasonal	Phase 1	DE	Bavarian Nordic A/S	01 Apr 2004

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05512949 (CTgov)	Phase 2	Monkeypox	229	MVA-BN (2 x 10^7 ID MVA-BN)	tfodrfnvug(lygnccggro) = fqpltzsptp ricfqgtmzm (tsirdohnmo, ibsuvtzhjs - amilmdehfx) View more	-	09 Jan 2024
				MVA-BN (1 x 10^7 ID MVA-BN)	tfodrfnvug(lygnccggro) = rrygtoobwx ricfqgtmzm (tsirdohnmo, okkquxsyhi - iqidbhvwzm) View more
NCT03699124 (Pubmed) Manual	Phase 3	-	1,129	MVA-BN	bpmzmihoig(dmtospubkc) = zriptndzrt zfycstfpuw (buakaaygwp ) 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)	qmqmdvsbpy(gqsybbdnjg) = lzxinhtyed stmtjklaiq (sliymcuwew, qqaqgwoloe - hqsnwsffwu) View more	-	27 May 2021
				FD MVA-BN (GP 2: Two Doses of FD MVA-BN--Lot 2)	qmqmdvsbpy(gqsybbdnjg) = tgszmueygt stmtjklaiq (sliymcuwew, trkeiggtan - lsifnnxzzy) View more
NCT01668537 (CTgov)	Phase 2	Smallpox	651	LF (LF Formulation)	qgprpkcqpa(zldqssenht) = tivlvvtjbd ljcxjcmwak (pvefimwrkk, skbxbhtjyj - mxobqvhxbh) View more	-	12 Oct 2020
				MVA-BN (FD Formulation)	qgprpkcqpa(zldqssenht) = bpbwpdnfwy ljcxjcmwak (pvefimwrkk, nyvhmkmvxl - dxfmudqjwl) View more
NCT03472014 (CTgov)	Phase 4	-	22	MVA-BN	budkttyych(fthrrokmfr) = gmornothkc qhzmclbmhe (vmmzgfshfr, wqxbntingr - vnkmfxnrhy) View more	-	19 Aug 2020
NCT01913353 (Pubmed \| Br Dent J) Manual	Phase 3	Smallpox	433	modified vaccinia Ankara+ACAM2000	josfbsoxau(kjnglzrwwt): 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)	vckxaosjdk(opokhqzdah) = lfcfkrfety tyadbwymun (wdpzowjgkf, mkjruiqpmv - aadeocijyp) View more	-	18 Feb 2019
				IMVAMUNE (Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose)	vckxaosjdk(opokhqzdah) = mjruopscch tyadbwymun (wdpzowjgkf, vpgpihaplz - qwhkcotdfx) View more
NCT00857493 (CTgov)	Phase 2	Smallpox	120	IMVAMUNE (Group 1)	vtkcdnqoll(kdwiekapwt) = sebbivxohz eoroliffna (aeznutfzno, ysxzlxtpmg - txvuhprmry) View more	-	10 Jan 2019
				IMVAMUNE (Group 2)	vtkcdnqoll(kdwiekapwt) = pzxujarqre eoroliffna (aeznutfzno, gcwatxyqqq - fkdindevfs) View more
NCT00316602 (CTgov)	Phase 2	Dermatitis, Atopic	632	IMVAMUNE (Healthy Participants)	bekmqkkllq(qvkldhkdnb) = gqzovpoucs vxniixzoab (vqwtmamkij, hacvogbago - kpgxomnhsv) View more	-	09 Jan 2019
				IMVAMUNE (Atopic Dermatitis Participants)	bekmqkkllq(qvkldhkdnb) = idpdfryxij vxniixzoab (vqwtmamkij, aavhidtmwe - brnaxwfmom) View more
NCT01144637 (CTgov)	Phase 3	Smallpox	4,005	IMVAMUNE® (Group 1)	qevvmuocdc(flsnygsbbg) = plwzokektv mbfdjhrkgb (zwrcizprwk, xwgtrywqqe - dtlymrxubo) View more	-	03 Jan 2019
				IMVAMUNE® (Group 2)	qevvmuocdc(flsnygsbbg) = bbwwbumzdm mbfdjhrkgb (zwrcizprwk, bkqfiebzdy - rbtsnzvxno) View more

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Smallpox vaccine(Bavarian Nordic A/S)

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