An Open-label, Single Arm, Phase III Clinical Study to Evaluate the Efficacy and Safety of CJ Smallpox Vaccine in Previously Vaccinated Healthy Volunteers

The currently available stock of smallpox vaccine would be insufficient in the face of an incident of smallpox attack. Thus, new manufacturing methods for smallpox vaccine are urgently needed because previous manufacturing methods using calf lymph are no longer acceptable in the view of current standards. Recently, CJ corporation in Republic of Korea has developed cell-culture derived smallpox vaccine (CJ-50300) which was manufactured by infecting MRC-5 cells. The aim of this clinical trial were to assess safety, reactogenicity, and immunogenicity of CJ-50300 in previously vaccinated healthy volunteers

开始日期2010-10-01

申办/合作机构

Seoul National University Hospital

[+1]

100 项与 Smallpox vaccine(HK inno.N Corp.) 相关的临床结果

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100 项与 Smallpox vaccine(HK inno.N Corp.) 相关的转化医学

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项与 Smallpox vaccine(HK inno.N Corp.) 相关的文献（医药）

2024-04-01·Virology

Monkeypox: Can we count on the current smallpox immunization?

Article

作者: Wang, Xia ; Zhang, Zehan ; Zhang, Fengwei ; Ren, Hongguang ; Yue, Junjie ; Chai, Zili ; Jin, Yuan ; Liu, Wenting ; Yang, Zilong

Two vaccines ACAM 2000 and JYNNEOS have obtained approval from the Food and Drug Administration as preventive measures against monkeypox, contributing significantly to the management of the monkeypox epidemic. Nonetheless, research has demonstrated that smallpox vaccination offers approximately 88.8% protection against monkeypox, while immunization with these vaccines generates relatively low levels of neutralizing antibodies. In this work, we performed a comprehensive comparison of antigens between the 2022-2023 monkeypox strains and the smallpox vaccine strains. Our analysis has revealed considerable amino acid changes in all 27 antigens, including core and envelope proteins. Amino acid substitutions within B cell epitopes were observed in 26 of these antigens, with at least half of the antigen substitutions occurring within B cell epitopes in 20 out of the 26 antigens analyzed. These findings may raise potential concerns regarding the efficacy of these vaccines.

2024-02-01·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

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

2024-02-01·Archives of virology

Tracing the journey of poxviruses: insights from history

Review

作者: Dhanya, K ; Lodha, Lonika ; Pattanaik, Amrita ; Ma, Ashwini ; Siddalingaiah, Nayana ; Mani, Reeta S

The historical significance of the poxviruses is profound, largely due to the enduring impact left by smallpox virus across many centuries. The elimination of smallpox is a remarkable accomplishment in the history of science and medicine, with centuries of devoted efforts resulting in the development and widespread administration of smallpox vaccines. This review provides insight into the pivotal historical events involving medically significant poxviruses. Understanding the remarkable saga of combatting smallpox is crucial, serving as a guidepost for potential future encounters with poxvirus infections. There is a continual need for vigilant observation of poxvirus evolution and spillover from animals to humans, considering the expansive range of susceptible hosts. The recent occurrence of monkeypox cases in non-endemic countries stands as a stark reminder of the ease with which infections can be disseminated through international travel and trade. This backdrop encourages introspection about our journey and the current status of poxvirus research.

项与 Smallpox vaccine(HK inno.N Corp.) 相关的新闻（医药）

2024-06-28

·GlobeNewswire-Health Care

Bavarian Nordic Joins Global Efforts to Fight Mpox Outbreak in Africa

Bavarian Nordic is committed to support global efforts to address the mpox situation in Africa through a donation of 15,000 doses of mpox vaccineEmergency Use Authorization for the MVA-BN vaccine has been issued in the DR Congo COPENHAGEN, Denmark, June 28, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced an extended commitment to help fight the current mpox outbreak in Africa. The Company’s MVA-BN vaccine, the only FDA and EMA-approved mpox vaccine, which served as an important tool during the 2022-2023 mpox outbreak, could soon also become available in the DR Congo (DRC) and other countries in Africa. Mpox is on the rise in African countries with increasing incidence of the more severe clade I. So far in 2024, more than 9,000 mpox cases and over 400 deaths have been reported across seven African countries of which the vast majority (96%) having occurred in the DRC1. Earlier this week, the regulatory authorities in the DRC, ACOREP (Autorité Congolaise de Réglementation Pharmaceutique), issued an Emergency Use Authorization allowing for the use of the MVA-BN vaccine for individuals at risk of mpox. Locally, in the DRC, clinical studies are also planned to support a full regulatory approval of the MVA-BN vaccine, as recently announced by Bavarian Nordic. To further strengthen the response in the DRC and throughout the African region, Bavarian Nordic will collaborate with global health partners, including WHO, UNICEF and Gavi. Bavarian Nordic applauds Gavi’s Board decision to approve a new Vaccine Investment Strategy which includes the establishment of a global mpox vaccine stockpile. In the near term, Bavarian Nordic is committed to work in partnership with Gavi, WHO and UNICEF to coordinate dose donations in response to the ongoing outbreak in the DRC and other African countries. To support these efforts, Bavarian Nordic has committed to donating 15,000 doses of its MVA-BN mpox vaccine to the African response. “The spread of mpox in the Democratic Republic of the Congo and elsewhere is highly concerning and could pose a global threat if it is not urgently contained,” said Dr Sania Nishtar, CEO of Gavi, the Vaccine Alliance. “Gavi and its partners welcome Bavarian Nordic’s resolve to help fight this outbreak and its contribution in doses. Our Alliance welcomes the availability of new vaccines for countries and is committed to working with Bavarian Nordic and the relevant authorities to facilitate their arrival and timely administration in line with country plans.” “Mpox has been a public health threat in several African countries for more than 50 years and is now spreading across the continent with higher incidence and severity. Global partners are uniting to build a stronger public health response throughout the affected region. and we are proud to contribute through a donation of our mpox vaccine,” said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. About mpox in the DRC and other African countriesAfrica is currently tackling one of the largest and deadliest known mpox outbreak to date. Over 8,700 mpox cases and 408 deaths have been reported in the DRC this year alone, with children accounting for the majority of infections and deaths. Cases have also been confirmed in the Republic of Congo, Cameroon, Central African Republic, Ghana, Liberia and South Africa. Mpox was first identified in the DR Congo in 1970. In most cases, mpox symptoms - typically fever and headache, followed by painful lesions - resolve within a few weeks. However, for some, mpox can lead to medical complications, such as bronchopneumonia, sepsis, encephalitis, loss of vision, or death. The mpox virus strain behind the current outbreak, known as clade I, is estimated to be fatal in up to 10% of cases. About the smallpox/mpox vaccineMVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is a non-replicating smallpox vaccine and the only mpox vaccine approved in the U.S. and Switzerland (marketed as JYNNEOS®), Canada (marketed as IMVAMUNE®), and the EU/EEA and United Kingdom (marketed as IMVANEX®). Originally developed 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 adult population (18 years and older) in individuals considered at risk for smallpox or mpox. During the 2022-2023 mpox outbreak, the vaccine was granted an Emergency Use Authorization by the U.S. FDA for both pre- and post-exposure use in adolescents. Bavarian Nordic has been a long-term supplier of the vaccine to the U.S. and Canada as well as several other countries as part of their national biological preparedness. During the 2022-2023 mpox outbreak, Bavarian Nordic has furthermore supported governments and supranational organizations by expanding access to the vaccine to more than 70 countries worldwide. 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 1 https://africacdc.org/download/africa-cdc-weekly-event-based-surveillance-report-june-2024/ Attachment 2024-06-28-en

上市批准疫苗加速审批

2024-06-26

·BioSpace

Bavarian Nordic Submits Marketing Authorization Application for its Chikungunya Vaccine Candidate to EMA

Regulatory review of the single-dose CHIKV VLP vaccine candidate for immunization to prevent disease caused by chikungunya virus infection in individuals 12 years of age and older is now underway in both the EU and in the U.S. COPENHAGEN, Denmark, June 26, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of the Company’s vaccine candidate for immunization to prevent disease caused by chikungunya virus infection in individuals 12 years of age and older. The application was granted accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) in February 2024, supporting the potential approval of the vaccine by the European Commission in the first half of 2025. The MAA submission includes results from two phase 3 clinical trials in more than 3,600 healthy individuals 12 years of age and older. The results showed that the CHIKV VLP vaccine was highly immunogenic, as demonstrated by the strong induction of chikungunya neutralizing antibodies 21 days after vaccination, with antibody titers equal to or above the threshold agreed with authorities as a marker of seroprotection in the majority of individuals. The CHIKV VLP vaccine was well-tolerated across both studies and vaccine-related adverse events were mainly mild or moderate in nature. “The MAA marks our second major submission in just a few weeks as part of our efforts to launch the chikungunya vaccine next year in the U.S. and Europe. Chikungunya, like other mosquito-borne infectious diseases, represents an increasing public health threat due to factors such as climate-change, but also resulting from improved disease surveillance and diagnosis. Our CHIKV VLP vaccine is designed for ease of use in individuals 12 years of age and older at risk of chikungunya virus and represents an important contribution to the development of preventative solutions against this debilitating disease,” said Paul Chaplin, President and CEO of Bavarian Nordic. About CHIKV VLP vaccine CHIKV VLP is an adjuvanted VLP-based vaccine candidate for active immunization to prevent disease caused by CHIKV infection. Pending regulatory approval, the single-dose vaccine will be made in a pre-filled syringe, designed to ease administration by saving vaccinators' time and reducing the risk of administrative errors. The CHIKV VLP vaccine candidate received Breakthrough Therapy designation and Fast Track designation from the FDA in October 2020 and April 2018, respectively, and PRIME designation from the EMA in September 2019. These designations are designed to facilitate the development or expedite review of medicines that either target an unmet medical need or may demonstrate substantial improvement over available therapy. In February 2024, the Committee for Medicinal Products for Human Use (CHMP) under EMA granted accelerated assessment for the MAA for the CHIKV VLP vaccine candidate based on the vaccine’s major interest for public health and therapeutic innovation. About chikungunya Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), which belongs to the group of arboviruses like dengue virus. CHIKV disease typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain. While mortality is relatively low, morbidity is high; nearly 50% of individuals with CHIKV disease have debilitating long-term symptoms that can intensify with age. In the past 20 years, the CHIKV has emerged in several previously non-endemic regions in Asia, Africa, southern Europe, and the Americas, often causing large unpredictable outbreaks. Recent data1 suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to lack of proper testing. About Bavarian Nordic Bavarian 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 . 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. Contacts Europe: Rolf Sass Sørensen, Vice President Investor Relations, rss@bavarian-nordic.com, Tel: +45 61 77 47 43 US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600 Company Announcement no. 19 / 2024 1 Ribas Freitas AR, Pinheiro Chagas AA, Siqueira AM, Pamplona de Góes Cavalcanti L. How much of the current serious arbovirus epidemic in Brazil is dengue and how much is chikungunya? Lancet Reg Health Am. 2024 Apr 30;34:100753. doi: 10.1016/j.lana.2024.100753. PMID: 38711542; PMCID: PMC11070701. Attachment 2024-19-en

临床结果临床3期疫苗快速通道突破性疗法

2024-05-31

·GlobeNewswire-Health Care

Bavarian Nordic Submits Supplemental BLA Seeking U.S. FDA Approval of Freeze-Dried Formulation of Smallpox and Mpox Vaccine

COPENHAGEN, Denmark, May 31, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a freeze-dried formulation of JYNNEOS® for prevention of smallpox and mpox disease in adults 18 years of age and older. The liquid-frozen formulation of JYNNEOS® was approved by the FDA in September 2019. It remains the only approved mpox vaccine anywhere in the world and the only non-replicating smallpox vaccine approved in the U.S. This formulation of JYNNEOS® has specific cold-chain requirements, while the freeze-dried formulation provides more flexibility in terms of transportation, storage conditions and shelf life, thus being more suitable for long-term stockpiling. The sBLA submission is based on clinical data from a Phase 3 lot consistency study and data from a Phase 2 study that showed bioequivalence between the freeze-dried and liquid-frozen formulations, as well as other clinical and non-clinical data, including process development and manufacturing data. Following a standard review time of 10 months for the sBLA, approval of the freeze-dried formulation could be obtained in the first quarter of 2025. “We are pleased to finalize this submission, marking a significant milestone in our development of this next generation of our smallpox/mpox vaccine and in our partnership with the U.S. government on developing a vaccine suited for addressing public health challenges, now and in the future. The licensure of this new formulation, which is ideally suited for long-term stockpiling, should ensure future orders beyond the current contract valued at almost USD 300 million with the U.S. government” said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. Bavarian Nordic has an ongoing contract with the U.S Biomedical Advanced Research and Development Authority (BARDA) valued at USD 299 million to supply a freeze-dried doses of JYNNEOS® for stockpiling. This contract allows the production of freeze-dried doses prior to the licensure of the formulation and the Company has started to manufacture vaccines under this contract in the first quarter of 2024, aiming to fulfil the first USD 119 million contract option during this year. This has already been included in the Company’s financial guidance for 2024, which therefore remains unchanged. Additional options valued at USD 180 million are pending exercise by BARDA. The bulk vaccine for manufacturing the freeze-dried vaccines were initially manufactured under previous contracts, however a significant part of this inventory was repurposed for manufacturing of liquid-frozen doses during the mpox outbreak in 2022-2023 and would thus need to be replaced via new orders to enable fulfilment of the remaining freeze-dried option. About the smallpox/mpox vaccineMVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is a non-replicating smallpox vaccine and the only mpox vaccine approved in the U.S. and Switzerland (marketed as JYNNEOS®), Canada (marketed as IMVAMUNE®), the EU/EAA and United Kingdom (marketed as IMVANEX®). Originally developed 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 adult population in individuals considered at risk for smallpox or mpox infection. Bavarian Nordic has been a long-term supplier of the vaccine to the U.S. and Canada, as well as numerous other countries as part of their national biological preparedness. During the 2022-2023 mpox outbreak, Bavarian Nordic has furthermore supported governments and supranational organizations by expanding access to the vaccine to more than 70 countries worldwide. Federal funding acknowledgementsThis project has been funded in whole or in part with federal funds from the HHS Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201700019C. 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. 17 / 2024 Attachment 2024-17-en

临床结果疫苗上市批准临床2期

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天花	临床3期	韩国	HK inno.N Corp.	2008-01-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00607243 (CTgov)	临床2/3期	天花	123	CJ-50300 (Conventional-dose Group)	糧糧壓積範鏇構構製獵(壓齋壓簾淵鬱齋壓願襯) = 齋製製襯網繭鹽範製範願蓋齋憲襯製窪窪觸繭 (願積觸願遞構願壓窪範, 壓窪積觸膚廠繭醖繭蓋 ~ 醖構製遞憲顧獵顧選淵) 更多	-	2013-07-09
				CJ-50300 (Low-dose Group)	糧糧壓積範鏇構構製獵(壓齋壓簾淵鬱齋壓願襯) = 鬱鏇鏇淵艱淵襯淵觸鹹願蓋齋憲襯製窪窪觸繭 (願積觸願遞構願壓窪範, 壓廠網襯選糧選觸糧構 ~ 顧襯夢淵鹽壓構壓衊鹽) 更多
NCT00607243 (Pubmed \| Vaccine)	临床2/3期	-	123	CJ-50300 vaccine	構鏇衊醖餘壓餘襯鹹積(繭網鑰製餘鹹鹹膚糧蓋) = one case of possible generalized vaccinia occurred in the conventionally dosed group 窪齋廠顧襯壓簾艱願夢 (鹽蓋憲糧鹽廠鑰衊鹹壓 )	-	2010-08-16
				Placebo