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.

开始日期2029-03-01

申办/合作机构

Womack Army Medical Center

[+1]

NCT07199569

/ Recruiting临床2期

A Randomized, Double-blind, Phase 2b Comparability Trial in Adults 18 to 49 Years of Age to Assess Immunogenicity, Safety, and Reactogenicity of the MVA-BN Vaccine Manufactured in Different Production Cells

andomized, double-blind, phase 2b trial to assess comparability in immunogenicity, safety, and reactogenicity of MVA-BN vaccine manufactured in primary chicken
embryo fibroblast (CEF) cells and the CCX.E10 quail cell line in adults

开始日期2025-10-27

申办/合作机构

Bavarian Nordic A/S

[+1]

NCT06844487

/ Recruiting临床3期IIT

Phase 3, Randomised Maternal and Infant (From 4 to 24 Months of Age) Safety and Immunogenicity Trial of MVA-BN® Vaccine in the Democratic Republic of the Congo

This Phase 3 double-blinded, randomized study aims to evaluate the safety and immunogenicity of the two-dose MVA-BN mpox vaccine regimen, administered subcutaneously, in infants and children aged 4 to 24 months in the Democratic Republic of the Congo (DRC), a population at high risk of mpox infection and complications. The study will compare the safety and immunogenicity of a full-dose regimen versus a half-dose regimen in this population. A hierarchical testing strategy will be applied as follows: first, non-inferiority of the full-dose regimen in infants/children (4-24 months old) will be evaluated against the full-dose regimen in adults from the POX-MVA-045 study. If non-inferiority is demonstrated, the immunogenicity of the half dose in infants/children (4-24 months old) will subsequently be tested for non-inferiority vs the full dose in adult. The trial will be conducted in Boende, Tshuapa Province, DRC.
The trial plans to enroll 344 male and female infants/children, who will be randomized to receive two doses of the MVA-BN vaccine administered 28 days apart. Participants in Child Group 1 (N=172) will receive the standard vaccine dose (0.5 mL), while those in Child Group 2 (N=172) will receive half the standard dose (0.25 mL), with both groups following the same dosing schedule.
This study builds on positive safety and immunogenicity data from prior trials that support the use of the standard dose regimen in younger children. However, considering the developmental differences in the immune systems of infants and young children/adolescents, it aims to evaluate whether a half-dose regimen can provide similar immunogenicity while potentially reducing reactogenicity. The findings will offer valuable insights into the optimal dosing strategy for this age group, balancing safety and immunogenicity to inform future vaccination recommendations.

开始日期2025-05-29

申办/合作机构

University of Antwerp

[+5]

100 项与天花和猴痘活疫苗(Bavarian Nordic A/S) 相关的临床结果

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100 项与天花和猴痘活疫苗(Bavarian Nordic A/S) 相关的转化医学

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100 项与天花和猴痘活疫苗(Bavarian Nordic A/S) 相关的专利（医药）

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231

项与天花和猴痘活疫苗(Bavarian Nordic A/S) 相关的文献（医药）

2026-01-01·VACCINE

Evaluation of the safety and immunogenicity of two fractional intradermal regimens of MVA-BN compared to standard dose vaccination

Article

作者: Martin, Thomas C S ; Oikonomopoulou, Zacharoula ; Rolsma, Stephanie L ; Creech, C Buddy ; Rouphael, Nadine G ; Davey, Richard T ; Whitaker, Jennifer A ; Desrosiers, Aimee ; Diemert, David J ; Baden, Lindsey R ; El Sahly, Hana M ; Watanabe, Amy ; Jaunarajs, Anna ; Tomashek, Kay M ; Lerner, Andrea ; Sherman, Amy C ; Moss, Bernard ; Frey, Sharon E ; Beigel, John H ; Little, Susan J ; Hoet, Bernard ; Rebolledo, Paulina A

INTRODUCTION:

Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine is being used to mitigate disease in the current global mpox outbreak, but a global vaccine shortage may limit large scale vaccination.

METHODS:

Participants were randomized 1:1:1 to receive two doses of MVA-BN administered 28 days apart: intradermal (ID) 2 × 10⁷ TCID₅₀ (2 × 10⁷ ID), ID 1 × 10⁷ TCID₅₀ (1 × 10⁷ ID), or standard dose subcutaneous (SC) 1 × 10⁸ TCID₅₀ (1 × 10⁸ ID). The primary objective was non-inferiority testing of each ID regimen compared to the standard SC regimen using vaccinia virus plaque reduction neutralizing titer assay (PRNT) geometric mean titers (GMT) at Day 43 (2 weeks post-second vaccination). Secondary objectives were non-inferiority testing of individual peak humoral immune responses, comparison of humoral immune responses, vaccinia virus-specific PRNT half-life (t_½), and safety.

RESULTS:

Day 43 non-inferiority by PRNT GMT was established for the 2 × 10⁷ ID regimen but not the 1 × 10⁷ ID regimen. The 2 × 10⁷ ID regimen was also non-inferior to the SC dose at Days 15 and 29, prior to the second dose; the 1 × 10⁷ ID regimen did not meet the non-inferiority criteria at any point post-vaccination. The three study regimens had similarly high seroconversion rates and similar anti-vaccinia PRNT half-lives. Most participants experienced injection site and systemic reactogenicity of moderate severity or less and only mild unsolicited adverse events (mostly skin discoloration and nodules at the injection site).

CONCLUSION:

The 2 × 10⁷ ID regimen, but not the 1 × 10⁷ ID regimen, was non-inferior to the SC regimen on Day 43. The study supports use of the 2 × 10⁷ ID regimen if needed.

CLINICALTRIALS:

govNCT05512949.

2025-12-31·Virulence

Mpox: Global epidemic situation and countermeasures

Review

作者: Luo, Yinghua ; Jin, Chenghao ; Hou, Wenshuang ; Tang, Yanjun ; Wu, Nan ; Liu, Yanzhi ; Quan, Quan

Mpox, is a zoonotic disease caused by the monkeypox virus and is primarily endemic to Africa. As countries gradually stop smallpox vaccination, resistance to the smallpox virus is declining, increasing the risk of infection with mpox and other viruses. On 14 August 2024, the World Health Organization announced that the spread of mpox constituted a public health emergency of international concern. Mpox's transmission routes and symptoms are complex and pose new challenges to global health. Several vaccines (such as ACAM2000, JYNNEOS, LC16m8, and genetically engineered vaccines) and antiviral drugs (such as tecovirimat, brincidofovir, cidofovir, and varicella immunoglobulin intravenous injection) have been developed and marketed to prevent and control this disease. This review aims to introduce the epidemic situation, epidemiological characteristics, physiological and pathological characteristics, and preventive measures for mpox in detail, to provide a scientific basis for the prevention and control of mpox viruses worldwide.

2025-11-01·SEXUALLY TRANSMITTED DISEASES

Clinical and Sociodemographic Factors Associated With Ocular Mpox in California, May 2022 to September 2023

Article

作者: Saadeh, Kayla ; Tang, Eric C ; Chapman, Eric ; Hanft, Wyatt ; Johnson, Kelly A ; Ramos, Marisa ; Watson, Jessica ; Snyder, Robert E

Background:

Inoculation of the eye with monkeypox virus can cause vision-threatening disease necessitating hospitalization and urgent treatment. Ocular mpox is poorly understood, including who is most affected.

Methods:

We performed a cross-sectional study comparing ocular and non-ocular mpox cases reported to the California Department of Public Health from May 1, 2022, to September 30, 2023. χ2 and t tests were used to compare between-group sociodemographic characteristics, HIV status, and vaccine status. Bivariate and multivariate logistic regressions adjusting for HIV and race/ethnicity were used to calculate odds ratios and 95% confidence intervals for the association between JYNNEOS vaccination and ocular mpox.

Results:

Of 5878 mpox infections, 2403 (40.9%) had complete ocular symptom reporting and were included in this analysis. Of these, 260 (10.8%) were ocular cases. Among the 2403 included cases, most were cisgender men (94.6%) and reported male-to-male sexual contact (72.0%). The proportion of non-ocular versus ocular mpox cases differed significantly by race/ethnicity and HIV status (P < 0.05), with more ocular cases being Hispanic/Latinx (50.8% vs. 41.8%), Black (14.2% vs. 8.9%), and with HIV (50.8% vs. 40.4%). After adjusting for race/ethnicity and HIV status, people with ≥1 dose of JYNNEOS had approximately half the odds of having ocular symptoms compared with people who were unvaccinated (adjusted odds ratio, 0.52; 95% confidence interval, 0.24–0.97).

Conclusions:

A higher proportion of Black, Latinx, or people living with HIV had ocular mpox symptoms, suggesting that these groups may benefit from focused interventions to prevent infection and this complication. JYNNEOS before mpox exposure may protect against ocular complications, stressing the importance of vaccination to prevent severe sequelae, especially for vulnerable populations.

396

项与天花和猴痘活疫苗(Bavarian Nordic A/S) 相关的新闻（医药）

2025-12-17

·雪球

$智飞生物(SZ300122)$$生物医药ETF(SZ159859)$$创业板ETF(SZ159915)$猴痘疫苗

$智飞生物(SZ300122)$$生物医药ETF(SZ159859)$$创业板ETF(SZ159915)$猴痘疫苗，目前的市场格局和中国的情况比较特殊。结合最新的行业动态和当前时间点（2025年12月），我整理了以下详细信息：1.主要供应商目前全球范围内的供应商只有一家：*巴伐利亚北欧公司(BavarianNordic)：这家丹麦公司生产的Jynneos（在美国的名称）/Imvanex（在欧洲的名称）是目前全球唯一被FDA和EMA批准专门用于预防猴痘的疫苗。它是一种非复制型天花疫苗，安全性相对较高。2.中国市场（目前尚无正式上市销售）这是一个非常关键的现状：截至目前（2025年12月），中国国内尚无专门的猴痘疫苗正式获批上市并产生销售。*替代方案：在此之前，中国主要依靠储备的天花疫苗（如天坛株等）作为战略储备，用于紧急情况下的暴露后预防，但这不属于常规的“猴痘疫苗”销售范畴。*最新突破（刚刚起步）：就在今天（2025年12月17日），智飞生物自主研发的“注射用重组猴痘病毒亚单位疫苗（CHO细胞）”刚刚获得国家药监局（NMPA）的临床试验申请受理。这意味着国产疫苗刚刚迈出上市的关键一步。🛡️这个疫苗有什么意义？猴痘疫苗的意义不仅在于医学防护，更在于国家战略安全和公共卫生防御体系的完善。1.医学防护意义：精准阻断与降低重症*预防感染与阻断传播：猴痘主要通过密切接触传播（包括性接触、飞沫等）。疫苗能有效刺激人体产生针对猴痘病毒的抗体，建立免疫屏障，从而阻断病毒在人群中的传播链。*降低重症风险：虽然猴痘多为自限性疾病（症状自行消失），但对于新生儿、儿童、孕妇及免疫缺陷人群，可能导致严重并发症甚至死亡。疫苗能显著降低这些高危人群的重症率和死亡率。2.公共卫生战略意义：应对突发与补齐短板*应对“国际关注的突发公共卫生事件”：世界卫生组织（WHO）曾多次宣布猴痘疫情为PHEIC。拥有有效的疫苗是各国政府应对突发疫情、保护医护人员和高风险人群的最核心手段。*填补国产空白（中国视角）：过去，全球只有欧美企业的疫苗。中国目前多家企业（如智飞生物）加速研发，是为了打破国外垄断。一旦国产疫苗上市，将确保我们在面对猴痘威胁时，拥有自主可控的供应能力，不再受制于进口供应链。3.经济与社会意义：减少医疗负担*有效的疫苗接种可以减少因患病导致的误工、隔离和医疗支出，避免疫情大规模爆发对社会经济运行造成冲击。📊总结：年销售额：十亿美元级别(主要来自欧美政府采购)主要意义：控制社区传播，保护高危人群战略储备，未来填补国内空白，应对潜在输入风险一句话总结：目前全球只有丹麦一家公司主要在卖，但就在今天，智飞生物的国产疫苗终于迈出了上市的关键一步，这对于未来我们应对这种病毒有着重大的“从无到有”的战略意义。

2025-12-12

·E苗工坊

营销信息｜疫苗行业资讯周刊（50）

欧林生物冲刺港股IPO 百克生物斩获上市公司金牛奖 “金信披奖” 数字信息干预促进流感疫苗接种的有效性评估：一项中国集群随机试验世卫组织：流感疫苗仍能有效预防住院，对旅行者至关重要猴痘仍构成全球健康风险，多国持续报告病例且疫苗可预防默沙东2批次口服五价轮状病毒疫苗获中国药检院签发北京科兴旗下3批次Sabin株脊髓灰质炎灭活疫苗获北京药检院予以签发全球首款尼帕病毒疫苗II期临床试验在孟加拉国启动新型癌症疫苗1期临床，复发或死亡风险降低86% 四川造！全球首个！通用型EB病毒治疗性细胞疫苗技术成功应用重组呼吸道合胞病毒疫苗（CHO细胞）开展I/II期临床试验鼻喷重组呼吸道合胞病毒疫苗（5型副流感病毒载体）-SAX201开展成人I期临床试验成都所的冻干人用狂犬病疫苗（2BS细胞）申报上市中慧生物冻干人用狂犬病疫苗（人二倍体细胞）的III期临床试验 01# 官方信息欧林生物冲刺港股IPO 2025年12月9日，成都欧林生物科技股份有限公司向港交所主板递交上市申请，中信证券为独家保荐人，若成功将成 “A+H” 两地上市疫苗企业。欧林生物聚焦 “超级细菌疫苗” 与 “成人疫苗” 领域，2022-2024年及 2025 年上半年收入分别为 5.47 亿、4.94 亿、5.86 亿、3.05 亿元，同期利润分别为 2657.6 万、1144.2 万、1571.9 万、1323.1 万元。其吸附破伤风疫苗为营收支柱，2024 年销售额 5.36 亿元占比超九成，2022-2024 年批签发市场份额超 80%。百克生物斩获上市公司金牛奖 “金信披奖” 2025年12月6日，中国证券报主办的2025科创投资大会暨上市公司金牛奖（金信披奖）颁奖典礼在安徽合肥举行，百克生物凭信息披露、公司治理及投资者关系管理方面的出色表现，获 “金信披奖”。该奖项是资本市场权威评选，聚焦信息披露等领域，选治理规范、信披优秀企业。百克生物重视信披质量，依规通过多渠道传动态、多形式沟通，获此奖是肯定。未来，其将夯实信披基础、提升治理效能，同时完善疫苗产品管线，增强竞争力与股东回报能力。 02# 最新文献数字信息干预促进流感疫苗接种的有效性评估：一项中国集群随机试验本文由侯志远、郝利新等发表于 npj Digital Medicine，旨在评估基于行为科学理论设计的数字化信息推送（nudges）干预对中国6–35月龄儿童流感疫苗接种率的提升效果。研究于2024–2025流感季在中国杭州市开展，采用务实性、六臂集群随机对照试验。研究将36个社区卫生服务中心按经济发展水平分层后，随机分配至6个组：标准信息组、收益框架-统计证据组、收益框架-叙事证据组、损失框架-统计证据组、损失框架-叙事证据组，以及无信息对照组，最终共纳入2011名符合条件的儿童家长。干预信息由社区医生通过微信群推送，信息设计上比较了“信息框架（收益型 vs. 损失型）”与“证据类型（统计型 vs. 叙事型）”的独立与联合效应。主要结局为干预后5个月内儿童与家长的实际流感疫苗接种情况，数据来自官方免疫规划信息系统。结果显示，在儿童接种方面，损失框架结合叙事证据的干预效果最为显著且持久，其接种率（24.0%）显著高于对照组（9.4%），调整后风险比为2.50（95%CI：1.27–4.94），且该效果在5个月随访期内持续存在；损失框架结合统计证据仅在干预后第1个月内有效（接种率16.9%，RR=2.73; 95% CI: 1.50–4.99），但效果随时间迅速衰减。标准信息、收益框架结合统计或叙事证据的干预均未显著提升儿童接种率。分层分析显示，损失框架结合叙事证据在多数人口学分组中均显著有效，在高经济水平地区效果尤为突出（RR=5.56）。该干预对家长自身接种行为的影响有限，仅在既往未接种过流感疫苗的家长中观察到轻微提升。时序分析进一步证实，损失框架结合叙事证据能显著且持续地促使家长更早为孩子接种流感疫苗，其促接种效果在整个5个月的流感季内均保持显著。研究指出，损失框架、情境化的叙事证据比统计证据更能触发情绪共鸣与风险感知，持续影响接种行为，符合前景理论与叙事沉浸理论的行为机制预期。研究证实，通过微信平台推送基于损失框架和叙事化证据的数字化行为干预在儿童流感疫苗接种中具有可行性与可扩展性。 03# 国际新闻世卫组织：流感疫苗仍能有效预防住院，对旅行者至关重要近日，世界卫生组织（WHO）发布《季节性流感全球形势》疫情通报，指出北半球自10月起流感活动增强，甲型流感病毒占主导。截至12月10日，初步估计流感疫苗仍能保护儿童和成人免于住院，但对当前季节临床疾病的有效性尚不明确。世卫组织表示，即便流行病毒与疫苗毒株存在基因差异，疫苗仍可能对变异病毒及所含其他毒株起效，且仍是预防重症的重要手段，其正持续监测流感活动并支持各国监测工作。世卫组织与美国疾控中心强调疫苗对国际旅行者关键，尤其高风险人群及照护者；美国路易斯安那州等近期流感病例已上升。猴痘仍构成全球健康风险，多国持续报告病例且疫苗可预防 2025年12月8日，世界卫生组织（WHO）发布猴痘多国疫情第60期情况报告，梳理2022年5月首录疫情后的全球流调情况与最新数据。报告指出，截至当日猴痘病毒所有进化枝仍在传播，若疫情未快速控制、人际传播未阻断，恐出现社区持续传播。2025年10月，世卫各区域44国报告2501例新增确诊病例（含12例死亡，病死率 0.5%），约75%病例来自非洲区域；非洲以外，多国存在特定进化枝本地传播或输入病例。美国疾控中心称猴痘可通过疫苗预防，接种两剂 JYNNEOS 疫苗保护效果最佳，且无论是否接种，均需持续降低感染风险。 04# 临床及批发签默沙东2批次口服五价轮状病毒疫苗获中国药检院签发 12月10日，据国家药监局旗下中国食品药品检定研究院生物制品批签发公示，2025 年 12月1日至7日，Merck Sharp & Dohme LLC（默沙东相关企业）的2批次口服五价重配轮状病毒减毒活疫苗（Vero 细胞）通过检验并获签发。数据来源为该研究院批签发产品公示汇总。风险提示：市场有风险，投资需谨慎，本文信息仅作参考，不构成投资建议，数据真实性与完整性无法核验，具体以公司公告为准。北京科兴旗下3批次Sabin株脊髓灰质炎灭活疫苗获北京药检院予以签发 12月9日消息，国家药品监督管理局旗下北京市药品检验研究院披露的生物制品批签发产品公示情况显示，2025年11月16日至2025年11月22日，北京市药品检验研究院共批签发5批次Sabin株脊髓灰质炎灭活疫苗（Vero细胞）其中北京科兴生物制品有限公司 SINOVAC BIOTECH CO., LTD.获批3批次；北京生物制品研究所有限责任公司获批2批次。全球首款尼帕病毒疫苗II期临床试验在孟加拉国启动牛津大学今日宣布与国际腹泻病研究中心合作，在孟加拉国启动全球首个尼帕病毒候选疫苗 II 期临床试验。试验由相关联盟资助，评估疫苗安全性与免疫反应，疫苗由印度血清研究所生产。尼帕病毒致死率达75%，与麻疹同属副黏病毒科，世卫组织因其大流行潜力列为研究重点，1998年以来录得750例、415例死亡，孟加拉国常暴发，印度自 2001年已暴发7次。研究负责人称，此试验对确保疫苗有效且惠及需保护人群意义重大。新型癌症疫苗1期临床，复发或死亡风险降低86% 肠癌、胰腺癌因 KRAS 突变率高且难靶向治疗，患者术后复发风险大。新型疫苗 ELI-002-2P借助 “双亲性” 尾巴结合白蛋白，精准送达淋巴结激活免疫。1期临床25名高危患者中，17位强响应者随访约 20 个月，11位无进展，整体复发或死亡风险较8位弱响应者降低 86%。该 “现货型” 疫苗成本或更低，虽处早期阶段，但为 KRAS 突变癌症防复发提供新方向。四川造！全球首个！通用型EB病毒治疗性细胞疫苗技术成功应用 11月21日，四川大学华西乐城医院成功为一名EB病毒感染患者完成全球首个通用型“抗EB病毒感染的细胞疫苗治疗技术”的首次治疗。患者治疗后状态良好，无明显不适反应。该项目的成功落地，为EB病毒感染治疗带来全新突破。该技术作为全球首个针对EB病毒感染的治疗性疫苗方案，采用皮下注射方式，安全性好、临床使用便捷。其通过激活患者自身免疫功能，诱导产生针对EB 病毒抗原的特异性杀伤T细胞，进而清除EB病毒阳性肿瘤细胞及病毒感染细胞。目前该技术产品已获美国食品药品监督管理局（FDA）授予的孤儿药资格认定。此次成果落地，填补了国内 EB病毒感染针对性治疗的空白，为EB病毒感染患者提供了治疗选择。这一成果从研发、转化、生产到临床应用，充分彰显了华西医学在生物治疗领域的全链条创新能力，为推动我国精准医疗发展、提升EB病毒感染相关疾病治疗水平、切实惠及广大患者提供了坚实支撑，也为助力华西医学整体率先迈入世界一流、我国生物医药产业高质量发展注入强劲动力。重组呼吸道合胞病毒疫苗（CHO细胞）开展I/II期临床试验怡道生物科技（苏州）有限公司重组呼吸道合胞病毒疫苗（CHO细胞）开展I/II期临床试验，登记号CTR20254873。 Ⅰ期试验目的主要目的：评价不同剂量重组呼吸道合胞病毒疫苗（CHO细胞）在18岁及以上人群接种的安全性和耐受性。次要目的：初步探索不同剂量重组呼吸道合胞病毒疫苗（CHO细胞）在18岁及以上人群接种的免疫原性。 Ⅱ期试验目的主要目的：评价不同剂量重组呼吸道合胞病毒疫苗（CHO细胞）在60岁及以上人群接种的免疫原性。次要目的：评价不同剂量重组呼吸道合胞病毒疫苗（CHO细胞）在60岁及以上人群接种的安全性。鼻喷重组呼吸道合胞病毒疫苗（5型副流感病毒载体）-SAX201开展成人I期临床试验根据CDE临床试验登记平台最新显示，广州思安信生物技术有限公司鼻喷重组呼吸道合胞病毒疫苗（5型副流感病毒载体）-SAX201开展成人I期临床试验（登记号CTR20254869）；据悉，该产品基于公司5型副流感病毒(PIV5)载体技术平台。PIV5作为病毒载体，具有相比Adv、MVA等传统病毒疫苗载体的药学优势成都所的冻干人用狂犬病疫苗（2BS细胞）申报上市根据CDE最新2025年12月06日公示，成都所的冻干人用狂犬病疫苗（2BS细胞）申报上市，受理号CXSS2500134，注册分类3.3类。中慧生物冻干人用狂犬病疫苗（人二倍体细胞）的III期临床试验中慧生物-B发布公告，宣布公司近期启动了冻干人用狂犬病疫苗（人二倍体细胞）的III期临床试验。这一疫苗的开发旨在针对三种免疫方案，2022年11月已获得中华人民共和国国家药品监督管理局批准的新药临床试验许可，并于2023年4月获批Zagreb（四针）和简易四针方案的补充临床试验申请。公司于2024年10月完成该在研疫苗的I期临床试验。好内容请转发，让更多精进成长的人获益。疫苗营销新视界，成长精进在工坊

疫苗IPO财报临床2期

2025-12-02

·GlobeNewswire-Health Care

Bavarian Nordic to Launch Share Buy-back Program of up to DKK 500 Million

COPENHAGEN, Denmark, December 2, 2025 – Bavarian Nordic A/S (OMX: BAVA) today announced its intent to launch a one-time share buy-back program of up to DKK 500 million to be executed over the next 12 months. This decision should be viewed in the context of a current strong cash position, resulting from the recent sale of the Priority Review Voucher and a continued positive cash flow from operations. As of September 30, 2025, securities, cash and cash equivalents were DKK 2,978 million, of which approximately DKK 800 million constitute deferred payments to GSK (last milestone payment) and royalty plus tax related to the sale of the Priority Review Voucher, all payable in the near future. For the time being the Company finds the cash balance post the buy-back program adequate to maintain flexibility and run the business in an uncertain world. Bavarian Nordic intends to hold the shares bought back as treasury stock, for the purpose of adjusting the capital structure. The share buy-back program will be carried out in accordance with the authorization granted by the general meeting of shareholders to the Board of Directors and will be subject to safe harbour regulations. Additional details, including the key terms of the program will be provided upon the final decision of the Board of Directors to launch the program. Bavarian Nordic currently holds 966,845 shares as treasury shares, corresponding to 1.22% of the company’s share capital, part of which will be used to fulfil the company’s obligations relating to the Company’s long-term share-based incentive programs for the Board of Directors and Executive Management. 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. Contact investors:Europe: Disa Tuominen, IR Manager, detu@bavarian-nordic.com US: Graham Morrell, Gilmartin Group, graham@gilmartinir.com, Tel: +1 781 686 9600 Contact media:Nicole Seroff, Vice President Corporate Communications, nise@bavarian-nordic.com, Tel: +45 53 88 06 03 Company Announcement no. 45 / 2025 Attachment Bavarian Nordic to Launch Share Buy-back Program of up to DKK 500 Million

疫苗优先审批

100 项与天花和猴痘活疫苗(Bavarian Nordic A/S) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	天花和猴痘活疫苗(Bavarian Nordic A/S)	J07BX	DB15483

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
猴痘	欧盟	Bavarian Nordic A/S	2013-07-31
猴痘	冰岛	Bavarian Nordic A/S	2013-07-31
猴痘	列支敦士登	Bavarian Nordic A/S	2013-07-31
猴痘	挪威	Bavarian Nordic A/S	2013-07-31
天花	欧盟	Bavarian Nordic A/S	2013-07-31
天花	冰岛	Bavarian Nordic A/S	2013-07-31
天花	列支敦士登	Bavarian Nordic A/S	2013-07-31
天花	挪威	Bavarian Nordic A/S	2013-07-31
牛痘病毒感染	欧盟	Bavarian Nordic A/S	2013-07-31
牛痘病毒感染	冰岛	Bavarian Nordic A/S	2013-07-31
牛痘病毒感染	列支敦士登	Bavarian Nordic A/S	2013-07-31
牛痘病毒感染	挪威	Bavarian Nordic A/S	2013-07-31

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临床结果

适应症

分期

评价

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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


NCT05512949 (NEWS) 人工标引	临床2期	猴痘	229	MVA-BN (aged between 12 and 17 years)	齋襯築襯憲範壓窪廠觸(鏇願製構鑰選鏇鏇範願) = After two doses, antibody levels were found to be equivalent at day 43 to those in adults aged 18 to 50 years. 構顧築醖觸築觸壓蓋襯 (鏇範築選鬱蓋繭遞淵選 ) 更多	积极	2024-10-17
Literature 人工标引	N/A	猴痘	45	MVA-BN 2 doses	鏇遞鑰願簾鑰繭鹽獵蓋(鏇壓觸構淵遞顧淵繭範) = 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 網鹹廠糧鬱夢鹹衊夢糧 (衊鹹鏇鏇衊膚夢鏇衊憲 )	不佳	2024-10-03
				MVA-BN 1 doses
NCT05740982 (NEWS) 人工标引	临床2期	埃博拉病毒性疾病	526	IMVANEX (adolescents 12-17 years of age)	鬱夢鏇觸襯範鹹範糧顧(壓淵壓廠蓋醖窪蓋範糧) = a similar safety profile between both age groups 餘製憲窪構繭餘餘壓鑰 (構鏇繭遞醖繭簾築觸鏇 ) 更多	积极	2024-09-19
				IMVANEX (adults aged 18 years and older)
NCT05512949 (CTgov)	临床2期	猴痘	229	MVA-BN (2 x 10^7 ID MVA-BN)	鏇窪製選廠製積鏇壓艱(廠餘餘餘鏇鹹鑰築淵糧) = 衊積獵遞艱鹽壓淵廠選鹽廠築憲廠範憲築蓋襯 (構鹽獵衊鹹艱憲築醖積, 鏇壓網鏇醖壓衊衊範餘 ~ 襯窪夢膚鹽鬱窪觸鹽齋) 更多	-	2024-01-09
				MVA-BN (1 x 10^7 ID MVA-BN)	鏇窪製選廠製積鏇壓艱(廠餘餘餘鏇鹹鑰築淵糧) = 淵觸淵鹹襯襯繭鏇淵獵鹽廠築憲廠範憲築蓋襯 (構鹽獵衊鹹艱憲築醖積, 艱獵遞餘構鏇鑰鬱積築 ~ 願膚窪簾製襯廠憲鏇餘) 更多
NCT03699124 (Pubmed) 人工标引	临床3期	-	1,129	MVA-BN	簾窪窪鹽窪遞艱繭窪鬱(築簾鏇繭選築顧鑰壓廠) = 網壓夢遞壓積簾壓鏇網鏇築觸醖顧廠積夢鹽鏇 (衊鏇獵遞積鹽糧壓選餘 ) 更多	积极	2022-11-29
NCT03699124 (CTgov)	临床3期	天花	1,129	FD MVA-BN (GP 1: Two Doses of FD MVA-BN--Lot 1)	範廠鏇鏇膚衊簾繭廠夢(淵壓網淵襯範衊淵觸夢) = 築餘憲淵繭廠鏇憲壓廠壓製鹹鑰積遞餘範鏇鹽 (窪齋選觸齋顧膚膚壓顧, 餘鬱遞遞糧鏇鹽鹽膚選 ~ 壓構壓艱鹹鏇鹹鏇顧觸) 更多	-	2021-05-27
				FD MVA-BN (GP 2: Two Doses of FD MVA-BN--Lot 2)	範廠鏇鏇膚衊簾繭廠夢(淵壓網淵襯範衊淵觸夢) = 構顧簾顧衊觸願餘憲蓋壓製鹹鑰積遞餘範鏇鹽 (窪齋選觸齋顧膚膚壓顧, 構繭鹽鹹壓壓願鹹鏇糧 ~ 窪壓鑰鹽衊廠積觸糧淵) 更多
NCT01668537 (CTgov)	临床2期	天花	651	LF (LF Formulation)	夢膚製廠網範製襯壓蓋(鏇淵製繭製壓繭鬱窪選) = 鑰艱糧願餘膚窪顧醖鹹觸範鹽築簾糧壓願餘顧 (廠築鬱夢蓋鑰鏇醖夢積, 壓選齋觸鏇壓鹹網齋鬱 ~ 鏇製艱鏇網範鹹夢構顧) 更多	-	2020-10-12
				MVA-BN (FD Formulation)	夢膚製廠網範製襯壓蓋(鏇淵製繭製壓繭鬱窪選) = 窪選構範遞構窪壓夢襯觸範鹽築簾糧壓願餘顧 (廠築鬱夢蓋鑰鏇醖夢積, 壓齋餘夢製製淵艱遞觸 ~ 鑰範構願夢襯淵廠鑰鬱) 更多
NCT03472014 (CTgov)	临床4期	-	22	MVA-BN	觸憲衊遞衊壓鏇觸窪積 = 淵齋願簾憲鑰鏇淵鑰膚淵鏇糧獵窪製遞壓膚觸 (鹹醖夢顧壓餘壓餘選膚, 糧選壓遞鬱構選構顧淵 ~ 選膚憲膚觸鹽觸構衊網) 更多	-	2020-08-19
NCT01913353 (Pubmed \| Br Dent J \| N Engl J Med) 人工标引	临床3期	天花	433	modified vaccinia Ankara+ACAM2000	餘顧夢積淵衊壓積廠獵(鬱糧膚窪獵選壓鑰夢簾): RO = 97.9 (95% CI, 96.6 ~ 98.3) 更多	优效	2019-11-14
				ACAM2000
NCT00686582 (CTgov)	临床2期	天花	304	IMVAMUNE (Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose)	窪製遞顧齋膚餘築窪憲 = 鏇築鑰鏇遞鹽壓範鏇醖鹹鏇觸蓋齋淵鹽蓋艱願 (鏇觸鏇艱範選廠獵鑰鬱, 鑰簾範獵鏇糧鏇鑰膚夢 ~ 鏇網鹹網遞網淵餘築窪) 更多	-	2019-02-18
				IMVAMUNE (Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose)	窪製遞顧齋膚餘築窪憲 = 範醖獵簾壓憲夢製膚鹽鹹鏇觸蓋齋淵鹽蓋艱願 (鏇觸鏇艱範選廠獵鑰鬱, 憲鹹製觸壓鹹遞膚艱築 ~ 鬱齋繭築遞蓋鬱鑰窪願) 更多