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]

CTIS2024-518007-22-00

/ Recruiting临床3期

A Phase III Randomised, Open Label Trial of an Intradermal or Subcutaneous booster dose of MVA-BN Vaccine to Investigate MPXV Immunogenicity and Safety for Protection Against Mpox in an Intradermally or Subcutaneously Primary Vaccinated Population – an adaptive protocol and a Non-Randomised Trial of a Subcutaneous Booster Dose for Subcutaneously Primary Vaccinated

开始日期2025-12-05

申办/合作机构-

NCT07199569

/ Active, not 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

Randomized, 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]

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

2026-08-03·JOURNAL OF INFECTIOUS DISEASES

A Humoral Dilemma: Reassessing Monkeypox Virus Neutralizing Antibodies at More Than 2 Years From Mpox or Modified Vaccinia Ankara-Bavarian Nordic Vaccination

Article

作者: Raccagni, Angelo Roberto ; Moschetta, Nicolò ; Capra, Nicolò ; Lolatto, Riccardo ; Castagna, Antonella ; Nozza, Silvia ; Loi, Gabriele ; Canetti, Diana ; Clementi, Nicola ; Criscuolo, Elena

Abstract:

Background:

The persistence of immunological memory after immunization against monkeypox virus (MPXV) is unclear. This study assessed MPXV-specific neutralizing antibodies (nAbs) at > 2 years from mpox or Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccination.

Methods:

Retrospective study including individuals with previous mpox or vaccination with MVA-BN, whose MPXV-specific nAb titers were already assessed at 6 months from either event at our center. Neutralizing titers were determined at > 2 years from mpox or vaccination by plaque reduction neutralization test (positive ≥ 1:10) as the maximum dilution with reduction of cytopathic effect of 90% and 50% (IC90 and IC50). Groups were compared using χ2 test, Fisher exact test, or Wilcoxon rank-sum test. Association between titers at > 2 years and individuals characteristics was evaluated with ordinal logistic regression.

Results:

Overall, 48 individuals with previous mpox and 42 vaccinees were included, all were men. At > 2 years from mpox or vaccination, 22 of 90 (24.44%) and 53 of 90 (58.8%) had positive nAb titers, respectively, at IC90 and IC50. At IC50 previous mpox was associated with positive titers (68.75% vs 47.62%; P = .042), with univariate analysis associating higher titers at 6 months to higher titers at > 2 years (odds ratio [OR] = 6.45; 95% confidence interval [CI], 1.89–22.07; P = .003). In multivariate analysis, historical smallpox vaccination was associated with higher titers at > 2 years (OR = 5.37; 95% CI, 1.31–22.00; P = .020), whilst previous mpox was marginally associated (OR = 2.08; 95% CI, .94–4.62; P = .073).

Conclusions:

This was a retrospective study including individuals with previous mpox or vaccination with MVA-BN whose MPXV-specific nAb titers were already assessed at 6 months from either event. MPXV-specific nAbs waned at > 2 years from previous infection or vaccination, often becoming undetectable. Higher nAb titers at 6 months (univariate) and prior smallpox vaccination (multivariate) were associated with nAb detection at > 2 years, whilst previous mpox was marginally associated.

2026-08-01·VACCINE

Protocol for a phase 3, randomized, double-blind clinical trial evaluating the safety and immunogenicity of the MVA-BN® vaccine against mpox in children aged 4 to less than 24 months in the Democratic Republic of the Congo: Data to guide future paediatric vaccination strategies

Article

作者: Tshilumba, Solange Milolo ; Muteba, Dominique ; Kimbulu, Primo ; Muhindo-Mavoko, Hypolite ; Van Geertruyden, Jean-Pierre ; Lemey, Gwen ; Mitashi, Felly ; Azoum, Mahmoud Abu ; Kasereka, Gustave ; Jordan, Elke ; Salloum, Maha ; Bisumba, Aurelie ; Mitashi, Patrick ; Bikioli, Freddy ; Matuvanga, Trésor Zola ; Larivière, Ynke ; Ruiz, Paulina Morales ; Maketa, Vivi ; Van Damme, Pierre

INTRODUCTION:

This article describes the protocol of the PregInPoxVac vaccine trial, evaluating the safety and immunogenicity of two MVA-BN vaccination regimens (full-dose and half- dose) administered subcutaneously with a 28-day interval in infants aged 4 to <24 months old. Non-inferiority of the full dose and half dose regimens will be compared to adults receiving a full dose regimen as part of the POX-MVA-045 study (ClinicalTrials.govIdentifier:NCT06549530). The PregInPoxVac study is being conducted in Boende, Tshuapa Province, Democratic Republic of the Congo (DRC), a mpox-endemic area; the POX-MVA-045 study is being conducted in Kinshasa, DRC, and Entebbe, Uganda. This is a randomized, double-blind, phase 3 trial assessing two dosing regimens in infants, with immunogenicity and safety compared to a predefined adult reference dataset.

METHODS:

This is a phase 3, randomized, double-blind vaccine trial. A total of 344 healthy children aged 4 to <24 months will be enrolled at the Boende General Referral Hospital in the DRC. Participants will be randomized in a 1:1 ratio to receive either two full doses (0.5 mL) or two half doses (0.25 mL) of the MVA-BN® vaccine, administered subcutaneously 28 days apart. The primary objective is to evaluate the immunogenicity and safety of the paediatric vaccination regimen compared to the reference adult regimen, as defined in the POX-MVA-045 vaccine trial. Immunogenicity will be assessed through a hierarchical non-inferiority analysis of neutralizing antibody responses comparing full-dose and half-dose regimens in infants with the full-dose adult reference cohort. As a secondary analysis, the immunogenicity and safety observed in full dose infants will be compared to half dose infants. Additionally, total binding antibodies against vaccinia will also be compared between infants and adults as a secondary objective. Solicited adverse events (AEs) will be recorded for 7 days following each injection or until resolution of the event. Unsolicited AEs will be recorded for 28 days following each injection or until resolution of the event. Medically attended AEs (MAAEs), AEs of special interest (AESIs), serious AEs (SAEs) will be recorded from signing of the informed consent through 12 months after the second dose. Participant enrolment was conducted between 29 May and 30 October 2025.

ETHICS AND DISSEMINATION:

The protocol was approved by the Antwerp University Hospital Committee for Medical Ethics (Approval No. 2025-7480), the National Health Ethics Committee of the DRC Ministry of Health (CNES) (Approval No. 641/CNES/BN/PMMF/2025) and by the Congolese Pharmaceutical Regulatory Authority (ACOREP:Approval No. 556/ACRP/DG/CAB/D15/2025). The trial has been registered on ClinicalTrials.gov (Identifier: NCT06844487).Written informed consent will be obtained from all parents or legal guardians prior to any study-related procedures being performed. The results will be published in peer-reviewed scientific journals and presented at national and international conferences.

2026-07-30·Eurosurveillance

Vaccine safety surveillance during an mpox outbreak, Germany, June 2022 to February 2024

Article

作者: Streit, Renz ; Oberle, Doris ; Koppe, Uwe ; Jansen, Klaus ; Lachmann, Raskit ; Hofmann, Alexandra

BACKGROUND:

In May 2022, first cases of mpox clade IIb were detected in Germany, and MVA-BN vaccine was available from June 2022 onwards. Vaccination has been recommended by the Standing Committee on Vaccination (STIKO) since June 2022 to contain monkeypox virus infection and prevent disease.

AIM:

Our primary aim was to evaluate the safety of the mpox vaccine Jynneos (modified Vaccinia Ankara, Bavaria-Nordic, MVA-BN) after the rollout of the vaccination campaign in Germany from June 2022 to February 2024; a secondary aim was to describe mpox cases and vaccinations.

METHODS:

To identify cases and persons with adverse events following immunisation (AEFIs), we used existing surveillance systems. A voluntary system was implemented in June 2022 to monitor mpox vaccination. We performed a descriptive analysis of cases, vaccinations, individual case safety reports (ICSRs) and AEFIs.

RESULTS:

Until 29 February 2024, 3,807 mpox cases were notified (data retrieved July 2024). According to the voluntary mpox vaccination monitoring, a total of 78,739 mpox vaccine doses of Jynneos were administered. A search of the national AEFI database identified 32 ICSRs, of which seven were serious. A total of 87 AEFIs were reported, most of which were local or systemic reactions that are generally associated with vaccination. The overall adverse event reporting rate adjusted for missing information on vaccine utilisation in one of 16 federal states was 98.7 adverse events per 100,000 doses.

CONCLUSION:

The safety profile of the MVA-BN vaccine was in line with the summary of product characteristics. No new safety signals were identified.

420

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

2026-08-21

·BioSpace

Bavarian Nordic Reports Strong First Half 2026 Results

COPENHAGEN, Denmark, August 21, 2026 – Bavarian Nordic A/S (OMX: BAVA) announced today its interim financial results and business progress for the second quarter and first half of 2026 and released its financial calendar for 2027. Financial highlights Revenue in the second quarter (Q2) increased by 23% to DKK 2,034 million. Travel Health revenue increased by 45% (56% when adjusting for discontinued partnerships) to DKK 1,022 million, primarily driven by continued strong RabAvert/Rabipur sales (DKK 649 million, +55%), as well as strong Encepur sales (DKK 268 million, +58%) and the continued launch of Vimkunya (DKK 37 million, +415%). Public Preparedness revenue increased by 6% to DKK 975 million driven by a stronger-than-expected contract base in 2026, while also reflecting the normal quarterly phasing of revenue from this business. EBITDA in the second quarter (Q2) was DKK 925 million, corresponding to an EBITDA margin of 45%. Gross margin reached 61% driven by an advantageous product mix and strong manufacturing performance. First half (H1) total revenue was DKK 3,092 million, an increase of 3%, reflecting the strong growth in Travel Health, offset by lower Public Preparedness revenue in line with expectations (no material impact from mpox outbreaks expected in 2026). EBITDA in the first half was DKK 1,090 million, corresponding to an EBITDA margin of 35%. Updated full-year guidance The Company has upgraded its full-year guidance for 2026 and now expects revenue of approximately DKK 5,700 million, corresponding to the upper end of the previous guidance range (DKK 5,500 – 5,700 million). The EBITDA margin is now expected to reach approximately 30% (previously approximately 28%). Share buy-back The planned share buy-back program of DKK 500 million was completed in July. The company will initiate another share buy-back program in 2026 of up to DKK 750 million, reflecting the strength of the Company’s balance sheet and cash generation while preserving the ability to pursue value-accretive acquisition opportunities. DKK million Q2 2026 Q2 2025 H1 2026 H1 2025 2026 Guidance Revenue 2,034 1,652 3,092 2,998 ~5,700 EBITDA margin 45% 33% 35% 32% ~30% Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: “We delivered a strong first half of 2026, with record Travel Health revenue, continued robust profitability and solid execution across our manufacturing network. Demand for our rabies vaccines remained exceptionally strong across key markets, while our chikungunya vaccine continued to gain traction in Europe following multiple launches during the period. In Public Preparedness, additional government contracts for our mpox/smallpox vaccine strengthened our revenue base and enhanced visibility beyond 2026, while further regulatory progress broadened the potential use of the vaccine across wider populations. Based on our first-half performance, operational momentum and the business secured for the remainder of the year, we remain confident in delivering our upgraded financial guidance for 2026.” Business highlights for the second quarter Additional regulatory approvals were obtained for the Vimkunya chikungunya vaccine in Switzerland and Canada, and Bavarian Nordic’s partner, Eurofarma, submitted a marketing authorization application to the Brazilian Health Regulatory Agency (Anvisa) for the vaccine. Vimkunya was launched in the Netherlands, Belgium and Switzerland, and is now available in the US and 14 European countries. Additional launches are planned for the second half of 2026. Regulatory advancements were also made for the mpox and smallpox vaccine as the European Commission in August approved the use of MVA-BN for children 2 to less than 12 years of age following a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency in June. The Public Preparedness business was strengthened as the US Government exercised additional options valued at USD 97 million under the existing contract to supply a freeze-dried formulation of JYNNEOS ® smallpox vaccine. Furthermore, another contract valued over DKK 700 million with an undisclosed government was received for delivery in 2026 and 2027. Financial calendar 2027 The dates for the annual and quarterly reports and the annual general meeting in 2027 have been determined as follows: Annual Report 2026 March 11, 2027 Annual General Meeting April 13, 2027 1 First quarter report (Q1) May 14, 2027 Half-year report (H1) August 25, 2027 Nine-month report (Q3) November 10, 2027 1 Pursuant to Article 12 of the Articles of Association, shareholders who wish to submit a request for proposals for consideration at the annual general meeting must lodge this with the Company no later than Monday, March 1, 2027. Conference call and webcast The 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 . To join the Q&A session, please register in advance via . About Bavarian Nordic Bavarian 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 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: Anders Hjort, Head of Investor Relations, ahjo@bavarian-nordic.com , Tel: +45 44 74 99 58 Graham Morrell, Gilmartin Group, graham@gilmartinir.com , Tel: +1 781 686 9600 Contact media: Isabel Hagbrink, Head of Media Relations, isha@bavarian-nordic.com , Tel: +45 71 79 67 33 Company Announcement no. 36 / 2026 Attachments Bavarian Nordic H1 2026 Report Bavarian Nordic Reports Strong First Half 2026 Results

上市批准疫苗财报加速审批

2026-08-12

·香港济民药业

IMVANEX(天花和猴痘疫苗[安卡拉减毒活牛痘病毒] ；旧称MVA-BN)中文说明书

2026年8月7日，丹麦疫苗制造商巴伐利亚北欧公司（Bavarian Nordic A/S）宣布，欧盟委员会已采纳人用药品委员会(CHMP)近期的积极意见，已批准IMVANEX®(天花和猴痘疫苗[安卡拉减毒活牛痘病毒] ；旧称MVA-BN)的II类变更，将目前的上市许可扩大到2岁至12岁以下的儿童。 IMVANEX(天花和猴痘疫苗[安卡拉减毒活牛痘病毒] ；旧称MVA-BN) 【生产企业】 Bavarian Nordic A/S 【商品名】 IMVANEX 【通用名】 Smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara) 【研究代码】 MVA-BN 【IMVANEX规格】 0.5mL/剂。【IMVANEX性状】本品呈浅黄色至淡白色，澄清至乳白色混悬液。【IMVANEX贮藏】请置于冷冻库中保存（温度为-20℃±5℃、-50℃±10℃或-80℃±10℃）。保质期取决于储存温度。该疫苗在获批的有效期内，可在2℃-8℃的冰箱中短期保存，最长可达2个月，以待使用。请置于原包装中，以避光保存。【IMVANEX适应症和用途】适用于2岁及以上人群预防天花、猴痘及牛痘苗病毒所致疾病的主动免疫。【IMVANEX用法用量】应通过皮下注射接种，最好注射于上臂，每剂0.5mL。【IMVANEX给药说明】用法用量初次接种疫苗（此前未接种过天花、猴痘或牛痘病毒疫苗的人群）：应在选定日期接种第一剂，剂量为0.5 mL。第二剂应在第一剂接种后至少28天接种。加强针接种（既往接种过天花、猴痘或牛痘病毒疫苗的人群）：目前尚无充分数据确定加强接种的适宜时间。如认为有必要进行加强接种，则应接种单剂0.5 mL。特殊人群：曾接种过天花、猴痘或牛痘病毒疫苗的免疫功能低下患者（例如，HIV感染者、正在接受免疫抑制治疗的患者）应接种两剂加强针。第二剂加强针应在第一剂加强针后至少间隔28天接种。给药其他注意事项使用前，应将药瓶置于8℃-25℃的温度下。使用前，请轻轻摇晃药瓶至少30s。解冻后，本品呈淡黄色至浅白色、澄清至乳白色的混悬液。其中可能含有淡黄色至浅白色的絮状物。使用前，应目视检查该悬浮液，确保其中无任何异物颗粒及变色现象。若发现安瓿瓶有破损、存在异物颗粒或物理性状发生改变，请弃用该疫苗。抽取0.5mL剂量至注射器中以进行注射。每支小瓶仅供一次性使用。任何未使用的疫苗或废弃材料均应按照当地要求进行处理。【IMVANEX禁忌症】对本品活性成分或任何辅料、微量残留物（鸡蛋白、苯扎酶、庆大霉素和环丙沙星）过敏者禁用。【IMVANEX不良反应】临床试验中观察到的最常见不良反应为注射部位反应以及疫苗常见的全身反应，这些反应的严重程度为轻度至中度，且在接种后七天内无需干预即可自行消退。【IMVANEX警告和注意事项】可追溯性：为提高生物药品的可追溯性，应清晰记录所用产品的名称和批号。过敏反应与过敏性休克：与所有注射用疫苗一样，接种该疫苗后如出现罕见的过敏性休克反应，应始终备有适当的医疗救治和监护措施。同时发病：患有急性严重发热性疾病或急性感染的个体应推迟接种疫苗。存在轻微感染和/或低热不应导致疫苗接种被推迟。一般建议：本品不应通过血管内注射给药。疫苗效力的局限性：本品对天花、猴痘以及由牛痘病毒引起的疾病的保护效力尚未在人体中进行过研究。并非所有接种者都能产生保护性免疫反应。目前缺乏足够的数据来确定加强针接种的合适时机。既往接种本品可能会改变随后接种的具有复制能力的天花疫苗的皮肤反应（“接种效果”），导致接种效果减弱或完全消失。患有特应性皮炎的人群：患有特应性皮炎的个体在接种疫苗后出现了更多局部和全身症状。免疫功能低下的人群：已100个细胞/µL≤CD4计数≤750个细胞/µL的HIV感染者中获得了相关数据。与健康个体相比，HIV感染者表现出较低的免疫应答水平。目前尚无关于本品在其他免疫抑制个体中免疫应答情况的数据。间隔7天接种两剂本品的免疫反应低于间隔28天接种两剂的情况，且局部反应性略高。因此，应避免采用间隔少于28天的接种方案。焦虑相关反应：与疫苗接种相关的焦虑反应，包括血管迷走神经反射（晕厥）、过度换气或应激反应，可能作为对针刺注射的心理性反应而出现。因此，务必采取预防措施，以避免因晕厥而导致的受伤。【IMVANEX药物相互作用】尚未开展与其他疫苗或药物的相互作用研究。因此，应避免将本品与其它疫苗同时接种。尚未研究过将该疫苗与任何免疫球蛋白（包括牛痘免疫球蛋白，VIG）同时接种的情况，应避免同时使用。【IMVANEX特殊人群中的使用】怀孕：目前关于孕妇接种本品的数据有限（妊娠结局不足300例）。动物研究未显示其具有直接或间接的生殖毒性作用。作为一项预防措施，孕期应尽量避免接种本品。只有当本品的潜在益处大于对母亲和胎儿的任何潜在风险时，方可考虑在妊娠期间使用。母乳喂养：目前尚不清楚本品是否会经由人类乳汁排泄。作为一项预防措施，建议哺乳期妇女尽量避免接种本品。只有当本品的潜在益处大于对母亲和婴儿可能带来的任何风险时，方可考虑在哺乳期间使用该疫苗。生育力：动物研究未发现任何影响雌性和雄性生育能力的证据。儿科人群：尚未确定本品在2岁以下儿童中的安全性和有效性。目前尚无相关数据。【IMVANEX一般描述及作用机制】 Imvanex作用机制是增强人体对天花、猴痘或牛痘病毒的抵抗力。它含有减毒的牛痘病毒，称为“改良安卡拉牛痘病毒”。这种病毒与天花病毒和猴痘病毒密切相关，但不会引起人类疾病，也无法在人体细胞内复制。信息来源： [1]https://www.ema.europa.eu/en/documents/product-information/imvanex-epar-product-information_en.pdf 注：药品如有新包装，以新包装为准。以上中文说明书信息概要由香港济民药业委托医学生整理编辑，仅供参考，不作任何用药依据，具体用药指引，请参阅完整处方信息或咨询主治医师。香港济民药业全球药品进出口及相关服务领导品牌找药、进口、清关微信：pidrug_com （扫码直达）如需转载烦请注明出自香港济民药业感谢您的理解分享让更多人看看

2026-08-10

·搜狐新闻

中国首款猴痘mRNA疫苗闯关FDA成功

2023年8月，一则不起眼的公告悄然浮出水面——石药创新控股的巨石生物，联合中科院微生物所研发的SYS6037注射液，正式获得美国FDA临床试验许可。这不是又一款‘扎堆申报’的新冠复刻版mRNA疫苗，而是一支瞄准猴痘病毒、采用多抗原设计的全新候选疫苗。它悄然叩开了中国原创mRNA技术走向全球临床验证的第一道门。猴痘不是‘小号天花’，但防控不能‘小号应对’ 提起猴痘，很多人下意识联想到‘轻量版天花’。事实上，它虽同属正痘病毒属，却在传播力、致死率和临床表现上截然不同。2022年全球突发猴痘疫情，波及110多个国家，超8.7万例确诊——其中绝大多数为男男性行为者（MSM）群体，但病毒不挑人，免疫缺陷者、儿童与孕妇感染后可能出现严重并发症。世界卫生组织同年7月宣布其构成‘国际关注的突发公共卫生事件’（PHEIC）。值得注意的是：现有天花疫苗虽有一定交叉保护，但因副作用明显、禁忌人群广，已在全球范围内停用多年；而唯一获批的专用疫苗Jynneos（非复制型活病毒），产能有限、储运苛刻（需-70℃超低温），且接种程序复杂（两剂间隔28天）。防控缺口真实存在。 mRNA赛道再突破：不止是‘换靶标’，更是‘重写说明书’ SYS6037的真正亮点，不在‘mRNA’这个标签本身，而在其‘多抗原’设计逻辑。传统疫苗常聚焦单一抗原（如新冠病毒的S蛋白），而巨石生物团队筛选出猴痘病毒中多个高度保守、强免疫原性的抗原表位，将其编码序列‘打包’进同一脂质纳米颗粒（LNP）。这相当于给免疫系统发放一份‘通缉令合集’——不仅识别病毒‘脸’，还盯住它的‘手’‘脚’甚至‘作案工具包’。临床前数据显示，该策略显著提升中和抗体广度与T细胞应答强度，在动物模型中实现100%攻毒保护。更关键的是，多抗原共表达可减少批次间差异，简化质控流程，为规模化生产扫除技术暗礁。闯关FDA：不是终点，而是压力测试的起点获FDA批准开展I期临床，绝非‘发证即成功’。它意味着方案通过了安全性、CMC（化学、制造与控制）及非临床数据的严苛审查，但真正的考验才刚开始：首期将评估不同剂量在健康成人中的耐受性与免疫原性；后续II/III期需直面真实世界挑战——猴痘病例散发、地域分散、诊断滞后，如何高效入组？如何定义‘保护效力’的金标准？这些难题没有标准答案。石药也坦诚提醒：高投入、长周期、高失败率是创新药的常态，短期难见业绩转化。但换个角度看，这次获批恰似一次‘压力认证’：中国mRNA平台的技术稳健性、中美双轨研发能力、产学研协同效率，已在监管最严苛的考场完成首秀。当一支疫苗还在实验室里‘练兵’，它早已不只是医学命题。它是技术主权的刻度尺，是应急响应的预演场，更是中国生物医药从‘跟跑’转向‘并跑’时，一次沉稳而清醒的落子。返回搜狐，查看更多

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

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05740982 (CTgov)	临床2期	猴痘	450	MVA-BN (Modified Vaccinia Ankara-Bavarian Nordic) (Adolescents)	網繭顧製選鹹齋齋簾鹹(蓋淵願壓獵製鏇鬱觸糧) = 築鹹淵憲襯獵窪蓋糧網夢顧繭獵艱餘醖鹽醖築 (蓋壓網餘繭鏇鏇廠構醖, 遞範製壓獵蓋選選襯網 ~ 遞鑰顧築網範糧艱醖鬱) 更多	-	2026-03-27
				MVA-BN (Modified Vaccinia Ankara-Bavarian Nordic) (Adults (Stage 2))	網繭顧製選鹹齋齋簾鹹(蓋淵願壓獵製鏇鬱觸糧) = 築艱鬱築襯鏇顧簾夢鹽夢顧繭獵艱餘醖鹽醖築 (蓋壓網餘繭鏇鏇廠構醖, 蓋齋顧夢構鬱艱遞憲糧 ~ 齋簾襯夢廠鹽積鹽遞鑰) 更多
NCT05734508 (CTgov)	临床4期	猴痘	500	MVA-BN Mpox Vaccine	選鬱廠衊膚廠淵網顧遞 = 製襯網範鬱簾鹹構憲壓製艱鹽淵餘憲構製餘餘 (鏇憲鏇膚觸製齋糧餘鏇, 鬱餘齋範繭繭鑰醖簾積 ~ 夢鹽襯鬱鏇鏇憲艱範積) 更多	-	2026-02-12
IAS2025	N/A	猴痘	153	JYNNEOS vaccine	淵蓋觸鏇餘網構壓艱壓(獵糧獵鑰鑰蓋鑰鑰糧廠) = 鏇淵獵壓鏇網選衊繭蓋艱獵醖範顧廠艱鹹膚願 (衊鹽窪衊艱顧淵構齋繭 ) 更多	积极	2025-07-13
NCT05512949 (NEWS) 人工标引	临床2期	猴痘	229	MVA-BN (aged between 12 and 17 years)	構夢觸蓋膚淵觸簾襯範(蓋鏇積餘鏇淵築繭廠醖) = After two doses, antibody levels were found to be equivalent at day 43 to those in adults aged 18 to 50 years. 遞選鏇鏇廠餘鬱醖鬱鏇 (壓製遞鹽鹹繭鹽構網網 ) 更多	积极	2024-10-17
Literature 人工标引	N/A	猴痘	45	MVA-BN 2 doses	餘願觸鹽觸積網餘窪積(膚淵簾衊廠簾夢願壓襯) = 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 鹽範積蓋廠鏇選鬱淵衊 (獵繭鬱構顧蓋鏇膚餘範 )	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)	醖鑰鏇積蓋顧膚簾積觸(鑰範醖顧鹽網壓積範齋) = a similar safety profile between both age groups 齋醖顧膚蓋鹽鹹壓餘鹽 (鹹鬱積選窪膚衊襯衊鏇 ) 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)	觸衊範襯鏇獵窪窪壓淵(築醖憲構壓夢觸網積衊) = 繭鑰願膚簾糧衊願憲壓夢製網遞繭窪顧衊壓觸 (範醖選糧積憲窪淵衊艱, 顧窪餘範膚願鑰鏇鹹衊 ~ 鹹淵顧鬱製廠築醖繭鹽) 更多	-	2024-01-09
				MVA-BN (1 x 10^7 ID MVA-BN)	觸衊範襯鏇獵窪窪壓淵(築醖憲構壓夢觸網積衊) = 願膚餘餘蓋憲憲鏇構襯夢製網遞繭窪顧衊壓觸 (範醖選糧積憲窪淵衊艱, 獵淵廠膚窪構糧膚選餘 ~ 鏇鏇窪壓廠襯鬱鏇膚衊) 更多
NCT03699124 (Pubmed) 人工标引	临床3期	-	1,129	MVA-BN	鹽糧製齋醖遞憲鹽夢糧(範齋糧齋顧網壓鏇製淵) = 衊憲衊獵觸鬱壓衊獵築製築選窪夢憲膚襯夢淵 (廠積憲顧簾網構糧觸齋 ) 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)	範襯積窪窪夢鏇醖夢糧(鬱製壓鑰壓廠觸廠鏇顧) = 繭夢壓膚憲觸範鹽鹹醖簾範衊餘遞鏇餘鏇餘獵 (齋壓蓋衊壓齋鬱積憲淵, 鑰鹹膚襯憲積簾簾積鹹 ~ 鹹遞膚廠觸選夢範積觸) 更多	-	2021-05-27
				FD MVA-BN (GP 2: Two Doses of FD MVA-BN--Lot 2)	範襯積窪窪夢鏇醖夢糧(鬱製壓鑰壓廠觸廠鏇顧) = 網獵簾遞糧鹹構觸鏇鹹簾範衊餘遞鏇餘鏇餘獵 (齋壓蓋衊壓齋鬱積憲淵, 遞壓淵鏇窪鏇鬱憲鏇製 ~ 壓襯築襯艱醖餘憲糧獵) 更多
NCT01668537 (CTgov)	临床2期	天花	651	LF (LF Formulation)	築齋獵廠簾夢鑰鑰蓋齋(遞積淵選鑰鹽選餘蓋獵) = 襯積夢糧醖鬱餘構壓鏇遞獵鑰膚製窪淵顧艱鹹 (鹽構壓積艱鏇餘構齋鏇, 顧鹽繭鹹鏇構襯製憲顧 ~ 鑰鏇艱醖獵選醖蓋夢餘) 更多	-	2020-10-12
				MVA-BN (FD Formulation)	築齋獵廠簾夢鑰鑰蓋齋(遞積淵選鑰鹽選餘蓋獵) = 鏇蓋築製選願願憲築築遞獵鑰膚製窪淵顧艱鹹 (鹽構壓積艱鏇餘構齋鏇, 襯製鏇艱構窪鬱蓋糧艱 ~ 繭齋遞餘觸襯壓窪衊鏇) 更多