Tick-borne Encephalitis (TBE) can be prevented by vaccine. Vaccine failure, defined as a case of TBE regardless of previous vaccination, has been described and seems to be more predominant with increasing age, suggesting a less effective immune response following with increasing age. In fact previous studies has shown a reduced antibody response in elderly individuals compared to younger when vaccinated against TBE. As a result, in Sweden, an extra vaccine dose has been recommended during the primary vaccine schedule to individuals > 50 years of age. This alternative vaccine schedule has not been tested. The investigator aim to test if an extra vaccine dose in the primary vaccine schedule for those > 50 years of age improves the immune response and offers a corresponding immunity to younger individuals following TBE vaccination.

开始日期2024-01-01

申办/合作机构-

NCT04648241

/ Completed临床3期

A PHASE 3, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A TICK-BORNE ENCEPHALITIS VACCINE IN HEALTHY JAPANESE PARTICIPANTS 1 YEAR OF AGE AND OLDER

The main purpose of this study is to provide safety and immunogenicity data in Japanese participants.

开始日期2021-01-18

申办/合作机构

Pfizer Inc.

EUCTR2014-003549-90-SE

/ Unknown statusN/AIIT

Is it possible to improve humoral response to TBE vaccine in elderly (50+ year olds) by means of changed dosage intervals/number of doses?

开始日期2014-11-24

申办/合作机构-

100 项与蜱传脑炎疫苗相关的临床结果

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100 项与蜱传脑炎疫苗相关的转化医学

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100 项与蜱传脑炎疫苗相关的专利（医药）

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项与蜱传脑炎疫苗相关的文献（医药）

2024-10-19·Journal of travel medicine

Five accelerated schedules for the tick-borne encephalitis vaccine FSME-Immun® in last-minute travellers: an open-label, single-centre, randomized controlled pilot trial

Article

作者: Andries, Petra ; Ledure, Quentin ; Van Der Beken, Yolien ; De Koninck, Katrien ; de Viron, Emeline ; Genbrugge, Els ; Damanet, Benjamin ; Hing, Mony ; Djebara, Sarah ; Willems, Betty ; Van Herrewege, Yven ; Ghoos, Katrijn ; Ariën, Kevin K ; Berens-Riha, Nicole ; Tsoumanis, Achilleas ; Michiels, Johan ; Aerssens, Annelies ; De Hondt, Annelies ; Van Innis, Martine ; Vanbrabant, Peter ; Heyndrickx, Leo ; Spiessens, An ; Zaman, Kristy ; Soentjens, Patrick ; Landuyt, Hanne ; Buyze, Jozefien ; Dooms, Eric

Abstract:

Background:

The purpose of this exploratory study was to evaluate different accelerated tick-borne encephalitis (TBE) vaccine schedules for last-minute travellers.

Methods:

In a single-centre, open-label pilot study, 77 TBE-naïve Belgian soldiers were randomized to one of the following five schedules with FSME-Immun®: group 1 (‘classical accelerated’ schedule) received one intramuscular (IM) dose at Day 0 and Day 14, group 2 two IM doses at Day 0, group 3 two intradermal (ID) doses at Day 0, group 4 two ID doses at Day 0 and Day 7 and group 5 two ID doses at Day 0 and Day 14. The last dose(s) of the primary vaccination scheme were given after 1 year: IM (1 dose) or ID (2 doses). TBE virus neutralizing antibodies were measured in a plaque reduction neutralization test (PRNT90 and 50) at Days 0, 14, 21, 28, Months 3, 6, 12 and 12+21 days. Seropositivity was defined as neutralizing antibody titres ≥10.

Results:

The median age was 19–19.5 years in each group.Median time to seropositivity up to Day 28 was shortest for PRNT90 in ID-group 4 and for PRNT50 in all ID groups. Seroconversion until Day 28 peaked highest for PRNT90 in ID-group 4 (79%) and for PRNT50 in ID-groups 4 and 5 (both 100%). Seropositivity after the last vaccination after 12 months was high in all groups. Previous yellow fever vaccination was reported in 16% and associated with lower geometric mean titres of TBE-specific antibodies at all-time points.The vaccine was generally well tolerated. However, mild to moderate local reactions occurred in 73–100% of ID compared with 0–38% of IM vaccinations, and persistent discolouration was observed in nine ID vaccinated individuals.

Conclusion:

The accelerated two-visit ID schedules might offer a better immunological alternative to the recommended classical accelerated IM schedule, but an aluminium-free vaccine would be preferable.

2024-08-06·JOURNAL OF THE HISTORY OF MEDICINE AND ALLIED SCIENCES

Arbovirology and Cold War Collaborations: A Transnational History of the Tick-borne Encephalitis Vaccine, 1930-1980

Article

作者: Mazanik, Anna

Abstract:

This article analyzes the history of immunization against tick-borne encephalitis (TBE) and specifically the processes that led to the creation and application of TBE vaccines in the Soviet Union and Austria. Rather than presenting the development of TBE vaccines from the perspective of national scientific schools, the article investigates their history as a transnational project, focusing on the connections among the Soviet Union, Czechoslovakia, Austria, the United States, and the United Kingdom. It argues that biomedical research on TBE was profoundly intertwined with political and military agendas and depended on civil international cooperation as well as Soviet, American, and British military concerns, infrastructures and funding. The article consists of four parts that discuss (1) the identification of the TBE virus and the creation of the first TBE vaccine in the Soviet Union in the 1930s; (2) the internationalization of TBE research and vaccine development in the 1940s-1960s; (3) the history of TBE research and virology in Austria in the 1930s-1960s and the role of the US military funding; and (4) the cooperation of Austrian virologist Christian Kunz with the Microbiological Research Establishment Porton Down in the UK leading to the development of the Austrian/British vaccine against TBE in the 1970s.

2024-05-01·Vaccine

Phase 3 immunogenicity and safety study of a tick-borne encephalitis vaccine in healthy Japanese participants 1 year of age and older

Article

作者: Watanabe, Tohru ; Yonekawa, Motoharu ; Erber, Wilhelm ; Koelch, Doris ; Kogawara, Osamu ; Jug, Bogdan ; Aizawa, Masakazu ; Yoshii, Chihiro ; Lockhart, Stephen P ; Ito, Shuhei ; Yamaji, Masako ; de Solom, Richard

BACKGROUND:

Tick-borne encephalitis (TBE) virus infects the central nervous system and may lead to severe neurological complications or death. This study assessed immunogenicity, safety, and tolerability of TBE vaccine in Japanese participants 1 year of age and older.

METHODS:

This phase 3, multicenter, single-arm, open-label study was conducted in Japanese adult (≥ 16 years) and pediatric (1-< 16 years) populations. Participants received a single 0.5-mL (adult) or 0.25-mL (pediatric) dose of TBE vaccine at each of 3 visits. The primary endpoint was the proportion of participants who were seropositive (neutralization test [NT] titer ≥ 1:10) 4 weeks after Dose 3. Secondary and exploratory endpoints included NT seropositivity rates 4 weeks after Dose 2, immunoglobulin G (IgG) seropositivity 4 weeks after Doses 2 and 3, NT geometric mean titers (GMTs), IgG geometric mean concentrations (GMCs), and geometric mean fold rises. Primary safety endpoints were frequencies of local reactions, systemic events, adverse events (AEs), and serious AEs.

RESULTS:

Among 100 adult and 65 pediatric participants, 99.0 % and 100.0 % completed the study, respectively. NT seropositivity was achieved in 98.0 % adult and 100.0 % pediatric participants after Dose 3; seropositivity after Dose 2 was 93.0 % and 92.3 %, respectively. In both age groups, IgG seropositivity was ≥ 90.0 % and ≥ 96.0 % after Doses 2 and 3, respectively; GMTs and GMCs were highest 4 weeks after Dose 3. Reactogenicity events were generally mild to moderate in severity and short-lived. AEs were reported by 15.0 % (adult) and 43.1 % (pediatric) of participants. No life-threatening AEs, AEs leading to discontinuation, immediate AEs, related AEs, or deaths were reported. No serious AEs were considered related to TBE vaccine.

CONCLUSIONS:

TBE vaccine elicited robust immune responses in Japanese participants 1 year of age and older. The 3-dose regimen was safe and well tolerated, and findings were consistent with the known safety profile of this TBE vaccine.

CLINICALTRIALS:

gov: NCT04648241.

项与蜱传脑炎疫苗相关的新闻（医药）

2025-11-27

·终身学习者新锐也

读财报| 辉瑞罕见病药物增长对整体业绩的贡献：转型期的关键增长引擎与战略缓冲

辉瑞2025年第三季度财报显示，罕见病药物板块表现亮眼，成为其业绩承压背景下的一抹亮色。在总营收同比下降6%、净利润下滑21%的背景下，以Vyndaqel（治疗ATTR心肌病）和Genotropin（人生长激素）为代表的罕见病药物实现显著增长，不仅为辉瑞提供了稳定的现金流，更在战略层面成为其抵御行业周期波动、推动转型的重要支撑。以下从财务贡献、战略价值、风险对冲及长期潜力四个维度，深入分析罕见病药物对辉瑞整体业绩的贡献。一、财务贡献：高增长填补核心产品缺口，优化收入结构 1. 营收增长引擎：罕见病药物增速显著高于整体水平 - Vyndaqel：第三季度销售额达15.91亿美元，同比增长10%，虽略低于分析师预期，但作为罕见病领域的核心产品，其稳定增长对冲了新冠疫苗Comirnaty（同比下降19%）和肺炎疫苗Prevnar（下降3%）的下滑压力。 - Genotropin：销售额同比暴涨76%至1.58亿美元，尽管基数较小，但高增速凸显其市场潜力。生长激素市场的需求增长与辉瑞产品的竞争力共同驱动了这一表现。 - 其他罕见病产品：如脑膜炎疫苗FSME-IMMUN/TicoVac等亦表现不俗，共同构成罕见病板块的整体增长动力。 2. 利润贡献：高利润率提升整体盈利能力 - 罕见病药物通常因患者群体较小、研发成本高而享有较高定价权，毛利率显著高于普通药物。Vyndaqel等高利润产品的增长直接增厚了辉瑞的营业利润，部分抵消了核心产品利润下滑的影响。 - 在整体营业利润同比下降21%的背景下，罕见病药物的高利润率成为稳定利润基盘的关键因素。 3. 收入结构优化：降低对传统疫苗的依赖 - 辉瑞正逐步摆脱对新冠产品和传统疫苗的依赖，罕见病药物作为非新冠业务的重要组成部分（占比约10%），其增长加速了收入结构的多元化转型。当疫苗业务受政策、市场波动影响时，罕见病药物的稳定增长提供了缓冲。二、战略价值：构建第二增长曲线，强化长期竞争力 1. 差异化竞争优势：填补市场空白，巩固领先地位 - 罕见病领域因研发难度大、竞争壁垒高，辉瑞通过Vyndaqel等产品的布局，在ATTR心肌病等细分赛道占据主导地位，享有较强的市场定价权与护城河。 - 高壁垒特性使这些产品不易受仿制药冲击，生命周期更长，为辉瑞提供可持续的现金流。 2. 创新驱动转型：管线储备奠定未来增长基础 - 辉瑞在罕见病领域拥有丰富的在研管线，涵盖基因疗法、靶向治疗等前沿技术，如针对杜氏肌营养不良症、血友病等疾病的创新疗法已进入临床阶段。这些储备项目为未来5-10年的增长提供了确定性。 - 罕见病药物的成功验证了辉瑞的研发能力，有助于其在肿瘤、代谢等其他治疗领域建立技术协同，推动整体创新转型。 3. 并购协同效应：增强战略灵活性 - 辉瑞在并购策略中愈发重视罕见病资产，如通过收购小型生物技术公司获取前沿疗法。这些收购不仅直接补充产品线，更通过技术整合提升内部研发效率，形成“自研+并购”的双轮驱动模式。三、风险对冲：抵御行业周期性波动与政策不确定性 1. 需求刚性：降低市场波动敏感性 - 罕见病患者对治疗存在刚性需求，受经济周期和公共卫生政策变动的影响较小。相较于疫苗（受接种政策、疫情波动影响大）和普通药物（竞争激烈），罕见病药物的需求稳定性更强，成为辉瑞抵御外部风险的“压舱石”。 2. 政策支持：全球鼓励罕见病研发 - 各国政府对罕见病药物的研发提供税收优惠、加速审批等支持政策（如美国《孤儿药法案》），辉瑞可借助政策红利降低研发风险，加速产品上市与商业化。四、长期潜力：千亿赛道中的增长空间与挑战 1. 市场扩容：未被满足的需求驱动增长 - 全球罕见病患者超3亿人，但仅约10%有有效治疗药物，存在巨大未被满足的临床需求。随着诊断技术进步和支付能力提升，罕见病药物市场规模预计将以10%以上年增速扩张，为辉瑞提供广阔空间。 2. 挑战与风险： - 高研发成本与商业化压力：罕见病药物研发周期长、投入高，若关键产品临床失败或商业化不及预期，将拖累整体业绩。 - 竞争加剧：随着赛道吸引力提升，诺华、罗氏等巨头亦加速布局，辉瑞需持续投入以维持领先地位。 - 支付压力：高昂定价可能面临医保控费或患者支付能力限制，影响销量增长。结论：战略缓冲与长期增长的双重角色辉瑞罕见病药物的增长不仅短期内填补了核心产品下滑的缺口，优化了收入结构，更在战略层面成为其转型期的关键增长引擎与风险缓冲器。通过构建高壁垒产品组合、布局前沿管线、利用政策红利，辉瑞正将罕见病领域打造为“第二增长曲线”，为长期竞争力奠定基础。然而，高研发投入、竞争加剧及支付压力仍是潜在挑战。未来，辉瑞需在持续投入与创新效率间寻求平衡，同时通过并购整合加速布局，以充分释放罕见病赛道的增长潜力，实现从“疫情依赖”到“创新驱动”的彻底转型。建议： 1. 加大管线投入，聚焦突破性疗法：优先开发临床需求迫切、竞争格局佳的罕见病领域，同时探索基因编辑、细胞疗法等颠覆性技术。 2. 深化商业化能力：通过患者支持计划、医保谈判策略等提升药物可及性，平衡定价与销量增长。 3. 强化并购整合：积极收购具有临床验证潜力的罕见病生物科技公司，快速补充产品线并获取技术能力。 4. 政策合作：与政府、非营利组织合作推动罕见病诊断与支付体系建设，创造有利生态。罕见病药物已成为辉瑞穿越行业周期、实现可持续增长的重要支柱，其战略价值将在未来愈发凸显。

2025-11-25

·研发客

政策漩涡里的疫苗四强：业绩承压，战略分化

• 赛诺菲RSV预防抗体Beyfortus撑起其疫苗板块业绩，将探索在中国多个地区扩大应用； • GSK的疫苗业务同比增长2%，涨幅受美国市场严重拖累； • 默沙东新上市的肺炎球菌疫苗Capvaxive有望成为业绩增长新引擎； • 辉瑞疫苗业绩持续受新冠产品影响，正在美国以外市场寻求机会。美国疫苗信任危机愈演愈烈，赛诺菲、GSK、默沙东和辉瑞这四家全球第一梯队疫苗公司业绩承压。据第三季度财报，多款明星疫苗产品的销售业绩出现了不同程度的下滑。这些公司提到，疫苗业绩下滑或多或少都受到了美国疫苗宏观政策变化的影响。自今年初Robert F. Kennedy Jr上任美国卫生与公众服务部（HHS）部长以来，一系列改革动作不断，如撤换美国疾病预防与控制中心（CDC）免疫实践咨询委员会（ACIP）所有成员、将新冠疫苗从美国CDC此前制定的儿童疫苗接种计划中移除等，相关政策屡屡掀起舆论风暴。 11月19日，美国CDC更新网站称，“疫苗不会导致自闭症”的说法缺乏证据支持，研究尚未排除婴儿疫苗会导致自闭症的可能性（见下图）。这动摇了该机构长期以来认为“疫苗不会导致自闭症”的立场。此前，“疫苗导致自闭症”的说法刚被提出就遭到医学界的驳斥。在疫苗政策“背刺”之下，四家MNC正竭力施策以扭转业绩颓势。赛诺菲：Beyfortus逆势增长据赛诺菲10月公布的第三季度财报，主要受流感疫苗销售额下降的影响，其疫苗整体销售额同比下降7.8%，为33.57亿欧元。不过，第三季度唯一实现增长的婴儿RSV预防用长效抗体尼塞韦单抗（Beyfortus）对冲了今年以来疫苗板块一大部分下滑的业绩。在Beyfortus的销售贡献下，今年前三季度疫苗整体销售额同比下降为0.7%。（见下图）来源|赛诺菲官网具体来看，第三季度流感和新冠肺炎疫苗销售额为15.25亿欧元，下降16.8%。主要受德国市场价格竞争压力的影响，欧洲地区销售额下降25.6%；由于本季初疫苗接种率较低，美国销售额下降11.4%。目前赛诺菲疫苗管线的业绩贡献对流感疫苗依赖程度较高，该公司对今年冬天流感季的业绩表现似乎不太乐观。“在最初的几周里，我们观察到流感疫苗的接种率略显疲软，尤其是在美国。”赛诺菲全球执行副总裁、疫苗全球负责人Thomas Triomphe在接受Fierce采访时曾提到。此外，降幅较大的还有脊髓灰质炎/百日咳/b型流感嗜血杆菌（PPH）基础疫苗和加强疫苗。该疫苗第三季度下降12.2%，销售额为6.42亿欧元。根据赛诺菲的解释，下降原因是今年早些时候部分公共市场的基础疫苗销售交付节奏有所调整。而Beyfortus的逆势增长成为亮点：销售额为7.39亿欧元，同比增长19.8%。这主要得益于其在全球多个国家和地区销售网络的快速扩张，尤其是在欧洲销售增长了166.3%，世界其他地区销售增长了526.7%。不过，Beyfortus在美国市场销售额下降了21.4%，赛诺菲对下降原因的解释是“去年同期基数较高以及季初现有库存水平的限制”。目前，Beyfortus已在包括中国、美国在内的40多个国家为婴儿提供防护。其对中国市场寄予厚望，但囿于中国药品注册分类的限制，Beyfortus作为预防用抗体，想像疫苗一样通过疾控路径触达到更多高危人群面临诸多挑战。拓展阅读注册分类为何影响了药品可及？赛诺菲告诉研发客，在国内有关部门的指导和支持下，多个地区进行了诸多创新尝试和探索。自2024年Beyfortus正式在中国落地使用以来，该产品已经在上海、北京、天津、湖北等地收获了诸多创新管理和使用经验。内蒙古、山东、辽宁、重庆等地区也在探索拓展该产品应用场景的可能性。未来，赛诺菲希望通过更多地方的创新应用实践，让Beyfortus更好地惠及更多中国家庭。赛诺菲还在继续巩固RSV领域的布局。目前，赛诺菲正加速推进预防老年人RSV和人偏肺病毒的mRNA疫苗SP0256以及用于预防RSV、人偏肺病毒和3型副流感病毒疫苗SP0291的临床研究。今年7月，赛诺菲看中了Vicebio公司针对RSV的非mRNA疫苗，以11.5亿美元预付款收购了该公司。 10月下旬，其处于临床后期的一款针对幼儿RSV感染的鼻内减毒活疫苗SP0125，因Ⅲ期研究效果不佳而终止。目前，在RSV赛道赛诺菲仍主要依赖Beyfortus。 GSK：直言美国市场拖累疫苗业绩今年第三季度，GSK的疫苗业务收入为26.78亿英镑，按固定汇率计算同比增长2%（见下图）。GSK在财报中提到，这主要得益于带状疱疹疫苗Shingrix和RSV疫苗Arexvy在美国以外市场的强劲增长。来源|GSK官网具体来看，Shingrix第三季度季度销售额达8.3亿英镑，同比增长13%，这主要由欧洲市场需求增加推动（+48%）。财报指出，美国市场销售额下降15%，拖累了整体业绩，原因是“未接种疫苗消费者群体的接种速度持续放缓”。财报还提到，销售额还受到阶段性影响，即今年上半年GSK给中国合作方智飞生物的交货量有所减少。 GSK首席商务官Luke Miels在接受Fierce采访时曾提到，GSK会调整Shingrix在美国的策略，将专注于合并症患者和高风险人群，已取得了一定积极的成效。但由于疫苗相关的宏观因素，美国市场仍然充满挑战。 Luke Miels将于2026年1月1日接替Emma Walmsley出任GSK的首席执行官。目前，GSK正在加大Shingrix在美国以外地区的推广力度，美国以外前十大市场Shingrix的接种率约为10%，有进一步放量的空间。脑膜炎疫苗和Arexvy第三季度的业绩分别实现5%和36%的增长，同样归功于欧洲和国际市场的贡献。因季前渠道库存减少加上市场接受度降低，Arexvy在美国的销售额出现了下滑。财报特别提到，去年6月美国ACIP修改了Arexvy针对老年人的应用范围，不再建议60~74岁无高风险者接种，这一定程度导致今年上半年美国市场的需求下降。 GSK的流感疫苗和其他成熟疫苗的销售额分别下降了22%和8%。其中，流感疫苗销量下降主要发生在竞争激烈的美国市场。默沙东：老品承压，新品破局默沙东的疫苗管线中，除了新上市的肺炎球菌疫苗Capvaxive外，其他几款核心疫苗产品的销售额在今年第三季度均有所下降。下降最为显著的是人乳头瘤病毒（HPV）疫苗Gardasil/Gardasil 9，其第三季度销售额为17.49亿美元，同比下降了24%。其业绩下滑的主要原因是中国市场需求减少，若不计中国市场，销售额下降为2%。默沙东高管在第三季度财报电话会议上还提到，日本的疫苗补种报销计划已经到期，且美国疫苗推荐政策可能带来后续挑战。 “美国市场存在一些宏观因素的影响。” 默沙东首席财务官Caroline Litchfield在会议中谈及美国市场时称。ACIP推迟了原定于今年夏季对HPV疫苗指南修订的投票，不过，Caroline Litchfield认为，ACIP未来可能出台的相关建议，或许会对后续销售产生影响。受美国市场需求下滑影响，ProQuad（预防麻疹、腮腺炎、风疹和水痘‌）、MMR II（预防麻疹、腮腺炎和风疹）和Varivax（预防水痘）三款疫苗合并统计销售额为6.84亿美元，同比下降了3%。另一款肺炎球菌疫苗Vaxneuvance的销售额为2.26亿美元，下降了6%。不过，这一降幅已被美国CDC针对该疫苗的储备行动，以及RSV预防性抗体Enflonsia的业绩所抵消。当前或许不是推出新款疫苗的最好时机，但新上市的肺炎球菌疫苗Capvaxive的表现颇为亮眼：第三季度2.44 亿美元的销售额显著高于第二季度的1.29亿美元。Capvaxive是全球首款成人肺炎球菌疫苗，自去年10月该疫苗获美国CDC推荐50岁及以上人群使用以来，累计销售额已达5.3亿美元。 Capvaxive连同默沙东其他管线中的肺动脉高压药物 Winrevair（第三季度同比增长141%）、新的抗癌药物Welireg（第三季度同比增长42%），以及斥资100亿美元收购Verona Pharma时获得的慢阻肺药物Ohtuvayre，可能成为2028年Keytruda专利到期后新的增长引擎。辉瑞：新冠疫苗的挑战仍在持续在辉瑞财报重点提及的疫苗中，仅蜱传脑炎疫苗TicoVac在第三季度实现了销售额增长。新冠疫苗Comirnaty全球销售额同比下滑19%，为11.5亿美元。新冠疫苗销售下滑对辉瑞而言并非新挑战，自新冠从疫情期转向流行期后，Comirnaty和抗病毒药物Paxlovid便难以再达到疫情时期的销售水平。 Comirnaty近期表现不佳还因为受到了“美国新冠疫苗推荐范围收窄导致适用人群减少”的影响。8月底，辉瑞与BioNTech合作开发的更新版新冠疫苗获得了FDA的批准，但与此前的批准不同，更新版疫苗对多个年龄段人群的使用有限制，仅适用于有基础疾病的人群。刨除新冠疫苗的影响，辉瑞其他疫苗业务在第三季度的表现同样不太乐观。肺炎球菌疫苗Prevnar系列第三季度全球销售额为17亿美元,下降3%；RSV疫苗Abrysvo下降22%，为2.79亿美元。 Prevnar和Abrysvo的市场表现主要受到了美国市场的拖累，其在美国以外市场销售额均实现了增长，其中Abrysvo增幅达75%。在财报电话会议上谈及辉瑞疫苗业务时，辉瑞CEO Albert Bourla表示对美国以外市场的机会感兴趣，称其疫苗产品是国际市场的重点关注对象。针对Abrysvo在美国近期的困境，Albert Bourla坦言“的确面临目标人群接种意愿降低的阻力”，但Abrysvo在美国仍占据59%的市场份额，辉瑞将继续巩固其领先地位。他还提到，尽管第三季度Prevnar系列在美国的销售额下滑，但其在全球儿科肺炎球菌疫苗领域仍处于领先地位，在美国成人结合型肺炎球菌疫苗市场也保持领先。此外，新冠疫情可能发生起伏，Comirnaty的使用率也可能将随之变化。 mRNA双雄分野虽然上述四家MNC疫苗业绩下滑并不能全然归因于美国市场的变化，但或多或少均受到了美国市场的拖累。业界担忧，美国疫苗政策环境的持续变动或将产生全球性的潜移默化影响，为全球疫苗产业增添更多不确定性。这一趋势不仅体现在四家疫苗巨头的业绩变化之上，曾与之同台争辉的Moderna和BioNTech，其近况也可窥见一斑。 BioNTech率先转身，凭借新冠疫苗赚取的大量资金收购肿瘤药项目，构建“mRNA+IO+ADC”三轮驱动的肿瘤治疗管线，如今230多亿美元的市值已是Moderna的2倍有余。 Moderna则没那么幸运。过去一年间，美国卫生与公众服务部部长Robert F. Kennedy Jr.多次质疑mRNA疫苗的安全性和有效性，提出取消联邦政府为mRNA疫苗研究提供的资助，Moderna屡屡被其反疫苗言论及政策波及。如今Moderna正将研发重点转向肿瘤项目。11月20日，Moderna砍掉了3条mRNA疫苗管线，现有疫苗管线保留已获批或临近上市的产品，Moderna预计这些产品能使其在2028年实现收支平衡，后续将为肿瘤和罕见病项目的研发提供资金。为了在等待新增长点出现期间拥有充足的资金，Moderna近日向投资管理公司Ares Management贷款15 亿美元。拓展阅读多家MNC退出之际，Moderna加大在英国的投资编辑 | 姚嘉 yao.jia@PharmaDJ.com 总第2671期访问研发客网站，深度报道和每日新闻抢鲜看 www.PharmaDJ.com

财报疫苗高管变更

2025-10-13

·Business Wire

Pfizer to Highlight Advancements in Respiratory Health and Infectious Disease Research at IDWeek 2025

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE, “Pfizer”) will present data across its infectious disease portfolio at the upcoming IDWeek 2025 congress, held in Atlanta from October 19-22, 2025. Data in 46 abstracts from company- and collaborator-led studies will showcase significant advancements in preventing and treating infectious diseases. “IDWeek 2025 offers a critical opportunity to highlight our cutting-edge scientific progress and collaborate with global health experts in our ongoing battle against infectious diseases,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Vaccines Officer, Pfizer. “At Pfizer, we continue to prioritize innovation and rigorous data generation through clinical studies and real-world analysis supporting the vaccines and therapeutics for our infectious disease pipeline.” Presentations will include research from Pfizer’s diverse infectious disease portfolio, including COVID-19, respiratory syncytial virus (RSV), pneumococcal disease, Lyme disease, meningococcal disease, and other serious bacterial and viral infections. Details for the oral and poster presentations are below: Title/Abstract Number Presenting Name/Type Date/Time (ET) Location ORAL & LATE-BREAKING PRESENTATIONS Attitudes about COVID and Community Engagement with Patients (ACCEPt): Global Survey Reveals the Ongoing Impact of Long COVID-19 on Medically Vulnerable Populations, Five Years On R Paredes Oct 22 4:15 – 4:30PM B211-B212 Effectiveness of the JN.1-adapted BNT162b2 COVID-19 Vaccine in High-Risk Groups against Hospitalization in Europe: A Test-Negative Case-Control using the id.DRIVE Platform H Volkman Oct 21 1:45 – 3:00PM B401-B402 Real-world Abrysvo Vaccine Effectiveness (VE) against Respiratory Syncytial Virus (RSV)-related Lower Respiratory Tract Disease (LRTD) Hospitalizations and Emergency Department Admissions over Two RSV Seasons—Kaiser Permanente of Southern California (KPSC), October 2023–April 2025 S Tartof Oct 20 3:15 – 4:30PM B401-B402 Immunosuppression and RSV Prefusion F Protein Vaccine Effectiveness in Older Adults: A Prespecified sub analysis from the DAN-RSV Trial A Jensen Oct 20 3:15 – 4:30PM B401-B402 POSTER PRESENTATIONS COVID-19 COVID-19 vaccine uptake in children aged 1 - 4 years from state vaccine registry data through March 2024 T Ahi Oct 22 12:15 PM Poster Hall B4-5 Public Health and Economic Impact of Increased Uptake of an Additional Dose of Pfizer-BioNTech KP.2-Adapted COVID-19 Vaccine, 2024-2025 Formula, Among US Adults ≥ 65 Years of Age A Yehoshua 12:15 PM Poster Hall B4-5 Physician Perceptions and Decision-Making Factors in Prescribing COVID-19 Antivirals: Qualitative Research Findings M Fernandez 12:15 PM Poster Hall B4-5 Ibuzatrelvir Potently Reduced Viral RNA Levels Despite the High Rate of Anti-S Seropositivity: a Post Hoc Analysis of Serology in the Phase 2b Study in Adults Without Risk Factors for Severe COVID-19 JH Kim 12:15 PM Poster Hall B4-5 Inpatient Burden of Respiratory Syncytial Virus, COVID-19, or Influenza in the United States Among Children < 5 Years of Age K Andersen 12:15 PM Poster Hall B4-5 Severity of Omicron COVID-19 variants: a global systematic literature review D Malhotra 12:15 PM Poster Hall B4-5 COVID-19 Case Attack Rate Differences by Vaccination Status and Vaccine Effectiveness among US Nursing Home Residents, October 5, 2024 to January 5, 2025 F Khan 12:15 PM Poster Hall B4-5 Invasive Group B Streptococcus (GBS) Invasive Group B Streptococcus among hospitalized pregnant and postpartum women, 2016-2024: a Unites States database study S Willis 12:15 PM Poster Hall B4-5 Long-Term Healthcare Utilization and Expenditures for Infants with Invasive Bacterial Infections During Birth Hospitalizations K Schley 12:15 PM Poster Hall B4-5 Lyme Disease Risk Perception and Communication about Lyme Disease Prevention by Healthcare providers: A Mixed-Methods Study N Patel 12:15 PM Poster Hall B4-5 Gestational Lyme disease incidence and pregnancy-related outcomes among women in the United States, 2015-2024 S Willis 12:15 PM Poster Hall B4-5 Healthcare Costs Associated With Lyme Disease Among Medicare Fee-for-Service Beneficiaries in the United States: A Retrospective Claims-Based Study H Yu 12:15 PM Poster Hall B4-5 Meningococcal Disease Need for Broad Protection Against Invasive Meningococcal Disease Among US College Students J Presa 12:15 PM Poster Hall B4-5 Characterization of Factor H Binding Protein Expression for Neisseria meningitidis Serogroup B Isolates, 2015–2022 K Weiss 12:15 PM Poster Hall B4-5 Clinical Development of MenABCWY (PenbrayaTM), a Broadly Protective Pentavalent Meningococcal Vaccine L Zoloras 12:15 PM Poster Hall B4-5 Utility of the Pentavalent MenABCWY Meningococcal Vaccine (PenbrayaTM) Within Alternative US Meningococcal Vaccination Schedules J Presa 12:15 PM Poster Hall B4-5 Ten-year retrospective review of medical records at five hospitals in the United States highlights the potential for under-detection of invasive meningococcal disease F Angulo 12:15 PM Poster Hall B4-5 Awareness, Attitudes and Perceptions of Meningococcal Vaccines among Caregivers of Adolescents in the United States J Presa 12:15 PM Poster Hall B4-5 Pneumococcal Disease Re-evaluating economic & health impact of PCV20 in adults using real-world effectiveness data J Vietri 12:15 PM Poster Hall B4-5 Invasive pneumococcal pneumonia: is bacteremia the appropriate indication of severity? P Peyrani 12:15 PM Poster Hall B4-5 Variability in Case-Ascertainment Methodology and Rates of Adult Invasive Pneumococcal Disease using a US Healthcare Claims Database A Miles 12:15 PM Poster Hall B4-5 Temporal Trends in Rates of Hospitalized Pneumonia among US Adults and Residual Disparities by Race and Socioeconomic Status A Miles 12:15 PM Poster Hall B4-5 Demographic and Clinical Characteristics, by Pneumococcal Serotype, of Adults Hospitalized with Community Acquired Pneumonia in the US L Grant 12:15 PM Poster Hall B4-5 Differences in invasive pneumococcal disease clinical presentations and serotype distribution among children with and without underlying risk factors K Hulten 12:15 PM Poster Hall B4-5 Nasopharyngeal Colonization in South Texas Children Less Than 6 Years of Age With or Without Lower Respiratory Tract Infections K Hulten 12:15 PM Poster Hall B4-5 Real-world effectiveness of 20-valent pneumococcal conjugate vaccine among adults 65-74, 75-84, and ≥85 years of age in the United States A Miles 12:15 PM Poster Hall B4-5 Uptake and Series Completion with Pneumococcal Conjugate Vaccine by Social Determinants of Health among Children in the United States A Miles 12:15 PM Poster Hall B4-5 Influenza Symptom Burden During the First Week of Acute Influenza Infection Among US Adults: An Interim Analysis of a Nationwide Prospective Study during the 2024/25 Season T Hu 12:15 PM Poster Hall B4-5 The Burden of Influenza on Health-Related Quality of Life and Work Productivity During the First Week of infection Among US Adults: An Interim Analysis of a Nationwide Prospective Study T Hu 12:15 PM Poster Hall B4-5 The Socioeconomic Value of Adult Respiratory Vaccination in the United States: A Benefit-Cost Analysis T Hu 12:15 PM Poster Hall B4-5 Respiratory Syncytial Virus (RSV) How do recent population-level RSVpreF vaccine impact results from the United Kingdom relate to previously reported vaccine effectiveness results? N Aliabadi 12:15 PM Poster Hall B4-5 Bivalent RSV Prefusion F-Based Subunit Vaccine Recipients with Chronic Kidney Disease Achieved High Neutralizing Titers One Month After Vaccination F Rahman 12:15 PM Poster Hall B4-5 Immunogenicity and Safety of Bivalent Respiratory Syncytial Virus (RSVpreF) Vaccine In Non-Pregnant HIV Infected Older Adults T Mikati 12:15 PM Poster Hall B4-5 Estimating Risk of Guillain-Barré Syndrome in US Medicare-Enrolled Older Adults Following Medically Attended Respiratory Syncytial Virus Disease: A Self-Controlled Case Series Analysis C Liang 12:15 PM Poster Hall B4-5 Time to Testing, Diagnosis, and Hospitalization Among Pediatric and Adult Patients with RSV in Two Seasons: A Real-World Data Analysis using Electronic Health Records in US W Tang 12:15 PM Poster Hall B4-5 Time-Series Model Estimation of RSV-Attributable Respiratory Hospitalizations and Mortality in Adults in Finland C Liang 12:15 PM Poster Hall B4-5 Burden of Hospitalizations Due to Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of Age and Those with Congestive Heart Failure or Chronic Obstructive Pulmonary Disease Exacerbations A Tippett 12:15 PM Poster Hall B4-5 What if Adult RSV Vaccine Uptake in the US was High Like in Scotland? Missed Opportunities to Reduce Public Health and Economic Burden of RSV R Sato 12:15 PM Poster Hall B4-5 Strategies to promote adult vaccination against respiratory pathogens: a narrative literature review E Williams 12:15 PM Poster Hall B4-5 Attributes of Point-of-Care Nucleic Acid Amplification Tests for Respiratory Syncytial Virus (RSV): Results of a Systematic Literature Review K Date 12:15 PM Poster Hall B4-5 RSV Signs and Symptoms at Time of Hospitalization among Pediatric and Adult Population with RSV in Two Seasons: A Real-World Data Analysis using Electronic Health Records in US W Tang 12:15 PM Poster Hall B4-5 Tick-Borne Encephalitis (TBE) Tick-borne encephalitis (TBE) in international travelers and TBE vaccine recommendations for travelers to Europe F Angulo 12:15 PM Poster Hall B4-5 Prescribing Information for Pfizer Medicines Please see full Prescribing Information for ABRYSVO® (Respiratory Syncytial Virus Vaccine) or visit https://abrysvoadult.pfizerpro.com. Please see full Prescribing Information for COMIRNATY® (COVID-19 Vaccine, mRNA) or visit https://comirnatyhcp.com. Please see full Prescribing Information including BOXED WARNING for PAXLOVIDTM (Nirmatrelvir and Ritonavir) or visit https://paxlovid.pfizerpro.com. Please see full Prescribing Information for PREVNAR 20® (Pneumococcal 20-valent Conjugate Vaccine) or visit https://prevnar20.pfizerpro.com. Please see full Prescribing Information for PREVNAR 13® (Pneumococcal 13-valent Conjugate Vaccine). Please see full Prescribing Information for PENBRAYA® (Meningococcal Groups A, B, C, W, and Y Vaccine) or visit https://penbraya.pfizerpro.com. Please see full Prescribing Information for TRUMENBA® (Meningococcal Group B Vaccine) or visit https://trumenba.pfizerpro.com. Please see full Prescribing Information for TICOVAC™. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. DISCLOSURE NOTICE: The information contained in this release is as of October 13, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer’s infectious disease pipeline, in-line products and product candidates, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risk and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s infectious disease products and product candidates; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim and preliminary data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications, biologics license applications and/or emergency use authorization applications may be filed in any jurisdictions for any potential indication for Pfizer’s product candidates; whether and when any such applications that may be pending or filed for any of Pfizer’s product candidates may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether any such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pfizer’s products or product candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity; risks and uncertainties related to changes to vaccine or other healthcare policy in the U.S.; uncertainties regarding the ability to obtain or maintain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations, including uncertainties related to the potential impact of narrowing recommended patient populations; challenges related to public vaccine confidence or awareness; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

疫苗临床结果临床2期

100 项与蜱传脑炎疫苗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	蜱传脑炎疫苗	J07BA01	-

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
蜱传脑炎病毒感染	美国	Pfizer Manufacturing Ireland Unlimited Co.	2021-08-13

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临床结果

适应症

分期

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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


NCT04648241 (Pubmed) 人工标引	临床3期	蜱传脑炎病毒感染	164	Tick-borne encephalitis vaccine 0.5mL	艱構艱願襯醖簾壓鬱廠(範鹽鬱窪範齋製選構繭) = 壓鏇醖鬱鹹願夢範衊餘鏇繭膚餘範鹹鹹糧齋網 (夢齋顧製淵簾製觸顧願 ) 更多	积极	2024-04-12
NCT04648241 (Pubmed) 人工标引	临床3期	蜱传脑炎病毒感染	164	Tick-borne encephalitis vaccine 0.25mL	艱構艱願襯醖簾壓鬱廠(範鹽鬱窪範齋製選構繭) = 襯襯鏇憲壓蓋築窪憲夢鏇繭膚餘範鹹鹹糧齋網 (夢齋顧製淵簾製觸顧願 ) 更多	积极	2024-04-12
NCT04648241 (Phase 3 immunogenicity and safety study of a tick-borne encephalitis vaccine, CTgov)	临床3期	蜱传脑炎病毒感染	165	TBE vaccine (Adults (>=16 Years Old))	餘廠襯鹽構繭艱衊餘製 = 壓構觸憲壓襯艱淵壓夢遞廠齋壓廠鏇築窪膚構 (憲願鹽鑰淵窪艱築襯鹹, 獵顧製願糧顧膚觸壓繭 ~ 簾鬱鑰鑰蓋獵鹹範鹽繭) 更多	-	2023-11-22
	临床3期	蜱传脑炎病毒感染	165	TBE vaccine (Pediatric (1 to <16 Years Old))	餘廠襯鹽構繭艱衊餘製 = 齋窪艱遞簾選範糧廠醖遞廠齋壓廠鏇築窪膚構 (憲願鹽鑰淵窪艱築襯鹹, 築艱鏇齋餘鹽鹽構餘築 ~ 憲製顧壓醖鏇簾廠鹹遞) 更多	-	2023-11-22
NCT00894686 (Pubmed \| Vaccine)	临床4期	蜱传脑炎病毒感染	358	FSME-IMMUN	蓋鹽範蓋鏇鹽壓壓獵繭(顧窪構製餘築範窪廠遞) = 範鏇鏇簾築遞獵築鏇襯鹽網膚鹹觸醖膚選醖遞 (鬱襯鹹製積遞願選夢廠 ) 更多	-	2019-05-27
NCT00894686 (CTgov)	临床4期	蜱传脑炎病毒感染	179	FSME-IMMUN	壓積廠選淵壓鹽構壓淵 = 觸繭顧繭憲襯齋淵餘鑰繭壓餘壓艱夢築衊膚糧 (淵醖淵鑰製遞構鏇簾衊, 製廠艱願網鑰廠遞願餘 ~ 醖壓積範顧齋鹹憲鬱窪) 更多	-	2018-12-17