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.

EUCTR2017-002137-32-SE

/ Not yet recruiting临床2期IIT

Immunological responses after concomitant vaccination with the yellow fever-vaccine Stamaril and the TBE-vaccine FSME Immun, or JE-vaccine Ixiaro

开始日期2017-09-05

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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225

项与蜱传脑炎疫苗相关的文献（医药）

2024-12-31·Expert review of vaccines

Evidence for a 10-year TBE vaccine booster interval: an evaluation of current data

Review

作者: Torgler, Ralph ; Schelling, Jörg ; Einmahl, Suzanne ; Larsen, Carsten Schade

INTRODUCTION:

Tick-borne encephalitis (TBE) is rapidly spreading to new areas in many parts of Europe. While vaccination remains the most effective method of protection against the disease, vaccine uptake is low in many endemic countries.

AREAS COVERED:

We conducted a literature search of the MEDLINE database to identify articles published from 2018 to 2023 that evaluated the immunogenicity and effectiveness of TBE vaccines, particularly Encepur, when booster doses were administered up to 10 years apart. We searched PubMed with the MeSH terms 'Encephalitis, Tick-Borne/prevention and control' and 'Vaccination' for articles published in the English language.

EXPERT OPINION:

Long-term immunogenicity data for Encepur and real-world data on vaccine effectiveness and breakthrough infections following the two European TBE vaccines, Encepur and FSME-Immun, have shown that extending the booster interval from 3-5 years to 10 years does not negatively impact protection against TBE, regardless of age. Such extension not only streamlines the vaccination schedules but may also increase vaccine uptake and compliance among those living in endemic regions.

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 ; Spiessens, An ; Heyndrickx, Leo ; 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.

2024-09-01·VECTOR-BORNE AND ZOONOTIC DISEASES

Effectiveness of Vaccination Against Tick-Borne Encephalitis in the Czech Republic, 2018−2022

Article

作者: Bender, Cody ; Pilz, Andreas ; Erber, Wilhelm ; Edwards, Juanita ; Maly, Marek ; Madhava, Harish ; Krivohlavkova, Dagmar ; Zhang, Pingping ; Angulo, Frederick J. ; Vlckova, Iva ; Moïsi, Jennifer C. ; Harper, Lisa R. ; Kyncl, Jan ; Orlikova, Hana

Background: Tick-borne encephalitis (TBE) is caused by the tick-borne encephalitis virus (TBEV). TBEV infection can cause symptoms of central nervous system (CNS) inflammation and result in severe consequences including death. TBE is an increasing health threat in the Czech Republic and elsewhere in Europe. In 2020, 23% of 3734 TBE cases reported to the European Centre for Disease Prevention and Control were from the Czech Republic. TBE vaccination is universally recommended in the Czech Republic, but a full analysis of TBE vaccine effectiveness (VE) in the Czech Republic has not been published. Methods: TBE is a notifiable disease in the Czech Republic with mandatory reporting of cases (i.e., laboratory-confirmed TBEV infected patient with symptoms of CNS inflammation) and vaccination history to public health authorities. TBE VE was estimated using the screening method utilizing public health surveillance data from 2018 to 2022 and online household surveys of the general population on TBE vaccine uptake conducted in 2019-2022. Results: In 2018-2022, 3648 TBE cases were reported in the Czech Republic; 98.1% (3105/3166) of TBE cases with known vaccination history were unvaccinated. Among 42,671 persons surveyed from the general population who had known TBE vaccination history, 66.5% were unvaccinated. VE against TBE was 97.6% (95% confidence interval 95.7-98.7). When stratified by age group, VE was 97.1% (88.4-99.3) in 1-15 years of age, 97.9% (95.3-99.0) in 16-59 years of age, and 96.9% (90.5-99.0) in ≥60 years of age. TBE vaccination averted an estimated 1020 TBE cases in the Czech Republic from 2018 to 2022. Conclusions: This first published study with a full analysis of TBE VE in the Czech Republic showed that vaccination was highly effective for the prevention of TBE including in children, an age group with increasing TBE disease burden. Vaccination averted hundreds of TBE cases and hospitalizations despite the relatively low compliance with TBE vaccine recommendations. To prevent additional TBE cases in the Czech Republic, enhanced efforts to increase TBE vaccine uptake are needed.

项与蜱传脑炎疫苗相关的新闻（医药）

2022-10-08

·E药经理人

国产化、高端化，寡头垄断的格局中，中国疫苗企业如何突围？

全球疫苗行业已呈寡头垄断格局，但随着我国疫苗企业综合实力的不断提升，国产疫苗正走向国际市场，市场空间将进一步得到拓展。2020年新冠疫情在全球爆发，mRNA疫苗首次问世，在研发效率、保护效力等多方面展现出显著优势，以mRNA技术为代表的新兴疫苗技术有望带动整个疫苗产业的升级更迭。除了疾病预防，疫苗产品也向着疾病治疗领域拓展，成人疫苗治疗性疫苗进一步打开了疫苗行业的成长空间。全球疫苗行业呈寡头垄断格局，GSK、赛诺菲、默沙东和辉瑞四家公司的疫苗产品占据80%以上的市场份额。疫苗行业呈现出以品种驱动的特征，沛儿13、HPV4/9等重磅产品上市超过10年，年销售额依然位居前列，市场需求持续旺盛。据EvaluatePharma数据显示，2019年全球疫苗市场规模为326亿美元，剔除新冠疫苗的增量影响，市场规模将于2025年达到476亿美元，2020-2025年间复合增速预计为6.8%。2019年，我国非免疫规划苗市场规模达到425亿元，预计未来十年将实现12.2%的复合增长，于2030年达到1320亿元。新冠疫情以来，国内疫苗企业表现优秀，迅速研发上市多款新冠疫苗，2021年我国疫苗出口金额达157亿美元，我国疫苗企业为全球抗疫做出重要贡献，同时也展现出国内疫苗企业迅速壮大的研发实力，树立了良好的品牌形象。随着我国疫苗企业综合实力的不断提升，国产疫苗正走向国际市场，市场空间将进一步得到拓展。01全球疫苗市场稳定增长，行业呈寡头垄断格局据EvaluatePharma数据显示，2015-2019年间，全球疫苗市场维持增长态势，2019年市场规模约为326亿美元，同比增长6.9%。2020年新冠疫情在全球范围爆发，新冠疫苗陆续获批上市，受益于新冠疫苗的庞大增量贡献，全球疫苗市场近两年实现高增长。剔除新冠疫苗增量影响，随着疫苗接种率的提升、产品迭代更替以及疫苗向癌症等治疗领域的拓展，全球疫苗市场有望持续良好增长态势，预计到2025年全球疫苗市场规模将达到476亿美元，2020-2025年间复合增速预计为6.8%。全球疫苗市场规模资料来源：EvaluatePharma，东海证券研究所从疫苗产品销售额看，全球疫苗市场呈寡头垄断特点，葛兰素史克（GSK）、赛诺菲、默沙东和辉瑞四家公司的疫苗产品占据80%以上的市场份额。从疫苗产品销量看，印度血清研究所为全球最大的疫苗供应商，其以低价疫苗作为主要产品，主要面向中低收入国家和地区。从区域分布看，东南亚和非洲地区的疫苗采购量较大，但按照销售额统计，欧美发达国家虽然采购量不大，由于产品价格体系较高以及对优质疫苗的需求较大，从而占据全球疫苗市场70%以上的份额2020年全球疫苗市场竞争格局资料来源：WHO，前瞻产业研究院，东海证券研究所从疫苗品种看，2020年全球销量前十的产品全部由四家疫苗巨头公司生产，行业整体呈现以品种驱动的特征。辉瑞的13价肺炎球菌多糖结合疫苗、默沙东的HPV疫苗等重磅产品上市已超过十年，销售额依然位居前列。重磅产品的推出有望在上市后较长一段时间内保持良好竞争优势，为企业贡献稳定现金流。2020年全球疫苗销售前十产品资料来源：公开资料整理，东海证券研究所2020年新冠疫情在全球爆发，疫苗生产商纷纷开始新冠疫苗的研发和生产；2020年底，陆续有疫苗产品获批紧急使用，全球各国开始新冠疫苗的接种工作以应对新冠病毒的传播。mRNA疫苗在新冠疫情首次面世，其在研发速度、保护效力等多个方面展现出优于其他种类疫苗的良好优势；辉瑞的Comirnaty2021年实现368亿美元的销售收入，Moderna的Spikevax2021年实现177亿美元的销售收入。以mRNA技术为典型代表的新型疫苗技术近年来得到快速发展，未来有望逐步替代传统疫苗，成为主流技术。目前采用新型技术的疫苗产品较少，其安全性和免疫原性有待进一步观察和评估。随着研究的不断深入，新型疫苗在研发、生产、工艺等多方面也将不断改良与完善，从而带动整个疫苗产业的发展与更迭。02从辉瑞疫苗看国际疫苗巨头的发展辉瑞公司为疫苗领域四大巨头之一，手握重磅品种Prevenar13的同时，在此次新冠疫情中也通过与BioNTech合作成为mRNA新冠疫苗中的最大赢家。从辉瑞公司疫苗业务的发展史来看，战略合作和兼并收购成为公司发展壮大的重要举措。辉瑞制药成立于1849年，总部位于美国纽约，是一家全球大型制药企业，拥有医药保健、动物保健和消费者保健等多元化产品布局。2021年，辉瑞全球总销售收入为813亿美元，净利润为220亿美元。2000年，辉瑞以900亿美元收购华纳-兰伯特；2002年，又以600亿美元收购法玛西亚药厂。2009年，辉瑞以680亿美元收购惠氏，获得其生物制药技术和疫苗业务，自此进入疫苗领域；之后，惠氏的重磅系列产品Prevenar使得辉瑞跻身全球四大疫苗产商之一。2020年新冠疫情发生之后，辉瑞与BioNTech合作开发mRNA疫苗——Comirnaty/BNT162b2。从辉瑞近三年疫苗业务营收构成来看，2019年和2020年，疫苗产品总营收在65亿美元左右，占公司总营收的比重在15.90%。主要品种为肺炎疫苗Prevnar系列、脑膜炎球菌A、C、W135和Y群结合疫苗Nimenrix（该产品为2015年辉瑞向GSK收购项目所得）、蜱传脑炎疫苗FSME-IMMUN/TicoVac（该产品为2014年辉瑞对百特国际公司上市疫苗产品组合进行收购所得）以及B群脑膜炎球菌疫苗Trumenba。其中，近90%的销售收入都来自于Prevnar系列辉瑞Prevnar系列产品包括Prevnar13和Prevnar20（2013年之前还有Prevnar,为7价产品）。Prevnar13自2010年上市以来实现良好增长，被全球100多个国家纳入免疫规划。最高年份销售额突破60亿美元，多年居于疫苗产品榜首，被誉为“疫苗之王“，为辉瑞贡献了持续稳定的现金流。2020年，在进行新冠疫苗研发的过程中，辉瑞选择与具有mRNA疫苗技术平台的德国公司BioNTech合作。该产品前期的核心技术来自于BioNTech，后续产品的临床、生产和销售由辉瑞负责。在此之前，辉瑞已经与BioNTech就其他疫苗产品有过良好合作。Comirnaty/BNT162b2凭借优秀的临床数据顺利获批上市并且被众多国家政府采购，辉瑞凭借其丰富的运营和销售经验，使得Comirnaty/BNT162b2在2021年实现了368亿美元的销售收入，占2021年辉瑞总收入的45%。03高端化国产化国产疫苗开启国际化目前一些多联多价的优质产品只有国外产商供应，如四价、九价HPV疫苗、五价轮状病毒疫苗、DTaP-IPV/Hib五联苗、带状疱疹疫苗等；而国外生产商产品面向全球，供应给中国地区的量较少，因此会出现如国内九价HPV疫苗供不应求的现象。近年来，国内疫苗企业的研发力度加大，管线推进效率提升，陆续有重磅产品推出，沃森和康泰的13价肺炎疫苗陆续上市，对辉瑞的沛儿13形成良好替代；万泰和沃森的二价HPV疫苗顺利上市，尽管暂未对四价、九价HPV疫苗形成替代，但填补了国产宫颈癌疫苗的空白，与四价、九价HPV疫苗形成错位竞争。从国内企业在研管线看，四价HPV、九价HPV、DTaP-IPV/Hib五联苗、带状疱疹等外企独家品种都有所布局，并且部分已经进入到临床后期阶段，未来3-5年有望陆续上市。从产品质量上看，国产疫苗与进口疫苗并无明显差距；从价格上看，国产疫苗价格相对更低；从产能上看，国产疫苗产能稳定且充足。因此，面对外企的竞品，国产疫苗产品具备良好竞争实力。综合以上，国产疫苗正处于产品升级的过程中，未来会有越来越多的优质产品可供选择，消费属性进一步显现；随着国内企业在研产品的陆续推进，未来将逐步对现有外企独家产品产生替代，并凭借价格、产能等多方面的综合优势占据国内疫苗市场更大的市场份额。从我国疫苗出口情况看，据海关总署数据统计，2020年之前，我国疫苗出口数量在10万千克量级，出口金额在2亿美元以下；2021年受益于新冠疫苗增量，我国疫苗出口量达到500万千克，出口金额骤增至157亿美元。1987年，为了保证从不同渠道采购疫苗的安全性，WHO推出“疫苗预认证体系”；在此之后，疫苗产品要想进入联合国采购目录，必须经过WHO的“预认证”，而企业要想向WHO申请预认证，又有个重要的先决条件，即该国的疫苗监管体系必须通过WHO的认可。我国疫苗监管体系已于2011年、2014年先后两次通过评估，在2022年7月迎来了WHO升级评估标准后的新一轮全面评估，此次评估指标大幅增加、内容更加全面、标准更加严格。2022年8月23日，世卫组织宣布中国通过疫苗国家监管体系（NRA）评估。通过评估，不仅意味着中国拥有稳定、运行良好且完整统一的监管体系，能确保在中国生产、进口或流通的疫苗质量可控、安全、有效，也是我国疫苗出口全球的重要基础。2013年，中国生物旗下成都所生产的乙型脑炎减毒活疫苗成为首个通过WHO预认证的中国疫苗产品。WHO的预认证是疫苗企业走向海外的重要一步，据首个通过预认证的乙脑疫苗企业成都所的相关人员介绍，成都所从2006年起花了7年时间，投入近8亿元，建成了包括乙脑疫苗生产车间、spf动物生产车间等符合国际标准的厂房设施。截至目前，我国已有9款疫苗获得WHO预认证。新冠疫情发生后，世卫组织与全球疫苗免疫联盟和流行病防范创新联盟一起建立了新冠肺炎疫苗实施计划（COVAX），获得WHO紧急使用清单（EUL）的疫苗企业则有机会参与COVAX，实现产品出口。截至2021年底，我国累计向全球供应超过20亿剂新冠疫苗和原液；国药中生和科兴生物的新冠灭活疫苗纳入EUL之后，分别出口至全球超过100个国家和超过50个国家。我国疫苗企业在技术研发、产品布局、产能建设等多方面快速发展。2022年5月，100万剂沃森生物13价肺炎疫苗成功出口摩洛哥。随着综合实力的不断提高，国产疫苗有望逐步走向国际市场，成为面向全球的公共卫生产业。目前A股医药生物板块共有11家上市公司生产销售人用疫苗。从营收规模看，剔除其他业务和非自主生产疫苗产品之外，2021年自主研发疫苗产品营收规模最高的四家上市公司分别为智飞生物、康希诺、康泰生物和沃森生物。A股疫苗上市公司营收规模资料来源：Wind，东海证券研究所从产品管线看，除了智飞生物具有默沙东HPV疫苗、五价轮状疫苗等代理产品之外，其他公司的所有产品均为自主研发生产。从已上市且近几年获得批签发的疫苗产品来看，沃森生物、智飞生物和康泰生物产品种类较为丰富，其他公司产品较少且部分呈单品独大的特点，例如万泰生物的HPV2、成大生物和康华生物的狂犬疫苗、华兰生物和金迪克的流感疫苗等；康希诺的MCV2和MCV4分别于2021年年中和年末获批上市，目前暂未贡献收入。总体来看，除去新冠疫苗的影响，国内疫苗上市公司整体规模不大，除了沃森生物、智飞生物和康泰生物三家具有较为丰富的疫苗品种之外，其他疫苗公司尚处于依赖单品发展的阶段。文章编辑自东海证券《高端化国产化国际化，国内疫苗行业驶在快车道》登记邮箱信息订阅E药经理人信息服务扫描二维码精彩推荐集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中生 | 百济 | 石药 | 信达 | 君实 | 翰森 | 和黄医药 | 齐鲁 | 上海医药 | 复宏汉霖 | 康方生物 | 贝达 | 荣昌 | 科兴生物 | 泽璟制药 | 复星医药 | 海思科 | 再鼎 | 基石跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

疫苗信使RNA合作并购免疫疗法

2021-08-16

·Endpoints

Pfizer, US Army nab a new approval for a decades-old vaccine

It won’t make Pfizer even a minuscule fraction of what its other new vaccines have and will earn, but the New York drugmaker has gotten yet another inoculation approved by the FDA. Pfizer announced Monday that US regulators have OK’d Ticovac, the company’s vaccine for tick-borne encephalitis, a virus that infects the brain and nervous system and can sometimes cause long-term cognitive, skeletal or muscular effects. If you’ve never heard of tick-borne encephalitis, that’s likely because it essentially does not exist in the United States. From 2000 to 2017, the CDC recorded eight cases in the US, all from travelers who had spent time in China or Europe, where Ticovac has been approved since the 1970s. (China has its own home-grown vaccine, called SenTaiBao, as does Russia). The US approval comes after a years-long collaboration between Pfizer, which picked up the shot when it bought out Baxter’s vaccine unit for $635 million in 2014, and the US Army. Military service members stationed abroad make up the vast majority of US residents who receive Ticovac, but doing so can be cumbersome: It requires three different shots and the military member often needs to obtain clearance to leave base and travel to a different country for each of them. The US approval will hopefully mean that military members can receive doses while still in the US. Unlike its Covid-19 shot or the recently approved Prevnar 20 shot, the TicoVac OK won’t mean much for Pfizer’s bottom line: Last year, the company collected just $27 million from TicoVac sales. But it will help provide strong protection against the tick-borne virus: Estimates of TicoVac’s efficacy vary but tend to hover between 96% and 99%, about the best researchers can hope for in a vaccine. In an era of mRNA, it’s a reminder of just how effective old-fashioned technology can be. TicoVac is made from an inactivated virus, the same platform Jonas Salk used for polio. The approval also comes as tick-borne encephalitis becomes a broader issue. The CDC estimates that the virus has expanded its range over the last three years, likely due to a complex combination of causes, including both changes in climate and changes in how researchers diagnose and conduct surveillance.

疫苗信使RNA

2021-08-16

·BioSpace

FDA Gives Nod to Pfizer’s Tick-Borne Encephalitis Vaccine

This approval makes TICOVAC the only FDA-backed vaccine in the U.S. to protect people of all ages against the virus when visiting or living in TBE endemic regions. The U.S. Food and Drug Administration (FDA) has approved Pfizer’s tick-borne encephalitis (TBE) vaccine TICOVAC to prevent TBE in people aged 1 year and older. This approval makes TICOVAC the only FDA-backed vaccine in the U.S. to protect people of all ages against the virus when visiting or living in TBE endemic regions. TBE, a viral infection, is transmitted to humans via an insect bite. The infection, which affects the brain and spine, has been reported in over 35 countries across Asia and Europe but is not known to be endemic in the states. Recommendations from the European Centre for Disease Prevention and Control (ECDC) state that people who live or are traveling to endemic regions should receive TBE vaccination. Currently, experience with Pfizer’s TBE vaccine has been documented outside the U.S. for more than 45 years. Additionally, more than 170 million vaccine doses have been delivered to people since 1976. “We are proud to deliver the first vaccine to help protect people in the U.S. against TBE, if they are traveling to any risk areas,” said Pfizer’s global president of Vaccines, Nanette Cocero, Ph.D., in a statement . “This vaccine has helped to protect millions of people in TBE endemic regions since its first approval outside the U.S. 45 years ago. This authorization helps to ensure that people from the U.S. are also able to receive this vaccination if needed, reflecting our commitment to provide health for all.” The vaccine is marketed in Europe as FSME-Immun and TicoVac and in the U.S. as TICOVAC. The company says the vaccine was developed with “a master ‘seed’ virus that is similar to the TBE virus found in nature” and is capable of inducing “neutralizing antibodies against the natural TBE virus.” Clinical trials have assessed the safety and immunogenicity of the Pfizer TBE vaccine across patients aged 1 to 15 years as well as patients older than 16. Seropositivity rates after three doses were 99.5% in patients between 1 and 15 years and 98.7% to 100% in people older than 15 years. These studies also found TICOVAC was generally well-tolerated and corresponded with no unexpected side effects or serious adverse events related to the vaccine. Pfizer said after the FDA approval that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will soon discuss recommendations on the appropriate use of TICOVAC based on the available clinical evidence. On Thursday, the FDA also gave the amended Emergency Use Authorization for Pfizer and BioNTech’s COVID-19 vaccine, which allows a third booster shot for patients who are immunocompromised. The amendment specifically targets patients who have been diagnosed with illnesses considered “equivalent” to immunocompromising conditions as well as those who have received a solid organ transplant. News of the amendment arrive in the midst of rising cases attributable to the Delta variant. The CDC is also set to discuss additional recommendations for COVID-19 vaccine boosters in immunocompromised patients. These recommendations are expected sometime today. Amendments made to Pfizer and Moderna’s COVID-19 vaccine administration schedules were made after the FDA reviewed data that showed a booster shot, administered six months following the second dose, could offer increased protection for the immunocompromised. Additionally, the FDA states that people who are in close physical contact with these patients should also receive a booster shot. Featured Jobs on BioSpace

疫苗上市批准紧急使用授权

100 项与蜱传脑炎疫苗相关的药物交易

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

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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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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	製衊網觸齋積窪淵鬱醖(淵壓網鹽壓願膚憲夢憲) = 襯鏇襯製膚淵壓選築糧艱窪衊鏇窪鹽鏇衊獵憲 (壓窪鹽簾蓋膚膚鏇鏇網 ) 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	製衊網觸齋積窪淵鬱醖(淵壓網鹽壓願膚憲夢憲) = 簾憲鏇築夢窪鬱簾壓醖艱窪衊鏇窪鹽鏇衊獵憲 (壓窪鹽簾蓋膚膚鏇鏇網 ) 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))	艱鬱壓糧壓遞壓積壓獵 = 齋鬱願餘醖壓鏇鏇願糧鹹齋醖艱繭鑰鏇醖遞獵 (鏇網壓構製淵製餘積鹽, 鑰齋醖壓淵繭鏇廠鏇窪 ~ 遞餘選簾範鹽製製築糧) 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))	艱鬱壓糧壓遞壓積壓獵 = 淵網餘淵鹹鏇廠蓋壓糧鹹齋醖艱繭鑰鏇醖遞獵 (鏇網壓構製淵製餘積鹽, 鏇獵窪鹽範製築鏇廠積 ~ 憲艱壓齋簾構膚範獵憲) 更多	-	2023-11-22
NCT00894686 (Pubmed \| Vaccine)	临床4期	蜱传脑炎病毒感染	358	FSME-IMMUN	窪繭獵觸範簾壓積構醖(繭顧鹹觸繭鏇夢選餘蓋) = 醖觸夢蓋鏇鹹壓淵淵構選願淵衊艱糧膚壓構獵 (淵廠鏇鹹淵壓獵築淵夢 ) 更多	-	2019-05-27
NCT00894686 (CTgov)	临床4期	蜱传脑炎病毒感染	179	FSME-IMMUN	餘繭夢廠夢選淵蓋獵築 = 壓壓膚繭餘襯簾顧築獵顧範艱衊鑰築衊繭構顧 (繭獵選夢糧糧膚夢顧醖, 獵顧壓壓觸網築觸構遞 ~ 獵網鏇簾醖築顧製鹽糧) 更多	-	2018-12-17