辉瑞和瓦尔内瓦宣布莱姆病疫苗候选者在第三阶段VALOR试验中显示出强大功效-动脉网

Pfizer and Valneva Announce Lyme Disease Vaccine Candidate Demonstrates Strong Efficacy in Phase 3 VALOR Trial

辉瑞等信源发布 2026-03-23 19:29



可切换为仅中文







Vaccine candidate PF-07307405 (LB6V) demonstrated more than 70% efficacy in preventing Lyme disease in individuals aged five years and above

疫苗候选物PF-07307405（LB6V）在预防五岁及以上人群莱姆病方面显示出超过70%的有效性。

The investigational vaccine candidate was well tolerated with no safety concerns identified at time of analysis

研究性疫苗候选者在分析时被良好耐受，未发现安全问题。

Overall, results strengthen confidence in the vaccine candidate and Pfizer is planning submissions to regulatory authorities

总体而言，结果增强了人们对这种疫苗候选者的信心，辉瑞正计划向监管机构提交申请。

NEW YORK & LYON, France--(BUSINESS WIRE)--

纽约和法国里昂——（BUSINESS WIRE）——

Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced topline results from the Phase 3 VALOR “Vaccine Against Lyme for Outdoor Recreationists” clinical trial (

辉瑞公司（纽约证券交易所代码：PFE）和瓦尔内瓦SE（纳斯达克代码：VALN；泛欧巴黎交易所代码：VLA）今天宣布了第三阶段VALOR“针对户外活动者的莱姆病疫苗”临床试验的初步结果 (

NCT05477524

) of its investigational 6-valent OspA-based Lyme disease vaccine candidate PF-07307405 (LB6V, formerly known as VLA15) demonstrating:

) 其研究性六价基于OspA的莱姆病疫苗候选物PF-07307405（LB6V，之前称为VLA15）显示：

In the pre-specified analyses:

在预先指定的分析中：

Efficacy of 73.2% from 28 days post-dose 4 (season 2) in reducing the rate of confirmed Lyme disease cases compared to the placebo arm (95% CI 15.8, 93.5)

从第4剂（第2季节）后28天起，与安慰剂组相比，确诊莱姆病病例发生率降低的有效率为73.2%（95%置信区间15.8, 93.5）。

Efficacy of 74.8% from 1-day post-dose 4 (season 2) in reducing the rate of confirmed Lyme disease cases compared to the placebo arm (95% CI 21.7, 93.9)

从第2季第4剂次后1天起，与安慰剂组相比，确诊莱姆病病例发生率降低的有效率为74.8%（95%置信区间：21.7，93.9）。

Fewer than anticipated Lyme disease cases were accrued over the study period, and the pre-determined statistical criterion (95% confidence interval lower bound >20) was not met in the first pre-specified analysis (primary endpoint). Given the clinically meaningful efficacy and the fact that the 95% confidence interval lower bound was above 20 in the second pre-specified analysis, Pfizer is confident in the vaccine’s potential and is planning submissions to regulatory authorities..

研究期间累积的莱姆病病例少于预期，且在第一次预设分析（主要终点）中未达到预定的统计标准（95%置信区间下限>20）。然而，鉴于临床意义显著的有效性，并且在第二次预设分析中95%置信区间下限高于20，辉瑞公司对该疫苗的潜力充满信心，并计划向监管机构提交申请。

“Lyme disease can cause potentially serious consequences – where individuals and families face symptoms that can disrupt daily life, work, and long-term health – and there is currently no vaccine available,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Vaccines Officer, Pfizer. “The efficacy shown in the VALOR study of more than 70% is highly encouraging and creates confidence in the vaccine’s potential to protect against this disease that can be debilitating.”.

“莱姆病可能导致潜在的严重后果——患者及其家庭面临可能扰乱日常生活、工作和长期健康的症状——而目前尚无可用疫苗，”辉瑞公司高级副总裁兼首席疫苗官Annaliesa Anderson博士表示。“VALOR研究显示的超过70%的疗效非常令人鼓舞，并增强了我们对该疫苗预防这种可能致残的疾病潜力的信心。”

“These results bring us a step closer to our goal of delivering a much-needed vaccine to help protect against Lyme disease. We are grateful to our partner Pfizer for their strong commitment which we both share in developing this vaccine as quickly as possible”, said Thomas Lingelbach, CEO and Board member of Valneva..

“这些结果让我们距离实现提供一种迫切需要的疫苗以帮助预防莱姆病的目标更近了一步。我们感谢合作伙伴辉瑞的坚定承诺，我们都致力于尽快开发这种疫苗，”瓦尔内瓦公司首席执行官兼董事会成员托马斯·林格尔巴赫表示。

Developed in collaboration between Pfizer and Valneva

辉瑞和瓦尔内瓦合作开发

1,2

, the investigational 6-valent OspA-based Lyme disease vaccine is being evaluated for its efficacy, safety, tolerability, immunogenicity, and manufacturing lot consistency. The companies entered into a collaboration and license agreement in April 2020 for the co-development of PF-07307405 and for Pfizer to exclusively manufacture and commercialize PF-07307405, assuming regulatory success..

，这款基于6价OspA的在研莱姆病疫苗正在评估其有效性、安全性、耐受性、免疫原性以及生产批次的一致性。两家公司于2020年4月达成合作与许可协议，共同开发PF-07307405，并由辉瑞在监管成功的情况下独家制造和商业化PF-07307405。

2,3

About VALOR

关于VALOR

The VALOR trial is a multicenter, placebo-controlled, randomized, observer-blinded trial conducted at sites in areas of high incidence of Lyme disease across the U.S., Canada, and Europe.

VALOR 试验是一项多中心、安慰剂对照、随机、观察者盲法的试验，在美国、加拿大和欧洲高发莱姆病的地区进行。

Trial participants aged 5 years and older were randomized 1:1 into two trial groups and received four doses of either PF-07307405 or a saline placebo – one dose administered at months 0, 2, 5-9 followed by a fourth dose one year later, shortly before the start of the following Lyme disease season (season 2)..

试验中年龄在5岁及以上的参与者以1:1的比例随机分为两组，分别接种四剂PF-07307405或生理盐水安慰剂——第一剂在第0个月、第2个月、第5-9个月接种，随后在一年后，即下一个莱姆病季节（第二季）开始前不久接种第四剂。

About PF-07307405 (LB6V)

关于PF-07307405（LB6V）

There are currently no approved human vaccines for Lyme disease, and PF-07307405 is the Lyme disease vaccine candidate which has currently advanced the furthest along the clinical development timeline, with two pivotal Phase 3 trials completed. This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of .

目前尚无获准用于人类的莱姆病疫苗，而PF-07307405是目前在临床开发时间线上进展最快的莱姆病疫苗候选者，已完成两项关键的III期试验。这款在研的多价蛋白亚单位疫苗采用一种已确立的作用机制，针对的是莱姆病疫苗的外表面蛋白A（OspA）。

Borrelia burgdorferi

伯氏疏螺旋体

, the bacteria that cause Lyme disease. When a person is immunized with PF-07307405, their body creates antibodies against six

，引起莱姆病的细菌。当一个人接种PF-07307405疫苗后，他们的身体会产生针对六种抗原的抗体

Borrelia

伯氏疏螺旋体

OspA serotypes. As the tick feeds on the vaccinated person, these antibodies are ingested by the tick as part of its blood meal. Binding of vaccine-induced antibodies to OspA on

OspA血清型。当蜱虫叮咬接种过疫苗的人时，这些抗体作为蜱虫吸食血液的一部分被摄入。疫苗诱导的抗体与OspA结合

Borrelia

伯氏疏螺旋体

inside the tick inhibits the bacterium’s ability to leave the tick, preventing it from being transmitted to the human host. The vaccine candidate covers the six most prevalent OspA serotypes expressed by the

蜱虫内部抑制了细菌离开蜱虫的能力，防止其传播给人类宿主。该疫苗候选物涵盖了由

Borrelia burgdorferi

伯氏疏螺旋体

sensu lato species in North America and Europe.

广义上的北美和欧洲物种。

About Lyme Disease

关于莱姆病

Lyme disease is a systemic infection caused by

莱姆病是一种由以下原因引起的全身性感染

Borrelia burgdorferi

伯氏疏螺旋体

sensu lato bacteria that are transmitted to humans by the bite of infected

广义上的细菌，通过受感染的叮咬传播给人类

Ixodes

蜱属

ticks.

刻度。

It is considered the most common vector-borne illness in the Northern Hemisphere.

它被认为是北半球最常见的虫媒传播疾病。

4,5

4，5

The Centers for Disease Control and Prevention (CDC) has estimated that approximately 476,000 people in the U.S. are diagnosed and treated each year and 132,000 cases are reported annually in Europe from countries with surveillance systems.

美国疾病控制与预防中心 (CDC) 估计，美国每年约有 476,000 人被诊断和治疗，而欧洲拥有监测系统的国家每年报告的病例为 132,000 例。

Early symptoms of Lyme disease (such as a gradually expanding erythematous rash called erythema migrans or other nonspecific symptoms like fatigue, fever, headache, mild stiff neck, muscle and joint pains) are often overlooked or misinterpreted. Left untreated, the disease can disseminate and cause more serious chronic complications affecting the skin, joints (arthritis), the heart (carditis) or the nervous system..

莱姆病的早期症状（如逐渐扩大的红斑，称为游走性红斑，或其他非特异性症状，如疲劳、发烧、头痛、轻度颈僵硬、肌肉和关节疼痛）常常被忽视或误判。如果不及时治疗，该疾病可能会扩散并引发更严重的慢性并发症，影响皮肤、关节（关节炎）、心脏（心肌炎）或神经系统。

6,7

The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens.

随着该疾病的地理覆盖范围不断扩大，对莱姆病疫苗接种的医疗需求也在稳步增加。

About Pfizer: Breakthroughs That Change Patients’ Lives

关于辉瑞：改变患者生活的突破性进展

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.

在辉瑞，我们运用科学和全球资源，为人们带来能够延长生命并显著改善生活的疗法。我们努力在医疗保健产品的发现、开发和生产过程中，为质量、安全性和价值设定标准，包括创新药物和疫苗。

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.

每天，辉瑞的同事们都在发达市场和新兴市场开展工作，以促进健康、预防、治疗和攻克当今最令人恐惧的疾病。作为全球首屈一指的创新型生物制药公司之一，我们与医疗保健提供者、政府和当地社区合作，支持并扩大全球可靠、负担得起的医疗保健的可及性。

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 .

175 年来，我们一直努力为我们所服务的所有人带来改变。我们经常在我们的网站上发布可能对投资者重要的信息。

www.Pfizer.com

. In addition, to learn more, please visit us on

此外，要了解更多信息，请访问我们

www.Pfizer.com

and follow us on X at

关注我们在X平台上的账号

@Pfizer

@辉瑞

and

和

@Pfizer News

辉瑞新闻

，

领英

，

YouTube

and like us on Facebook at

并在Facebook上点赞关注我们

Facebook.com/Pfizer

Facebook.com/辉瑞

。

About Valneva SE

关于Valneva SE

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions..

我们是一家专业疫苗公司，致力于开发、生产和商业化针对未满足医疗需求的传染病预防疫苗。我们采取高度专业化和针对性的方法，运用我们在多种疫苗模式上的深厚专业知识，专注于提供首例、最佳或唯一的疫苗解决方案。

We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines. Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline.

我们有着强大的业绩记录，已将多种疫苗从早期研发推进到获批，并且目前市场上有三种自主研发的旅行疫苗。我们不断增长的商业业务收入有助于推动疫苗管线的持续发展。

More information is available at .

更多信息可访问。

www.valneva.com

。

Pfizer Disclosure Notice

辉瑞披露声明

The information contained in this release is as of March 23, 2026. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

本新闻稿中的信息截至2026年3月23日。辉瑞不对因新信息或未来事件或发展而更新本新闻稿中包含的前瞻性声明承担任何义务。

This release contains forward-looking information about an investigational Lyme disease vaccine candidate, PF-07307405 (LB6V, formerly known as VLA15), and a collaboration between Pfizer and Valneva for PF-07307405, including their potential benefits, the results of the Phase 3 VALOR clinical trial and plans to proceed with regulatory submissions, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.

本新闻稿包含关于一种研究性莱姆病疫苗候选药物 PF-07307405（LB6V，以前称为 VLA15）以及辉瑞与 Valneva 就 PF-07307405 展开合作的前瞻性信息，包括其潜在益处、三期 VALOR 临床试验的结果以及推进监管提交的计划，涉及重大风险和不确定性，可能导致实际结果与这些声明所表达或暗示的内容存在重大差异。

Risks and uncertainties include, among other things, 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, as well as uncertainties regarding the future of the Lyme disease vaccine program; 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 applications may be filed in any jurisdictions for PF-07307405; whether and when any such applications 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 PF-07307405 will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial po.

风险和不确定性包括（除其他事项外）研发过程中固有的不确定性，包括达到预期临床终点的能力、我们临床试验的启动和/或完成日期、监管提交日期、监管批准日期和/或上市日期，以及出现不利的新临床数据和对现有临床数据进行进一步分析的可能性，同时关于莱姆病疫苗计划的未来也存在不确定性；临床试验数据可能受到监管机构不同解释和评估的风险；监管机构是否会对我们的临床研究设计和结果感到满意；是否以及何时会在任何司法管辖区为PF-07307405递交申请；是否以及何时会批准任何此类申请，这将取决于众多因素，包括确定产品的益处是否大于其已知风险，以及确定产品的疗效，并且如果获得批准，PF-07307405是否会在商业上取得成功；监管机构对标签、生产流程、安全性及/或其他可能影响产品可用性或商业潜力的事项所做出的决定。

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, 2025 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.

辉瑞公司截至2025年12月31日的财政年度的10-K表格年报以及其后续的10-Q表格报告中，特别是在标题为“风险因素”和“前瞻性信息及可能影响未来结果的因素”的部分，还有其后续的8-K表格报告中，均可以找到更多关于风险和不确定性的描述，所有这些文件均已提交给美国证券交易委员会。

Securities and Exchange Commission and available at .

证券交易委员会，可访问。

www.sec.gov

and

和

www.pfizer.com

。

Valneva Forward-Looking Statements

瓦尔内瓦前瞻性声明

This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future.

本新闻稿包含某些与Valneva业务相关的前瞻性声明，包括关于产品候选的研发、开发和临床试验的进展、时间、结果和完成情况。此外，即使Valneva的实际结果或发展与其在本新闻稿中的前瞻性声明一致，这些结果或发展在未来也可能无法持续。

In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements.

在某些情况下，您可以通过“可能”、“应该”、“也许”、“预期”、“预计”、“相信”、“意图”、“估计”、“目标”、“针对”或类似词语来识别前瞻性陈述。这些前瞻性陈述主要基于Valneva截至本新闻稿发布之日的当前预期，并受许多已知和未知的风险、不确定性及其他因素的影响，这些因素可能导致实际结果、表现或成就与这些前瞻性陈述中明示或暗示的任何未来结果、表现或成就存在重大差异。

In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection.

特别是，Valneva的预期可能受到以下因素的影响，其中包括：疫苗开发和生产过程中的不确定性和延迟、意外的临床试验结果、意外的监管行动或延迟、普遍的竞争、货币波动、全球及欧洲信贷危机的影响，以及获取或维持专利或其他专有知识产权保护的能力。

Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized..

临床前研究或早期临床试验的成功可能不能预示未来临床试验的结果。鉴于这些风险和不确定性，无法保证本新闻稿中作出的前瞻性陈述将会实现。

References

参考文献

Valneva and Pfizer Announce Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine, VLA15. April 2020. Available at:

瓦尔内瓦和辉瑞宣布合作共同开发和商业化莱姆病疫苗VLA15。 2020年4月。可在：

Valneva and Pfizer Announce Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine, VLA15 | Pfizer

瓦尔内瓦和辉瑞宣布合作共同开发和商业化莱姆病疫苗VLA15 | 辉瑞

. Accessed February 11, 2026.

访问日期：2026年2月11日。

Valneva and Pfizer Enter into Equity Subscription Agreement and Update Terms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15. June 2022. Available at:

瓦尔内瓦和辉瑞达成股权认购协议，并更新了莱姆病疫苗候选药物VLA15的合作协议条款。2022年6月。可用链接：

Valneva and Pfizer Enter into an Equity Subscription Agreement and Update Terms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15 | Pfizer

瓦尔内瓦和辉瑞达成股权认购协议并更新莱姆病疫苗候选VLA15的合作协议条款 | 辉瑞

. Accessed February 11, 2026.

访问日期：2026年2月11日。

Stanek G, Wormser GP, Gray J, Strle F. Lyme borreliosis. Lancet. 2012;379(9814):461-473. doi:10.1016/S0140-6736(11)60103-7.

斯坦内克 G，沃姆瑟 GP，格雷 J，斯特莱 F。莱姆疏螺旋体病。《柳叶刀》。2012；379（9814）：461-473。doi:10.1016/S0140-6736(11)60103-7。

Burn L, Tran TMP, Pilz A, Vyse A, Fletcher MA, Angulo FJ, et al. Incidence of Lyme borreliosis in Europe from national surveillance systems (2005–2020). Vector Borne Zoonotic Dis. 2023;23(4):156‑171. doi:10.1089/vbz.2022.0071

Burn L, Tran TMP, Pilz A, Vyse A, Fletcher MA, Angulo FJ, 等。欧洲莱姆疏螺旋体病发病率：基于国家监测系统的数据（2005-2020）。《媒介传播与人畜共通疾病》。2023；23(4):156-171。doi:10.1089/vbz.2022.0071

Kugeler KJ, Schwartz AM, Delorey MJ, Mead PS, Hinckley AF, et al. Estimating the frequency of Lyme disease diagnoses, United States, 2010-2018. Emerg Infect Dis. 2021;27(2):616-619. doi:10.3201/eid2702.202731

Kugeler KJ, Schwartz AM, Delorey MJ, Mead PS, Hinckley AF, 等。估算美国2010-2018年莱姆病诊断的频率。《新兴传染病》2021;27(2):616-619。doi:10.3201/eid2702.202731

Centers for Disease Control and Prevention. Signs and Symptoms of Untreated Lyme Disease. May 15, 2024. Available from:

疾病控制与预防中心。未治疗的莱姆病的体征和症状。2024年5月15日。来源：

https://www.cdc.gov/lyme/signs-symptoms/?CDC_AAref_Val=https://www.cdc.gov/lyme/signs_symptoms/index.html

. Accessed February 11, 2026.

访问日期：2026年2月11日。

Steere AC, Strle F, Wormser GP, Hu LT, Branda JA, Hovius JWR, et al. Lyme borreliosis. Nat Rev Dis Primers. 2016;2:16090. doi:10.1038/nrdp.2016.90.

Steere AC, Strle F, Wormser GP, Hu LT, Branda JA, Hovius JWR, 等。莱姆疏螺旋体病。《自然综述疾病导论》。2016；2：16090。doi:10.1038/nrdp.2016.90。

Centers for Disease Control and Prevention. Press Kit: Understanding Lyme and Other Tickborne Diseases. June 26, 2024. Available from:

疾病控制与预防中心。新闻资料包：了解莱姆病及其他蜱传疾病。2024年6月26日发布。来源：

https://www.cdc.gov/ticks/communication-resources/press-kit.html?CDC_AAref_Val=https://www.cdc.gov/ncezid/dvbd/media/lyme-tickborne-diseases-increasing.html

. Accessed February 11, 2026.

访问日期：2026年2月11日。

Pfizer Media Contacts:

辉瑞媒体联系人：

PfizerMediaRelations@Pfizer.com

辉瑞媒体关系@辉瑞.com

Pfizer Investor Relations:

辉瑞投资者关系：

IR@pfizer.com

Valneva Media Contacts:

瓦尔内瓦媒体联系人：

+33 (0)6 4516 7099