Luis Jodar, Ph.D., Former Pfizer Chief Medical Officer for Vaccines and Infectious Diseases with Extensive Leadership Experience Across Clinical Development and Medical Affairs for Pneumococcal Conjugate Vaccines Prevnar 13 and Prevnar 20, Joins Vaxcyte as Chief Medical Officer

拥有肺炎球菌结合疫苗沛儿13和沛儿20在临床开发和医学事务方面丰富领导经验的前辉瑞公司疫苗与传染病首席医疗官Luis Jodar博士加入Vaxcyte，担任首席医疗官

David McAvoy, J.D., Former Teva Chief Legal Officer, Joins Vaxcyte as Chief Legal Officer

法学博士大卫·麦克沃伊，前梯瓦制药首席法务官，加入Vaxcyte担任首席法务官

Topline Safety, Tolerability and Immunogenicity Data from VAX-31 Adult Phase 3 OPUS-1 Pivotal Trial Expected by End of October 2026

VAX-31成人III期关键性OPUS-1试验的初步安全性、耐受性和免疫原性数据预计将于2026年10月底公布

SAN CARLOS, Calif., Sept. 03, 2026 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company, today announced the appointments of experienced industry leaders Luis Jodar, Ph.D. as Chief Medical Officer and David McAvoy, J.D. as Chief Legal Officer. The Company also announced that topline safety, tolerability and immunogenicity data from the VAX-31 adult Phase 3 OPUS-1 trial are now expected by the end of October, narrowing its previously communicated guidance of disclosing topline trial data in the fourth quarter of this year..

加利福尼亚州圣卡洛斯，2026年9月3日（环球电讯社）——临床阶段疫苗创新公司Vaxcyte, Inc.（纳斯达克股票代码：PCVX）今日宣布，任命经验丰富的行业领袖路易斯·霍达尔博士（Luis Jodar, Ph.D.）为首席医疗官，戴维·麦克沃伊法学博士（David McAvoy, J.D.）为首席法律官。该公司还宣布，预计将在10月底前公布来自VAX-31成人III期OPUS-1试验的顶层安全性、耐受性和免疫原性数据，这将此前公布的在今年第四季度披露顶层试验数据的指导范围进一步缩小。

“Luis and David join Vaxcyte at a pivotal time for the Company,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “Luis is one of the world’s foremost authorities on pneumococcal conjugate vaccines (PCVs), with nearly 20 years at Pfizer helping to lead the clinical development and medical affairs work behind the company’s foundational PCV franchise.

“路易斯和大卫在公司发展的关键时期加入Vaxcyte，”Vaxcyte首席执行官兼联合创始人格兰特·皮克林表示。“路易斯是全球肺炎球菌结合疫苗（PCV）领域最权威的专家之一，在辉瑞公司工作近20年，帮助领导了该公司核心PCV产品线的临床开发和医学事务工作。

He takes the helm of our clinical and medical organizations as we approach the OPUS-1 topline readout, now expected by the end of October, and prepare for the planned Biologics License Application (BLA) submission and potential launch. David has led legal organizations across the biopharmaceutical industry and spent decades counseling organizations through drug development, approval and commercialization.

在我们即将迎来OPUS-1的顶线数据读出（现预计于10月底公布）并为计划中的生物制品许可申请（BLA）提交及潜在上市做准备之际，他接管了我们的临床和医疗组织。David曾在生物制药行业领导多家法律组织，并在药物研发、审批和商业化方面为多家企业提供咨询，拥有数十年的经验。

These appointments deepen the leadership bench we are building to carry VAX-31 through to potential commercialization.”.

这些任命进一步夯实了我们正在打造的领导团队，以推动VAX-31走向潜在的商业化。

About Luis Jodar, Ph.D.

关于路易斯·霍达尔博士

Dr. Luis Jodar has more than 30 years of experience in vaccine development and launch across industry, international health organizations and academia. He spent 17 years at Pfizer Inc., most recently as Senior Vice President and Chief Medical Officer for Vaccines and Infectious Diseases, leading global medical and scientific functions and serving as a senior decision-maker in clinical development and regulatory strategy for programs including Prevnar 13.

路易斯·霍达尔博士在疫苗研发和上市方面拥有超过30年的经验，涉足业界、国际卫生组织以及学术界。他在辉瑞公司工作了17年，最近担任疫苗与传染病部门的高级副总裁兼首席医疗官，领导全球医学和科学职能，并在包括沛儿13（Prevnar 13）在内的多个项目的临床开发和监管战略中担任高级决策者。

®

®

, Prevnar 20

, 沛儿20

®

®

, Abrysvo

，Abrysvo

®

®

, Comirnaty

，Comirnaty

®

®

and Paxlovid

以及帕克斯洛维德

®

®

. Earlier, he helped lead the Meningitis Vaccine Project at the World Health Organization, which resulted in MenAfriVac

此前，他协助领导了世界卫生组织的脑膜炎疫苗项目，该项目促成了MenAfriVac疫苗的问世。

®

®

, now having reached over 400 million people across sub-Saharan Africa, and served as Deputy Director General of the International Vaccine Institute in Seoul. He holds a Ph.D. and a Doctor of Pharmacy from the Universidad Complutense de Madrid and completed postdoctoral research in Japan. Dr. Jodar has authored approximately 200 publications and served as the industry representative on the U.S.

，目前其工作已覆盖撒哈拉以南非洲超过4亿人口，并曾担任首尔国际疫苗研究所副所长。他拥有马德里康普卢滕塞大学的博士学位和药学博士学位，并在日本完成了博士后研究。霍达尔博士已发表约200篇著作，并曾在美国担任行业代表。

Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee..

美国食品药品监督管理局（FDA）疫苗及相关生物制品咨询委员会

About David McAvoy, J.D.

关于大卫·麦克沃伊，法学博士

Mr. McAvoy brings more than three decades of legal leadership in the biopharmaceutical industry to Vaxcyte. He joins the Company from Teva Pharmaceutical Industries Ltd., where he served as Executive Vice President and Chief Legal Officer, leading a 235-person legal, compliance and government affairs organization.

麦卡沃伊先生为Vaxcyte带来了在生物制药行业超过三十年的法律领导经验。他此前任职于梯瓦制药工业有限公司（Teva Pharmaceutical Industries Ltd.），担任执行副总裁兼首席法务官，领导一个由235人组成的法律、合规及政府事务团队。

Previously, he served as General Counsel and Chief Compliance Officer of Brickell Biotech, Inc., which he helped take public, and as General Counsel of Endocyte, Inc. through its $2.1 billion acquisition by Novartis AG leading to the successful launch of Pluvicto.

此前，他曾担任布里克尔生物科技公司（Brickell Biotech, Inc.）的总法律顾问兼首席合规官，并协助该公司上市；他还曾担任恩多赛特公司（Endocyte, Inc.）的总法律顾问，直至该公司以21亿美元被诺华集团（Novartis AG）收购，此举最终促成了Pluvicto的成功上市。

®

®

. Earlier, Mr. McAvoy spent 27 years at Eli Lilly and Company in senior legal roles, including General Counsel, International and FDA Senior Counsel, supporting the development, approval and launch of medicines across six therapeutic areas, among them Prozac

此前，麦卡沃伊先生在礼来公司（Eli Lilly and Company）担任高级法律职务长达27年，其中包括国际总法律顾问和美国食品药品监督管理局（FDA）高级法律顾问，支持六大治疗领域（包括百忧解）药物的开发、审批和上市。

®

®

and Cialis

以及希爱力

®

®

. He holds a Juris Doctor from the Indiana University Maurer School of Law, a Master of Science from the Indiana University School of Public and Environmental Affairs and a Bachelor of Arts from the University of Notre Dame.

他拥有印第安纳大学毛雷尔法学院的法律博士（J.D.）学位、印第安纳大学公共与环境事务学院的理学硕士（M.S.）学位，以及圣母大学的文学学士（B.A.）学位。

About the VAX-31 Adult Phase 3 OPUS Program

关于VAX-31成人三期OPUS计划

The VAX-31 adult Phase 3 program comprises three fully enrolled clinical trials, OPUS-1, OPUS-2 and OPUS-3, with 6,191 adults dosed in total, approximately 3,500 of whom received VAX-31. These studies, which were finalized in consultation and alignment with the FDA, are designed to generate a broad and robust safety, tolerability and immunogenicity dataset to support potential licensure for the prevention of invasive pneumococcal disease and pneumonia..

VAX-31 成人 III 期临床开发计划包括三项已完成入组的临床试验：OPUS-1、OPUS-2 和 OPUS-3，共有 6,191 名成人受试者接受给药，其中约 3,500 人接受了 VAX-31。这些研究在与美国食品药品监督管理局（FDA）协商并达成一致后完成，旨在生成广泛且稳健的安全性、耐受性和免疫原性数据，以支持其用于预防侵袭性肺炎球菌疾病和肺炎的潜在上市许可申请。

Anticipated OPUS Program milestones include:

预期的 OPUS 计划里程碑包括：

Announce topline safety, tolerability and immunogenicity data from the

公布安全性、耐受性和免疫原性的初步数据

OPUS-1

OPUS-1

Phase 3 pivotal, noninferiority trial by the end of October 2026.

到2026年10月底完成关键的第三阶段非劣效性试验。

Announce safety, tolerability and immunogenicity data from the

公布安全性、耐受性和免疫原性数据

OPUS-2

OPUS-2

and

和

OPUS-3

OPUS-3

Phase 3 trials in the first half of 2027.

2027年上半年进行三期临床试验。

About Vaxcyte

关于 Vaxcyte

Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. VAX-31, a 31-valent PCV candidate being evaluated in the OPUS Phase 3 adult clinical program and in a Phase 2 infant clinical program, is being developed for the prevention of invasive pneumococcal disease (IPD) and is the broadest-spectrum PCV candidate in the clinic today.

Vaxcyte 是一家疫苗创新公司，致力于设计高保真度疫苗，以保护人类免受细菌性疾病带来的危害。VAX-31 是一种 31 价肺炎球菌结合疫苗（PCV）候选产品，目前正在 OPUS 三期成人临床试验项目和二期婴儿临床试验项目中进行评估，旨在预防侵袭性肺炎球菌疾病（IPD），是当今临床在研中覆盖谱最广的 PCV 候选产品。

VAX-24, a 24-valent PCV candidate, has generated positive Phase 2 clinical results in both adults and infants and is designed to cover more serotypes than any PCV on-market. VAX-31 and VAX-24 are designed to improve upon standard-of-care PCVs by covering the serotypes in circulation that cause a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains.

VAX-24 是一种 24 价肺炎球菌结合疫苗（PCV）候选产品，已在成人和婴儿中取得积极的 II 期临床试验结果，其设计旨在覆盖比市面上任何 PCV 更多的血清型。VAX-31 和 VAX-24 旨在通过覆盖当前流行且导致相当比例侵袭性肺炎球菌疾病（IPD）、并与高病死率、抗生素耐药性及脑膜炎相关的血清型，同时保持对先前流行菌株的覆盖，从而改进现有标准护理 PCV。

VAX-XL, in earlier-stage development, also leverages the Company’s carrier-sparing, site-specific conjugation technology with the aim of further expanding coverage to deliver the broadest-spectrum candidate in the Company’s PCV franchise..

VAX-XL 处于早期开发阶段，同样利用公司的载体节省型、位点特异性偶联技术，旨在进一步扩大覆盖范围，以提供公司肺炎球菌结合疫苗（PCV）产品管线中谱系最广的候选疫苗。

VAX-A1 is a prophylactic vaccine candidate designed to provide broad, strain-independent protection against disease caused by Group A Strep and is currently being evaluated in a Phase 1 clinical study in adults. Group A Strep remains a significant global cause of morbidity and mortality across both adult and pediatric populations and is a leading driver of antibiotic use, underscoring the substantial public health burden..

VAX-A1 是一种预防性候选疫苗，旨在提供针对 A 组链球菌所致疾病的广泛、非菌株特异性保护，目前正在成人中开展 I 期临床研究。A 组链球菌仍然是导致全球成人和儿童发病率和死亡率的重要原因，也是抗生素使用的主要驱动因素，凸显了其沉重的公共卫生负担。

Vaxcyte is re-engineering the way highly complex vaccines are made through XpressCF

Vaxcyte 正在通过 XpressCF 技术重新构建高度复杂疫苗的生产方式

®

®

, its cell-free protein synthesis platform exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to develop and deliver high-fidelity vaccines with enhanced immunological benefits.

，其无细胞蛋白质合成平台已从Sutro Biopharma, Inc.获得独家授权。与传统的基于细胞的方法不同，该公司用于生产难以制造的蛋白质和抗原的系统旨在开发和提供具有高保真度且免疫学效益增强的疫苗。

Vaxcyte’s pipeline also includes VAX-GI, a vaccine candidate designed to prevent Shigella. For more information, visit .

Vaxcyte的管线还包括VAX-GI，这是一种旨在预防志贺氏菌病的候选疫苗。欲了解更多信息，请访问。

www.vaxcyte.com

www.vaxcyte.com

.

。

Forward-Looking Statements

前瞻性陈述

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to the potential benefits of Vaxcyte’s carrier-sparing platform and vaccine candidates, including breadth of coverage, the ability to deliver potentially best-in-class vaccines and improve upon the standard-of-care; the design, timing of initiation, progress and expected results of Vaxcyte’s clinical trials and regulatory plans, including the expected timing of the topline data readout from the OPUS-1 Phase 3 trial; the Company’s planned BLA submission for VAX-31; the anticipated contributions of the Company’s executive appointments; the future commercialization of Vaxcyte’s PCV programs; and other statements that are not historical fact.

本新闻稿包含1995年《私人证券诉讼改革法案》所定义的前瞻性陈述。这些陈述包括但不限于以下方面：Vaxcyte公司的载体节约型平台及其疫苗候选产品的潜在益处，包括覆盖范围的广度、提供潜在同类最佳疫苗的能力以及对现有标准治疗的改进；Vaxcyte临床试验的设计、启动时间、进展和预期结果，以及监管计划，包括OPUS-1 III期试验顶线数据读出的预期时间；公司计划提交的VAX-31生物制品许可申请（BLA）；公司高管任命所带来的预期贡献；Vaxcyte肺炎球菌结合疫苗（PCV）项目的未来商业化；以及其他非历史事实的陈述。

The words “anticipate,” “believe,” “could,” “expect,” “intend,” “plan,” “may,” “on track,” “potential,” “should,” “would” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

“anticipate”（预计）、“believe”（相信）、“could”（可能）、“expect”（预期）、“intend”（打算）、“plan”（计划）、“may”（或许）、“on track”（进展顺利）、“potential”（潜在的）、“should”（应当）和“would”（将）等词语及类似表述（以及其他涉及未来事件、状况或情形的词语或表述）均表明未来事件或结果存在不确定性，旨在标识前瞻性陈述，尽管并非所有前瞻性陈述都包含这些标识性词语。

These forward-looking statements are based on Vaxcyte’s current expectations and actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, including, without limitation, risks related to Vaxcyte’s product development programs, including development timelines, success and timing of chemistry, manufacturing and controls and related manufacturing activities, potential delays or inability to obtain and maintain required regulatory.

这些前瞻性陈述基于Vaxcyte当前的预期，由于存在各种风险和不确定性，实际结果及事件发生时间可能与前瞻性陈述中预期的情况存在重大差异，包括但不限于与Vaxcyte产品开发计划相关的风险，涉及开发时间表、化学、制造和控制（CMC）及相关制造活动的成功与否及其时间安排，以及获得和维持必要监管批准方面的潜在延迟或无法实现。

Contacts:

联系人：

Patrick Ryan, Executive Director, Corporate Affairs

帕特里克·瑞安，企业事务执行董事

Vaxcyte, Inc.

Vaxcyte公司

415-606-5135

415-606-5135

media@vaxcyte.com

media@vaxcyte.com

Jeff Macdonald, Executive Director, Investor Relations

杰夫·麦克唐纳，投资者关系执行董事

Vaxcyte, Inc.

Vaxcyte 公司

917-371-0940

917-371-0940

investors@vaxcyte.com

investors@vaxcyte.com