-- Company Expects to Announce Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series by the End of the First Quarter of 2025, Followed by Topline Data from Booster Dose by the End of 2025 --

--该公司预计在2025年第一季度末公布初级免疫系列的基线安全性、耐受性和免疫原性数据，然后在2025年底公布加强剂量的基线数据--

-- VAX-24, a 24-Valent Pneumococcal Conjugate Vaccine (PCV), is Designed to Cover More Serotypes Than Any Infant Pneumococcal Vaccine On-Market or in U.S. Clinics Today --

--VAX-24是一种24价肺炎球菌结合疫苗（PCV），旨在覆盖比目前市场上或美国诊所中任何婴儿肺炎球菌疫苗更多的血清型--

-- Company’s Potential Best-in-Class, Carrier-Sparing PCV Programs, VAX-24 and VAX-31, Intended to Deliver the Broadest-Spectrum of Coverage Against IPD --

--该公司潜在的同类最佳、节省运营商的PCV计划VAX-24和VAX-31，旨在针对IPD提供最广泛的覆盖范围--

SAN CARLOS, Calif., March 04, 2024 (GLOBE NEWSWIRE) --Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced the completion of enrollment in its Phase 2 study evaluating VAX-24, a broad-spectrum, carrier-sparing 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD), in healthy infants.

加利福尼亚州圣卡洛斯，2024年3月4日（环球通讯社）--Vaxcyte，Inc.（纳斯达克：PCVX），一家临床阶段疫苗创新公司，设计高保真疫苗以保护人类免受细菌性疾病的影响，今天宣布完成其评估VAX-24的第二阶段研究，VAX-24是一种广谱，携带者保留的24价肺炎球菌结合疫苗（PCV）旨在预防健康婴儿侵袭性肺炎球菌病（IPD）的候选人。

Vaxcyte expects to announce topline safety, tolerability and immunogenicity data from the Phase 2 study primary three-dose immunization series by the end of the first quarter of 2025, followed by topline data from the booster dose by the end of 2025..

Vaxcyte预计将在2025年第一季度末公布第二阶段研究初级三剂量免疫系列的基线安全性，耐受性和免疫原性数据，然后在2025年底公布加强剂量的基线数据。。

“Completing enrollment of the VAX-24 study with more than 800 healthy infants demonstrates yet another significant milestone in the development of our VAX-24 and VAX-31 PCV candidates,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “We believe VAX-24 has a potential best-in-class profile for this vital population and is designed to cover more serotypes than any infant pneumococcal vaccine on-market or in U.S.

Vaxcyte首席执行官兼联合创始人格兰特·皮克林（Grant Pickering）表示：“完成对800多名健康婴儿的VAX-24研究注册，证明了我们的VAX-24和VAX-31 PCV候选人发展的又一个重要里程碑。”。“我们认为VAX-24对于这一重要人群具有潜在的同类最佳特征，其血清型比市场上或美国的任何婴儿肺炎球菌疫苗都要多。

clinics today. We look forward to announcing the expected topline safety, tolerability and immunogenicity data from the primary immunization series by the end of the first quarter of 2025, which will follow participants receiving all three doses in this series, as well as the serology and data analsysis.”.

今天的诊所。我们期待着在2025年第一季度结束前公布初级免疫系列的预期topline安全性，耐受性和免疫原性数据，这将遵循参与者在本系列中接受所有三种剂量以及血清学和数据分析。”。

“Despite the effectiveness of current vaccines, IPD, which includes meningitis and bacteremia, remains persistent in the first years of life and is a leading cause of invasive disease in children two years of age and under,” said Jim Wassil, Executive Vice President and Chief Operating Officer of Vaxcyte.

Vaxcyte执行副总裁兼首席运营官吉姆·瓦西尔（JimWassil）表示：“尽管目前的疫苗有效，但包括脑膜炎和菌血症在内的IPD在生命的最初几年仍然持续存在，并且是两岁及以下儿童侵袭性疾病的主要原因。”。

“Given the significant burden of disease in young children, there remains a need for broader-spectrum vaccines like VAX-24 and VAX-31, our next-generation 31-valent PCV candidate, that are designed to provide greater protection than the current standard-of-care.”.

“鉴于幼儿的疾病负担沉重，仍然需要更广泛的疫苗，如VAX-24和VAX-31，我们的下一代31价PCV候选者，旨在提供比当前护理标准更大的保护。”。

About the VAX-24 Infant Phase 2 Study

关于VAX-24婴儿2期研究

The VAX-24 infant Phase 2 clinical study, which is now fully enrolled with 802 healthy infants, is a randomized, observer-blind, dose-finding two-stage clinical study evaluating the safety, tolerability and immunogenicity of VAX-24.

VAX-24婴儿2期临床研究现已完全纳入802名健康婴儿，是一项随机，观察者盲，剂量发现的两阶段临床研究，评估VAX-24的安全性，耐受性和免疫原性。

The Stage 1 portion of the study evaluated the safety and tolerability of a single injection of VAX-24 at three dose levels (low dose/1.1mcg, middle dose/2.2mcg, mixed dose/2.2mcg or 4.4mcg) and compared to VAXNEUVANCE™ (PCV15), which was the broadest-spectrum PCV at the time of study initiation, in 48 infants..

该研究的第一阶段评估了在三个剂量水平（低剂量/1.1mcg，中剂量/2.2mcg，混合剂量/2.2mcg或4.4mcg）下单次注射VAX-24的安全性和耐受性，并与48名婴儿的VAXNEUVANCE TM（PCV15）进行了比较，这是研究开始时频谱最广的PCV。。

The Stage 2 portion is evaluating the safety, tolerability and immunogenicity of VAX-24 at the same three dose levels and compared to Prevnar 20® (PCV20), currently the broadest-spectrum PCV recommended by the Advisory Committee on Immunization Practices (ACIP), in 754 infants.  Participants who received VAX-24 in Stage 1 will continue the standard dosing regimen as part of Stage 2 and will be included in the safety, tolerability and immunogenicity analysis of the study..

第二阶段部分是评估VAX-24在相同三个剂量水平下的安全性，耐受性和免疫原性，并与Prevnar 20®（PCV20）进行比较，Prevnar 20®（PCV20）是目前免疫实践咨询委员会（ACIP）推荐的最广泛的PCV，在754名婴儿中。在第一阶段接受VAX-24的参与者将继续标准给药方案作为第二阶段的一部分，并将纳入研究的安全性，耐受性和免疫原性分析。。

In line with recommendations from the ACIP, the study design includes a primary immunization series consisting of three doses given at two months, four months and six months of age, followed by a subsequent booster dose at 12-15 months of age, in conjunction with the other routinely recommended non-PCV vaccines on the infant immunization schedule..

根据ACIP的建议，研究设计包括一个初级免疫系列，包括在两个月，四个月和六个月大时给予三剂，然后在12-15个月大时给予随后的加强剂量，以及婴儿免疫计划中其他常规推荐的非PCV疫苗。。

The key prespecified immunogenicity study endpoints include an assessment of immune responses for all three VAX-24 doses and compared to PCV20 on the shared serotypes measured at 30 days post-dose three (PD3) and post-dose four (PD4). Immune responses will be assessed based on anti-pneumococcal polysaccharide serotype-specific immunoglobulin G (IgG) responses (proportion of participants achieving the accepted IgG threshold value of ≥0.35mcg/mL) at 30 days PD3 and IgG geometric mean titer ratios at 30 days PD4, among other immunogenicity endpoints..

关键的预先指定的免疫原性研究终点包括评估所有三种VAX-24剂量的免疫应答，并与在剂量三（PD3）和剂量四（PD4）后30天测量的共享血清型的PCV20进行比较。免疫反应将根据抗肺炎球菌多糖血清型特异性免疫球蛋白G（IgG）反应（参与者达到接受的IgG阈值≥0.35mcg/mL的比例）在30天PD3和30天PD4的IgG几何平均滴度比以及其他免疫原性终点进行评估。。

All participants in the study will be evaluated for safety through six months following the booster dose.

在加强剂量后的六个月内，将对研究的所有参与者进行安全性评估。

The study is being conducted at 32 sites in the United States.

这项研究正在美国的32个地点进行。

Additional information about the study can be found at www.clinicaltrials.gov under the identifier NCT05844423.

有关该研究的其他信息，请访问www.clinicaltrials.gov，标识符为NCT05844423。

About Pneumococcal Disease

关于肺炎球菌疾病

Pneumococcal disease (PD) is an infection caused by Streptococcus pneumoniae (pneumococcus) bacteria. It can result in IPD, including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media and sinusitis. In the United States, approximately 320,000 people get pneumococcal pneumonia each year, which is estimated to result in approximately 150,000 hospitalizations and 5,000 deaths.

肺炎球菌病（PD）是由肺炎链球菌（肺炎球菌）细菌引起的感染。它可导致IPD，包括脑膜炎和菌血症，以及非侵入性PD，包括肺炎，中耳炎和鼻窦炎。在美国，每年约有32万人患有肺炎球菌性肺炎，估计约有15万人住院，5000人死亡。

Pneumococci also cause over 50% of all cases of bacterial meningitis in the United States. Antibiotics are used to treat PD, but some strains of the bacteria have developed resistance to treatments. The morbidity and mortality due to PD are significant, particularly for young children and older adults, underscoring the need for a more broad-spectrum vaccine..

在美国，肺炎球菌也导致超过50%的细菌性脑膜炎病例。抗生素用于治疗帕金森病，但一些细菌菌株对治疗产生了耐药性。PD引起的发病率和死亡率很高，特别是对于幼儿和老年人，这强调了对更广谱疫苗的需求。。

About Vaxcyte’s PCV Franchise Candidates: VAX-24 and VAX-31

关于Vaxcyte的PCV特许经营候选人：VAX-24和VAX-31

Vaxcyte’s carrier-sparing PCV franchise candidates, including VAX-24, a Phase 3-ready 24-valent PCV, and VAX-31, the Company’s next-generation 31-valent PCV currently being evaluated in a Phase 1/2 study, are being studied for the prevention of IPD. The public health community continues to affirm the need for vaccines that offer broader protection to prevent IPD, which can be most serious for infants, young children, older adults and those with immune deficiencies or certain chronic health conditions..

Vaxcyte的运营商保留PCV特许经营候选人，包括VAX-24（一种3期就绪的24价PCV）和VAX-31（该公司的下一代31价PCV，目前正在进行1/2期研究评估），正在研究预防IPD。公共卫生界继续确认需要提供更广泛保护的疫苗来预防IPD，IPD可能对婴儿，幼儿，老年人以及免疫缺陷或某些慢性病患者最为严重。。

Both VAX-24 and VAX-31 are designed to improve upon the standard-of-care PCVs for both children and adults by covering the serotypes that are responsible for a significant portion of IPD in circulation and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains that are currently contained through continued vaccination practice.

VAX-24和VAX-31均旨在通过涵盖在循环中占IPD很大一部分且与高病死率，抗生素耐药性和脑膜炎相关的血清型，改善儿童和成人PCV的护理标准，同时保持目前通过持续接种疫苗的做法所包含的先前流行菌株的覆盖率。

Vaxcyte aims to efficiently create and deliver high-fidelity, broad-spectrum carrier-sparing conjugate vaccines in order to add coverage without compromising overall immune responses by using modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform.

Vaxcyte旨在通过使用现代合成技术（包括高级化学和XpressCF™无细胞蛋白质合成平台），有效创建和提供高保真，广谱载体保留的结合疫苗，以增加覆盖率而不损害整体免疫反应。

Vaxcyte is deploying this approach with VAX-24 and VAX-31, the latter of which has the potential to provide the broadest coverage of any PCV to reach the clinic with approximately 95 percent coverage of circulating IPD strains in the U.S. adult population..

Vaxcyte正在使用VAX-24和VAX-31部署这种方法，后者有可能为任何PCV提供最广泛的覆盖范围，以达到美国成年人群中约95%的循环IPD菌株覆盖率的诊所。。

In January 2023, Vaxcyte announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation to VAX-24 for the prevention of IPD in adults based on positive topline results from the Phase 1/2 proof-of-concept study, which evaluated the safety, tolerability and immunogenicity of VAX-24 in adults 18 to 64 years of age.

2023年1月，Vaxcyte宣布，美国食品和药物管理局根据1/2期概念验证研究的阳性结果，授予VAX-24突破性治疗指定，用于预防成人IPD，该研究评估了VAX-24在18至64岁成年人中的安全性，耐受性和免疫原性。

The Breakthrough Therapy designation process is designed to expedite the development and review of drugs and biologics that are intended to treat a serious or life-threatening condition, where preliminary clinical evidence indicates that the drug or biologic may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints..

突破性治疗指定过程旨在加速旨在治疗严重或危及生命的疾病的药物和生物制剂的开发和审查，初步临床证据表明该药物或生物制剂可能在一个或多个临床上显示出对现有疗法的显着改善。重要终点。。

About Vaxcyte

关于Vaxcyte

Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. Vaxcyte’s lead candidate, VAX-24, is a Phase 3-ready 24-valent, broad-spectrum, carrier-sparing PCV being developed for the prevention of IPD.

Vaxcyte是一家疫苗创新公司，设计高保真疫苗，以保护人类免受细菌性疾病的影响。该公司正在开发广谱结合物和新型蛋白质疫苗，以预防或治疗细菌性传染病。Vaxcyte的主要候选者VAX-24是一种3期就绪的24价广谱载波保留PCV，正在开发用于预防IPD。

VAX-31, the Company’s next-generation 31-valent PCV, is the broadest-spectrum PCV candidate in the clinic today..

VAX-31是该公司的下一代31价PCV，是目前临床上最广泛的PCV候选者。。

Vaxcyte is re-engineering the way highly complex vaccines are made through modern synthetic techniques, including advanced chemistry and the XpressCF™ 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 accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits.

Vaxcyte正在重新设计通过现代合成技术制造高度复杂疫苗的方式，包括高级化学和XpressCF™无细胞蛋白质合成平台，该平台仅由Sutro Biopharma，Inc.授权。与传统的基于细胞的方法不同，该公司生产难以制造的蛋白质和抗原的系统旨在加速其高效生产和提供具有增强免疫益处的高保真疫苗的能力。

Vaxcyte’s pipeline also includes VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine candidate designed to prevent Shigella. Vaxcyte is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked.

Vaxcyte的管道还包括VAX-A1，一种旨在预防a组链球菌感染的预防性候选疫苗；VAX-PG是一种治疗性候选疫苗，旨在减缓或阻止牙周病的进展；和VAX-GI，一种旨在预防志贺菌的候选疫苗。Vaxcyte致力于根除或治疗侵袭性细菌感染，如果不加以控制，会产生严重且昂贵的健康后果。

For more information, visit www.vaxcyte.com..

有关更多信息，请访问www.vaxcyte.com。。

Forward-Looking Statements

前瞻性声明

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 VAX-24 and VAX-31, including breadth of coverage, the ability to deliver a potentially best-in-class PCV franchise and the improvement upon the standard-of-care; the timing and availability of data for the VAX-24 infant Phase 2 study; the demand for Vaxcyte’s vaccine candidates; the potential benefits and opportunities available as a result of the Breakthrough Therapy designation for VAX-24 in adults; 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》所指的前瞻性声明。这些声明包括但不限于与VAX-24和VAX-31潜在益处相关的声明，包括覆盖范围广，提供潜在最佳PCV特许经营权的能力以及护理标准的改进；VAX-24婴儿2期研究数据的时间和可用性；对Vaxcyte候选疫苗的需求；成人VAX-24突破性治疗指定的潜在益处和机会；以及其他非历史事实的陈述。

The words “anticipate,” “believe,” “could,” “expect,” “intend,” “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.

“预期”、“相信”、“可能”、“预期”、“打算”、“可能”、“正在进行中”、“潜在”、“应该”、“会”等词语和类似表达（以及其他涉及未来事件、条件或情况的词语或表达）传达了未来事件或结果的不确定性，旨在识别前瞻性陈述，尽管并非所有前瞻性陈述都包含这些识别词。

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 approvals for its vaccine candidates, and the risks and uncertainties inherent with preclinical and clinical development processes; the success, cost and timing of all d.

这些前瞻性陈述基于Vaxcyte当前的预期和实际结果，由于风险和不确定性，事件发生的时间可能与这些前瞻性陈述中预期的时间有重大差异，包括但不限于与Vaxcyte产品开发计划相关的风险，包括开发时间表、成功和化学时间，制造和控制以及相关的制造活动，潜在的延误或无法获得和维持其候选疫苗所需的监管批准，以及临床前和临床开发过程固有的风险和不确定性；所有d的成功，成本和时机。

Contacts:

联系人：

Janet Graesser, Vice President, Corporate Communications and Investor Relations

Janet Graesser，公司传播和投资者关系副总裁

Vaxcyte, Inc.

Vaxcyte, Inc.

917-685-8799

917-685-8799

media@vaxcyte.com

media@vaxcyte.com

Jennifer Zibuda, Senior Director, Investor Relations

Jennifer Zibuda，投资者关系高级总监

Vaxcyte, Inc.

Vaxcyte, Inc.

860-729-8902

860-729-8902

investors@vaxcyte.com

investors@vaxcyte.com