欧盟委员会（EC）批准默克公司的CAPVAXIVE®（21价肺炎球菌结合疫苗）用于预防成人侵袭性肺炎球菌疾病和肺炎球菌性肺炎-动脉网

European Commission (EC) Approves Merck’s CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults

默沙东等信源发布 2025-03-27 15:01

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March 26, 2025 7:45 am ET

2025年3月26日上午7点45分（美国东部时间）

EC decision marks the fourth approval for CAPVAXIVE for pneumococcal vaccination in adults

欧洲委员会的决定标志着CAPVAXIVE在成人肺炎球菌疫苗接种方面获得了第四次批准。

RAHWAY, N.J.--(BUSINESS WIRE)--

新泽西州拉威市--（商业资讯）--

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the European Commission (EC) has approved CAPVAXIVE

默克公司（纽约证券交易所代码：MRK），在美国和加拿大以外地区称为MSD，今天宣布欧洲委员会（EC）已批准CAPVAXIVE。

(Pneumococcal 21-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by

用于主动免疫，预防由以下病原体引起的侵袭性疾病和肺炎的21价结合疫苗（肺炎球菌21价结合疫苗）

Streptococcus pneumoniae

肺炎链球菌

serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older. CAPVAXIVE is a pneumococcal vaccine specifically designed to help protect adults from the serotypes responsible for the majority of invasive pneumococcal disease (IPD) cases.

3、6A、7F、8、9N、10A、11A、12F、15A、15B、15C、16F、17F、19A、20A、22F、23A、23B、24F、31、33F 和 35B 型在 18 岁及以上个体中。CAPVAXIVE 是一种肺炎球菌疫苗，专门设计用于帮助成年人预防导致大多数侵袭性肺炎球菌病 (IPD) 病例的血清型。

The EC approval of CAPVAXIVE is based on safety and immunogenicity data from the Phase 3 STRIDE clinical program..

欧盟对CAPVAXIVE的批准是基于三期STRIDE临床项目的安全性和免疫原性数据。

This decision authorizes the marketing of CAPVAXIVE in all 27 European Union (EU) member states, as well as Iceland, Liechtenstein and Norway. The timing for availability of CAPVAXIVE in individual countries will depend on multiple factors, including the completion of reimbursement procedures. CAPVAXIVE was approved in the U.S.

该决定授权在所有 27 个欧盟 (EU) 成员国以及冰岛、列支敦士登和挪威销售 CAPVAXIVE。CAPVAXIVE 在各个国家的可用时间将取决于多种因素，包括报销程序的完成情况。CAPVAXIVE 已在美国获批。

in June 2024, in Canada in July 2024, and in Australia in January 2025..

2024年6月在加拿大，2024年7月在澳大利亚，2025年1月在澳大利亚。

“Pneumococcal disease continues to pose a significant risk for adults in Europe, among adults who are 65 or older, and also among younger adults who are immunocompromised or have chronic medical conditions,” said Dr. Lina Pérez Breva, Vaccine Research, Fisabio - Public Health, Valencia, Spain. “Based on data from the Phase 3 STRIDE clinical program, CAPVAXIVE offers coverage against the serotypes responsible for the majority of invasive disease cases in adults, making this approval in the EU an important step in helping to protect adults from pneumococcal disease.”.

“肺炎球菌病继续对欧洲的成年人构成重大风险，尤其是65岁及以上的成年人，以及免疫功能低下或患有慢性疾病的年轻成年人，”西班牙瓦伦西亚Fisabio公共卫生疫苗研究所的莉娜·佩雷斯·布雷瓦博士表示。“基于三期STRIDE临床试验项目的数据，CAPVAXIVE提供了针对大多数成人侵袭性病例致病血清型的覆盖，因此在欧盟的这项批准是帮助保护成人免受肺炎球菌病的重要一步。”

“By focusing on the serotypes that have been responsible for an increasing proportion of adult invasive pneumococcal disease cases, CAPVAXIVE allows us to offer protection specifically designed for adults,” said Dr. Paula Annunziato, senior vice president, infectious diseases and vaccines, Global Clinical Development, Merck Research Laboratories.

“通过专注于那些在成人侵袭性肺炎球菌病病例中占比不断增加的血清型，CAPVAXIVE使我们能够提供专门为成人设计的保护，”默克研究实验室全球临床开发部高级副总裁、传染病和疫苗部门的保拉·安农齐亚托博士说道。

“We are proud to bring CAPVAXIVE to adults in Europe who may benefit from its broad protection and are eager to continue working with regulatory authorities to expand CAPVAXIVE availability worldwide.”.

“我们很自豪能够将CAPVAXIVE带给欧洲可能受益于其广泛保护的成年人，并期待继续与监管机构合作，以扩大CAPVAXIVE在全球的可用性。”

European Union country-level data have demonstrated that the serotypes covered by CAPVAXIVE are responsible for more cases of IPD in adults compared to PCV20 (pneumococcal 20-valent conjugate vaccine), as shown in these selected four countries:

欧盟国家层面的数据表明，与PCV20（肺炎球菌20价结合疫苗）相比，CAPVAXIVE所覆盖的血清型在成人中导致更多的IPD病例，如下所示的四个选定国家：

Coverage of Serotypes Responsible for IPD in Select EU Countries

欧盟部分国家IPD相关血清型覆盖情况

Country

国家

Age

年龄

Year Reported

报告年度

CAPVAXIVE

PCV20

Germany

德国

≥60

2020

~84%

~58%

约58%

France

法国

>65

2022

~85%

~63%

Italy

意大利

>65

2023

~77%

约77%

~64%

Spain

西班牙

>65

2020

~82%

~62%

Data were included for select countries based on EU membership, population size and the most recent year reported. These values are based on country-level epidemiologic data and regional variations may exist; they do not reflect the efficacy of the respective vaccines. There are currently no studies comparing the efficacy of CAPVAXIVE and PCV20..

基于欧盟成员国身份、人口规模和最近报告的年份，选定了部分国家的数据。这些数值基于国家级流行病学数据，可能存在地区差异；它们并不反映相应疫苗的效力。目前尚无比较CAPVAXIVE和PCV20效力的研究。

The decision by the EC follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use released in

欧盟委员会的决定遵循了欧洲药品管理局人用药品委员会发布的积极建议。

January 2025

2025年1月

and was based on results from the pivotal Phase 3 STRIDE-3 trial (

并且基于关键的第三阶段STRIDE-3试验的结果 (

NCT05425732

), which evaluated CAPVAXIVE compared to PCV20 in adults 18 years of age and older who had not previously received a pneumococcal vaccine, and STRIDE-10 (

），该研究在18岁及以上未曾接种过肺炎球菌疫苗的成人中比较了CAPVAXIVE与PCV20的效果，并且STRIDE-10（

NCT05569954

), which compared CAPVAXIVE to PPSV23 (pneumococcal vaccine, polyvalent [23-valent]) in adults 50 years of age and older who had not previously received a pneumococcal vaccine. The approval is also supported by results from the Phase 3 STRIDE-4 (

），该研究在50岁及以上未曾接种过肺炎球菌疫苗的成人中，将CAPVAXIVE与PPSV23（23价肺炎球菌多价疫苗）进行了比较。此次批准还得到了3期临床试验STRIDE-4（

NCT05464420

), STRIDE-5 (

), 步幅-5 (

NCT05526716

), STRIDE-6 (

), 步幅-6 (

NCT05420961

), and STRIDE-7 (

），以及STRIDE-7（

NCT05393037

) trials (see “Clinical data supporting EC approval” below, for additional details).

）试验（详见下文“支持欧盟批准的临床数据”，了解更多信息）。

Clinical data supporting EC approval

支持欧洲委员会批准的临床数据

CAPVAXIVE was approved by the EC based on data that included Phase 3 clinical studies designed to evaluate its safety and immunogenicity in a variety of adult populations. These included:

CAPVAXIVE 获得欧洲委员会（EC）批准是基于包括旨在评估其在各类成人群体中的安全性和免疫原性的 3 期临床研究数据。这些研究包括：

STRIDE-3 (

NCT05425732

): A double-blind, Phase 3 study which evaluated CAPVAXIVE compared to PCV20 in individuals 18 years of age and older who had not previously received a pneumococcal vaccine. Participants 50 years of age and older were enrolled in cohort 1 (n=2,362), and participants 18 through 49 years of age were enrolled in cohort 2 (n=300).

): 一项双盲、III 期研究，评估了CAPVAXIVE与PCV20在18岁及以上未接种过肺炎球菌疫苗的人群中的效果。50岁及以上的参与者被纳入队列1（n=2,362），18至49岁的参与者被纳入队列2（n=300）。

Participants were randomized to receive a single dose of either CAPVAXIVE or PCV20. Results from the study include:.

参与者被随机分配接受单剂量的CAPVAXIVE或PCV20。研究结果包括：。

In adults 50 years of age and older (cohort 1), CAPVAXIVE was non-inferior to PCV20 for the 10 serotypes shared with both vaccines (3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, 33F), as assessed by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) one month post-vaccination;

在50岁及以上的成年人（队列1）中，对于两种疫苗共有的10种血清型（3、6A、7F、8、10A、11A、12F、19A、22F、33F），CAPVAXIVE在接种后一个月通过血清型特异性调理吞噬活性（OPA）几何平均滴度（GMTs）评估，显示不劣于PCV20；

CAPVAXIVE was superior to PCV20 for 10 of 11 serotypes included in CAPVAXIVE but not in PCV20 (9N, 15A, 16F, 17F, 20A, 23A, 23B, 24F, 31, 35B), as assessed by serotype-specific OPA GMTs one month post-vaccination and the proportions of patients with a greater than or equal to four-fold increase in OPA from pre-vaccination to one month post-vaccination;.

对于包含在CAPVAXIVE中但不包含在PCV20中的11种血清型中的10种（9N、15A、16F、17F、20A、23A、23B、24F、31、35B），CAPVAXIVE的表现优于PCV20，这一评估是基于接种疫苗一个月后血清型特异性OPA GMTs以及从接种前到接种后一个月OPA增加四倍或以上的患者比例。

Immune responses were observed for serotype 15C in participants receiving CAPVAXIVE but did not meet criteria for statistical superiority;

接受CAPVAXIVE的参与者对15C血清型产生了免疫反应，但未达到统计学优越性的标准；

In individuals 18 through 49 years of age (cohort 2), CAPVAXIVE elicited non-inferior immune responses (immunobridged) compared to individuals 50 through 64 years of age, as assessed by serotype-specific OPA GMTs one month post-vaccination;

在18至49岁（队列2）的人群中，CAPVAXIVE在接种疫苗一个月后，通过血清型特异性OPA GMTs评估，引发的免疫反应不劣于50至64岁的人群（免疫桥接）。

Across both cohorts, CAPVAXIVE had a safety profile comparable to PCV20.

在两个队列中，CAPVAXIVE 的安全性与 PCV20 相当。

STRIDE-10 (

NCT05569954

): A randomized, double-blind, Phase 3 study which evaluated CAPVAXIVE compared to PPSV23 in individuals 50 years of age or older who had not previously received a pneumococcal conjugate vaccine (n=1,484). Results from the study include:

): 一项随机、双盲、三期研究，评估了CAPVAXIVE与PPSV23在50岁及以上未接种过肺炎球菌结合疫苗的个体中的效果 (n=1,484)。研究结果包括：

CAPVAXIVE was non-inferior to PPSV23 for the 12 common serotypes and was superior to PPSV23 for the nine unique serotypes in CAPVAXIVE, as measured by serotype-specific OPA GMTs 30 days post-vaccination;

对于12种常见血清型，CAPVAXIVE与PPSV23相比具有非劣效性，并且在CAPVAXIVE所包含的九种独特血清型中表现优于PPSV23，这通过接种疫苗后30天的血清型特异性OPA GMTs测定。

The proportion of patients with ≥4-fold rise in OPA GMT ratios from Day 1 to Day 30 for serotype-specific OPA for V116 was superior to PPSV23 for eight out of nine serotypes unique to CAPVAXIVE compared to PPSV23;

从第1天到第30天，V116在针对血清型特异性OPA的OPA GMT比率上，有九种相对于PPSV23独有的血清型中的八种表现出比PPSV23更高的≥4倍上升比例；

CAPVAXIVE was found to have a safety profile comparable to PPSV23.

CAPVAXIVE 的安全性与 PPSV23 相当。

STRIDE-4 (

NCT05464420

): A randomized, double-blind, Phase 3 lot-to-lot consistency study which evaluated CAPVAXIVE in individuals 18 to 49 years of age who had not previously received a pneumococcal conjugate vaccine (n=2,162). Participants were randomized to receive a single dose of either one of three lots of CAPVAXIVE or PPSV23 (pneumococcal 23-valent polysaccharide vaccine).

): 一项随机、双盲、三期批间一致性研究，评估了18至49岁未接种过肺炎球菌结合疫苗的个体使用CAPVAXIVE的情况 (n=2,162)。参与者被随机分配接受单剂三种批次CAPVAXIVE之一或PPSV23（23价肺炎球菌多糖疫苗）。

Results from the study include:.

研究结果包括：。

Across the three lots, CAPVAXIVE elicited equivalent immune response, as assessed by serotype-specific OPA GMTs and Immunoglobulin G (IgG) geometric mean concentrations (GMCs) 30 days post-vaccination;

在三个组中，CAPVAXIVE 引发了相当的免疫反应，这通过接种疫苗后 30 天血清型特异性 OPA GMT 和免疫球蛋白 G (IgG) 几何平均浓度 (GMC) 进行了评估；

OPA GMTs were generally comparable between CAPVAXIVE combined lots and PPSV23 groups for the common serotypes and were higher in the CAPVAXIVE group for serotypes unique to CAPVAXIVE;

OPA GMTs 在 CAPVAXIVE 组合批次和 PPSV23 组之间对于常见血清型通常具有可比性，而对于 CAPVAXIVE 独有的血清型，CAPVAXIVE 组的 OPA GMTs 更高；

CAPVAXIVE has a safety profile comparable to PPSV23.

CAPVAXIVE 的安全性与 PPSV23 相当。

STRIDE-5 (

NCT05526716

): A randomized, double-blind, Phase 3 study which evaluated CAPVAXIVE when administered concomitantly or sequentially (30 days later) with QIV in adults 50 years of age and older (n=1,080). Results from the study include:

）：一项随机、双盲、三期研究，评估了在50岁及以上的成年人（n=1,080）中同时或顺序（30天后）与QIV一起使用CAPVAXIVE的情况。研究结果包括：

For the primary immunogenicity endpoints, CAPVAXIVE administered concomitantly with QIV was non-inferior to CAPVAXIVE administered sequentially with QIV for 20 of 21 serotypes in CAPVAXIVE (as assessed by OPA GMTs at one month post-vaccination), as well as for three of four influenza strains in QIV (as assessed by hemagglutination inhibition (HAI) GMTs at one month post-vaccination);.

对于主要的免疫原性终点，与四价流感疫苗（QIV）同时接种的CAPVAXIVE在CAPVAXIVE的21种血清型中的20种（通过接种疫苗后一个月的OPA GMT评估）以及QIV中的四种流感毒株中的三种（通过接种疫苗后一个月的血凝抑制（HAI）GMT评估）上，不劣于与QIV顺序接种的CAPVAXIVE。

The rates and severity of solicited systemic adverse reactions and solicited local adverse reactions at the CAPVAXIVE injection site were similar when CAPVAXIVE was administered with or without inactivated QIV.

当CAPVAXIVE与或不与灭活的QIV一起使用时，其在CAPVAXIVE注射部位所引起的全身性不良反应和局部不良反应的发生率和严重程度相似。

STRIDE-6 (

NCT05420961

): A randomized descriptive Phase 3 study which evaluated CAPVAXIVE in individuals 50 years of age and older who had previously received a pneumococcal vaccine at least one year before enrollment. Participants were enrolled into one of three cohorts based on their previous pneumococcal vaccination history (cohort 1: PPSV23, cohort 2: PCV13 [pneumococcal 13-valent conjugate vaccine], or cohort 3: PPSV23 followed by or preceded by PCV13, PPSV23 preceded by PCV15 [pneumococcal 15-valent conjugate vaccine], or PCV15 alone).

): 一项随机描述性III期研究，评估了CAPVAXIVE在50岁及以上曾至少一年前接种过肺炎球菌疫苗的个体中的效果。参与者根据其之前的肺炎球菌疫苗接种史被分为三个队列之一（队列1：PPSV23，队列2：PCV13 [肺炎球菌13价结合疫苗]，或队列3：PPSV23后接或前接PCV13，PPSV23前接PCV15 [肺炎球菌15价结合疫苗]，或单独接种PCV15）。

Participants in cohort 1 were randomized to receive CAPVAXIVE (n=231) or PCV15 (n=119), participants in cohort 2 were randomized to receive CAPVAXIVE (n=176) or PPSV23 (n=85), and participants in cohort 3 were allocated to receive CAPVAXIVE (n=106). In each of the 3 cohorts, serotype-specific OPA GMTs and the proportion of individuals with ≥4-fold rise in OPA responses from baseline to one-month post-vaccination were assessed.

第1组的参与者被随机分配接受CAPVAXIVE（n=231）或PCV15（n=119），第2组的参与者被随机分配接受CAPVAXIVE（n=176）或PPSV23（n=85），第3组的参与者被分配接受CAPVAXIVE（n=106）。在3个组中，分别评估了血清型特异性OPA GMTs以及从基线到接种疫苗后一个月OPA反应增加≥4倍的个体比例。

Results from the study include:.

研究结果包括：。

In cohort 1, CAPVAXIVE elicited OPA responses that were comparable to PCV15 for the 6 common serotypes, and higher for the 15 unique serotypes and serotype 15B;

在队列1中，CAPVAXIVE引发的OPA反应与PCV15对6种常见血清型相当，而对于15种独特血清型和血清型15B则更高；

In cohort 2, CAPVAXIVE elicited OPA responses comparable to PPSV23 for the 12 common serotypes and serotype 15B, and higher for the 9 unique serotypes;

在队列2中，CAPVAXIVE对12种常见血清型和血清型15B引发的OPA反应与PPSV23相当，对9种独特血清型引发的反应更高；

OPA responses to CAPVAXIVE were similar across the 3 cohorts of participants who previously received one or more pneumococcal vaccines;

OPA对CAPVAXIVE的反应在之前接种过一种或多种肺炎球菌疫苗的3个参与者队列中相似；

CAPVAXIVE had a safety profile comparable to both PCV15 and PPSV23.

CAPVAXIVE 的安全特性与 PCV15 和 PPSV23 相当。

STRIDE-7 (

NCT05393037

): A randomized, double-blind, Phase 3 study which evaluated CAPVAXIVE in individuals 18 years of age or older living with human immunodeficiency virus (HIV) (n=304) who were pneumococcal vaccine-naïve or vaccine-experienced prior to the study. Participants were randomized to receive either CAPVAXIVE or PCV15 + PPSV23.

): 一项随机、双盲、三期研究，评估了18岁或以上感染人类免疫缺陷病毒（HIV）的个体（n=304），这些个体在研究前未接种过肺炎球菌疫苗或已接种过疫苗。参与者被随机分配接受CAPVAXIVE或PCV15 + PPSV23。

Results from the study include:.

研究结果包括：。

CAPVAXIVE was immunogenic for all serotypes covered by the vaccine, as assessed by OPA GMTs and IgG GMCs 30 days post-vaccination;

CAPVAXIVE 对疫苗覆盖的所有血清型均具有免疫原性，这通过接种疫苗后30天的OPA GMT和IgG GMC评估得出；

CAPVAXIVE elicited comparable immune responses to PCV15+PPSV23 for all 13 shared serotypes and higher immune responses for the eight serotypes covered only by CAPVAXIVE, as assessed by serotype-specific OPA GMTs and IgG GMCs at Day 30;

对于所有13种共享血清型，CAPVAXIVE引发了与PCV15+PPSV23相当的免疫反应，而对于仅由CAPVAXIVE覆盖的8种血清型，其免疫反应更高，这一评估是基于第30天的血清型特异性OPA GMT和IgG GMC。

Fewer participants experienced adverse events (AEs) with CAPVAXIVE (71.6%) compared with PCV15+PPSV23 (91%), primarily due to fewer injection-site AEs.

与PCV15+PPSV23（91%）相比，使用CAPVAXIVE（71.6%）的参与者发生不良事件（AEs）的比例较低，这主要是因为注射部位的不良事件较少。

About CAPVAXIVE

关于CAPVAXIVE

CAPVAXIVE is Merck’s FDA-approved 21-valent pneumococcal conjugate vaccine indicated for active immunization for the prevention of invasive disease and pneumonia in adults 18 years of age and older. CAPVAXIVE is specifically designed to help address

CAPVAXIVE 是默克公司获得 FDA 批准的 21 价肺炎球菌结合疫苗，适用于 18 岁及以上成年人的主动免疫，以预防侵袭性疾病和肺炎。CAPVAXIVE 专门设计用于帮助应对

Streptococcus pneumoniae

肺炎链球菌

serotypes predominantly responsible for adult invasive pneumococcal disease (IPD), including eight unique serotypes, 15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B compared to other pneumococcal vaccines. CAPVAXIVE is administered as a single dose.

血清型主要是导致成人侵袭性肺炎链球菌病（IPD）的罪魁祸首，包括八种独特的血清型，15A、15C、16F、23A、23B、24F、31和35B，相较于其他肺炎链球菌疫苗。CAPVAXIVE以单剂量给药。

CAPVAXIVE Indication in the U.S.

美国CAPVAXIVE的适应症

CAPVAXIVE is indicated in the U.S. for:

美国的适应症为：

Active immunization for the prevention of invasive disease and pneumonia caused by

用于预防侵袭性疾病和肺炎的主动免疫

Streptococcus pneumoniae

肺炎链球菌

serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older;

3、6A、7F、8、9N、10A、11A、12F、15A、15B、15C、16F、17F、19A、20A、22F、23A、23B、24F、31、33F和35B型血清型，适用于18岁及以上的个体；

Active immunization for the prevention of pneumonia caused by

主动免疫以预防由以下原因引起的肺炎

S. pneumoniae

肺炎链球菌

serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older.

3、6A、7F、8、9N、10A、11A、12F、15A、15C、16F、17F、19A、20A、22F、23A、23B、24F、31、33F 和 35B 型血清型，适用于18岁及以上的个体。

CAPVAXIVE should not be administered to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid; see additional Select Safety Information below.

CAPVAXIVE 不应给予对 CAPVAXIVE 的任何成分或白喉类毒素有严重过敏反应史（例如，过敏性休克）的个体；请参阅以下额外的选择性安全信息。

The indication for the prevention of pneumonia caused by

预防肺炎的适应症是由

S. pneumoniae

肺炎链球菌

serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial..

血清型3、6A、7F、8、9N、10A、11A、12F、15A、15C、16F、17F、19A、20A、22F、23A、23B、24F、31、33F和35B是基于通过调理吞噬活性（OPA）测量的免疫反应获得加速批准的。此适应症的持续批准可能取决于在确证性试验中对临床益处的验证和描述。

Selected Safety Information for CAPVAXIVE in the U.S.

美国CAPVAXIVE的精选安全信息

Do not administer CAPVAXIVE to individuals with a history of a severe allergic reaction (eg, anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid.

请勿将CAPVAXIVE给予对CAPVAXIVE的任何成分或白喉类毒素有严重过敏反应（如过敏性休克）病史的个体。

Individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE.

免疫功能改变的个体，包括那些接受免疫抑制治疗的人，对CAPVAXIVE的免疫反应可能会降低。

The most commonly reported (>10%) solicited adverse reactions in individuals 18 through 49 years of age who received CAPVAXIVE were: injection-site pain (73.1%), fatigue (36.0%), headache (27.5%), myalgia (16.4%), injection-site erythema (13.8%), and injection-site swelling (13.3%).

在18至49岁接种CAPVAXIVE的个体中，报告发生率超过10%的最常见不良反应为：注射部位疼痛（73.1%）、疲劳（36.0%）、头痛（27.5%）、肌肉痛（16.4%）、注射部位红斑（13.8%）和注射部位肿胀（13.3%）。

The most commonly reported (>10%) solicited adverse reactions in individuals 50 years of age and older who received CAPVAXIVE were: injection-site pain (41.2%), fatigue (19.7%), and headache (11.0%).

在接种CAPVAXIVE的50岁及以上人群中，最常见的（>10%）征集性不良反应为：注射部位疼痛（41.2%）、疲劳（19.7%）和头痛（11.0%）。

Vaccination with CAPVAXIVE may not protect all vaccine recipients.

接种CAPVAXIVE疫苗可能无法保护所有接种者。

About pneumococcal disease

关于肺炎球菌疾病

Pneumococcal disease is an infection caused by a bacteria called

肺炎球菌病是由一种叫做肺炎链球菌的细菌引起的感染。

Streptococcus pneumoniae

肺炎链球菌

. There are about 100 different types (referred to as serotypes) of pneumococcal bacteria, which can affect adults differently than children. Pneumococcal disease can be invasive or non-invasive. Non-invasive pneumococcal illnesses include pneumonia (when pneumococcal disease is confined to the lungs), whereas invasive pneumococcal illnesses include pneumococcal bacteremia (infection in the bloodstream), bacteremic pneumococcal pneumonia (pneumonia with bacteremia) and pneumococcal meningitis (infection of the coverings of the brain and spinal cord).

约有100种不同类型的肺炎链球菌（称为血清型），其对成人和儿童的影响可能不同。肺炎链球菌疾病可以分为侵袭性和非侵袭性。非侵袭性肺炎链球菌病包括肺炎（当肺炎链球菌感染局限于肺部时），而侵袭性肺炎链球菌病包括肺炎链球菌菌血症（血液感染）、菌血症性肺炎链球菌肺炎（伴有菌血症的肺炎）以及肺炎链球菌脑膜炎（大脑和脊髓覆盖层的感染）。

Pneumococcal pneumonia is a type of bacterial pneumonia, which is the most common clinical presentation of pneumococcal disease in adults..

肺炎链球菌肺炎是一种细菌性肺炎，是成人肺炎链球菌感染最常见的临床表现。

About Merck

关于默克

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines.

在默克（美国和加拿大以外地区称为MSD），我们围绕一个使命团结一致：我们利用前沿科学的力量来拯救生命并改善世界各地人们的生活。一个多世纪以来，我们通过开发重要的药物和疫苗为人类带来希望。

We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.

我们立志成为全球首屈一指的研究密集型生物制药公司——今天，我们站在研究的最前沿，致力于提供创新的健康解决方案，推动人类和动物疾病预防与治疗的进步。我们培养多元化和包容性的全球员工队伍，并每天负责任地运营，以确保为所有人和社区创造一个安全、可持续和健康的未来。

For more information, visit .

欲了解更多信息，请访问。

www.merck.com

and connect with us on

并关注我们

X (formerly Twitter)

X（原名Twitter）

，

Facebook

，

Instagram

，

YouTube

and

和

领英

。

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

美国新泽西州拉威市默克公司前瞻性声明

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties.

本新闻稿由美国新泽西州拉威市的默克公司（Merck & Co., Inc.，以下简称“公司”）发布，包含符合1995年《美国私人证券诉讼改革法案》安全港条款的“前瞻性声明”。这些声明基于公司管理层的当前信念和预期，并受重大风险和不确定性的影响。

There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements..

对于管线候选产品，无法保证这些候选产品将获得必要的监管批准或其商业上将取得成功。如果基本假设被证明不准确或风险或不确定性变为现实，实际结果可能与前瞻性陈述中所述的结果存在重大差异。

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions..

风险和不确定性包括但不限于：行业总体状况和竞争；经济因素，包括利率和汇率波动；美国和国际制药行业监管和医疗立法的影响；全球医疗成本控制趋势；技术进步以及竞争对手获得的新产品和专利；新产品开发中的固有挑战，包括获得监管批准；公司准确预测未来市场状况的能力；生产困难或延误；国际经济的财务不稳定性和主权风险；对创新产品的专利和其他保护措施的有效性的依赖性；以及面临的诉讼（包括专利诉讼）和/或监管行动的风险。

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (.

公司不对任何前瞻性声明承担公开更新的义务，无论是否由于新信息、未来事件或其他原因。可能导致结果与前瞻性声明中描述的情况有重大差异的其他因素，可以在公司截至2024年12月31日的年度报告Form 10-K以及公司向证券交易委员会（SEC）提交的其他文件中找到，这些文件可在SEC的官方网站上查阅。

www.sec.gov

）。

Please see Prescribing Information for CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) at

请参阅CAPVAXIVE（21价肺炎球菌结合疫苗）的处方信息 tại

https://www.merck.com/product/usa/pi_circulars/c/capvaxive/capvaxive_pi.pdf

and Patient Information/Medication Guide for CAPVAXIVE at

以及CAPVAXIVE的患者信息/药物指南

https://www.merck.com/product/usa/pi_circulars/c/capvaxive/capvaxive_ppi.pdf

。

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媒体联系人：