CAPVAXIVE provides an additional pneumococcal vaccination option for adults aged 18 years and older in Singapore

CAPVAXIVE 为新加坡 18 岁及以上成年人提供了额外的肺炎球菌疫苗接种选择

MSD (trade name of Merck & Co., Inc., Rahway, N.J., USA) announced today that the Health Sciences Authority (HSA) of Singapore has approved CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae 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 adults 18 years of age and older..

默沙东（Merck & Co., Inc.，美国新泽西州拉威市，商品名）今日宣布，新加坡卫生科学局（HSA）已批准CAPVAXIVE（21价肺炎球菌结合疫苗），用于18岁及以上成人主动免疫，以预防由3、6A、7F、8、9N、10A、11A、12F、15A、15B、15C、16F、17F、19A、20A、22F、23A、23B、24F、31、33F和35B型肺炎链球菌引起的侵袭性疾病和肺炎。

CAPVAXIVE is a pneumococcal vaccine that helps protect adults against invasive pneumococcal disease and pneumococcal pneumonia caused by the indicated serotypes. In adults previously vaccinated with other pneumococcal vaccines, subsequent vaccination with CAPVAXIVE is estimated to provide a combined serotype coverage of 78% against serotypes causing IPD..

CAPVAXIVE 是一种肺炎球菌疫苗，有助于保护成人免受由指定血清型引起的侵袭性肺炎球菌疾病和肺炎球菌肺炎的侵害。在先前已接种其他肺炎球菌疫苗的成人中，后续接种 CAPVAXIVE 预计可对引起侵袭性肺炎球菌疾病（IPD）的血清型提供 78% 的联合血清型覆盖率。

The percentage estimate was calculated using the distribution of serotyped adult IPD isolates reported by the Singapore Communicable Diseases Agency for 2024. Where the data were reported as grouped categories rather than exact serotypes, the calculation assumed that the isolates corresponded to the relevant CAPVAXIVE-covered serotypes.

百分比估算是根据新加坡传染病局报告的2024年血清分型成人侵袭性肺炎球菌病（IPD）分离株的分布情况计算得出的。当数据以分组类别而非具体血清型报告时，计算假定这些分离株对应于CAPVAXIVE覆盖的相关血清型。

The estimate should therefore be considered approximate. It describes epidemiological serotype distribution and does not represent vaccine efficacy, effectiveness, additive protection from sequential vaccination, or the proportion of IPD cases that vaccination would prevent. No cross-protection between serotypes 6A and 6C was assumed..

因此，该估算值应被视为近似值。它描述的是流行病学血清型分布，并不代表疫苗效力、效果、序贯接种的附加保护作用，或疫苗接种可预防的侵袭性肺炎链球菌病（IPD）病例比例。未假设血清型6A和6C之间存在交叉保护。

The approval introduces an adult-focused pneumococcal conjugate vaccine (PCV) option in the context of changes in adult IPD serotype distribution observed over time in Singapore. CAPVAXIVE was approved in the USA in June 2024, in Canada in July 2024, in Australia in February 2025, and in Singapore in February 2026..

鉴于新加坡成人侵袭性肺炎球菌病（IPD）血清型分布随时间推移发生的变化，此次批准引入了面向成人的肺炎球菌结合疫苗（PCV）选项。CAPVAXIVE 于 2024 年 6 月在美国获批，2024 年 7 月在加拿大获批，2025 年 2 月在澳大利亚获批，并于 2026 年 2 月在新加坡获批。

Pneumococcal disease is caused by Streptococcus pneumoniae, which comprises different serotypes. Pneumococcal disease in adults is associated with significant morbidity and mortality worldwide, with disease incidence varying by age, region, and race. Mortality rates are elevated in older adults, adults with comorbid conditions (e.g., diabetes mellitus, chronic lung disease, chronic liver disease), and immunocompromised individuals (e.g., HIV infection, cancer, transplant, immunosuppressive therapies)..

肺炎球菌性疾病由包含不同血清型的肺炎链球菌引起。全球范围内，成人肺炎球菌性疾病与显著的发病率和死亡率相关，其发病率因年龄、地区和种族而异。老年人、患有合并症（如糖尿病、慢性肺病、慢性肝病）的成人以及免疫功能低下者（如HIV感染者、癌症患者、移植受者、接受免疫抑制治疗者）的死亡率升高。

Pneumococcal disease is classified as invasive pneumococcal disease (IPD) or non-invasive pneumococcal disease (non-IPD). IPD occurs when pneumococcal bacteria invade normally sterile parts of the body, such as the brain or bloodstream. The worldwide emergence of pneumococcal resistance to antibiotics is of concern, as is the replacement of vaccine serotypes by the emergence of non-vaccine serotypes..

肺炎球菌性疾病分为侵袭性肺炎球菌性疾病（IPD）和非侵袭性肺炎球菌性疾病（非IPD）。当肺炎球菌侵入体内通常无菌的部位（如脑部或血液）时，即发生IPD。全球范围内肺炎球菌对 antibiotics 的耐药性出现令人担忧，同时，非疫苗血清型的出现导致疫苗血清型被取代，这也同样引起关注。

“By focusing on serotypes associated with the evolving epidemiology of adult IPD, CAPVAXIVE was developed based on an understanding of pneumococcal serotype distribution in adult. The HSA approval reflects the scientific approach behind CAPVAXIVE, which demonstrated immunogenicity against the vaccine serotypes across the adult populations studied,” said Dr Ivan Su, Value and Implementation Lead, MSD Asia Pacific.

“CAPVAXIVE的研发基于对成人肺炎球菌血清型分布的理解，重点针对与成人侵袭性肺炎球菌疾病（IPD）不断变化的流行病学相关的血清型。新加坡卫生科学局（HSA）的批准体现了CAPVAXIVE背后的科学方法，该疫苗在所研究的成年人群中针对疫苗所含血清型均显示出免疫原性。”默沙东亚太区价值与实施负责人苏伊万博士表示。

“We are pleased that CAPVAXIVE is now available to adults in Singapore, providing an additional vaccination option for eligible adults.”.

“我们很高兴 CAPVAXIVE 现已在新加坡向成年人提供，为符合条件的成年人提供了额外的疫苗接种选择。”

“Invasive pneumococcal disease remains a concern among adults in Singapore. Continuous education and immunization against vaccine preventable diseases are important in safeguarding public health. Healthcare professionals play a vital role in protecting Singaporeans against invasive pneumococcal disease (IPD) and pneumococcal pneumonia through timely vaccination and proactive care,” said Dr Leong Hoe Nam, infectious diseases specialist at Rophi Clinic..

“侵袭性肺炎球菌疾病仍然是新加坡成年人面临的一个健康问题。持续开展健康教育以及针对疫苗可预防疾病的免疫接种，对于保障公共健康至关重要。医疗保健专业人员通过及时接种疫苗和提供主动护理，在保护新加坡民众免受侵袭性肺炎球菌疾病（IPD）和肺炎球菌肺炎侵害方面发挥着至关重要的作用。”罗菲诊所的传染病专家梁浩南医生表示。

Adj Prof See Kay Choong, Senior Consultant, Division of Respiratory & Critical Care Medicine, Department of Medicine, National University Hospital (NUH), said, “Complications from invasive pneumococcal disease (IPD) can lead to organ damage and even death. Many serotyped adult IPD cases are caused by serotypes not included in previously approved pneumococcal conjugate vaccines.”.

新加坡国立大学医院（NUH）内科部呼吸与重症医学科高级顾问、 adjunct 教授谢凯忠表示：“侵袭性肺炎球菌疾病（IPD）的并发症可能导致器官损伤甚至死亡。许多已分型的成人 IPD 病例是由此前获批的肺炎球菌结合疫苗未涵盖的血清型引起的。”

The previously approved pneumococcal vaccines referenced include PCV13, PCV15 and PCV20.

前述已获批的肺炎球菌疫苗包括PCV13、PCV15和PCV20。

Dr Sharon Ngoh, Family Physician and Medical Director at Parkway Shenton, said, “Singapore has a rapidly aging population, with 1 in 4 citizens expected to be aged 65 and above by 2030. Focusing on preventive care provides us with the opportunity to tap the potential of both our middle-aged workers and seniors.

百汇盛通家庭医生兼医疗总监吴 Sharon 博士表示：“新加坡人口老龄化迅速，预计到2030年，每四名公民中就有一人年龄在65岁及以上。注重预防性护理为我们提供了挖掘中年工作者和老年人潜力的机会。”

When healthy, they can continue contributing to our society and economy in many ways. Certain pneumococcal infections may be preventable – we should all be aware of IPD, what pneumococcal serotypes are and how they could affect us and those around us.”.

在健康状态下，他们能够以多种方式继续为社会和经济做出贡献。某些肺炎球菌感染是可以预防的——我们都应了解侵袭性肺炎球菌疾病（IPD）、肺炎球菌血清型的种类，以及它们可能对我们自身和周围人群造成的影响。

Adult invasive pneumococcal disease has been reported in Singapore across multiple surveillance years. The approval of CAPVAXIVE provides an additional pneumococcal vaccination option for eligible adults. CAPVAXIVE is now available for administration by the relevant healthcare providers in Singapore..

新加坡在多个监测年份中均有成人侵袭性肺炎球菌疾病的报告。CAPVAXIVE的获批为符合条件的成年人提供了额外的肺炎球菌疫苗接种选择。目前，新加坡的相关医疗保健提供者已可提供CAPVAXIVE的接种服务。

CAPVAXIVE will only protect against the S. pneumoniae serotypes indicated above and should be used in accordance with official recommendations.

CAPVAXIVE 仅能预防上述肺炎链球菌血清型，应按照官方建议使用。