GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved a prefilled syringe presentation of

GSK plc（LSE/NYSE：GSK）今天宣布，美国食品药品监督管理局（FDA）已批准了一种预填充注射器的呈现方式。

Shingrix (GSK’s Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster). The new prefilled syringe removes the need to reconstitute separate vials prior to administration, simplifying the vaccine administration process for healthcare professionals.

Shingrix (GSK的重组带状疱疹疫苗或RZV) 用于预防带状疱疹（疱疹病毒）。新的预填充注射器无需在使用前重新配制单独的小瓶，简化了医疗专业人员的疫苗接种过程。

The existing vaccine presentation consists of two vials, a lyophilised (powder) antigen and a liquid adjuvant, which healthcare professionals combine prior to administering. The approval of the new presentation is based on data demonstrating technical comparability between the new and existing vaccine presentation..

现有的疫苗形式由两个小瓶组成，一个是冻干（粉末）抗原，另一个是液体佐剂，医疗专业人员在使用前将两者混合。新疫苗形式的批准基于证明新旧疫苗形式之间技术上具有可比性的数据。

Brigid Groves, Vice President of Professional Affairs, American Pharmacists Association, said

美国药剂师协会专业事务副总裁布里吉德·格罗夫斯表示

: “The prefilled syringe presentation of GSK’s shingles vaccine is good news, providing a convenient method of administration. The FDA approval is a positive step toward driving prevention of this painful disease, and as a practicing pharmacist I welcome the availability of this new presentation.”

“GSK的带状疱疹疫苗预填充注射器是一个好消息，提供了便捷的管理方法。 FDA的批准是推动预防这种痛苦疾病的一个积极步骤，作为一名执业药剂师，我欢迎这种新形式的可用性。”

Consistent with the existing indications for

与现有的适应症一致

Shingrix, the prefilled syringe presentation is licenced in the US for immunisation of adults aged 50 years and older, as well as those aged 18 years and older who are or will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy.

Shingrix，预填充注射器的配方在美国获批用于50岁及以上成人的免疫接种，以及18岁及以上因已知疾病或治疗导致免疫缺陷或免疫抑制而有带状疱疹风险增加的成人。

The US Centers for Disease Control and Prevention (CDC) recommends two doses of GSK’s shingles vaccine to prevent shingles and related complications in adults aged 50 years or over, and two doses for adults aged 19 years or over who are or will be immunodeficient or immunosuppressed.

美国疾病控制与预防中心（CDC）建议，50岁及以上的成年人接种两剂GSK的带状疱疹疫苗，以预防带状疱疹及其相关并发症；对于19岁及以上免疫功能低下或即将免疫抑制的成年人，也建议接种两剂。

Tony Wood, Chief Scientific Officer, GSK, said

葛兰素史克首席科学官托尼·伍德表示

: “At GSK, we are committed to advancing scientific innovation and delivering practical solutions that address the needs of the healthcare community. This new presentation of

“在GSK，我们致力于推进科学创新，并提供满足医疗保健社区需求的实用解决方案。这一新的展示方式

Shingrix was developed to streamline the vaccination process, supporting healthcare professionals to provide protection against shingles, a disease that 1 in 3 US adults will develop in their lifetime.”

Shingrix旨在简化疫苗接种流程，支持医疗专业人员提供针对带状疱疹的保护，这是一种三分之一美国成年人在其一生中会患上的疾病。

The prefilled syringe presentation of GSK’s shingles vaccine is also undergoing regulatory review by the European Medicines Agency (EMA), with filing acceptance received in January 2025, marking another important regulatory milestone. In addition to GSK exploring submission of this presentation to other markets, this highlights GSK’s commitment to providing solutions to help increase adult immunisation rates..

GSK的带状疱疹疫苗预填充注射器剂型也正在接受欧洲药品管理局（EMA）的监管审查，并于2025年1月获得申报受理，标志着另一个重要的监管里程碑。除了GSK正在探索将此剂型提交至其他市场外，这也凸显了GSK致力于提供解决方案以帮助提高成人免疫接种率的承诺。

About shingles

关于带状疱疹

Shingles is a painful, blistering rash that can last for weeks. Approximately 99% of US adults over 50 years old have the virus that causes shingles inside their body, although not everyone will develop shingles.

带状疱疹是一种疼痛的、起水泡的皮疹，可能持续数周。大约99%的50岁以上美国成年人体内携带导致带状疱疹的病毒，尽管并非所有人都会发展成带状疱疹。

An estimated one million people develop shingles annually in the US.

据估计，美国每年有100万人感染带状疱疹。

Shingles is caused by the reactivation of the varicella-zoster virus (VZV), the same virus that causes chickenpox.

带状疱疹是由水痘-带状疱疹病毒（VZV）重新激活引起的，这种病毒与导致水痘的病毒相同。

By age 50, VZV is present in most adults

50岁时，大多数成年人体内存在VZV。

and may reactivate with advancing age.

并且可能随着年龄的增长而重新激活。

As people age, the strength of the immune system response to infection wanes, increasing the risk of developing shingles.

随着年龄的增长，免疫系统对感染的反应能力减弱，患带状疱疹的风险增加。

About Shingrix

关于Shingrix

(Recombinant Zoster Vaccine or RZV)

（重组带状疱疹疫苗或RZV）

Shingrix(GSK’s Recombinant Zoster Vaccine or RZV) is a non-live, recombinant subunit vaccine indicated for the prevention of shingles in adults 50 and over. It combines an antigen, glycoprotein E, with an adjuvant system, AS01

Shingrix(GSK的重组带状疱疹疫苗或RZV) 是一种非活性、重组亚单位疫苗，适用于预防50岁及以上成人带状疱疹。它结合了一种抗原——糖蛋白E，和一种佐剂系统AS01。

, and may help overcome the natural age-related decline in responses to immunisation that contributes to the challenge of protecting adults aged 50 and over from shingles.

，并且可能有助于克服与年龄相关的免疫反应自然下降，这种下降是导致保护50岁及以上成人免受带状疱疹感染的挑战之一。

RZV is not indicated to prevent primary varicella infection (chickenpox). In several countries, RZV is also approved for adults aged 18 years or over at increased risk for shingles. The use of RZV should be in accordance with official recommendations and local product label.

RZV不用于预防原发性水痘感染（鸡 pox）。在一些国家，RZV也被批准用于18岁及以上有带状疱疹高风险的成年人。RZV的使用应遵循官方建议和当地产品标签。

About GSK

关于GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

GSK是一家全球生物制药公司，致力于联合科学、技术和人才，共同战胜疾病。欲了解更多信息，请访问gsk.com。