NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practice (ACIP) voted to expand its recommendation for the use of certain pneumococcal vaccines, including PREVNAR 20® (20-valent Pneumococcal Conjugate Vaccine) for all adults aged 50 and older.

纽约--（商业新闻短讯）--辉瑞公司（纽约证券交易所：PFE）今天宣布，美国疾病控制与预防中心（CDC）免疫实践咨询委员会（ACIP）投票扩大其对所有50岁及以上成年人使用某些肺炎球菌疫苗的建议，包括PREVNAR 20®（20价肺炎球菌结合疫苗）。

This recommendation is pending final approval by the director of the CDC and the Department of Health and Human Services. With respect to PREVNAR 20, ACIP recommended:.

这项建议正在等待疾病预防控制中心主任和卫生与公众服务部的最终批准。关于PREVNAR 20，ACIP建议：。

Vaccination is recommended for all adults aged ≥50 years and for adults aged 19–49 years with certain underlying conditions or risk factors who have not received a PCV or whose vaccination history is unknown.

建议所有年龄≥50岁的成年人和19-49岁的成年人接种疫苗，这些成年人患有某些潜在疾病或危险因素，没有接受过PCV或其疫苗接种史未知。

“ACIP’s vote to expand adult pneumococcal vaccination to now include all adults aged 50 and older marks an important milestone in Pfizer’s long-standing commitment to reducing the burden of this life-threatening disease,” said Luis Jodar, PhD, Senior Vice President, Senior Vice President, Vaccines and Anti-Infectives Chief Medical Affairs Officers, Pfizer.

辉瑞公司高级副总裁、疫苗和抗感染首席医疗事务官Luis Jodar博士说：“ACIP投票将成人肺炎球菌疫苗接种扩大到现在所有50岁及以上的成年人，标志着辉瑞公司长期致力于减轻这种威胁生命的疾病负担的一个重要里程碑。”。

“PREVNAR 20 offers protection against the serotypes responsible for the majority of invasive pneumococcal disease cases in this age group. Expanding its use also provides an opportunity to limit the re-emergence of disease-causing strains like serotype 4, which has recently affected certain U.S. adult populations and is covered by the vaccine.”.

“PREVNAR 20提供了针对该年龄组大多数侵袭性肺炎球菌病病例的血清型的保护。扩大其使用范围还提供了一个机会，可以限制血清型4等致病菌株的再次出现，该菌株最近影响了某些美国成年人群，并被疫苗覆盖。”。

In the U.S., the 20 serotypes contained in PREVNAR 20 are estimated to cause over 2,000 deaths and more than 65,000 cases of invasive pneumococcal disease (IPD), including bacteremia and meningitis, and community-acquired pneumonia annually in adults aged 50 to 64.2 Between 2018 and 2022, more than half of IPD cases in people aged 50 to 64 were caused by these 20 serotypes.3 Vaccination with PREVNAR 20 helps prevent serotype 4 disease, which incidence has been rising in certain populations in the western U.S.4.

在美国，据估计，PREVNAR 20中包含的20种血清型每年会导致2000多人死亡，65000多例侵袭性肺炎球菌病（IPD），包括菌血症和脑膜炎，以及50至64.2岁成年人的社区获得性肺炎。2018年至2022年间，50至64岁人群中超过一半的IPD病例是由这20种血清型引起的[3]。PREVNAR 20疫苗接种有助于预防血清型4疾病，美国西部某些人群的发病率一直在上升。

About PREVNAR 20®

关于PREVNAR 20®

PREVNAR 20® is Pfizer’s next-generation pneumococcal conjugate vaccine that includes capsular polysaccharide conjugates for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) already included in Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]).

PREVNAR 20®是辉瑞公司的下一代肺炎球菌结合疫苗，包括13种血清型（1、3、4、5、6A、6B、7F、9V、14、18C、19A、19F和23F）的荚膜多糖结合物，已包含在PREVNAR 13®（肺炎球菌13价结合疫苗[白喉CRM197蛋白]）中。

The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) that cause invasive pneumococcal disease (IPD),5,6,7,8,9 and have been associated with high case-fatality rates,10,11,12,13 antibiotic resistance,14,15,16 and/or meningitis.17,18 PREVNAR 20 helps protect against disease caused by the 20 Streptococcus pneumoniae serotypes in the vaccine..

该疫苗还含有七种额外血清型（8,10A，11A，12F，15B，22F和33F）的荚膜多糖缀合物，这些血清型会导致侵袭性肺炎球菌病（IPD），5,6,7,8,9，并且与高病死率，10,11,12,13抗生素耐药性，14,15,16和/或脑膜炎有关。17,18 PREVNAR 20有助于预防疫苗中20种肺炎链球菌血清型引起的疾病。。

On June 8, 2021, Pfizer announced the U.S. Food and Drug Administration (FDA) approved PREVNAR 20 for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults aged 18 years or older. On September 30, 2022, the FDA approved the addition of information in the PREVNAR 20 prescribing information regarding coadministration with an influenza vaccine, adjuvanted (Fluad Quadrivalent19), in adults aged 65 years or older..

2021年6月8日，辉瑞公司宣布美国食品和药物管理局（FDA）批准PREVNAR 20用于预防18岁或以上成年人的侵袭性肺炎球菌疾病和肺炎球菌肺炎。2022年9月30日，FDA批准在PREVNAR 20中添加信息，规定65岁或以上成年人与流感疫苗佐剂（Fluad四价19）共同给药的信息。。

INDICATIONS FOR PREVNAR 20

PREVNAR 20的适应症

PREVNAR 20® is a vaccine indicated for:

PREVNAR 20®是一种疫苗，适用于：

the prevention of invasive disease caused by 20 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F) in individuals 6 weeks and older.

预防由20株肺炎链球菌菌株（1,3,4,5,6A，6B，7F，8,9V，10A，11A，12F，14,15B，18C，19A，19F，22F，23F和33F）在6周及以上的个体中引起的侵袭性疾病。

the prevention of otitis media (middle ear infection) caused by 7 of the 20 strains in individuals 6 weeks through 5 years.

预防由20种菌株中的7种在6周至5年的个体中引起的中耳炎（中耳感染）。

active immunization for the prevention of pneumonia caused by Streptococcus pneumoniae strains 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 18 years of age and older.

主动免疫预防18岁及以上人群肺炎链球菌菌株1、3、4、5、6A、6B、7F、8、9V、10A、11A、12F、14、15B、18C、19A、19F、22F、23F和33F引起的肺炎。

The indication of PREVNAR 20 for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in individuals 18 years of age and older is approved based on immune responses. Continued approval may depend on a supportive study

PREVNAR 20用于预防18岁及以上个体中肺炎链球菌血清型8,10A，11A，12F，15B，22F和33F引起的肺炎的适应症是基于免疫反应批准的。继续批准可能取决于支持性研究

IMPORTANT SAFETY INFORMATION FOR PREVNAR 20

PREVNAR 20的重要安全信息

PREVNAR 20® should not be given to anyone who has had a severe allergic reaction to any component of PREVNAR 20 or to diphtheria–toxoid-containing vaccine.

对于对PREVNAR 20的任何成分或含有白喉类毒素的疫苗有严重过敏反应的人，不应服用PREVNAR 20®。

Individuals with weakened immune systems may have a lower immune response. Safety data are not available for these groups.

免疫系统减弱的个体免疫反应可能较低。这些群体没有安全数据。

A temporary pause in breathing after getting the vaccine has been observed in some infants who were born prematurely. For premature infants, talk to your doctor about the infant's medical status when deciding to get vaccinated with PREVNAR 20.

在一些早产婴儿中观察到接种疫苗后呼吸暂时停止。对于早产儿，在决定接种PREVNAR 20疫苗时，请与医生谈论婴儿的医疗状况。

In individuals 2, 4, 6, and 12 through 15 months of age vaccinated with a 4-dose schedule, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, decreased appetite and injection site redness, injection site swelling, and fever.

在接种4剂疫苗的2、4、6和12至15个月大的个体中，报告的最常见副作用>10%是烦躁不安，注射部位疼痛，嗜睡，食欲下降和注射部位发红，注射部位肿胀和发烧。

In individuals 15 months through 17 years of age vaccinated with a single dose, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, fatigue and muscle pain, decreased appetite, injection site swelling and injection site redness, headache, and fever..

在单剂量接种疫苗的15个月至17岁的个体中，报告的最常见副作用发生率>10%，包括易怒，注射部位疼痛，嗜睡，疲劳和肌肉疼痛，食欲下降，注射部位肿胀和注射部位发红，头痛和发烧。。

In individuals 18 years and older, the most common side effects reported at a rate of >10% were pain at the injection site, muscle pain, fatigue, headache, and joint pain. Also, injection site swelling was common in individuals 18 years through 59 years of age.

在18岁及以上的个体中，报告的最常见副作用发生率>10%，是注射部位疼痛，肌肉疼痛，疲劳，头痛和关节痛。此外，注射部位肿胀在18岁至59岁的个体中很常见。

Ask your doctor about the risks and benefits of PREVNAR 20. Only a doctor can decide if PREVNAR 20 is right for you or your child.

询问您的医生PREVNAR 20的风险和益处。只有医生才能决定PREVNAR 20是否适合您或您的孩子。

View the full Prescribing Information.

查看完整的处方信息。

About Pfizer: Breakthroughs That Change Patients’ Lives

关于辉瑞：改变患者生活的突破

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

在辉瑞，我们运用科学和全球资源为人们带来治疗方法，延长并显着改善他们的生活。我们努力为包括创新药物和疫苗在内的保健产品的发现、开发和制造制定质量、安全和价值标准。

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world.

辉瑞公司的同事们每天都在发达市场和新兴市场开展工作，促进健康、预防、治疗和治愈，挑战我们这个时代最可怕的疾病。作为世界首屈一指的创新生物制药公司之一，我们与医疗保健提供者、政府和当地社区合作，支持和扩大全球可靠、负担得起的医疗保健服务。

For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer..

175年来，我们一直致力于为所有依赖我们的人带来改变。我们经常在我们的网站www.Pfizer.com上发布对投资者可能很重要的信息。此外，要了解更多信息，请访问我们的网站www.Pfizer.com，并在X上关注我们@Pfizer和@Pfizer News，LinkedIn，YouTube，以及在Facebook上关注我们。。

DISCLOSURE NOTICE:

披露通知：

The information contained in this release is as of October 23, 2024. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

本版本中包含的信息截至2024年10月23日。辉瑞没有义务因新信息或未来事件或发展而更新本版本中包含的前瞻性声明。

This release contains forward-looking information about PREVNAR 20® (20-valent Pneumococcal Conjugate Vaccine), including its potential benefits and a vote by ACIP to expand its recommendation for the use of certain pneumococcal vaccines, including PREVNAR 20 for all adults aged 50 and older and for adults aged 19–49 years with certain underlying conditions or risk factors who have not received a PCV or whose vaccination history is unknown, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.

本版本包含有关PREVNAR 20®（20价肺炎球菌结合疫苗）的前瞻性信息，包括其潜在益处，以及ACIP投票扩大其对某些肺炎球菌疫苗使用的建议，包括对所有50岁及以上的成年人以及19-49岁的成年人使用PREVNAR 20®（20价肺炎球菌结合疫苗），这些成年人患有某些潜在疾病或风险因素，但尚未接受PCV或其疫苗接种史未知，这涉及重大风险和不确定性，可能导致实际结果与此类声明所表达或暗示的结果存在重大差异。

Risks and uncertainties include, among other things, uncertainties regarding the commercial success of PREVNAR 20 and uncertainties regarding the commercial impact of ACIP’s recommendation; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any biologics license applications may be filed in any other jurisdictions for PREVNAR 20 for any potential indications; whether and when any such applications that may be pending or filed may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s effic.

风险和不确定性包括PREVNAR 20商业成功的不确定性以及ACIP建议的商业影响的不确定性；研究和开发中固有的不确定性，包括满足预期临床终点的能力，我们临床试验的开始和/或完成日期，监管提交日期，监管批准日期和/或发布日期，以及不利的新临床数据的可能性和现有临床数据的进一步分析；临床试验数据受到监管机构不同解释和评估的风险；监管机构是否会对我们临床研究的设计和结果感到满意；是否以及何时可以在任何其他司法管辖区为PREVNAR 20提交任何潜在适应症的生物制剂许可证申请；监管机构是否以及何时批准任何可能未决或提交的此类申请，这将取决于多种因素，包括确定产品的收益是否超过其已知风险以及确定产品的效率。

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S.

有关风险和不确定性的进一步说明，请参阅辉瑞公司截至2023年12月31日的10-K表年度报告，以及随后的10-Q表报告，包括标题为“风险因素”和“前瞻性信息和可能影响未来结果的因素”的部分，以及随后的8-K表报告，所有这些报告均已提交给美国。

Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com..

证券交易委员会（sec），网址为www.sec.gov和www.pfizer.com。。

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15 Tomczyk S, Lynfield R, Schaffner W, et al. Prevention of antibiotic-nonsusceptible invasive pneumococcal disease with the 13-valent pneumococcal conjugate vaccine. Clin Infect Dis. 2016;62(9):1119-1125.

15 Tomczyk S，Lynfield R，Schaffner W等人。用13价肺炎球菌结合疫苗预防抗生素不敏感的侵袭性肺炎球菌病。临床感染Dis。2016年；62（9）：1119-1125。

16 Mendes RE, Hollingsworth RC, Costello A, et al. Noninvasive Streptococcus pneumoniae serotypes recovered from hospitalized adult patients in the United States in 2009 to 2012. Antimicrob Agents Chemother. 2015;59(9):5595-5601.

。抗菌剂Chemother。2015年；59（9）：5595-5601。

17 Olarte L, Barson WJ, Lin PL, et al. Impact of the 13-valent pneumococcal conjugate vaccine on pneumococcal meningitis in US children. Clin Infect Dis. 2015;61(5):767-775.

17 Olarte L，Barson WJ，Lin PL等。13价肺炎球菌结合疫苗对美国儿童肺炎球菌性脑膜炎的影响。临床感染Dis。2015年；61（5）：767-775。

18 Thigpen MC, Whitney CG, Messonnier NE, et al. Bacterial meningitis in the United States, 1998–2007. NEJM. 2011;364(21):2016-2025.

18 Thigpen MC，Whitney CG，Messonnier NE等。1998-2007年美国细菌性脑膜炎。内杰姆。2011年；364（21）：2016-2025。

19 Fluad Quadrivalent is not a Pfizer product

Category: Vaccines

类别：疫苗