20‑Valent Pneumococcal Conjugate Vaccine: Pediatric First Approval.

IF 3.4 3区医学 Q1 PEDIATRICS Pediatric Drugs Pub Date : 2023-09-01 DOI:10.1007/s40272-023-00584-9

Matt Shirley

{"title":"20‑Valent Pneumococcal Conjugate Vaccine: Pediatric First Approval.","authors":"Matt Shirley","doi":"10.1007/s40272-023-00584-9","DOIUrl":null,"url":null,"abstract":"20‑valent pneumococcal conjugate vaccine (PCV20; Prevnar 20®; Apexxnar®) is a pneumococcal conjugate vaccine (PCV) developed by Pfizer for active immunization for the prevention of pneumococcal infections. PCV20 has a similar structure and formulation to Pfizer's 13-valent PCV (PCV13; Prevnar 13®; Prevenar 13®), with the addition of polysaccharides to target seven further Streptococcus pneumoniae serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F). PCV20 has been approved for active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniae in adults since June 2021 in the USA and since February 2022 in the EU. Following further evaluation of its safety, immunogenicity, and effectiveness in pediatric populations, in April 2023 PCV20 received its first pediatric approval, in the USA, for active immunization for the prevention of invasive pneumococcal disease (IPD) caused by S. pneumoniae serotypes 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 to 17 years of age and for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in individuals 6 weeks to 5 years of age. This article summarizes the milestones in the development of PCV20 leading to this first pediatric approval for active immunization for the prevention of IPD and otitis media caused by S. pneumoniae.","PeriodicalId":19955,"journal":{"name":"Pediatric Drugs","volume":null,"pages":null},"PeriodicalIF":3.4000,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pediatric Drugs","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40272-023-00584-9","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PEDIATRICS","Score":null,"Total":0}

引用次数: 0

Abstract

20‑valent pneumococcal conjugate vaccine (PCV20; Prevnar 20^®; Apexxnar^®) is a pneumococcal conjugate vaccine (PCV) developed by Pfizer for active immunization for the prevention of pneumococcal infections. PCV20 has a similar structure and formulation to Pfizer's 13-valent PCV (PCV13; Prevnar 13^®; Prevenar 13^®), with the addition of polysaccharides to target seven further Streptococcus pneumoniae serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F). PCV20 has been approved for active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniae in adults since June 2021 in the USA and since February 2022 in the EU. Following further evaluation of its safety, immunogenicity, and effectiveness in pediatric populations, in April 2023 PCV20 received its first pediatric approval, in the USA, for active immunization for the prevention of invasive pneumococcal disease (IPD) caused by S. pneumoniae serotypes 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 to 17 years of age and for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in individuals 6 weeks to 5 years of age. This article summarizes the milestones in the development of PCV20 leading to this first pediatric approval for active immunization for the prevention of IPD and otitis media caused by S. pneumoniae.

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

20价肺炎球菌结合疫苗:儿科首次批准。

20价肺炎球菌结合疫苗(PCV20;Prevnar 20®;Apexxnar®)是辉瑞公司开发的一种肺炎球菌结合疫苗(PCV)，用于主动免疫预防肺炎球菌感染。PCV20的结构和配方与辉瑞的13价PCV (PCV13;Prevnar 13®;Prevenar 13®)，添加了多糖，可靶向另外7种肺炎链球菌血清型(8、10A、11A、12F、15B、22F和33F)。PCV20已于2021年6月在美国和2022年2月在欧盟被批准用于预防成人肺炎和由肺炎链球菌引起的侵袭性疾病的主动免疫。后进一步评价其安全性、免疫原性和有效性在儿科人口,2023年4月PCV20收到首次儿科批准,在美国,活跃的免疫预防的侵入性肺炎球菌病(IPD)引起的肺炎链球菌血清型1,3,4,5,6,6 b, f 7, 8, 9, 10, 11, 12 f, 14日15 b, 18 c, 19日,19 f, f, 22日23 f, f和33个人6周17岁和预防中耳炎引起的肺炎链球菌血清型4,6B, 9V, 14, 18C, 19F和23F在6周至5岁的个体。本文总结了PCV20发展的里程碑，这是首个儿童批准主动免疫预防肺炎链球菌引起的IPD和中耳炎的疫苗。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

Pediatric Drugs PEDIATRICS-PHARMACOLOGY & PHARMACY

CiteScore

7.20

自引率

0.00%

发文量

审稿时长

>12 weeks

期刊介绍： Pediatric Drugs promotes the optimization and advancement of all aspects of pharmacotherapy for healthcare professionals interested in pediatric drug therapy (including vaccines). The program of review and original research articles provides healthcare decision makers with clinically applicable knowledge on issues relevant to drug therapy in all areas of neonatology and the care of children and adolescents. The Journal includes: -overviews of contentious or emerging issues. -comprehensive narrative reviews of topics relating to the effective and safe management of drug therapy through all stages of pediatric development. -practical reviews covering optimum drug management of specific clinical situations. -systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. -Adis Drug Reviews of the properties and place in therapy of both newer and established drugs in the pediatric population. -original research articles reporting the results of well-designed studies with a strong link to clinical practice, such as clinical pharmacodynamic and pharmacokinetic studies, clinical trials, meta-analyses, outcomes research, and pharmacoeconomic and pharmacoepidemiological studies. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pediatric Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.