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.

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），用于预防肺炎球菌感染的主动免疫。PCV20 具有与辉瑞 13 价 PCV（PCV13；Prevnar 13 ^®；Prevenar 13 ^®）相似的结构和配方，并添加了多糖以针对另外七种肺炎链球菌血清型（8、10A、11A、12F、15B、22F 和33F）。自 2021 年 6 月在美国和自 2022 年 2 月起在欧盟，PCV20 已被批准用于主动免疫，用于预防成人肺炎链球菌引起的肺炎和侵袭性疾病。经过进一步评估其在儿科人群中的安全性、免疫原性和有效性，PCV20 于 2023 年 4 月在美国获得首个儿科批准，用于主动免疫预防由肺炎链球菌血清型 1 引起的侵袭性肺炎球菌疾病 (IPD )， 3、4、5、6A、6B、7F、8、9V、10A、11A、12F、14、15B、18C、19A、19F、22F、23F 和 33F 在 6 周至 17 岁的个体中预防 6 周至 5 岁个体中由肺炎链球菌血清型 4、6B、9V、14、18C、19F 和 23F引起的中耳炎。本文总结了 PCV20 开发过程中的里程碑，这些里程碑导致首次儿科批准用于预防肺炎链球菌引起的 IPD 和中耳炎的主动免疫。