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13-07-2023 | Pneumococcal Vaccination | AdisInsight Report

20‑Valent Pneumococcal Conjugate Vaccine: Pediatric First Approval

Author: Matt Shirley

Published in: Pediatric Drugs | Issue 5/2023

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.

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Drijkoningen JJ, Rohde GG. Pneumococcal infection in adults: burden of disease. Clin Microbiol Infect. 2014;20(suppl 5):45–51.CrossRefPubMed

Wahl B, O’Brien KL, Greenbaum A, et al. Burden of Streptococcus pneumoniae and Haemophilus influenzae type b disease in children in the era of conjugate vaccines: global, regional, and national estimates for 2000–15. Lancet Glob Health. 2018;6(7):e744–57.CrossRefPubMedPubMedCentral

Centers for Disease Control and Prevention. Pneumococcal disease. 2022. https://www.cdc.gov/pneumococcal/index.html. Accessed 30 Jun 2023.

Wiese AD, Griffin MR, Grijalva CG. Impact of pneumococcal conjugate vaccines on hospitalizations for pneumonia in the United States. Expert Rev Vaccines. 2019;18(4):327–41.CrossRefPubMedPubMedCentral

Vadlamudi NK, Chen A, Marra F. Impact of the 13-valent pneumococcal conjugate vaccine among adults: a systematic review and meta-analysis. Clin Infect Dis. 2019;69(1):34–49.CrossRefPubMed

Perdrizet J, Horn EK, Hayford K, et al. Historical population-level impact of infant 13-valent pneumococcal conjugate vaccine (PCV13) national immunization programs on invasive pneumococcal disease in Australia, Canada, England and Wales, Israel, and the United States. Infect Dis Ther. 2023. https://doi.org/10.1007/s40121-023-00798-x.CrossRefPubMedPubMedCentral

Huang L, Wasserman M, Grant L, et al. Burden of pneumococcal disease due to serotypes covered by the 13-valent and new higher-valent pneumococcal conjugate vaccines in the United States. Vaccine. 2022;40(33):4700–8.CrossRefPubMed

Janssens E, Flamaing J, Vandermeulen C, et al. The 20-valent pneumococcal conjugate vaccine (PCV20): expected added value. Acta Clin Belg. 2023;78(1):78–86.CrossRefPubMed

US FDA. PREVNAR 20^® (pneumococcal 20-valent conjugate vaccine), suspension for intramuscular injection: US prescribing information. 2023. https://www.fda.gov/media/149987/download. Accessed 30 Jun 2023.

10.

US FDA. PREVNAR 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM₁₉₇ protein]), suspension for intramuscular injection: US prescribing information. 2017. https://www.fda.gov/media/107657/download. Accessed 30 Jun 2023.

11.

US FDA. Pneumococcal 7-valent conjugate vaccine (diphtheria CRM₁₉₇ protein) - Prevnar^®: US prescribing information. 2008. https://www.fda.gov/media/76076/download. Accessed 30 Jun 2023.

12.

Thompson A, Lamberth E, Severs J, et al. Phase 1 trial of a 20-valent pneumococcal conjugate vaccine in healthy adults. Vaccine. 2019;37(42):6201–7.CrossRefPubMed

13.

Shirley M. 20-valent pneumococcal conjugate vaccine: a review of its use in adults. Drugs. 2022;82(9):989–99.CrossRefPubMed

14.

US FDA. Approval letter - PREVNAR20. 2021. https://www.fda.gov/media/150021/download. Accessed 30 Jun 2023.

15.

European Medicines Agency. Apexxnar suspension for injection in pre-filled syringe - pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed): summary of product characteristics. 2023. https://www.ema.europa.eu/en/documents/product-information/apexxnar-epar-product-information_en.pdf. Accessed 30 Jun 2023.

16.

US FDA. Approval letter - PREVNAR20. 2023. https://www.fda.gov/media/167637/download. Accessed 30 Jun 2023.

17.

Pfizer Inc. U.S. FDA accepts for priority review the supplemental Biologics License Application for Pfizer's 20-valent pneumococcal conjugate vaccine in infants and children [media release]. 2023. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-accepts-priority-review-supplemental-biologics. Accessed 30 Jun 2023.

18.

Pfizer Inc. Pfizer reports third-quarter 2017 results [media release]. 2017. https://www.pfizer.com/news/press-release/press-release-detail/pfizer_reports_third_quarter_2017_results. Accessed 30 Jun 2023.

19.

Pfizer Inc. Data from Pfizer's adult and pediatric clinical trial programs for 20-valent pneumococcal conjugate vaccine presented at IDWeek 2020 [media release]. 2020. https://www.pfizer.com/news/press-release/press-release-detail/data-pfizers-adult-and-pediatric-clinical-trial-programs-20. Accessed 30 Jun 2023.

20.

Pfizer Inc. U.S. FDA accepts Biologics License Application for Pfizer's respiratory syncytial virus maternal vaccine candidate for Priority Review [media release]. 2023. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-accepts-biologics-license-application-pfizers. Accessed 30 Jun 2023.

21.

Pfizer Inc. Form 10-K. Annual report pursuant to Section 13 or 15(d) of the Securites Exchange Act of 1934 for the fiscal year ended December 31, 2022. 2023. https://www.sec.gov/ix?doc=/Archives/edgar/data/78003/000007800323000024/pfe-20221231.htm#i8050b09ca8a0411dbcb0b6576ce1fc7a_46. Accessed 30 Jun 2023.

22.

Watson W. 20-valent pneumococcal conjugate vaccine (PCV20) phase 3 in pediatrics. In: ACIP February 22, 2023.

23.

US FDA. Clinical review - PREVNAR 20. 2023. https://www.fda.gov/media/169126/download. Accessed 30 Jun 2023.

24.

Senders S, Klein NP, Lamberth E, et al. Safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in healthy infants in the United States. Pediatr Infect Dis J. 2021;40(10):944–51.CrossRefPubMedPubMedCentral

25.

Eskola J, Kilpi T, Palmu A, et al. Efficacy of a pneumococcal conjugate vaccine against acute otitis media. N Engl J Med. 2001;344(6):403–9.CrossRefPubMed

26.

Black S, Shinefield H, Fireman B, et al. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Pediatr Infect Dis J. 2000;19(3):187–95.CrossRefPubMed

27.

Fireman B, Black SB, Shinefield HR, et al. Impact of the pneumococcal conjugate vaccine on otitis media. Pediatr Infect Dis J. 2003;22(1):10–6.CrossRefPubMed

Title: 20‑Valent Pneumococcal Conjugate Vaccine: Pediatric First Approval
Author: Matt Shirley
Publication date: 13-07-2023
Publisher: Springer International Publishing
Keyword: Pneumococcal Vaccination
Published in: Pediatric Drugs / Issue 5/2023
Print ISSN: 1174-5878
Electronic ISSN: 1179-2019
DOI: https://doi.org/10.1007/s40272-023-00584-9

Keynote webinar | Spotlight on medication adherence

Springer Medicine

20‑Valent Pneumococcal Conjugate Vaccine: Pediatric First Approval

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

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