Pfizers 20-valenta konjugerade pneumokockvaccin godkänns i USA för vuxna

• Det första godkännandet av ett konjugerat vaccin som bidrar till att skydda mot 20 serotyper som orsakar majoriteten av invasiv pneumokocksjukdom och lunginflammation^{1,2,3,4,5,6,7}
• Bidrar till skydd mot fler serotyper av pneumokocksjukdom än något annat konjugerat vaccin.
• Bygger på Pfizers mer än 20-åriga tradition av att utveckla innovativa konjugerade pneumokockvaccin.

Den amerikanska läkemedelsmyndigheten FDA har godkänt Prevnar 20™ (20-valent konjugerat pneumokockvaccin) för förebyggande av invasiv sjukdom och lunginflammation orsakad av de 20 serotyper av Streptococcus pneumoniae (pneumokocker) i vaccinet hos vuxna 18 år och äldre. Efter FDA-godkännandet väntas U.S. Centers for Disease Control and Preventions (CDC) Advisory Committee on Immunization Practices (ACIP) sammanträda i oktober för att diskutera och uppdatera rekommendationer om säker och lämplig användning av pneumokockvacciner för vuxna.

Prevnar 20 innehåller kapsulära polysackaridkonjugat för de 13 serotyper (1, 3, 4, 5, 6A, 6B,

7F, 9V, 14, 18C, 19A, 19F och 23F) som redan ingår i Prevnar 13 (13-valent konjugerat pneumokockvaccin [Diphtheria CRM197 Protein]). Vaccinet innehåller också kapsulära polysackaridkonjugat för sju ytterligare serotyper (8, 10A, 11A, 12F, 15B, 22F och 33F) som orsakar invasiv pneumokocksjukdom (IPD)^8,9,10,11,12och som är associerade med en hög andel dödsfall^13,14,15,16, antibiotikaresistens^4,17,18 och/eller meningit^19,20.

Läs hela pressmeddelandet på engelska här. 

Den 26 februari 2021 accepterade den europeiska läkemedelsmyndigheten EMA Pfizers ansökan och den formella granskningsprocessen av EMA:s Committee for Medicinal Products for Human use (CHMP) pågår för närvarande. Läs mer här.

Referenser:

1 Centers for Disease Control and Prevention. Active Bacterial Core (ABCs) surveillance. National Center for

Immunization and Respiratory Diseases. Atlanta, GA.

2 Ladhani, SN, Collins S, Djennad A, et al. Rapid increase in non-vaccine serotypes causing invasive pneumococcal

disease in England and Wales, 2000–17: a prospective national observational cohort study. Lancet Infect Dis.

2018;18(4):441-451.

3 Menéndez R, España PP, Pérez-Trallero E, et al. The burden of PCV13 serotypes in hospitalized pneumococcal

pneumonia in Spain using a novel urinary antigen detection test. CAPA study. Vaccine. 2017;35(39):5264-5270.

4 Azzari C, Cortimiglia M, Nieddu F, et al. Pneumococcal serotype distribution in adults with invasive disease and in

carrier children in Italy: Should we expect herd protection of adults through infants’ vaccination? Hum Vaccin

Immunother. 2016;12(2):344-350.

5 Pivlishi T. Impact of PCV13 on invasive pneumococcal disease (IPD) burden and the serotype distribution in the

U.S. Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices. October 24th,

2018.

6 European Centre for Disease Prevention and Control. Invasive pneumococcal disease. In: ECDC. Annual

epidemiological report for 2016. Stockholm: ECDC; 2018.

7 Beall B, Chochua S, Gertz RE Jr, et al. A population-based descriptive atlas of invasive pneumococcal strains

recovered within the U.S. during 2015-2016. Front Microbiol. 2018;19(9).

8 Baisells E, Guillot L, Nair H, et al. Serotype distribution of Streptococcus pneumoniae causing invasive disease in

children in the post-PCV era: A systematic review and meta-analysis. PlosOne. 2017;12(5): e0177113.

9 Hausdorff W & Hanage W. Interim results of an ecological experiment – Conjugate Vaccination against the

pneumococcus and serotype replacement. Hum Vaccin Immunother. 2016;12(2):358-374.

10 Cohen R, Cohen J, Chalumeau M, et al. Impact of pneumococcal conjugate vaccines for children in high- and nonhigh

income countries. Expert Rev Vaccines. 2017;16(6):625-640.

11 Moore M, Link-Gelles R, Schaffner W, et al. Effect of use of 13-valent pneumococcal conjugate vaccine in children

on invasive pneumococcal disease in children and adults in the USA: analysis of multisite, population-based

surveillance. Lancet Infect Dis. 2015;15(3):301-309.

12 Metcalf B, Gertz RE, Gladstone RA, et al. Strain features and distributions in pneumococci from children with

invasive disease before and after 13-valent conjugate vaccine implementation in the USA. Clin Microbiol Infect.

2016;22(1):60. e9-60. e29.

13 Oligbu G, Collins S, Sheppard CL, et al. Childhood Deaths Attributable to Invasive Pneumococcal Disease in

England and Wales, 2006–2014. Clin Infect Dis. 2017;65(2):308-314.

14 van Hoek, Andrews N, Waight PA, et al. Effect of Serotype on Focus and Mortality of Invasive Pneumococcal

Disease: Coverage of Different Vaccines and Insight into Non-Vaccine Serotypes. PlosOne. 2012;7(7): e39150.

15 Stanek R, Norton N, Mufson M. A 32-Years Study of the Impact of Pneumococcal Vaccines on Invasive

Streptococcus pneumoniae Disease. Am J Med Sci. 2016;352(6):563-573.

16 Harboe ZB, Thomsen RW, Riis A, et al. Pneumococcal Serotypes and Mortality following Invasive Pneumococcal

Disease: A Population-Based Cohort Study. PlosOne. 2009;6(5): e 1000081.

17 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.

18 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.

19 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.

20 Thigpen MC, Whitney CG, Messonnier NE, et al. Bacterial Meningitis in the United States, 1998–2007. NEJM.

2011;364(21):2016-2025.