Prevenar 13^® includes coverage to the serotypes 3, 6A and 19A.¹

• Based on serotype surveillance in Europe performed before the introduction of Prevenar, Prevenar 13^® is estimated to cover 73% to 100% (depending on the country) of serotypes causing IPD in children less than 5 years of age¹
• Of the 94 pneumococcal serotypes identified till date, 11 account for ≥70% of IPD globally in children <5 years of age, all of whom are included in Prevenar 13^®4,*

IPD, invasive pneumococcal disease; OM, otitis media.

1. Egyptian Drug Authority Prevenar 13 leaflet approval date 7/4/2021, revision date November 2020.
2. Selva L, et al. Serotype 3 is a common serotype causing invasive pneumococcal disease in children less than 5 years old, as identified by real-time PCR. Eur J Clin Microbiol Infect Dis. 2012;31(7):1487-1495.
3. Hackel M, et al. Serotype prevalence and antibiotic resistance in Streptococcus pneumoniae clinical isolates among global populations. Vaccine. 2013;31(42):4881-4887.
4. Rodrigo C, et al. The relevance of pneumococcal serotypes. Curr Infect Dis Rep. 2014;16(4):403.

Objectives:

The study population was living in Norway between 2004-2012. The objective is to compare the change in IPD incidence and serotype distribution in Norway resulting from the introduction of PCV7 and the subsequent shift to PCV13 in the childhood immunisation programme.⁶

Methods:

This is an observational retrospective population-based cohort study. The diversity in serotype distribution per year was analysed using the Simpson’s index of diversity. Immunisation history of young children was obtained from the Norwegian Vaccination Registry to determine vaccine failure. An IPD case was defined as a case in which S. pneumoniae was isolated from a normally sterile site (for >99% of the cases, from blood or cerebrospinal fluid). ⁶

• Within 1 year of Prevenar 13^® introduction (ENGLAND AND WALES): Vaccine effectiveness for serotype 19A was estimated at 70% in children <24 months of with ≥1 dose^5,§
• PCV13 minus PCV 7 introduction (UNITED STATES) demonstrated 93% reduction in the IPD caused by serotype 19A and 7A in <5 years aged children⁷

^§The effectiveness of Prevenar 13^® in IPD was measured in children from England and Wales. Using nonvaccine-type IPD cases as controls, the study estimated vaccine effectiveness for serotypes 1, 3, 6A, 7F and 19A.⁵

CI, confidence interval; GMT, geometric mean titre; IPD, invasive pneumococcal disease; NIP, National Immunization Programme; OM, otitis media; PCV, pneumococcal conjugate vaccine.

1. Egyptian Drug Authority Prevenar 13 leaflet approval date 7/4/2021, revision date November 2020.
2. Picazo J, et al. Relationship between serotypes, age, and clinical presentation of invasive pneumococcal disease in Madrid, Spain, after introduction of the 7-valent pneumococcal conjugate vaccine into the vaccination calendar. Clin Vaccine Immunol. 2011;18(1):89-94.
3. Pilishvili T, et al. Sustained reductions in invasive pneumococcal disease in the era of conjugate vaccine. J Infect Dis. 2010;201(1):32-41.
4. Kim SH, et al. Changing trends in antimicrobial resistance and serotypes of Streptococcus pneumoniae isolates in Asian countries: an Asian Network for Surveillance of Resistant Pathogens (ANSORP) study. Antimicrob Agents Chemother. 2012;56(3):1418-1426.
5. Miller E, et al. Effectiveness of the new serotypes in the 13-valent pneumococcal conjugate vaccine. Vaccine. 2011;29(49):9127-9131.
6. Steens A, et al. Prompt effect of replacing the 7-valent pneumococcal conjugate vaccine with the 13-valent vaccine on the epidemiology of invasive pneumococcal disease in Norway. Vaccine. 2013;31(52):6232-6238.
7. Moore MR, et al. Eff ect 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.

• Serotype 6A is 1 of the 7 most common serotypes responsible for causing IPD globally in children <5 years of age²
• Serotype 6A is associated with multidrug resistance to macrolides³
• Bacteraemic pneumonia caused by serotype 6A was significantly more likely to lead to mortality versus other serotypes⁴

• A reduction in IPD caused by serotype 6A was observed following PCV7 introduction. Further reductions in serotype 6A IPD were demonstrated following the introduction of Prevenar 13^®5

CSF, cerebrospinal fluid, IPD, invasive pneumococcal disease; NIP, National Immunization Programme;  OM, otitis media; PCV, pneumococcal conjugate vaccine.

1. Egyptian Drug Authority Prevenar 13 leaflet approval date 7/4/2021, revision date November 2020.
2. Rodrigo C, et al. The relevance of pneumococcal serotypes. Curr Infect Dis Rep.2014;16(4):403.
3. Liñares J, et al. Changes in antimicrobial resistance, serotypes and genotypes in Streptococcus pneumoniae over a 30-year period. Clin Microbiol Infect. 2010;16(5):402-410.
4. Weinberger DM, et al. Association of serotype with risk of death due to pneumococcal pneumonia: a meta-analysis. Clin Infect Dis. 2010;51(6):692-699.
5. Richter SS, et al. Pneumococcal serotypes before and after introduction of conjugate vaccines, United States, 1999–2011. Emerg Infect Dis. 2013;19(7):1074-1083.

Adjusted incidence rates ratio for pneumonia hospitalization in vaccine versus  pre-vaccine period  was 0.67 (0.59-0.75) among infants and 0.74 (0.67-0.81) among 1-year olds.^2,*

*Data collected from 107 public health facilities in Leon, Nicaragua, 2008-2012. Nicaragua introduced routine immunization with PCV13 on December 12, 2010, using a 3 + 0 dosing schedule at 2, 4 and 6 months of age. Children 12 to 24 months of age were also offered PCV13 during the first year of the programme.^2
†An observational prospective study in 5645 patients 1 month to 15 years of age in 8 paediatric EDs, assessing CAP.^5
‡An observational retrospective study of hospitalization at the Hospital Pediatrico-Centro Hospitalario Pereira Rossell.³
  

Abbreviations:

CAP, community acquired pneumonia; ED, emergency department; IPD, invasive pneumococcal disease; NIP, National Immunization Programme; OM, otitis media; PCV, pneumococcal conjugate vaccine.

References:

1. Egyptian Drug Authority Prevenar 13 leaflet approval date 7/4/2021, revision date November 2020.
2. Becker-Dreps S, et al. Changes in childhood pneumonia and infant mortality rates following introduction of the 13-valent pneumococcal conjugate vaccine in Nicaragua. Pediatr Infect Dis J. 2014;33(6):637-642.
3. Pirez MC, et al. Changes in hospitalizations for pneumonia after universal vaccination with pneumococcal conjugate vaccines 7/13 valent and haemophilus influenzae type b conjugate vaccine in a Pediatric Referral Hospital in Uruguay. Pediatr Infect Dis J. 2014;33(7):753-759.
4. Simonsen L, et al. Effect of 13-valent pneumococcal conjugate vaccine on admissions to hospital 2 years after its introduction in the USA: a time series analysis. Lancet Respir Med. 2014;2(5):387-394.
5. Angoulvant F, et al. Early impact of 13-valent pneumococcal conjugate vaccine on community-acquired pneumonia in children. Clin Infect Dis. 2014;58(7):918-924.

Abbreviations:
AOM, acute otitis media; OM, otitis media.

References:

1. Egyptian Drug Authority Prevenar 13 leaflet approval date 7/4/2021, revision date November 2020.
2. Marom T, et al. Trends in otitis media–related health care use in the United States, 2001-2011. JAMA Pediatr. 2014;168(1):68-75.

• The incidence of VT-IPD decreased in the targeted (<5 years) and non-targeted (≥5) age groups since PCV7 introduction and further decreased after the replacement with PCV13.²

• Overall IPD hospitalization rates in the United States decreased 21% in children aged <2 years and 17% in those aged 2-4 years ^3,*

*A US study of ICD-9–coded electronic health hospital discharge records of children <5 years of age between 2005 and 2012 to evaluate the effectiveness of Prevenar 13^® in reducing pneumococcal-related disease burden. IPD hospitalizations were compared between 2007 and 2009 and 2011 to 2012.³
 

ICD-9, International Classification of Diseases, Ninth Revision; IPD, invasive pneumococcal disease; PCV, pneumococcal conjugate vaccine; US, United States; VT-IPD, vaccine-type invasive pneumococcal disease.

References:

1. Egyptian Drug Authority Prevenar 13 leaflet approval date 7/4/2021, revision date November 2020.
2. Steens A, et al. Prompt effect of replacing the 7-valent pneumococcal conjugate vaccine with the 13-valent vaccine on the epidemiology of invasive pneumococcal disease in Norway. Vaccine. 2013;31(52):6232-6238.
3. Simonsen L, et al. Effect of 13-valent pneumococcal conjugate vaccine on admissions to hospital 2 years after its introduction in the USA: a time series analysis. Lancet Respir Med. 2014;2(5):387-394.