Impact of the 13-Valent Pneumococcal Conjugate Vaccine on Invasive Pneumococcal Disease After Introduction Into Routine Pediatric Use

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Abstract

Background

In 2010, the 13-valent pneumococcal conjugate vaccine (PCV13) replaced 7-valent PCV (PCV7) for protection against invasive pneumococcal disease (IPD). This study used laboratory surveillance data to examine the effect of PCV13 on IPD before and after PCV13 introduction among children aged 6 weeks to <6 years and those aged ≥6 weeks.

Methods

Observational laboratory-based IPD surveillance data were compared for the periods May 2010–April 2018 and May 2008–April 2010 (the PCV7 period) using a database of Kaiser Permanente Northern California (KPNC) members with laboratory-confirmed IPD.

Results

Among children aged 6 weeks to 6 years, overall IPD incidence decreased from 11.57 per 100 000 during the PCV7 period to 4.09 per 100 000 after PCV13 introduction; PCV13-type IPD incidence decreased from 5.12 to 0.84 per 100 000. Non-PCV13−serotype IPD did not change significantly in this age group (PCV7 period, 1.71 per 100 000 and after PCV13, 2.52 per 100 000). Of cases occurring in this group, bacteremia was the most common clinical diagnosis. Across all ages, IPD decreased from 9.49 to 6.23 per 100 000 and PCV13-type IPD decreased from 4.67 to 1.89 per 100 000, changes being mostly due to decreases in serotypes 19A and 7F. IPD caused by non-PCV13 serotypes did not change (3.34 and 3.35 per 100 000). Overall, pneumococci isolated after PCV13 introduction had increased susceptibility to penicillin, cefotaxime, and ceftriaxone.

This prospective, laboratory-based surveillance study in Kaiser Permanente Northern California members examined annual IPD incidence before and after PCV13 introduction. In children aged 6 weeks to <6 years, IPD caused by PCV13 serotypes decreased significantly (84%) during the surveillance period.

Conclusions

IPD incidence decreased further in every age group after PCV13 introduction, suggesting both direct vaccination effects in the infant population and indirect effects in adults.

Clinical Trials Registration

NCT01128439.

Abstract

In this prospective, laboratory-based surveillance study of Kaiser Permanente Northern California members, we examined annual invasive pneumococcal disease (IPD) incidence before and after 13-valent pneumococcal conjugate vaccine (PCV13) introduction. In children aged 6 weeks to <6 years, IPD caused by PCV13 serotypes decreased significantly (84%) during the surveillance period.

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Most cited references 22

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Insights into the interaction between influenza virus and pneumococcus.

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Bacterial infections following influenza are an important cause of morbidity and mortality worldwide. Based on the historical importance of pneumonia as a cause of death during pandemic influenza, the increasingly likely possibility that highly pathogenic avian influenza viruses will trigger the next worldwide pandemic underscores the need to understand the multiple mechanisms underlying the interaction between influenza virus and bacterial pathogens such as Streptococcus pneumoniae. There is ample evidence to support the historical view that influenza virus alters the lungs in a way that predisposes to adherence, invasion, and induction of disease by pneumococcus. Access to receptors is a key factor and may be facilitated by the virus through epithelial damage, by exposure or up-regulation of receptors, or by provoking the epithelial regeneration response to cytotoxic damage. More recent data indicate that alteration of the immune response by diminishing the ability of the host to clear pneumococcus or by amplification of the inflammatory cascade is another key factor. Identification and exploration of the underlying mechanisms responsible for this synergism will provide targets for prevention and treatment using drugs and vaccines.

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Discovery of a new capsular serotype (6C) within serogroup 6 of Streptococcus pneumoniae.

In Park, David G. Pritchard, Rob Cartee … (2007)

Using two monoclonal antibodies, we found subtypes among pneumococcal isolates that are typed as serotype 6A by the quellung reaction. The prevalent subtype bound to both monoclonal antibodies and was labeled here 6Aalpha, whereas the minor subtype bound to only one monoclonal antibody and was labeled 6Abeta. To determine the biochemical nature of the two serologically defined subtypes, we purified capsular polysaccharides (PSs) from the two subtypes and examined their chemical structures with gas-liquid chromatography and mass spectrometry. The study results for 6Aalpha PS are consistent with the previously published structure of 6A PS, which is -->2) galactose (1-->3) glucose (1-->3) rhamnose (1-->3) ribitol (5-->phosphate. In contrast, the 6Abeta PS study results show that its repeating unit is -->2) glucose 1 (1-->3) glucose 2 (1-->3) rhamnose (1-->3) ribitol (5-->phosphate. We propose to continue referring to 6Aalpha as serotype 6A but to refer to 6Abeta as serotype 6C. Serotype 6C would thus represent the 91st pneumococcal serotype, with 90 pneumococcal serotypes having previously been recognized. This study also demonstrates that a new serotype may exist within an established and well-characterized serogroup or serotype.

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Prevention of pneumococcal disease among infants and children - use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine - recommendations of the Advisory Committee on Immunization Practices (ACIP).

J. Nuorti, Cynthia G. Whitney, (2010)

On February 24, 2010, a 13-valent pneumococcal polysaccharide-protein conjugate vaccine (PCV13 [Prevnar 13, Wyeth Pharmaceuticals Inc., marketed by Pfizer Inc.]) was licensed by the Food and Drug Administration (FDA) for prevention of invasive pneumococcal disease (IPD) caused among infants and young children by the 13 pneumococcal serotypes covered by the vaccine and for prevention of otitis media caused by serotypes also covered by the 7-valent pneumococcal conjugate vaccine formulation (PCV7 [Prevnar, Wyeth]). PCV13 contains the seven serotypes included in PCV7 (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and six additional serotypes (serotypes 1, 3, 5, 6A, 7F, and 19A). PCV13 is approved for use among children aged 6 weeks-71 months and supersedes PCV7, which was licensed by FDA in 2000. This report summarizes recommendations approved by the Advisory Committee on Immunization Practices (ACIP) on February 24, 2010, for the use of PCV13 to prevent pneumococcal disease in infants and young children aged <6 years. Recommendations include 1) routine vaccination of all children aged 2-59 months, 2) vaccination of children aged 60-71 months with underlying medical conditions, and 3) vaccination of children who received ≥1 dose of PCV7 previously (CDC. Licensure of a 13-valent pneumococcal conjugate vaccine [PCV13] and recommendations for use among children-Advisory Committee on Immunization Practices [ACIP], 2010. MMWR 2010;59:258-61). Recommendations also are provided for targeted use of the 23-valent pneumococcal polysaccharide vaccine (PPSV23, formerly PPV23) in children aged 2-18 years with underlying medical conditions that increase their risk for contracting pneumococcal disease or experiencing complications of pneumococcal disease if infected. The ACIP recommendation for routine vaccination with PCV13 and the immunization schedules for children aged ≤59 months who have not received any previous PCV7 or PCV13 doses are the same as those published previously for PCV7 (CDC. Preventing pneumococcal disease among infants and young children: recommendations of the Advisory Committee on Immunization Practices [ACIP]. MMWR 2000;49[No. RR-9]; CDC. Updated recommendation from the Advisory Committee on Immunization Practices [ACIP] for use of 7-valent pneumococcal conjugate vaccine [PCV7] in children aged 24-59 months who are not completely vaccinated. MMWR 2008;57:343-4), with PCV13 replacing PCV7 for all doses. For routine immunization of infants, PCV13 is recommended as a 4-dose series at ages 2, 4, 6, and 12-15 months. Infants and children who have received ≥1 dose of PCV7 should complete the immunization series with PCV13. A single supplemental dose of PCV13 is recommended for all children aged 14-59 months who have received 4 doses of PCV7 or another age-appropriate, complete PCV7 schedule. For children who have underlying medical conditions, a supplemental PCV13 dose is recommended through age 71 months. Children aged 2-18 years with underlying medical conditions also should receive PPSV23 after completing all recommended doses of PCV13.

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Author and article information

Journal

Journal ID (nlm-ta): J Pediatric Infect Dis Soc

Journal ID (iso-abbrev): J Pediatric Infect Dis Soc

Journal ID (publisher-id): jpids

Title: Journal of the Pediatric Infectious Diseases Society

Publisher: Oxford University Press (US )

ISSN (Print): 2048-7193

ISSN (Electronic): 2048-7207

Publication date Collection: February 2021

Publication date (Electronic): 16 May 2020

Publication date PMC-release: 16 May 2020

Volume: 10

Issue: 2

Pages: 141-150

Affiliations

[1 ] Vaccine Study Center, Kaiser Permanente , Oakland, California, USA

[2 ] Department of Pediatrics, Boston University School of Public Health , Boston, Massachusetts, USA

[3 ] Department of Pediatrics, Boston Medical Center , Boston, Massachusetts, USA

[4 ] Vaccine Clinical Research and Development, Pfizer Inc , Pearl River, New York, USA

[5 ] Vaccine Clinical Research and Development, Pfizer Inc , Collegeville, Pennsylvania, USA

Author notes

Correspondence: Laurie Aukes, Kaiser Permanente Vaccine Study Center, 1 Kaiser Plaza, Ordway Bldg 16th Floor, Oakland, CA 94612 USA ( Laurie.A.Aukes@ 123456kp.org ).

To the sorrow of the authors, Dr Roger Baxter passed away in December 2016. The authors dedicate this work to him.

Article

Publisher ID: piaa035

DOI: 10.1093/jpids/piaa035

PMC ID: 7996647

PubMed ID: 32415771

SO-VID: 7443ed52-5841-49ff-93db-e5fc3278d88c

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence ( http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

History

Date received : 01 August 2019

Date: 07 April 2020

Date accepted : 08 April 2020

Page count

Pages: 10

Funding

Funded by: Pfizer, DOI 10.13039/100004319;

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Impact of the 13-Valent Pneumococcal Conjugate Vaccine on Invasive Pneumococcal Disease After Introduction Into Routine Pediatric Use

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Most cited references 22

Insights into the interaction between influenza virus and pneumococcus.

Discovery of a new capsular serotype (6C) within serogroup 6 of Streptococcus pneumoniae.

Prevention of pneumococcal disease among infants and children - use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine - recommendations of the Advisory Committee on Immunization Practices (ACIP).

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