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What is the new recommendation for 13-valent pneumococcal vaccine in elderly adults?

Introduction

In 2014, the Advisory Committee on Immunization Practices (ACIP) recommended all adults ≥65 years receive both the 23-valent pneumococcal polysaccharide vaccine (PPSV; Pneumovax 23) and the 13-valent pneumococcal conjugate vaccine (PCV; Prevnar 13).1 At that time, routine vaccination of children with PCV13 beginning in 2010 had reduced pneumococcal disease burden among adults through indirect effects, which were anticipated to continue. Therefore, the 2014 ACIP recommendation was accompanied by a commitment to later reevaluate the ongoing need for routine use of PCV13 in adults ≥65 years.

In 2019, ACIP concluded its reevaluation of the need for continued routine PCV13 vaccination in adults ≥65 years, and no longer recommends this practice, although these adults should continue to receive PPSV23 as previously recommended.1 This change may generate questions regarding the rationale for this recommendation, and which older adults may remain appropriate candidates for PCV13 vaccination. This review summarizes the 2019 ACIP recommendations regarding PCV13 vaccination in adults ≥65 years.

Background

Pneumococcal disease is a common cause of community-acquired infection in the US, with incidence highest in children < 2 years old and adults >65 years old.1,2 Pneumococcal disease can cause serious illness, including sepsis, meningitis, and pneumonia with bacteremia (invasive pneumococcal disease [IPD]) or without bacteremia (noninvasive disease).1 Infection with Streptococcus pneumoniae is an important cause of morbidity and mortality in the US. The Centers for Disease Control and Prevention (CDC) estimated that in 2017, S. pneumoniae was responsible for 3,255 cases of IPD and 371 deaths per 100,000 population.3 The cost of care for IPD is also considerable; a 2016 analysis estimated overall mean costs per episode of IPD in at-risk adults ≥65 years at $27,472.4 Pneumococcal vaccination therefore has been a public health priority to reduce the burden of pneumococcal disease.

The PCV13 and PPSV23 vaccines are the two pneumococcal vaccines currently approved for use in the US.1,2 The vaccines cover 12 shared serotypes, and PPSV23 covers 11 additional distinct serotypes. The PPSV23 vaccine has been recommended since the 1980s in adults ≥65 years and patients ≥2 years with certain chronic and immunocompromising conditions.5 The PCV13 vaccine was recommended by ACIP in 2010 for use in all children <5 years old, replacing the 7-valent pneumococcal conjugate vaccine (PCV7), which had been in use since 2000. The series of PCV13 and PPSV23 was recommended for all adults ≥65 years old in 2014. This recommendation was based on the CAPiTA randomized controlled trial, which showed that PCV13 reduced first episodes of vaccine-type community-acquired pneumonia by approximately 45% compared with placebo in adults ≥65 years.6

Indirect benefits of childhood PCV13 vaccination

At the time of the 2014 recommendation for routine PCV13 use in older adults, ACIP noted the decline in IPD incidence in this population.1,5,7 This decline was attributed to the indirect beneficial effects of ongoing routine PCV13 vaccination in children. Declines in PCV13-type IPD among adults ≥65 years were nine-fold from 2000 through 2014, prior to introduction of the PCV13 program in this age group.8 These indirect effects were anticipated to continue, in addition to the direct benefits to adults receiving PCV13 vaccination with the 2014 introduction of this program.

The majority of pneumonia cases among adults ≥65 years is now primarily attributable to non-PCV13 serotypes.8 From 2015 to 2016, only 4% of all pneumonia cases were attributable to PCV13 serotypes. The CDC estimated that among adults ≥65 years, in order to prevent one case of PCV13-type IPD, 26,300 adults would need to be vaccinated, and to prevent one case of PCV13-type outpatient pneumonia, 2,600 would need to be vaccinated.

Cost-effectiveness analyses also suggested decreased benefit of continued routine PCV13 vaccination in adults ≥65 years.1 Models now predict estimated cost-effectiveness ratios ranging from $200,000 to $560,000 per quality-adjusted life-year (QALY) with continued use of both vaccines vs use of PPSV23 alone.9,10 In contrast, the estimated cost per QALY in 2014 was $65,000, indicating greater benefit at that time.

New recommendations

Based on this evidence, routine vaccination of all adults ≥65 years with PCV13 is no longer recommended.1 Instead, shared decision-making is recommended to occur among these adults if they do not have an immunocompromising condition, cerebrospinal fluid (CSF) leak, or cochlear implant and if they have not previously received PCV13. This decision-making should consider the patient’s risk for exposure to PCV13 serotypes and risk for pneumococcal disease based on comorbidities; patients with risk factors may still receive some benefit from PCV13 vaccination. Risk of exposure to PCV13 serotypes may be increased in adults residing in nursing homes or long-term care facilities, settings with low pediatric uptake of PCV13 vaccination, or those traveling to settings with no pediatric PCV13 program. Comorbidities that may increase risk for pneumococcal disease include chronic heart, lung, or liver disease, diabetes, alcoholism, smoking, and multiple chronic conditions.

The 11 distinct serotypes covered by PPSV23 account for approximately 35% of IPD among adults ≥65 years, and there are no indirect effects from PCV13 use in children on these serotypes.1  Therefore, recommendations for PPSV23 are unchanged, and this vaccine is still recommended for all adults ≥65 years. Adults who received at least 1 dose of PPSV23 before age 65 years should receive 1 additional dose after age 65, at least 5 years after the previous dose.

Conclusion

The indirect beneficial effects of routine pediatric vaccination with PCV13 since 2010 have translated to minimal additional benefit from the 2014 ACIP recommendation to also routinely vaccinate all adults ≥65 years with PCV13. Because PCV13-type disease is at historically low levels among adults ≥65 years and most pneumococcal disease among these adults is due to non-PCV13 serotypes, ACIP no longer recommends their routine vaccination with PCV13. Shared clinical decision-making is now recommended for adults ≥65 years who do not have an immunocompromising condition, CSF leak, or cochlear implant and who have not previously received PCV13. Adults ≥65 years should continue to receive PPSV23 vaccine at the previously recommended schedule.

References

  1. Matanock A, Lee G, Gierke R, Kobayashi M, Leidner A, Pilishvili T. Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged ≥65 years: Updated recommendations of the Advisory Committee on Immunization Practices. MMWR. 2019;68(46):1069-1075.
  2. DynaMed [database online]. Ipswitch, MA: EBSCO Health; 2020. www.dynamed.com. Accessed February 5, 2020.
  3. Centers for Disease Control and Prevention. Active Bacterial Core Surveillance (ABCs) Report Emerging Infections Program Network Streptococcus pneumoniae, 2017. Centers for Disease Control and Prevention website. https://www.cdc.gov/abcs/reports-findings/survreports/spneu17.pdf. Published March 7, 2019. Accessed February 5, 2020.
  4. Weycker D, Farkouh RA, Strutton DR, Edelsberg J, Shea KM, Pelton SI. Rates and costs of invasive pneumococcal disease and pneumonia in persons with underlying medical conditions. BMC Health Serv Res. 2016;16:182.
  5. Ahmed SS, Pondo T, Xing W, et al. Early impact of 13-valent pneumococcal conjugate vaccine use on invasive pneumococcal disease among adults with and without underlying medical conditions-United States [published online ahead of print August 12, 2019]. Clin Infect Dis. doi: 10.1093/cid/ciz739.
  6. Tomczyk S, Bennett NM, Stoecker C, et al. Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged ≥65 years: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2014;63(37):822-825.
  7. Campos-Outcalt D. Pneumococcal conjugate vaccine update. J Fam Pract. 2019;68(10):564-566.
  8. Matanock A. Considerations for PCV13 use among adults ≥65 years old and a summary of the evidence to recommendations framework. Centers for Disease Control and Prevention website. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2019-06/Pneumococcal-2-Matanock-508.pdf. Published June 2019. Accessed February 5, 2020.
  9. Stoecker C, Kobayashi M, Matanock A, Cho BH, Pilishvili T. Cost-effectiveness of continuing pneumococcal conjugate vaccination at age 65 in the context of indirect effects from the childhood immunization program [published online ahead of print December 27, 2019]. Vaccine. doi: 10.1016/j.vaccine.2019.12.029.
  10. Stoecker C, Kim L, Gierke R, Pilishvili T. Incremental cost-effectiveness of 13-valent pneumococcal conjugate vaccine for adults age 50 years and older in the United States. J Gen Intern Med. 2016;31:901-908.

Prepared by:
Ryan Rodriguez, PharmD, BCPS
Clinical Assistant Professor, Drug Information Specialist
University of Illinois at Chicago College of Pharmacy

March 2020

The information presented is current as of February 10, 2020.  This information is intended as an educational piece and should not be used as the sole source for clinical decision making.

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