VACCINE UPDATE

Recommendation for conjugate pneumococcal and pneumococcal polysaccharide vaccines in adults older than 65 years Sarah A. Niemi, Stephan L. Foster, and Mary S. Hayney

Pneumococcal infections are caused by encapsulated gram-positive bacteria and are a leading cause of serious illness in adults and children. A study published in 2011 found that patients older than 65 years had the most serious pneumococcal infections and incurred the majority of direct medical costs secondary to these infections.1 The study showed that in these adults, pneumococcal pneumonia alone caused 242,000 hospitalizations, 1.4 million hospital days, and 16,000 deaths in the United States over the span of a single year. Two types of pneumococcal vaccines are available in the United States. These include the polysaccharide 23-valent vaccine (Pneumovax 23—Merck; PPSV23), and the conjugate 13-valent vaccine (Prevnar 13—Pfizer; PCV13). The PPSV23 vaccine has proven to be effective in adults for prevention of invasive pneumococcal disease (infection in a normally sterile site, such as blood or cerebrospinal fluid, but not sputum), but it has limited effectiveness against nonbacteremic pneumonia. 2,3 The conjugate vaccine was developed for children because it induced a greater antigenic response, and the PCV7 vaccine was licensed in 2000 covering seven serotypes. Coverage was expanded in 2010 when the PCV13 was approved to cover 13 serotypes.4 The 2010 Advisory Committee on Immunization Practices (ACIP) statement on use of pneumococcal vaccine in adults recommended one dose of PPSV23 vaccine in all adults older than 65 years to prevent invasive pneumococcal disease.5 In multicenter studies in the United States 212 JAPhA | 5 5:2 | M AR/AP R 2 0 1 5

and Europe, the 12 serotypes that are common to both vaccines had similar or higher levels of antibodies induced with the PCV13 vaccination compared with the PPSV23.6 This led to FDA licensure through accelerated-approval processes of the PCV13 vaccine for use in adults older than 50 years to prevent invasive pneumococcal disease in December 2011.6 In 2012, the ACIP made recommendations for the use of PCV13 and PPSV23 in adults older than 19 years with immunocompromising conditions, functional or anatomic asplenia, cerebrospinal fluid leaks, or cochlear implants.7 On February 20, 2013, ACIP expanded this recommendation to include children aged 6–18 years.8

Expanded recommendations in 2014 The ACIP made a new recommendation on August 13, 2014, to use the PCV13 and PPSV23 universally for all adults older than 65 years. The new recommendation was officially approved by the Centers for Disease Control and Prevention on September 19, 2014.9 If neither vaccine has been given or vaccine history is unknown, the conjugate vaccine should be given first followed by the PPSV23 vaccine in 6–12 months. The recommendation states that if the polysaccharide vaccine was already administered to someone older than 65 years, the PCV13 vaccine should

be given 1 year later. Both vaccines are still recommended to provide broader coverage since the PPSV23 covers more serotypes (see Figure 1). The ACIP also stated that the routine PCV13 use among adults 65 years or older should be re-evaluated in 2018 because of the herd effects that will likely occur, and the recommendation should be revised as needed.9 The ACIP made this recommendation based on the results of Pfizer’s Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA).10 The study was conducted with 84,496 adults who were 65 years or older in the Netherlands. The study met its primary objective; and found that the PCV13 vaccine was 45.56% effective in preventing vaccine-type pneumococcal community-acquired pneumonia. The study also met both of its secondary objectives, finding that the PCV13 vaccine was 75% effective against vaccine-type invasive pneumococcal disease and 45% effective against vaccine-type nonbacteremic community-acquired pneumonia. The reduction in nonbacteremic community-acquired pneumonia was important because the commonly used PPSV23 vaccine has shown no efficacy to prevent noninvasive pneumonia,11 while providing similar efficacy (74%) against vaccine-type invasive disease.12 One concern with the new recommendation is the anticipated decline in utility of universally vaccinating people older than 65 due to the herd effect from immunized children. Herd effect is a type of immunity manifested across a whole population when a substantial part of the population is immunized. When the PCV7 vaccine was routinely given to children in 2000, the

Send your immunization questions to the JAPhA Contributing Editors who coordinate the Vaccine Update column: ❚❚

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Mary S. Hayney, PharmD, MPH, BCPS, Professor of Pharmacy, School of Pharmacy, University of Wisconsin, Madison ([email protected]).

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VACCINE UPDATE

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Pneumococcal Vaccine Decision Tree for Adults > 65 Years Old VACCINE UPDATE Who Previously Did Not Receive PCV13 If PCV13 was given before age 65 years, no additional PCV13 is needed.

Has patient received PPSV23 since turning age 65 years?

NO

Give PCV13 if it has been at least 1 year after last PPSV23.

6-12 months later

YES

Give PPSV23 if it has been >5 years since last PPSV23.

Give PCV13 one year after last PPSV23.

References

Figure 1. Pneumococcal vaccine decision tree for adults 65 years or older who previously did not receive the conjugate 13-valent vaccine (Prevnar 13—Pfizer).Abbreviations used: PCV13, conjugate 13-valent vaccine; PPSV23, polysaccharide 23-valent vaccine (Pneumovax 23—Merck). pneumococcal infection rates in both children and adults fell drastically for serotypes covered by PCV7.13 Since the PCV13 was approved in 2010 and trends are similar to the PCV7, we should see overall reduction in PCV13 vaccine-type disease by 2017–19.3 Because of the likely herd effect, plans to review this recommendation in 2018 are in place.9

Implications for pharmacists Pharmacists can play a large role in the implementation and adherence to the new pneumococcal vaccine recommendation. In 2013, an estimated 14.1% of the population, or about 44.6 million people in the United States, were older than 65 years.14 Since the new recommendation applies to all people in this age group, the workload for health care professionals is great in assuring these patients are educated and vaccinated in time for the influenza season when pneumonia has the largest impact. Pharmacists are accessible and have the ability to educate patients about these new recommendations. 214 JAPhA | 5 5:2 | M AR/AP R 2 0 1 5

cination. The Centers for Medicare & Medicaid Services (CMS) recently modified their Medicare coverage for pneumococcal vaccines to be in line with ACIP recommendations. 15 Medicare Part B covers both pneumococcal vaccine preparations and administration for Medicare beneficiaries provided 1 year after the first vaccine. This is interpreted to be at least 11 months between doses of vaccine. CMS does not specify the order in which the vaccine preparations are administered, but pharmacists should follow the ACIP recommendations outlined above.

They can inform patients about the benefits in reducing both community-acquired pneumonia and invasive pneumococcal disease with the completion of the pneumococcal vaccination series. Both community and hospital pharmacists can implement programs to screen and immunize all patients older than 65 with appropriate pneumococcal vaccines. The use of immunization information systems by pharmacists in all settings is a standard of practice. Although these vaccine are considered safe and generally well tolerated, pharmacists should be prepared to discuss adverse reactions to these vaccines. Adverse reactions to either vaccine preparation are similar and include pain, redness, and swelling at the injection site and limb pain. Fatigue, headache, chills, decreased appetite, and muscle and joint pain have also been reported.9 Pharmacists can also help educate patients on the importance of receiving both PCV13 and PPSV23 at appropriate intervals to expand coverage and offer strategies to promote follow up for the second vacja p h a.org

1. Huang SS, Johnson KM, Ray GT, et al. Healthcare utilization and cost of pneumococcal disease in the United States. Vaccine. 2011;29(18):3398–3412. 2. Mirsaeidi M, Schraufnagel DE. Pneumococcal vaccines: Understanding Centers for Disease Control and Prevention recommendations. Ann Am Thorac Soc. 2014;11(6):980–985. 3. Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices. ACIP Presentation Slides: August 2014 Meeting. www.cdc.gov/vaccines/acip/meetings/ slides‐2014‐08.html. Accessed January 13, 2015. 4. Centers for Disease Control and Prevention. Licensure of a 13-valent pneumococcal conjugate vaccine (PCV13) and recommendations for use among children—Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2010;59(09):258–261. 5. Centers for Disease Control and Prevention. Updated recommendations for prevention of invasive pneumococcal disease among adults using the 23-valent pneumococcal polysaccharide vaccine (PPSV23). MMWR Morb Mortal Wkly Rep. 2010;59(34):1102–1106. 6. Food and Drug Administration. FDA expands use of Prevnar 13 vaccine for people ages 50 and older. Silver Spring, MD: U.S. Department of Health and Human Services, Food and Drug Administration; 2011. http://www.fda. gov/newsevents/newsroom/pressan-

Journal of the American Pharmacists Association

VACCINE UPDATE

nouncements/ucm285431.htm. cessed January 13, 2015.

Ac-

7. Centers for Disease Control and Prevention. Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine for adults with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2012;61:816–819. 8. Centers for Disease Control and Prevention. Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among children aged 6–18 years with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2013;62(25):521–524. 9. Centers for Disease Control and Prevention (CDC). Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults age ≥65 years: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2014;63(37):822–825.

10. Pfizer. Pfizer presents detailed results from landmark Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) evaluating efficacy of Prevnar 13. http://www.pfizer.com/ news/press‐release/press‐release‐ detail/pfizer_presents_detailed_results_from_landmark_community_acquired_pneumonia_immunization_trial_in_adults_capita_evaluating_efficacy_of_prevenar_13. Accessed September 5, 2014. 11. Fry AM, Zell ER, Schuchat A, et  al. Comparing potential benefits of new pneumococcal vaccines with the currently polysaccharide vaccine in the elderly. Vaccine. 2002;21(3–4):303–311. 12. Moberley S, Holden J, Tatham DP, Andrews RM. Vaccines for preventing pneumococcal infection in adults. Cochrane Database Syst Rev. 2013;1:CD000422. 13. Centers for Disease Control and Prevention. Direct and indirect effects of routine vaccination of children with 7-valent pneumococcal conjugate vaccine on incidence of invasive pneumococcal disease—United States, 1998– 2003. MMWR Morb Mortal Wkly Rep. 2005;54(36):893–897.

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14. United States Census Bureau. State & county QuickFacts. http://quickfacts. census.gov/qfd/states/00000.html. Accessed September 19, 2014. 15. Department of Health and Human Services. Centers for Medicare & Medicaid Services. Modifications to Medicare Part B coverage of pneumococcal vaccinations. MLN Matters. December 31, 2014. http://www.cms.gov/Outreach‐ and‐Education/Medicare‐Learning‐ Network‐MLN/MLNMattersArticles/ Downloads/MM9051.pdf. Accessed January 13, 2015. Sarah A. Niemi, Student Pharmacist, School of Pharmacy, University of Wisconsin, Madison, WI Stephan L. Foster, PharmD, FAPhA, FNAP, Professor, College of Pharmacy, University of Tennessee Health Sciences Center Memphis, and APhA Liaison Representative to ACIP, CAPT (Ret) U.S. Public Health Service Mary S. Hayney, PharmD, MPH, Professor of Pharmacy, School of Pharmacy, University of Wisconsin, Madison, WI. [email protected] doi: 10.1331/JAPhA.2015.15511

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Vaccine Update: Recommendation for conjugate pneumococcal and pneumococcal polysaccharide vaccines in adults older than 65 years.

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