Ask the Experts: What are the new recommendations for PCV13 in adults?
Pharmacists may be called upon to help primary care providers navigate difficult dosing guidelines for PCV13 and PPSV23.
The Advisory Committee on Immunization Practices (ACIP) updated its recommendation for pneumococcal 13-valent protein conjugate vaccine (PCV13; Prevnar-13–Pfizer) at the June 20–21, 2012, meeting. In June 2012 Pharmacy Today,1 we described the FDA approval of PCV13 for use in adults 50 years or older based on safety and serological immunogenicity data.2 Before this decision, PCV13 was only FDA approved and ACIP recommended for the prevention of pneumonia and otitis media in children aged 6 weeks through 5 years.3 ACIP decided to not change its pneumococcal vaccination guidelines in adults at the February 2012 meeting and to continue the same recommendation for 23-valent pneumococcal polysaccharide vaccine (PPSV23; Pneumovax 23–Merck). Any new recommendation would depend on evaluation of data on immunogenicity and cost effectiveness. Routine recommendation for adults would not be discussed again until an efficacy study on vaccine effectiveness against pneumonia (expected in 2013) and an evaluation of indirect (herd) effects of vacation of children are completed.
Several studies were discussed at the June 2012 ACIP meeting concerning pneumococcal disease in high-risk patients. A GRADE analysis (more information available at www.cdc.gov/vaccines/acip/recs/GRADE/table-refs.html) was presented, and the working group concluded that PPSV23 was effective against invasive pneumococcal disease; however, no evidence on effectiveness against pneumonia was available. One study cited, by Cohen et al.,4 described a 40-times-higher prevalence of invasive pneumococcal disease (IPD) among HIV-infected individuals compared with individuals without HIV. The incidence was even higher in those younger than 35 years. Cohen et al. reported a decrease in IPD among HIV-infected individuals during a time period starting before 7-valent protein conjugate vaccine (PCV7; Prevnar-7—Wyeth) was introduced (1998) through 2007, demonstrating a herd effect. By 2007, they reported that 8.7% of cases of IPD in HIV patients were caused by serotypes included in PCV7, 38.9% of serotypes were covered by PCV-13, and 57% of serotypes were included in PCPSV23.
Another older study by French et al.5 was presented. This study evaluated the effectiveness of PPSV23 vaccination in HIV-infected African adults and concluded that PPSV23 was ineffective. PCV7 also was studied in HIV patients in Africa, and vaccine effectiveness was demonstrated.6 Other data were presented, and although some were conflicting, ACIP decided that PCV13 was effective, the benefits outweighed the risks, and the high disease burden in immunocompromised patients warranted its use.
On June 20, 2012, ACIP voted for the recommendation of PCV13 for adults 19 years or older with very specific immunocompromising conditions, and the provisional recommendations were posted on September 18, 2012.7 The recommendations are for adults 19 years or older with immunocompromising conditions, functional or anatomic asplenia, cerebrospinal fluid leaks, or cochlear implants. PCV13 should be given in addition to PPVS23, the recommendations for which did not change.3
For patients younger than 65 years who have not previously received PPSV23, a dose of PCV13 should be administered and followed 8 weeks later by the first dose of PPSV23. The second dose of PPSV23 then should be administered 5 years later. In addition, these patients should receive another PPSV23 at 65 years or older if at least 5 years has passed since the last dose.
For patients younger than 65 years who previously received PPSV23, a dose of PCV13 should be given no sooner than 1 year following the most recent dose of PPSV23. Again, the same rules apply for repeat doses of PPSV23 (i.e., repeat dose of PPSV23 5 years after last dose of PPSV23 if it at least 8 weeks after PCV13). Again, another dose of PPSV23 should be given at 65 years or older if at least 5 years has passed.
For patients 65 years or older who have received a dose of PPSV23, a single dose of PVC13 should be administered if at least 8 weeks have elapsed since that dose.
Figure 1. Dosing guidelines for PCV13 and PPSV23
One of the most surprising components of the recommendation was the fact that this was the first time a third dose of PPSV23 was recommended. It was previously stated that the maximum for a lifetime was two doses.
These vaccine dosing guidelines are very confusing. Not many pharmacists are likely to be involved in the decision processes for these complicated patients. However, we may be called upon to help primary care provider decide how to dose these patients.
Stephan L. Foster, PharmD, FAPhA
Professor and Vice Chair
College of Pharmacy
University of Tennessee Health Sciences Center
APhA Liaison Representative to the Advisory Committee on Immunization Practices (ACIP)
CAPT (Ret) U.S. Public Health Service
College of Pharmacy
University of Tennessee Health Sciences Center
- Foster SL, Beregovsky I. Which pneumococcal vaccine should be used in adults? Pharmacy Today. 2012;18(6):39.
- Centers for Disease Control and Prevention. Licensure of 13-valent pneumococcal conjugate vaccine for adults aged 50 years and older. Accessed at www.cdc.gov/mmwr/preview/mmwrhtml/mm6121a3.htm, October 4, 2012.
- Centers for Disease Control and Prevention. Prevention of pneumococcal disease among infants and children: use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine. Accessed at www.cdc.gov/mmwr/preview/mmwrhtml/rr5911a1.htm, October 4, 2012.
- Cohen AL, Harrison LH, Farely MM, et al. Prevention of invasive pneumococcal disease among HIV-infected adults in the era of childhood pneumococcal immunization. AIDS. 2010;24:2253–62.
- French N, Nakiyingi J, Carpenter LM, et al. 23-valent pneumococcal polysaccharide vaccine in HIV-1-infected Ugandan adults: double-blind, randomised and placebo controlled trial. Lancet. 2000;355:2106–11.
- French N, Gordon SB, Mwalukomo T, et al. A trial of 7-valent pneumococcal conjugate vaccine in HIV-infected adults. N Engl J Med. 2010.;362:812–22.
- Centers for Disease Control and Prevention. ACIP provisional recommendations for the use of 13-valent pneumococcal conjugate vaccine in adults with Immunocompromising conditions. Accessed at www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-adults-ic.pdf, October 4, 2012.