New Recommendations for 13-Valent Pneumo Vaccine in Compromised Adults

Abstract & Commentary

By Mary-Louise Scully M.D.

Director, Travel and Tropical Medicine Center, Samsun Clinic, Santa Barbara, CA.

Dr. Scully reports no financial relationships to this field of study

Synopsis: New recommendations have been approved for the use of 13-valent pneumococcal conjugate vaccine in conjunction with the 23-valent-polysaccharide pneumococcal vaccine in immunocompromised adults ages 19 and older.

Source: Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices (ACIP). June 20-21 2012 (slide presentations). Atlanta Georgia http://www.cdc.gov/vaccines/recs/acip/slides-jun12.htm#pcv accessed July 7, 2012.

At the June 20, 2012 meeting in Atlanta, Georgia the CDC Advisory Committee on Immunization Practices [ACIP] voted in favor of recommending the addition of 13-valent pneumococcal conjugate vaccine (PCV13) to the 23-valent pneumococcal polysaccharide vaccine (PPSV23) for adults aged 19 and older with immunocompromising conditions. PCV13 was licensed in December 2011 for use among adults ≥50 years of age based on non-inferior immunogenicity compared to PPSV23. The serotypes in PCV13 include serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.

The indications are for adults 19 years of age or older with immunocompromising conditions. They include HIV infections, chronic renal failure, malignancies, leukemias, lymphomas, multiple myeloma, Hodgkin's disease, immunosuppressive drugs, solid organ transplants, congenital or acquired immunodeficiencies, functional or anatomic asplenia and patients with CSF leaks or cochlear implants. The categories are divided into vaccine naïve versus previously PPSV23- immunized.

1. For pneumococcal vaccine naïve patients it is recommended that PCV13 be given before PPSV23 whenever possible. After a single dose of PCV13 is given, a dose of PPSV23 should be given at least 8 weeks after PCV13. Another dose of PPSV23 can then be given 5 years later, and at age 65.

2. Patients previously immunized with one or more doses of PPSV23 should receive 1 dose of PCV13 given at least 1 or more years after the last PPSV23 dose was received. In situations where a patient needs additional doses of PPSV23 according to the previous guidelines, the next dose of PPSV23 should be at least 8 weeks after PCV13, and at least 5 years after the most recent dose of PPSV23.

The PCV13 is currently licensed for children aged 6 weeks through 71 months and adults aged 50 years and older. Therefore, it should be noted that for persons aged 19-49 years, this is an off-label use of the PCV13 vaccine.

Commentary

Vaccine strategies continue to emerge in attempts to reduce the morbidity and mortality of pneumococcal disease in both children and adults. Before universal infant immunization with pneumococcal 7-valent conjugate vaccine (PCV7) in the United States, Streptococcus pneumoniae was estimated to cause over 17,000 cases of invasive pneumococcal disease (IPD) among children < 5 years of age, including 800 cases of meningitis and 200 deaths.1 The routine use of PCV7 essentially eliminated IPD secondary to serotypes included in the vaccine both in children and also in adults due to herd immunity. There was an increase in the proportion of cases of IPD caused by non-vaccine serotypes, or so-called replacement strains, but this increase was small compared to the overall decline in numbers of IPD (net decline of 24,878 cases).2 When PCV13 replaced PCV7 in 2010 for routine childhood use, certain troublesome serotypes such as, serotype 19A, which had emerged as an important cause of multidrug resistant otitis media in children, were included in newer PCV13 vaccine. The looming question is whether the routine use of PCV13 in children will also reduce IPD from these vaccine serotypes in adults, similar to what was observed after the introduction of PCV7, which lead to a near elimination of vaccine serotype IPD in adults of all age groups.

Although this recommendation for use of PCV13 in immunocompromised patients was approved, the decision on the routine use of PCV13 in adults over 50 years will likely depend on evolving data and the results of a randomized, controlled trial ongoing in the Netherlands. Since, for patients 19-49 years of age, PCV13 vaccine represents off label use, there may be issues about insurance reimbursement for the vaccine. Patients meeting the new guidelines directives may therefore have "out of pocket" costs similar to what many patients experienced with the initial licensing of the Herpes zoster (shingles) vaccine. The cost per dose of PCV13 in the private sector is about $120 US dollars. This is a price that some immunocompromised patients, with the available financial means, might be willing to pay to reduce their risk of pneumococcal disease.

References

  1. CDC. Preventing Pneumococcal Disease among Infants and Young Children: Recommendation of the ACIP. MMWR 2000;49(No. RR-9):1-35.
  2. CDC. 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 2005;54(36): 893-897.