ATLANTA — Adults who have immunocompromising conditions should receive the 13-valent pneumococcal conjugate vaccine (Prevnar 13, PCV13) in addition to the 23-serotype polysaccharide vaccine (Pneumovax 23, PPSV23), according to the CDC’s Advisory Committee on Immunization Practices.
The decision, made Wednesday at one of ACIP’s regular meetings at CDC headquarters here, was based on evidence indicating that broader protection against pneumonia and invasive pneumococcal disease could be achieved by using both vaccines and that the benefits of PCV13 likely outweigh the harms in patients with compromised immune systems, who have an elevated risk of invasive disease compared with other individuals.
The high-risk group includes organ transplant patients and those with functional or anatomic asplenia, congenital or acquired immunodeficiencies, HIV infection, chronic renal failure or nephrotic syndrome, leukemia, lymphoma, Hodgkin disease, generalized malignancy, diseases requiring treatment with immunosuppressive drugs (including long-term systemic corticosteroids or radiation therapy), and multiple myeloma.
The new guidance regarding PCV13 also includes those with cochlear implants and those with cerebrospinal fluid leaks.
The CDC currently recommends using PPSV23 for all individuals 65 and older and for those ages 2 to 64 who are at risk for pneumococcal infection because of chronic illnesses or underlying medical conditions, including those that compromise the immune system.
PCV13 has been approved by the FDA for use in patients ages 6 months through 5 years for the prevention of invasive pneumococcal disease and in those ages 50 and older for the prevention of pneumonia and invasive pneumococcal disease.
Routine revaccination with PPSV23 is not recommended, but a second dose is advised no sooner than 5 years after the first dose for adults ages 19 to 64 with functional or anatomic asplenia or immunocompromising conditions. Everyone should receive a PPSV23 dose at age 65 or older, regardless of prior vaccination history, according to the CDC.
The PCV13 recommendations will be integrated into that PPSV23 guidance, which remains unchanged.
The guidance approved by the ACIP members by a vote of 14-0, with one abstention, included the following:
- Adults 19 and older with immunocompromising conditions who have not previously received PCV13 or PPSV23 should receive a single dose of PCV13 followed by a dose of PPSV23 at least 8 weeks later.
- Adults 19 and older with immunocompromising conditions who have previously received at least one dose of PPSV23 should receive a single dose of PCV13 no sooner than 1 year after the last PPSV23 dose. If patients require another PPSV23 dose, it should be administered no sooner than 8 weeks after PCV13 and 5 years after the last PPSV23 dose.
Presentations to ACIP showed that the use of PCV13 in patients with immunocompromising conditions would be cost-effective, although it was more cost-effective for patients with HIV than for those with hematologic cancer, solid organ transplant, or those on dialysis.
As a condition of the approval of PCV13 for individuals 50 and older, the FDA required a post-marketing randomized controlled trial evaluating the vaccine in individuals 65 and older. That study, the CAPiTA trial, is currently ongoing in the Netherlands, and results are expected in 2013.
Recommendations from ACIP do not become final until accepted by the director of the CDC and published in Morbidity and Mortality Weekly Report. All ACIP recommendations have been accepted in the past.