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CDC Recommends Pneumococcal Vaccine Combo for Immune Compromised People

Immunocompromised individuals, including people with HIV, should receive both the 13-valent pneumococcal conjugate vaccine Prevnar 13 and the 23-valent pneumococcal polysaccharide vaccine Pneumovax 23 to prevent pneumococcal pneumonia and invasive disease, according to the latest recommendations from the Centers for Disease Control and Prevention (CDC).

The CDC's Advisory Committee on Immunization Practices (ACIP) initially adopted the dual vaccine recommendation at a meeting this past June; the full recommendations were described in the October 12, 2012,Morbidity and Mortality Weekly Report.

Streptococcus pneumoniae remains a leading cause of serious illness among adults in the U.S., including bacteremia, meningitis, and pneumonia, the report noted as background. An estimated 4000 deaths due to pneumococcal infection occur in the U.S. each year,primarily among adults. The incidence of invasive pneumococcal disease ranges from 3.8 per 100,000 among people age 18-34 years, to 36.4 per 100,000 among those age 65 years or older. Immune-compromising conditions dramatically increase the risk, with rates of 173 per 100,000 among people with HIV and 186 per 100,000 among adults with hematologic malignancies such as leukemia.

Merck's Pneumovax 23 -- which is effective against 23 different S. pneumoniae serotypes -- was approved by the U.S. Food and Drug Administration (FDA) for prevention of pneumococcal pneumonia and invasive disease for all adults age 65 years or older and for high-risk adults age 19 to 64 years. Pneumovax 23 alone is currently recommended for healthy adults.

Wyeth's Prevnar 13 -- active against 13 serotypes -- was approved in December 2011 for adults age 50 years or older for prevention of pneumonia and invasive pneumococcal disease, based on studies showing similar or better antibody response compared with Pneumovax 23. It was previously approved for children and was preceded by an earlier version  (Prevnar 7) active against 7 serotypes.

ACIP recommended "routine use" of Prevnar 13 -- in addition to Pneumovax 23 -- for adults age 19 years or older with immune-compromising conditions includingcongenital or acquired immunodeficiency, HIV infection, chronic kidney failure or nephrotic syndrome, leukemia, lymphoma, Hodgkin disease, or generalized malignancy. It also indicated for organ transplant recipients and people with multiple myeloma or other conditions requiring treatment with immunosuppressive drugs. The recommendation also applies to people with functional or anatomic asplenia (missing or dysfunctional spleen), cerebrospinal fluid (CSF) leaks, or cochlear (inner ear) implants.

Half of all cases of invasive pneumococcal disease among immune-compromised adults reported during 2010 were caused by S. pneumoniae serotypes found in Prevnar 13, while another 21% were caused by serotypes found only in Pneumovax 23, according to the ACIP report.

Adults who have not yet received any pneumococcal vaccination should first receive Prevnar 13 as soon as possible, followed by the first dose of Pneumovax 23 at least 8 weeks later. Studies in non-immune-compromised individuals showed that antibody responses were greater among people who received Prevnar 13 before Pneumovax 23, as opposed to vice versa.

People with immune-compromising conditions and those with asplenia should receive a second dose of Pneumovax 23 after 5 years. All adults are eligible for a dose of Pneumovax 23 at age 65, but this should occur at least 5 years after the last prior dose.

People who previously received Pneumovax 23should receive a dose of Prevnar 13no sooner that 1 year after the last Pneumovax 23dose. Additional Pneumovax 23doses -- if needed -- should be administered at least 8 weeks after Prevnar 13and at least 5 years after the latest Pneumovax 23dose.

Both vaccines appeared safe and effective in clinical trials to date. Overall incidence of serious adverse events reported within 1 month after an initial dose was < 2% for both vaccines, according to the report. The most common side effects were injection site soreness and swelling. Prevnar 13 data are limited for people with HIV, though studies have shown that Prevnar 7 (which includes half the serotypes in the newer version) is safe and effective in this population. Pneumovax 23 contains 12 of the serotypes in Prevnar 13, plus 11 more.

A CDC cost-effectiveness analysis looking at immune-compromised adults indicated that using both vaccines should be cost saving. A mathematical model found that the combination would prevent an estimated 57 cases of invasive pneumococcal disease, adding 1360 quality-adjusted life years and saving $7.6 million.

"Although conflicting evidence regarding [Pneumovax 23] efficacy in HIV-infected adults has been published, the GRADE evaluation reviewed by the ACIP concluded that potential benefits from [Pneumovax 23] use in this population outweigh any potential harms," the committee members concluded. "Given the high burden of invasive pneumococcal disease caused by serotypes in [Pneumovax 23] but not in [Prevnar 13], broader protection might be provided through use of both pneumococcal vaccines."

10/16/12

Reference

NM Bennett, CG Whitney, M Moore, et al. 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). Morbidity and Mortality Weekly Report 61(40):816-819. October 12, 2012.