CDC Panel Endorses PCV13 Use in Immunocompromised Children

Miriam E. Tucker

February 20, 2013

An advisory panel for the Centers for Disease Control and Prevention (CDC) has voted for the use of the 13-valent pneumococcal conjugate vaccine in children with immunodeficiencies and has also addressed issues regarding the use of Haemophilus influenzae B (Hib) vaccines.

At its meeting held February 20, the CDC's Advisory Committee on Immunization Practices (ACIP) voted unanimously (15 - 0) to recommend routine use of a single dose of PCV13 for children aged 6 to 18 years who have an immunocompromising condition and have not previously received the vaccine.

Those conditions include anatomic or functional asplenia (including sickle cell disease), HIV infection, chronic renal failure and nephrotic syndrome, cochlear implants or cerebrospinal fluid leaks, diseases associated with immunosuppressive drug treatment, and congenital immunodeficiency.

The recommendation follows the January 25, 2012, licensure of the vaccine by the US Food and Drug Administration for use in children aged 6 through 17 years. In 2010, the ACIP had said PCV13 "may be used" off-label for high-risk children in those age groups.

The vaccine, which is recommended as routine immunization for all children at ages 2, 4, 6, and 12 to 15 months, had also previously been both licensed and recommended for use in high-risk children aged 6 weeks through 71 months and had been previously recommended for adults aged 19 years and older who have immunocompromising conditions.

As per the previous recommendation, individuals aged 2 years and older with those underlying conditions should also be given a dose of the 23-valent polysaccharide pneumococcal vaccine (PPSV23) at least 8 weeks after receiving PCV13. Previous recommendations also addressed giving PCV13 to those who already received PPSV23.

Along with the January licensure, rationale for the new recommendation included the fact that children with immunocompromising conditions, although a very small group, are also at very high risk for pneumococcal disease. Moreover, PCV13 may provide protection beyond that of PPSV23, and the new recommendation harmonizes with the recommendation for high-risk adults, Tamara Pilishvili, from the CDC's National Center for Immunization and Respiratory Diseases told the committee.

The risk ratio for invasive pneumococcal disease among children aged 6 to 18 years who have hematologic malignancy compared with those without is 1068. For sickle cell disease and HIV/AIDS, those risk ratios are 43.5 and 158, respectively.

Among children in that age group, data from 2011 show that 33% of the risk was a result of a serotype included in the PCV13 vaccine, 38% because of a serotype included in PPSV23 but not PCV13, and just 29% because of a strain that neither vaccine covers, Pilishvili said.

In a separate unanimous vote, the committee also included the new use of PCV13 for coverage under the federal Vaccines for Children program.

Hib Immunization

In another agenda item, the panel voted unanimously to update its 1993 statement on the use of Hib vaccines. There were no new recommendations, but the new statement will now include an overview of current Hib epidemiology and will also provide a list of current Hib vaccines, recommendations for routine vaccination, and guidance for special populations in as single document, as well as guidance for chemoprophylaxis of household and childcare contacts of infected individuals.

The committee split 12 to 3, however, on its vote for the Vaccines for Children inclusion of the meningococcal CY-Hib vaccine (HibMenCY; MenHibrix, GlaxoSmithKline).

The HibMenCY vaccine, licensed in June 2012 and expected to be available in late summer 2013, was recommended previously by ACIP only for use in infants at high risk for meningococcal disease, not for routine use in all infants.

For Hib immunization, some committee members felt the vaccine should also be available in special circumstances, such as for family members of patients who have had meningococcal infection. However, other panel members expressed concern that if it were included in the list of available Hib vaccines, it could "take over" and end up being used routinely for all children.

After a lengthy discussion, the committee finally voted in favor of including HibMenCY in the Vaccines for Children program as a Hib vaccination alternative but also to include language referencing the fact that it is really only recommended for high-risk children.

The CDC usually follows the advice of the ACIP.

One of the 15 ACIP members disclosed having received a research grant from Merck. The rest of the members and Pilishvili have disclosed no relevant financial relationships.

ACIP February 2013 Meeting. Presented February 20, 2013.