Vaccination with the 13-valent pneumococcal conjugate vaccine should be routine for certain high-risk children aged 6-18 years, panel members unanimously agreed at a meeting of the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.
Specifically, the panel recommended expanding the indication for this vaccine to include a group of older children – those between 6 and 18 years of age – who are at high risk for invasive pneumococcal disease (IPD) because of immunocompromising conditions, functional or anatomic asplenia, cerebrospinal fluid leaks, or cochlear implants, regardless or whether they have previously received the PCV7 or pneumococcal polysaccaride vaccine (PPSV23) vaccines. The 13-valent pneumococcal conjugate vaccine (PCV13) is already recommended by ACIP for high risk children 24-71 months of age who have these underlying conditions.*
The ACIP panel voted 15-0 in favor of this recommendation proposed by ACIP’s pneumococcal vaccines work group at its Feb. 20 meeting.
The inclusion of the older pediatric age group will harmonize the PCV13 pediatric recommendation and may improve vaccine uptake in these groups, Tamara Pilishvili, M.P.H., a member of the CDC’s pneumococcal vaccines work group, said at the meeting. Previously, the recommendation for this group was that a dose of PCV13 "may be administered" to children and adolescents 6 through 18 years of age who have certain medical conditions.
Initially approved in 2010, PCV13 (marketed by Pfizer as Prevnar 13) was approved in January 2013 for children aged 6 through 17 years for preventing invasive disease caused by the Streptococcus pneumoniae serotypes contained in the vaccine (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). PCV13 contains the seven strains contained in PCV7 (4, 6B, 9V, 14, 18C, 19F, and 23F), plus six more (1, 3, 5, 6A, 7F, and 19A).
PCV13 was added to the most recent updated adult schedule, released in January, for PCV13-naive adults 19 years and older who have immunocompromising conditions such as chronic renal failure, functional or anatomic asplenia, cerebrospinal fluid leaks, or cochlear implants and are immunocompromised (such as HIV infection).
After a review of the available evidence, the working group concluded that the burden of disease is "extremely high" among immunocompromised children aged 6-18 years and that the vaccine would probably be effective and the benefits would likely outweigh the risks in this group, Ms. Pilishvili of the respiratory diseases branch in the CDC’s National Center for Immunization and Respiratory Diseases, said at the meeting.
When compared with children without underlying conditions, the relative risk of IPD is over 1,000 times higher among children with a hematologic malignancy, almost 44-fold higher among children with sickle cell disease, and 158-fold higher among those with HIV/AIDS, she said, citing unpublished CDC data.
In addition, the use of both PCV13 and PPSV23 would provide broader serotype coverage for high-risk children in this age group, she said. In 2011, 38% of the IPD cases among high-risk children aged 6-18 years were caused by serotypes included in the PCV13 vaccine, 33% were the result of non-PCV13 serotypes in the PPSV23 vaccine, and 29% were caused by serotypes not included in either vaccine, she said.
Studies reviewed by the working group indicated that vaccination with other PCV vaccines reduced IPD, which included vaccine efficacy studies of PCV7 and PCV9, which, when combined, were estimated to be 69% effective in reducing IPD from serotypes included in the vaccines, Other evidence reviewed by the working group included immunogenicity data of PCV13 in people with sickle cell disease who had previously been vaccinated with PPSV23, in an open-label, single-arm study of children aged 6-7 years, as well as HIV-infected children.
Experts in immunization-related fields are members of the ACIP committee, which develops written recommendations for the routine administration of vaccines to children and adults in the civilian population.
*Updated 2/22/13