Recommendations for the Prevention of Streptococcus pneumoniae Infections in Infants and Children: Use of 13-Valent Pneumococcal Conjugate Vaccine (PCV13) and Pneumococcal Polysaccharide Vaccine (PPSV23)

BACKGROUND

IPD is a leading cause of morbidity and mortality throughout the world, and an estimated 14.5 million episodes occurred in children younger than 5 years in the year 2000, resulting in an estimated 826 000 pediatric deaths representing 11% of all deaths in children 1 through 59 months of age.³ In the United States, before introduction of PCV7, an estimated 16 250 cases of IPD occurred annually in children younger than 5 years, and 80% of cases of IPD in children were attributable to 1 of the 7 serotypes contained in PCV7.⁴ After widespread use of PCV7, IPD attributable to all pneumococcal serotypes decreased by 75% in children younger than 5 years and decreased by 45% overall when all age groups were considered, secondary to herd immunity. The reduction in IPD attributable to serotypes contained in PCV7 was even more dramatic (100% in children younger than 5 years and 94% when people of all ages were considered). After accounting for the indirect effects on incidence of IPD, the cost per life-year saved (estimated at $10 400) made PCV7 immunization a cost-effective intervention.⁵ In an analysis of 753 cases of IPD in children who had been completely immunized with PCV7, only 4% were true “vaccine failures.” The remaining cases were attributable to serotypes not contained in PCV7.⁶

Rates of IPD attributable to serotypes not contained in PCV7 have increased for all age groups since 2000. By 2006–2007, only 2% of IPD cases in children younger than 5 years were caused by PCV7 types, but the 6 additional serotypes included in the new PCV13 vaccine caused 63% of IPD cases in this age group. A report published in the Morbidity and Mortality Weekly Report estimated that 4600 cases of IPD occurred in US children younger than 5 years in 2007. Approximately 2900 of these cases (63%) were attributable to serotypes contained in PCV13 and would be potentially preventable with widespread use of PCV13.⁷

RECOMMENDATIONS

Children who have not previously received PCV7 or PCV13 or who are incompletely immunized with PCV7 or PCV13:

• PCV13 is recommended for all children 2 through 59 months of age and for children 60 through 71 months of age who have underlying medical conditions that increase their risk of pneumococcal disease or complications (Table 1).

• PCV13 is recommended as a 4-dose series given at 2, 4, 6, and 12 through 15 months of age (Table 2).

• For children within this age range who have received 1 or more doses of PCV7, the series should be completed with PCV13 when it is available in the office. Thus, previously administered PCV7 doses count toward completion of the recommended series (Table 3).

• The immunization schedule for infants and toddlers 2 through 59 months of age who have not received any previous PCV7 or PCV13 or who need “catch-up” immunization are the same as those published previously for PCV7, with PCV13 replacing PCV7 in the schedule (see Table 3.53 in Red Book⁸ (p532)). The only addition to Table 3.53 is the extension of age in children with underlying medical conditions, for whom PCV13 is recommended through 71 months of age.

Supplemental dose recommendation:

• A single supplemental dose of PCV13 is recommended for all healthy children 14 through 59 months of age who are fully immunized with PCV7. The supplemental dose should be given at least 8 weeks after the last dose of PCV7.

• For children fully immunized with PCV7 who have underlying medical conditions that increase their risk of pneumococcal disease or complications, a single supplemental dose of PCV13 is recommended for children 14 through 71 months of age, including children who may have previously received PPSV23.

• No active recall of patients is recommended. The supplemental dose should be given at the next medical visit of the child.

Children 6 through 18 years of age with conditions that place them at high risk:

• A single dose of PCV13 may be administered to children 6 through 18 years of age who are at increased risk of IPD because of sickle cell disease, anatomic or functional asplenia, HIV infection or other immunocompromising condition, or presence of cochlear implant or cerebrospinal fluid leaks, regardless of whether they have previously received PCV7 or PPSV23.

Use of PPSV23 among children 2 through 18 years of age who are at increased risk of IPD:

• Children with an underlying medical condition that increases the risk of IPD should receive PPSV23 at 2 years of age or as soon as possible after a diagnosis of chronic illness is made after the age of 2 years.

• Doses of PCV13 should be completed before PPSV23 is given, with a minimum interval of 8 weeks between the last dose of PCV13 and the dose of PPSV23.

• If a child has previously received PPSV23, he or she should also receive the recommended doses of PCV13.

• A second dose of PPSV23 is recommended 5 years after the first dose in children with sickle cell disease or functional or anatomic asplenia, HIV infection, or other immunocompromising conditions, but no more than 2 total doses of PPSV23 are recommended at this time.

IMPLEMENTATION OF THE NEW RECOMMENDATIONS

The introduction of a new vaccine may have considerable impact on the practice. Therefore, the AAP has developed implementation guidance on supply, payment, coding, and liability issues; these documents can be found at www.aapredbook.org/implementation.

PCV13 is approved for the Vaccines for Children (VFC) program through 18 years of age, and the vaccine will be covered by the Vaccine Injury Compensation Program. PPSV23 is not covered by the Vaccine Injury Compensation Program.

COMMITTEE ON INFECTIOUS DISEASES, 2009–2010

Joseph A. Bocchini Jr, MD, Chairperson

John S. Bradley, MD

Michael T. Brady, MD

Henry H. Bernstein, DO

Carrie L. Byington, MD

Margaret C. Fisher, MD

Mary P. Glode, MD

Mary Anne Jackson, MD

Harry L. Keyserling, MD

David W. Kimberlin, MD

Walter A. Orenstein, MD

Gordon E. Schutze, MD

Rodney E. Willoughby Jr, MD

LIAISONS

Beth P. Bell, MD - Centers for Disease Control and Prevention

Robert Bortolussi, MD - Canadian Paediatric Society

Marc A. Fischer, MD - Centers for Disease Control and Prevention

Richard L. Gorman, MD - National Institutes of Health

Lucia Lee, MD - Food and Drug Administration

R. Douglas Pratt, MD - Food and Drug Administration

Jennifer S. Read, MD, MS, MPH, DTM&H - Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health

Bruce G. Gellin, MD, MPH - National Vaccine Program Office

Jeffrey R. Starke, MD - American Thoracic Society

Jack T. Swanson, MD - AAP Committee on Practice and Ambulatory Medicine

CONSULTANTS

H. Cody Meissner, MD

Lorry G. Rubin, MD

EX OFFICIO

Larry K. Pickering, MD - Red Book Editor

Carol J. Baker, MD - Red Book Associate Editor

Sarah S. Long, MD - Red Book Associate Editor

STAFF

Jennifer Frantz, MPH