13-valent pneumococcal conjugate vaccine PCV13 new ACIP recommendations

1. 13-valent pneumococcal conjugate vaccine (PCV13) � new ACIP recommendations Current issues in immunization April 1, 2010 Pekka Nuorti, MD, DSc National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention

2. Presentation outline Licensure of 13-valent pneumococcal conjugate vaccine (PCV13) Rates of invasive pneumococcal disease (IPD) and serotypes after PCV7 and before PCV13 Advisory Committee on Immunization Practices (ACIP) recommendations for use of PCV13 Transition from PCV7 to PCV13 2

3. 3 13-valent pneumococcal conjugate vaccine (PCV13) Serotypes in PCV13 (Prevnar 13�) PCV7 types: 4, 6B, 9V, 14, 18C, 19F, 23F additional serotypes: 1, 3, 5, 6A, 7F, 19A Approved by FDA and recommended for use by ACIP on February 24, 2010 Children 6 weeks through 5 years (71 months) of age Indications Prevention of IPD caused by the 13 serotypes Prevention of otitis media caused by PCV7 serotypes

4. 4 Overall incidence of IPD before and after PCV7, children <5 years, U.S.,1998 and 2007

5. Proportion of IPD cases by vaccine serotype, children <5 years, U.S.,2007 <5 years PCV13 types: 64.4% PCV7 types: 1.9% 19A: 41.9% 19A, 7F and 3 = 98% of PCV6 types (260/266) 1,5 and 7F are not commonly carried <5 years PCV13 types: 64.4% PCV7 types: 1.9% 19A: 41.9% 19A, 7F and 3 = 98% of PCV6 types (260/266) 1,5 and 7F are not commonly carried

6. 6 PCV13 � immunogenicity and safety Safety 13 clinical trials with >7400 infants and children Common adverse reactions: injection site reactions, fever, decreased appetite, irritability, increased or decreased sleep Safety profile comparable to PCV7, which has a good safety record Immunogenicity Randomized, U.S. multicenter study PCV13 induced antibodies comparable to those shown to be protective in PCV7

7. 7 ACIP recommendations for PCV13 PCV13 is recommended for All children 2 through 59 months of age Children 60 through 71 months who have underlying medical conditions that increase their risk of pneumococcal disease or complications

9. 9 Prevention of pneumococcal disease in children � recommendation overview Routine recommendation Infants and children who have not previously received PCV7 or PCV13 Transition recommendation Children incompletely vaccinated with PCV7 or PCV13 Supplemental PCV13 dose recommendation Children completely vaccinated with PCV7 High risk children >6 years of age PPSV23 after PCV13 Children >2 years with underlying medical conditions

10. 10 1. No previous PCV7/PCV13 vaccination - routine recommendation

11. Children who have not previously received PCV7 or PCV13 Unvaccinated children <59 months ACIP recommendation and immunization schedules for PCV13 are the same as for PCV71,2 PCV13 replaces PCV7 for all doses Routine infant immunization 4-dose series at 2, 4, 6, and 12 to 15 months fewer doses if series started at age >7 mos

12. 12

13. PCV13 � dosing intervals Minimum age of administration: 6 weeks Minimum intervals: 4 weeks between doses 1 and 2 and doses 2 and 3 8 weeks between next-to-last and last doses 13

14. 14 2. Incomplete PCV7/PCV13 vaccination - transition recommendation

15. Children previously vaccinated with PCV7 or PCV13 15

16. 16 Children >24 months who are incompletely vaccinated with PCV7 or PCV13* Healthy children 24 through 59 months with any incomplete PCV schedule (PCV7 or PCV13) single dose of PCV13 Children 24 through 71 months with underlying medical conditions any incomplete schedule of <3 doses of PCV (PCV7 or PCV13), 2 doses of PCV13 if received 3 doses of PCV (PCV7 or PCV13), a single dose of PCV13

17. 17 3. Complete PCV7 vaccination - supplemental PCV13 dose

18. 18 Children with complete PCV7 vaccination A single supplemental dose of PCV13 is recommended for children who have received a complete, age-appropriate series of PCV7 all children 14 through 59 months of age children with an underlying medical condition through 71 months of age (including those who have already received a dose of PPSV23) Supplemental PCV13 dose should be given at the next medical visit and at least last 8 weeks after last PCV7 dose

19. 19 4. High risk children >6 years of age Studies among children >6 years with HIV or sickle cell disease underway to evaluate PCV13 safety and optimal number of doses A single dose of PCV13 may be administered to children 6 through 18 years of age who are at increased risk for IPD because of sickle cell disease HIV-infection and other immunocompromising conditions cochlear implant or CSF leaks

20. 20 Supplemental PCV13 dose� ACIP considerations Local and systemic adverse reactions similar to 4 dose PCV13 series1,2 Immune responses to 6 additional serotypes are comparable to 3-dose PCV13 infant series1,2 Programmatic feasibility implementation during first year after licensure to be given at next medical visit � no active recall Cost-effective strategy3 In addition, potential for enhanced indirect effects

21. 21 5. PPSV23 after PCV13 for children 2 through 18 years at increased risk for IPD In addition to PCV13, children with underlying medical conditions should receive PPSV23 at age >2 years Recommended doses of PCV13 should be completed before PPSV23 is given Children who have previously received PPSV23 should also receive recommended PCV13 doses

22. Transition from PCV7 to PCV13 When PCV13 available in the office, it should be used as recommended and instead of PCV7 Private PCV7 supplies may be returned to manufacturer For public vaccine supplies, contact state or local immunization program about unused PCV7 If PCV13 is not yet available, then PCV7 should be used for children who are due for vaccination These children should complete their series with PCV13 at subsequent visits 22

23. Summary of key points PCV13 is recommended for all children <5 years of age and to children <6 years of age with underlying medical conditions Children who have received >1 dose of PCV7 should complete their immunization series with PCV13 Children who are completely vaccinated with PCV7 should receive a single dose of PCV13 23

24. Conclusions PCV13 succeeds PCV7 and provides broader protection against IPD for young children includes serotype 19A, the most common cause of IPD among children Achieving and maintaining high PCV13 coverage can further reduce the burden of pneumococcal diseases in the U.S. 24

25. Additional information Licensure of a 13-valent pneumococcal conjugate vaccine (PCV13) and recommendations for use among children � Advisory Committee on Immunization Practices (ACIP), 2010 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5909a2.htm ACIP provisional recommendations for use of PCV13 http://www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-mar-2010-508.pdf PCV13 Vaccine Information Statement (VIS) http://www.cdc.gov/vaccines/pubs/vis/default.htm Prevnar 13 Package Insert http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ ucm201667.htm Details of routine pneumococcal conjugate vaccine schedule http://www.cdc.gov/vaccines/recs/schedules/child-schedule.htm