Use of Combination Vaccines

1. Use of Combination Vaccines Andrew Kroger M.D., M.P.H. Immunization Services Division National Center for Immunization and Respiratory Diseases CDC

2. Background

3. Background Discussed in context of timing and spacing of vaccination Combine equivalent component vaccines into a single product Similar to simultaneous vaccination

4. Combination Vaccine Definition: a product that can be divided equally into independently available routine vaccines.

5. Combination Vaccines Hib-HepB - Comvax HepA-HepB - Twinrix DTaP-HepB-IPV - Pediarix MMRV - ProQuad DTaP-IPV - Kinrix DTaP-IPV/Hib - Pentacel

6. Single Component Products MMR � no single component measles, mumps, rubella products available Tdap � cannot be equally divided into component products (no single component pertussis product) IPV � monovalent polio vaccines not in use in the U.S.

7. Combination Vaccines The use of licensed combination vaccines is preferred over separate injection of their equivalent component vaccines. Only combinations approved by the U.S. Food and Drug Administration (FDA) should be used.

8. Use of Combination Vaccines

9. New Combination Vaccine Recommendation The use of a combination vaccine generally is preferred over separate injections of its equivalent component vaccines. Considerations should include provider assessment*, patient preference, and the potential for adverse events. *Provider assessment should include number of injections, vaccine availability, likelihood of improved coverage, likelihood of patient return, and cost and storage considerations Approved June 2009 ACIP meeting Aug 2009, Provisional Recs, ACIP

10. Other Combination Vaccine Topics

11. End User Mixing Not to be confused with manufacturer mixing of various components Only ONE combination vaccine involves mixing by the user or immunization provider Pentacel � Powder (Hib � ActHib) Diluent (liquid DTaP-IPV)

12. Nomenclature Dash ( - ) indicates manufacturer mix Slash ( / ) indicates end-user mixing Pentacel = DTaP-IPV/Hib

13. The Suite Effect Different manufacturers create combinations vaccines with a different suite of single components One Pentacel + one Pediarix = Two DTaP Two IPV One Hib One HepB

14. Interchangeability of Combination and Single-Component Products Off-label Often necessary to avoid extra doses of vaccine antigens Using Pediarix and Engerix-B in series with the same patient

15. Interchangeability of Manufacturer Products Off-label Again necessary in the context of a patient who switches providers and it is unclear which product was received previously Example � using Pentacel (DTaP-IPV/Hib) and Pediatrix (DTaP-HepB-IPV)on two different visits to providers

16. Interchangeability of Products In General, ACIP recommends using the same brand whenever possible Applies to both combination and single-component products Off-label usage Data ascertained if there are correlates of protective immunity (serology markers)

17. Correlates of Protection Ready correlates HepB HepA Measles Tetanus Hib Rubella Uncertain correlate Pertussis RV Mening HPV

18. Conjugate Vaccine Carrier Proteins Vaccine Hib (ActHib) Hib (PedvaxHib) Mening (Menactra) Mening (Menveo) Pneumo (Prevnar 13) Carrier Protein Tetanus toxoid Outer meningitis protein Diphtheria toxoid Diphtheria toxoid Diphtheria toxoid

19. Conjugate Vaccines as Combination Vaccines Contain both antigen of interest and conjugate protein Pentacel � tetanus toxoid in vaccine (DTaP) and in conjugate ActHib Provides protection against tetanus No increase in local adverse events