Immunization Update

1. Immunization Update Doug Stewart, DO, MPH Associate Professor of Pediatrics University of Oklahoma - Tulsa

2. Outline • Outcome • Options, Guidelines, and Standards • Advisory Committee on Immunization Practices (ACIP) • Current guideline for children • Important points • Recent changes • Anticipated changes • Current guideline for adults • Recent changes • Anticipated changes

3. Comparison of 20th Century Annual Morbidity and Current Morbidity, Vaccine-Preventable Diseases (pre-1990 Vaccines) Numbers in yellow indicate at or near record lows in 2004 †Source: CDC. MMWR April 2, 1999. 48: 242-264 * Provisional 2004 Data

4. Comparison of Pre-Vaccine EraEstimated Annual Morbidity and Current Morbidity,Vaccine-Preventable Diseases (post-1990 Vaccines) N/A = not available

5. Taxonomy of Degrees of Flexibility Unanimous Standard Degree of unanimity? Majority Guideline Preferences known? Yes Indifferent Option with preference indifferent Type of ambivalence? No Outcomes known? Evenly split Option with preferences split Yes Strongly divided No Option with preferences unknown Option with outcomes unknown From Eddy, D. A Manual for Assessing Health Practices & Designing Practice Policies: The Explicit Approach . Philadelphia: American College of Physicians;1992.

6. Three Dimensions of Practice Policies Standard Guideline Option Boundary Pathway Utilization review Advise physicians Precertification Coverage Credentialing From Eddy, D. A Manual for Assessing Health Practices & Designing Practice Policies: The Explicit Approach . Philadelphia: American College of Physicians;1992.

7. Guideline for Children

8. Guideline for Adults

9. ACIP • Advisory panel to HHS and CDC • Statutory authority from Congress • Advise on communicable disease control, emphasis on vaccines • Route, dose, schedule, special populations • 15 members plus non-voting liaison members • Terminates April 2006

10. Status of New Vaccines Table updated 11/15/05 http://aapredbook.aappublications.org/news/vaccstatus.shtml

11. Status of New Vaccines Table updated 11/15/05 http://aapredbook.aappublications.org/news/vaccstatus.shtml

12. Tdap Scott A. Halperin, MD From the 39th National Immunization Conference – Washington, D.C. (March 2005)

13. Tdap • Adolescent/adult formulation of tetanus and diphtheria toxoids plus acellular pertussis vaccine • Reduced content of diphtheria toxoid • Reduced content of acellular pertussis antigens

14. How frequent is pertussis in adolescents and adults? • We still don’t know. • Prospective population-based data • 3.7-4.5 cases/1000 person years • Ward et al, APERT study ~800,000-1,000,000 cases annually in the United States

15. Stage Inc Catarr Convalesc Paroxysmal Clinical picture Coughing paroxysms followed by vomiting, cyanosis, or whoop Gradual decrease in frequency and severity of coughing episodes None Commoncold Culture - - - - - - - - - - - - - - - - +++++++++ +++++ Lympho-cytosis 0 1 2 3 4 5 6 Weeks after exposure Clinical and Laboratory Course of Pertussis

16. Transmission of Pertussis • Adolescents get pertussis from community and household contacts • Adults get pertussis from their school age children • The disease ranges from asymptomatic to severe • Adult and adolescent parents give pertussis to their young infants • Young infants are at high risk of morbidity and even mortality

17. Extending Pertussis Immunizationto Adolescents and Adults • Is there a disease of sufficient frequency to be prevented? • Is the disease of sufficient severity to warrant prevention? • Are there any other reasons to immunize? • Is there a safe and effective vaccine? • Can the program be implemented? • Would immunization be costeffective? • Yes • Yes • Yes/maybe • Yes • Yes • Yes

18. Options for implementation • Universal adolescent • Universal adolescent and adult • Young adults • Every 10 years • Targeted immunization • Cocoon strategy (infant households) • Teachers, health care workers, child care workers • Pregnant women

19. Recommendations from June 2005 • ACIP recommended universal adolescent (11 – 18 years of age) use of Tdap in place of Td in June 2005 • Became CDC policy when published in MMWR • Use in adults? • Deferred to a Oct 2005 meeting to give ACIP members time to review data. Need better adult burden of disease data.

20. Latest on Tdap (11/9/05) ADVISORY COMMITTEE ON IMMUNIZATION PRACTICE RECOMMENDS ADULT VACCINATION WITH NEW TETANUS, DIPHTHERIA, AND PERTUSSIS VACCINE (Tdap) The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) at its recent meeting (October 26 and 27) in Atlanta, voted to recommend that adults from 19 to 64 years of age be vaccinated with a newly licensed adult booster tetanus, diphtheria, and pertussis (whooping cough) vaccine (Tdap). Under the ACIP recommendation, the Tdap vaccine would replace the currently recommended tetanus-diphtheria vaccine that is used as the adult booster vaccine.

21. Latest on Tdap (11/9/05) ADVISORY COMMITTEE ON IMMUNIZATION PRACTICE RECOMMENDS ADULT VACCINATION WITH NEW TETANUS, DIPHTHERIA, AND PERTUSSIS VACCINE (Tdap) The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) at its recent meeting (October 26 and 27) in Atlanta, voted to recommend that adults from 19 to 64 years of age be vaccinated with a newly licensed adult booster tetanus, diphtheria, and pertussis (whooping cough) vaccine (Tdap). Under the ACIP recommendation, the Tdap vaccine would replace the currently recommended tetanus-diphtheria vaccine that is used as the adult booster vaccine.

22. Tdap pearl • Will eventually replace Td • Doubles the cost of previous strategy that focused only on Td • Real beneficiary will be very young infants

23. Influenza

24. Influenza pearls • Incrementalism in immunization policy • Rapid change in plans – both good and bad • Order vaccine early (as in April) • Pay attention to surveillance

25. INFLUENZA - Who Should Not Be Vaccinated ? • There are some people who should not be vaccinated without first consulting a physician. These include: • severe allergy to chicken eggs. • severe reaction to TIV vaccination in the past. • developed Guillain-Barré syndrome (GBS) within 6 weeks of getting TIV vaccine previously. • TIV vaccine is not approved for use in children less than 6 months of age. • People who have a moderate or severe illness with a fever should wait to get vaccinated until their symptoms lessen

26. Live Attenuated Influenza Vaccine • Important new tool for prevention of influenza in healthy persons 5-49 years • Administered by nasal spray, no preservative • Efficacy in children 5-17 years (lab confirmed influenza) • 87-93% (seasons with good vaccine match and antigenically drifted circulating influenza strains) • 1 dose 89% and 2 doses 94% Belshe R et al NEJM 1998, Belshe et al CID 2004

27. Live Attenuated Influenza Vaccine (continued) • Studies pending on comparative effectiveness of live, attenuated versus inactivated influenza vaccines • Additional safety data being collected for licensure among children 1-4 years • CAIV-T supplement to BLA early 2006?

28. Most promising intervention?

29. New Viral Vaccines Jane Seward, M.B.B.S., M.P.H. Centers for Disease Control and Prevention From the 39th National Immunization Conference – Washington, D.C. (March 2005)

30. MMRV Vaccine • Merck and Co., Inc, licensing application filed 2004. Licensed Sept 2005. ACIP recommended Oct 2005 (to be posted) • Lyophilized, frozen formulation • Immunological equivalency with MMR and V vaccines • Some increase in fever post vaccination versus MMR alone • Potential to decrease number of injections in childhood schedule and to increase varicella vaccine coverage to equal MMR coverage

31. HAV • Two versions with supplement to original license approved in late 2005 • Recommended by ACIP Oct 2005 – to be posted • Minimum age now 12 mo • Universal – not just high risk states

33. Level 1 Cytomegalovirus Influenza (universal) Level 2 Hepatitis C Herpes simplex virus Human papillomavirus Respiratory syncytial virus (infants, elderly) Level 3 Parainfluenza virus Rotavirus Level 4 Epstein-Barr virus IOM Report , (Viral) Vaccines for the 21st Century, United States IOM Report, 2000, Vaccines for the 21st Century: tool for decision making

34. Preventive Viral Vaccines on the Horizon • Live, attenuated influenza (1-4 years) • HPV (cervical dysplasia and cancer, anogenital warts) • Rotavirus (RV diarrhea) • Zoster (shingles and post herpetic neuralgia)

35. 39th National Immunization Conference – Washington, D.C. March 2005 New Vaccines for Meningococcal Disease Nancy Rosenstein, MD Meningitis and Special Pathogens Branch Division of Bacterial and Mycotic Diseases

36. Rates of Meningococcal Disease by Age Group and Burden of Disease, U.S., 1991-2002* *ABCs data

37. Rates of Meningococcal Disease by Age Group and Serogroup, U.S., 1992-2001* *ABCs data

38. Changing Serogroup Distribution in the U.S.* C 40% C 31% Y 37% B 43% Y 9% B 25% W135 2% W135 3% 1990-1992 1997-2001 *ABCs

39. MCV4 (A/C/Y/W-135) • Licensed January 2005 for 11 – 55 yoa • BLA supplement to original filed March 2005 for ages 2 – 10 years • 11 – 55 years recommended by ACIP and posted in 2005 • Younger age pending licensure • G-B Syndrome and shortage

40. ACIP Recommendations for Use of MCV4 and MPSV4 • Vaccination recommended for • Preadolescent visit and high school entry • College freshmen living in dormitories • Other groups at high risk • Catch-up campaigns not recommended • Other individuals can chose to be vaccinated • In 11-55 yo, MCV4 preferred, MPSV4 acceptable

41. Duration of Protection, MCV4 • MPSV4 in adults > 3-5 years protection • Conjugate vaccines induce memory and higher antibody levels which should provide longer protection • UK studies =90% VE at 3 yrs in 11-18 yo • Therefore, we assume MCV4 will provide protection of >8 yrs

42. Routine Vaccination of Adolescents with MCV4 • Goal is routine vaccination of young adolescents at pre-adolescent visit (11-12 year old) • For adolescents who have not already received vaccine, vaccination at high school entry (15 years old) is recommended as an effective strategy to reduce meningococcal disease incidence in adolescents and young adults. • ACIP recognizes that supply may be an issue for the first few years

43. Routine Vaccination of Adolescents • Other adolescent who wish to decrease their risk of meningococcal disease may elect to receive MCV4 • All 11-18 yo covered by VFC

44. Last thoughts on immunization • The Immunization Action Coalition www.immunize.org • “The Pink Book” • MMWR by e-mail • Immunization registries • Modify guidelines to suit your own practice • Educate your staff (see “The Pink Book”)

45. Guideline for Children

46. Thank you and “Go Cowboys!”

47. Well Visits By Age 100 80 60 PercentAnnual WellVisits 40 20 0 0 2 4 6 8 10 12 14 16 18 20 22 24 Age (years) IMS National Disease and Therapeutic Index (NDTI) Projected-Total DiagnosisVisits - Calendar 2003 (000)NDTI. US Census Bureau National Population Projections - Last Revised Date: January 19, 2001.