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Update on ACIP Recommendations Charlene Graves, MD, FAAP Medical Director, Immunization Program, ISDH 317-233-7164 October 2007.

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Presentation on theme: "Update on ACIP Recommendations Charlene Graves, MD, FAAP Medical Director, Immunization Program, ISDH 317-233-7164 October 2007."— Presentation transcript:

1 Update on ACIP Recommendations Charlene Graves, MD, FAAP Medical Director, Immunization Program, ISDH October 2007

2 Objectives Focus on ACIP Recommendations from New vaccines: MCV4, rotavirus, zoster, TdaP, HPV Revised recommendations: varicella, hepatitis A, and influenza vaccines Rationale for the ACIP recommendations

3 Rates of Meningococcal Disease* by Age, United States, * Serogroups * Serogroups A/C/Y/W135 U.S. Rate

4 Meningococcal Conjugate Vaccine ( Menactra, MCV4 ) Licensed by FDA in January 2005 Age indication: years of age Vaccinate all persons years old Medical indications: asplenia, terminal complement deficiencies, HIV Can revaccinate with Menactra 5 years after MPSV4


6 Pertussis Cases - Indiana, 2005 Percent by Age Group

7 Tdap Vaccines FDA licensed in May & June of 2005 BOOSTRIX (GSK) for year olds ADACEL (SFP) for year olds Clinical efficacy 92% Local injection site reactions (pain) in 70-75%

8 ACIP Tdap Recommendations 2/06, 12/ year-olds and adults should receive ONE DOSE of Tdap to replace a Td booster dose (includes wound management) Interval between Td and Tdap: desired as 5 years, but OK to give as close as months apart Do not use (yet) in pregnant women (postpartum OK) or 65 year-olds+ Adult/adolescent priority – households with infant below 12 months of age

9 Rotavirus Disease Gastrointestinal symptoms in young children, dehydration common 95%+ children infected by age 5 1 st infection more likely to be severe disease Many are infected more than once $1 billion in medical costs each year Historical: Rotashield, intussception

10 Rotavirus Vaccine Goal: to prevent SEVERE disease, not ALL disease Rotateq – FDA licensed 2/06, ACIP 8/06 Live, attenuated, pentavalent vaccine Oral administration, 3 doses: 2,4,6 months of age (6-32 weeks) Not recommended to begin series after 12 weeks of age. Minimum interval between doses is 4 weeks. Public health price is $52, private purchase is $63.25 (per dose)

11 Rotateq – Clinical Trials & Follow-Up 70,000 children in 11 countries Efficacy – 74% against ANY disease, 98% against SEVERE disease Hospitalizations– 96% decrease E.D., office visits–94%, 86% decrease Intussception: Post-licensing monitoring shows less cases than expected for age group 6-35 mos Vaccinate if breastfeeding or past episode of rotavirus infection

12 In the future - Rotarix (GSK) U.S. licensure possible in Live, attenuated vaccine 2 doses: start at age 6 weeks, minimum of 4 weeks to 2 nd dose Trials: 63,000 infants, worldwide Efficacy: severe disease – 85% decrease; hospitalization – 84 %

13 Herpes Zoster (Shingles) Lifetime risk of HZ may be 30% million cases in U.S. each yr Postherpetic neuralgia (PHN) VZV – resides in neurons of sensory ganglia after having chickenpox Ones immunity keeps VZV latent With aging, cell-mediated immunity (CMI) decreases and HZ increases


15 HZ Vaccine Background Hypothesis: vaccine to boost CMI will decrease shingles Vaccine is live, attenuated, but 18X more virus than in varicella vaccine Trials: 38,500 aging (20,750 were years old; 17, yo) Results: 61% efficacious in preventing disease; 66% in preventing PHN (4 year follow-up) Store vaccine in freezer, protect from light, give within 30 minutes of reconstitution

16 Herpes Zoster Vaccine (Zostavax) Provis. Recommendations 10/06 FDA licensure 5/06, Merck For 60 years+, best immune response when years, less after that Safety profile was good Vaccinate even if had HZ before If born before 1980, assume had chickenpox, despite no hx of disease Contraindic: immunosuppressed; active untreated TB, allergic to neomycin, gelatin Questions: Duration of protection, cost- benefit

17 HPV Characteristics > 100 types identified anogenital Oncogenic types 16, 18: 70% of cervical cancer Non-oncogenic types 6, 11 for genital warts

18 0–1 Year 0–5 Years 1–20 Years Invasive Cervical Cancer Cleared HPV Infection 1. Pinto AP, Crum CP. Clin Obstet Gynecol. 2000;43:352–362. CIN 1 Initial HPV Infection Continuing Infection CIN 2/3 Natural History of HPV Infection and Potential Progression to Cervical Cancer 1

19 HPV Vaccine Strategies Vaccinate before onset of sexual activity Vaccinate both males and females Immune response strongest at youngest ages Unknowns: What antibody titers are protective How long protection will last Getting vaccine to women rarely tested for cervical cancer

20 Gardisil FDA licensed in June 2006 for 9-26 year old females Quadrivalent vaccine (types 6, 11, 16, 18). Retail purchase at $120 per dose. I.M. injection at starting age, then 2 months and 6 months later % efficacy for warts, Pap changes, infection As of March 2007, 5 million doses distributed in U.S. – ¾ in 9-17 yr olds, ¼ in year olds

21 ACIP Recommendations, 3/07 Routine immunization of females years of age Catch-up for females years not previously vaccinated Ideally, vaccinate before sexual activity Pap test, HPV DNA, HPV antibody NOT recommended before vaccination. No change in cervical cancer screening recommendations

22 Varicella Vaccine Recommendations, 6/07 Goal – decrease breakthrough disease and reduce/eliminate outbreaks of varicella Routine vaccination at mos. 2 nd dose recommended routinely at 4-6 years of age; 3 months as minimum interval between doses 2 nd dose recommended for person of ANY age who have had only 1 dose 13 yrs or older, if not immune – 2 doses at least 4 weeks apart

23 Why Hepatitis A Vaccine for All? From , 65% of reported cases in states with vaccination recommendations (endemic) In 2004, 63% of cases in states without such recommendations Disease is asymptomatic in most children less than 6 y.o. 1-2 y.o. have highest rate of transmission to parents Day care exposure: 9% of cases in 2003

24 Updated Hepatitis A Vaccine Recommendations Hepatitis A vaccine for all 1-2 year olds and catch- up vaccination thru 18 years of age (5/06) Twinrix accelerated schedule: give at 0, 7, days and 12 months – for travelers, deployment for disasters Hep A post-exposure prophylaxis(PEP): 1-40 years – vaccine. For 40 years+ use IG (0.02ml/kg). PEP used up to 2 weeks after exposure (ACIP 6/07)

25 Updated Recommendations on Influenza Vaccine Influenza vaccine: Give to all children 6 months-59 months of age, also caregivers of children 6-59 months old. For 6 mos- 8yrs of age, need 2 doses the first year of vaccination 6 mo-8 yrs – if only 1 dose the 1 st year given, need 2 doses the next year FluMist – FDA expanded age indication down to 2 year-olds (9/07)

26 TIV Dosing Schedule for Children Age Dose# Doses 6-35 mos0.25 ml 1 or yrs0.50 ml 1 or 2 9 yrs+0.50 ml1 Fluzone is only TIV vaccine for 6-48 mos. of age; fine for older children also Fluvirin available for 4 yrs+ Fluarix, Flulaval, Afluria available for 18 yrs+

27 Finding ACIP Recommendations and Meeting Minutes CDC National Immunization Program ACIP Meetings – agendas, presentations ACIP Recommendations ACIP Provisional Recommendations VFC Resolutions

28 Thats It. Any Questions??

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