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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 317-233-7164 October 2007

2 Objectives Focus on ACIP Recommendations from 2005-2007 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, 1991-2002 * Serogroups * Serogroups A/C/Y/W135 U.S. Rate

4 Meningococcal Conjugate Vaccine ( Menactra, MCV4 ) Licensed by FDA in January 2005 Age indication: 11-55 years of age Vaccinate all persons 11-18 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 10-18 year olds ADACEL (SFP) for 11-64 year olds Clinical efficacy 92% Local injection site reactions (pain) in 70-75%

8 ACIP Tdap Recommendations 2/06, 12/06 11-18 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 18-24 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 2007-08 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% 0.5-1 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 60-69 years old; 17,800 70+ 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 60-70 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 30-40 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 94-100% 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 18-26 year olds

21 ACIP Recommendations, 3/07 Routine immunization of females 11-12 years of age Catch-up for females 13-26 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 12-15 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 1990-97, 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, 21- 30 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 2 3-8 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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