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Update on ACIP Recommendations

Update on ACIP Recommendations. Charlene Graves, MD, FAAP Medical Director, Immunization Program, ISDH 317-233-7164 Chgraves@isdh.in.gov October 2007 . Objectives. Focus on ACIP Recommendations from 2005-2007 New vaccines: MCV4, rotavirus, zoster, TdaP, HPV

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Update on ACIP Recommendations

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  1. Update on ACIP Recommendations Charlene Graves, MD, FAAP Medical Director, Immunization Program, ISDH 317-233-7164 Chgraves@isdh.in.gov 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 U.S. Rate * Serogroups A/C/Y/W135

  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

  5. Pertussis Cases - Indiana, 2005Percent by Age Group

  6. 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%

  7. ACIP Tdap Recommendations2/06, 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

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

  9. 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)

  10. 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

  11. 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 2nd dose • Trials: 63,000 infants, worldwide • Efficacy: severe disease – 85% decrease; hospitalization – 84 %

  12. 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 • One’s immunity keeps VZV latent • With aging, cell-mediated immunity (CMI) decreases and HZ increases

  13. 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

  14. 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

  15. HPV Characteristics • > 100 types identified • 30-40 anogenital • Oncogenic types • 16, 18: 70% of cervical • cancer • Non-oncogenic types • 6, 11 for genital warts

  16. Natural History of HPV Infection and Potential Progression to Cervical Cancer1 0–1 Year 1–20 Years 0–5 Years Invasive Cervical Cancer InitialHPV Infection ContinuingInfection CIN 2/3 CIN 1 Cleared HPV Infection 1. Pinto AP, Crum CP. Clin Obstet Gynecol. 2000;43:352–362.

  17. 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

  18. 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

  19. 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

  20. Varicella Vaccine Recommendations, 6/07 • Goal – decrease breakthrough disease and reduce/eliminate outbreaks of varicella • Routine vaccination at 12-15 mos. • 2nd dose recommended routinely at 4-6 years of age; 3 months as minimum interval between doses • 2nd 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

  21. 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

  22. 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)

  23. 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 1st year given, need 2 doses the next year • FluMist – FDA expanded age indication down to 2 year-olds (9/07)

  24. TIV Dosing Schedule for Children • Age Dose# Doses • 6-35 mos 0.25 ml 1 or 2 • 3-8 yrs 0.50 ml 1 or 2 • 9 yrs+ 0.50 ml 1 • 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+

  25. Finding ACIP Recommendations and Meeting Minutes • CDC National Immunization Program www.cdc.gov/vaccines/recs/default.htm • ACIP Meetings – agendas, presentations • ACIP Recommendations • ACIP Provisional Recommendations • VFC Resolutions

  26. That’s It. Any Questions??

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