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Update on ACIP Recommendations

This update focuses on the ACIP recommendations from 2005-2007, including new vaccines such as MCV4, rotavirus, zoster, TdaP, and HPV. It also discusses revised recommendations for varicella, hepatitis A, and influenza vaccines. Learn about the rationale behind these recommendations and the impact of these diseases.

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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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