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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

Update on ACIP Recommendations

Charlene Graves, MD, FAAP

Medical Director, Immunization Program, ISDH

317-233-7164

Chgraves@isdh.in.gov

October 2007

objectives
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

rates of meningococcal disease by age united states 1991 2002
Rates of Meningococcal Disease* by Age, United States, 1991-2002

U.S. Rate

* Serogroups A/C/Y/W135

meningococcal conjugate vaccine menactra mcv4
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
slide7

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%
slide8

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
slide9

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
slide10

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)
slide11

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
slide12

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 %
slide13

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
slide15

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
slide16

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
slide17

HPV Characteristics

  • > 100 types identified
  • 30-40 anogenital
  • Oncogenic types
    • 16, 18: 70% of cervical
    • cancer
  • Non-oncogenic types
    • 6, 11 for genital warts
slide18

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.

slide19

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
slide20

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
slide21

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
slide22

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
slide23

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
slide24

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)

slide25

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)
slide26

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+
slide27

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