1. Update on ACIP Recommendations
Charlene Graves, MD, FAAP
Medical Director, Immunization Program, ISDH
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: 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, 12/06
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 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
1st 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 2nd 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
One’s 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 30-40 anogenital
Oncogenic types
16, 18: 70% of cervical
cancer
Non-oncogenic types
6, 11 for genital warts

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

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 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.
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

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 1st 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 mos ml or 2
3-8 yrs ml or 2
9 yrs 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+

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

28. That’s It. Any Questions??