Update on ACIP Recommendations Charlene Graves, MD, FAAP Medical Director, Immunization Program, ISDH 317-233-7164 [email protected] October 2007.

Update on ACIP Recommendations

Charlene Graves, MD, FAAPMedical Director, Immunization Program,

ISDH317-233-7164

[email protected] 2007

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

0

0.5

1

1.5

2

2.5

11 13 15 17 19 21 23 25 27 29

Age (yr)

Rate

s pe

r 100

,000

ABCs NETSS

* Serogroups * Serogroups A/C/Y/W135

U.S. Rate

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

Pertussis Incidence Indiana, 1995-2006

0

50

100

150

200

250

300

350

400

450

Pertussis Cases - Indiana, 2005Percent by Age Group

<1 yr19%

1-4yrs16%

5-9yrs12%

10-18 yrs24%

19+yrs29%

<1 yr 1-4yrs 5-9yrs 10-18 yrs 19+yrs

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%

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

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

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)

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

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 %

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

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

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

HPV Characteristics

> 100 types identified 30-40 anogenital Oncogenic types

16, 18: 70% of cervical cancer

Non-oncogenic types 6, 11 for genital warts

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

InitialHPV

Infection

ContinuingInfection

CIN 2/3

Natural History of HPV Infection and Potential Progression to Cervical Cancer1

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

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

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

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

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

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)

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)

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+

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

That’s It. Any Questions??