May 6, 2012Charlene Graves, MD, FAAPFormer Medical Director , ISDH Immunization Program (2000 – 2007)Chairman, INAAP Immunization Committee

Disclosure

I became a scientific speaker for vaccines manufactured by GlaxoSmithKline in May of 2008.

Today’s TopicsVaccination to protect adults against:

Pertussis Influenza Pneumococcal infection ShinglesOther: Human papillomavirus, Hepatitis B,

measlesUpdate on childhood and teen vaccination

new recommendations from 2011 and 2012Strategies to improve adult vaccination rates

Recent Data on Adult Vaccination RatesMMWR, Feb. 3, 2012

Tetanus, 19-49 years 64.0%

Tetanus, 50-64 years 63.4%

Tetanus, 65 years and older 53.4%

Tdap, 19-64 years 8.2%

Pneumococcal, 19-64 yrs, high-risk

18.5% 2020 goal = 60%

Pneumococcal, 65 years and older

59.7% 2020 goal = 90%

Hepatitis B, 19-49 years, high-risk

42.0%

Hepatitis B, 19-59 years with diabetes

22.8%

Hepatitis B, 60 years +, with diabetes

10.9%

Hepatitis B, 19-49 years, not high-risk

10.9%

Pertussis Infection Update Year CDC Reported Cases

2004 25,800+

2007 10,000+

2009 16,858

2010 27, 000+

(744 cases in Indiana)

More on Pertussis48% of pertussis cases involve adults and

adolescents (2009)Adults and adolescents are the reservoir for

infection in young infants, who have severe disease

10 infants died of pertussis in California, 27 in U.S., in 2010

Highly communicable through contact with respiratory droplets

Stages of disease: catarrhal, paroxysmal, convalescent

Impact of PertussisAdults with pertussis: 61% missed work, for an

average, of 10 days66% required 2 or more medical visits during

their illnessComplications: pneumonia (up to 5%), rib

fracture (up to 4%), loss of consciousness (3-6%), hospitalization (up to 3%)

Especially dangerous when infants get infected. In one study, 76% of infant pertussis infections were traced back to adults (56%) or adolescents (20%)

Diagnosis and ManagementEvaluate anyone with a cough lasting 2 weeks

of longerN-P specimen for PCR +/- cultureAntibiotics for patient and all close contacts

Erythromycin (10 days)Clarithromycin (7 days)Azithromycin (5 days)Begin antibiotics prior to return of lab test results

Not contagious after 5 days of antibiotic treatment

Pertussis VaccinationTwo Tdap vaccines licensed by the FDA in 2005

Boostrix is licensed for age 10 and older (GSK)Adacel is licensed for ages 11-64 years (SFP)

Tdap vaccine recommended for adolescents and adults up to 65 years of age in 2006

ACIP recommends that all adults (including senior citizens, as of Feb. 2012)receive a one-time Tdap booster to replace the Td shot needed every 10 years

As of Oct. 2011, ACIP recommends that all pregnant women receive a Tdap vaccination after the 20th week of pregnancy. (revised from previous post-partum, before leaving hospital).

Tdap VaccinationThere is NO MINIMUM INTERVAL between

Td vaccination and receiving Tdap vaccineTdap should be used to replace Td booster in

wound management situationsImmunogenicity and safety records for both

Tdap vaccines are excellent. Injection site reactions: pain in 60%, redness

and/or swelling in 20%

Tdap Vaccination Coverage RatesAs of 2010, only 8.2% of U.S. adults had Tdap

vaccine**In contrast, 68.7% of U.S. teens have had

TdapIndiana: 72.3% of teens have had Tdap

Why is Tdap vaccine so under-utilized?Role of health care provider recommendationNeed for adult patient education

**NHIS data, MMWR Feb.3, 2012

Influenza Burden of influenza: 3,000-49,000

deaths/year (U.S.)90% of deaths in 65 years and olderPediatric deaths : 282 in 2009-10, 122 in

2010-11225,000 hospitalization per year (U.S.)Risk of hospitalization equal in young

children compared to the elderlyRacial and ethnic disparities in adult

vaccination

Influenza Vaccination Basics Everyone 6 months of age and older should be

vaccinatedFor 6 mos. through 8 yrs. of age, 2 doses given at

least 4 weeks apart needed in first season (priming immune system)

Trivalent influenza vaccine (TIV) = injectionLive attenuated influenza vaccine (LAIV) =

FluMistLong list of high-risk conditions meriting flu

vaccination

Influenza Pandemic of 2009-2010

H1N1, 2009-10

Age 18 yrs.+

25-64 yrs, high-risk

65 yrs +

Initial target group

6 mos. – 17 yrs

Indiana 19.7% 20.9% 21.8% 37.5% 46.7% Vaccination rates

U.S. Data

270,000 hospitalizations

1,270 deaths

12,270 deaths, all ages

Fluzone High-Dose VaccineLicensed by FDA in December of 2009Alternative for 65 years or older60 micrograms of hemaglutinin vs. usual 15

mcg for each flu strainIncreased local reactions at injection site

(36%) compared to Fluzone (24%)Increased antibody levels, clinical efficacy

unknown

Fluzone Intradermal VaccineLicensed in May of 2011For 18-64 years of age0.1 ml microinjection syringeAdministration in deltoid preferredMore local reactions, including itching, but

resolve in 3 to 7 days

FluMist vaccine (LAIV)Licensed for 2-49 years of age, non-pregnantNot recommended for 2-4 year-olds with

recurrent wheezing or wheezing in past year, or anyone with high risk medical conditions (live attenuated vaccine)

OK for health care workers unless work in stem cell transplant unit

Quadrivalent LAIVLicensed in March 2012, available for 2012-13

flu season2 strains each flu A and flu BImproved protection against B strains

Flu Vaccine and Egg AllergyUse TIV (not LAIV) in persons with egg allergy, if

no history of anaphylactic or severe reaction to eggs

Flu vaccine appears safe to use if a person has only hives related to egg allergy

Observe for 30 minutes post-vaccinationAngioedema, respiratory distress, lightheadedness,

recurrent emesis, or required epinephrine or emergency care need allergist evaluation

Skin prick testing for egg allergy is poorly predictive of a severe reaction

Invasive Pneumoccal Disease (IPD)About 43,500 cases and 5,000 deaths per year in U.S.85% of cases of IPD and nearly all deaths are in adults

PPSV23 Update – added indications for use in smokers and patients with asthma (MMWR 9/3/10)

2-64 years if heart, lung, sickle-cell disease, diabetes, alcoholism, CSF leak, cochlear implant

Any medical condition, drug or treatment lowering ones resistance to infection

Nursing home/long term care patients

Pneumococcal VaccinationData from NHIS, 2010 (MMWR Feb.3, 2012)

19-64 yrs., high risk 18.5% Incr. 1.0% from 2009

65 yrs and older 59.7% Decrease 1.0%Non-Hispanic whites 63.5%Hispanics 39.0%Non-Hispanic blacks 46.2%Non-Hispanic Asians 48.2%2020 goal 90%

Pneumococcal VaccinesPneumococcal polysaccharide (PPSV23) since

1983

Pneumococcal conjugate (PCV7) since 2000 for 2 to 71 months of age – routine for all 2-59 mos. of age, high-risk 60-71 mos. of age

Marked decrease in IPD (45% drop) and in hospitalizations for both children and adults since introduction of PCV7

Pneumococcal Vaccines, continuedPCV13 licensed for children in 2/10 and for

adults 50 years and older in 12/11

PCV13 recommendations in MMWR 3/12/10 – replaces PCV7, same ages and doses for 2-59 mos. of age

MMWR 12/10/10 – Spells out details of use of PCV13 and PPSV23 in infants and children

4th dose of PCV13 for children is underutilized

PCV-13 Considerations for AdultsFDA-licensed for 50 yrs.+…..but not yet

recommended by the ACIP – why?Data is insufficient for this recommendation at

this timeAwaiting the outcome of a study in the

Netherlands comparing efficacy to PPSV23 in seniors

PCV7 greatly decreased IPD among children and adults

PCV13 possibly shows early decline in IPD in adults

Herpes ZosterShingles is a common and painful diseaseOver 1 million cases/year in U.S.Vaccine (Zostavax) licensed in 2006 for 60

years+Contraindications: primary or acquired

immunodeficiency, anaphylactic reaction to gelatin or neomycin, pregnancy

Vaccination with shingles vaccine – only 14.4% of adults 60 years of age or older in 2010 (NHIS; MMWR 2//3/12)

More on ZostavaxFDA approved Zostavax for 50-59 years of age

in 3/11

FDA approval for 50 to 59 yrs based on 70% decrease in zoster if vaccinated

However, shortage of vaccine and/or delayed orders have been a problem for Merck

Thus, ACIP declined to recommend it for use in this age group

Human Papillomavirus BasicsHPV infection acquired soon after sexual

initiationPersistent infection of 1-2 years leads to

precancerous cell changesHPV types 16 and 18 involved in 70% of cervical

cancersHPV types 6 and 11 involved in 90% of genital

wartsHPV type 16 a major player in other HPV-

associated cancers: vaginal, vulvar, anal, penile, oropharyngeal

HPV-Associated Cancers, U.S., 2004-08 (MMWR, 4/20/12)Average of 33, 369 such cancers each year Average of 21,290 in females, 12,080 in malesEstimated NEW CASES of HPV-associated

cancers each year = 26,000 (18,000 female, 8,000 male)

Cervical cancer is most common (11,967 per year) but oropharyngeal cancer (11, 726) is a close second

Anal cancer rate is higher in females than males

HPV Vaccination RecommendationsQuadrivalent vaccine (Gardasil) licensed in 2006

(HPV types 16, 18, 6 and 11)Bivalent vaccine (Cervarix) licensed in 2009 (16

and 18)3 doses of vaccine needed over a 6 month periodVaccinate 11-12 year-old females routinely with

either vaccine (2006) Vaccinate 11-12 year-old males routinely with

GardasilCatch-up vaccination for females, through age 26,

for males through age 21MSM and HIV-infected vaccinate through age 26

Improving HPV Vaccination RatesHPV vaccination of 13-17 year-old females in

U.S. in 2010 was 32% for 3 doses (lags other teen vaccines)

HPV vaccination of women 19-26 years of age was 20.7% in 2010 (MMWR 2/3/12)

Provider recommendation for 11-12 year old females:Family physicians -26% Pediatricians – 48% ObGyns – 36%.........in a 2009 study

Improving HPV Vaccination RatesProvider recommendation for HPV

vaccination is a key factor; focus more on youngest patients (11-12 yo)

One approach to families:HPV infection is a common, serious problem

( cervical cancers, other cancers, genital warts)Your child is susceptible to HPV infectionHPV infection occurs soon after sexual debut;

best immune response to vaccination is at younger ages, PRIOR to sexual activity

HPV vaccination prevents cancers – few vaccines can do that

Hepatitis B vaccination and diabetesStudies show increased risk for acute hepatitis B in

diabetic patients and a trend for higher mortality if infected.

Assisted monitoring of blood glucose without correct infection control practices increased exposure to infection

October 2011 ACIP recommended hepatitis B vaccination for diabetic patients below age 60 as soon as possible after diabetes is diagnosed

For diabetic patients aged 60 and older, consider hepatitis B vaccination after assessment of risk and likelihood of immune response

Measles in U.S., 2011 (MMWR 4/20/12)

222 cases (196 in U.S. residents), 17 outbreaksFrom 2001-10, annually 37-140 cases, 2-10

outbreaksMedian age of 14 years32% hospitalized90% of cases were import-associated86% of patients were unvaccinated/unknown

status46% of importations were from Europe(3 outbreaks in Indiana in past 15 months)

Measles, Mumps Immunity Issues Killed (inactivated) measles vaccine used from

1963 to 1967Could affect people now 42 to 50 years of age If received killed measles vaccine, NOT

immuneIf health care worker vaccinated with killed

mumps vaccine before 1979, also need revaccination

Revaccinate with 2 doses of MMR vaccine, minimum of 28 days apart

Indiana Child/Teen Vaccination Rates, National Immunization Survey, 2010

Vaccine Age group

Series, 2 year-olds

PCV, 4 doses, 2 year-olds

Rotavirus, 2 year-olds

Hep A, 2 year-olds

Tdap, Teens

Mening Teens

3 HPV, Teens

Indiana

71.6%

80.2% 54.3% 46.9% 72.3% 70.6% 24.8%

U.S. 72.7% 83.3% 59.2% 49.7% 68.7% 62.7% 32.0%

Childhood Vaccination Recommendation UpdatesMeningococcal conjugate vaccines (MCV4)

Menactra or Menveo1/11 – expanded age range to 2 to 55 years of age

for high risk patients – (2 doses + boosters, can use either vaccine)

4/11 – expanded use of Menactra (2 doses + boosters) to 9-23 months of age high-risk patients (MMWR 10/14/11)

High-risk: complement component deficiencies, asplenia, HIV, community meningococcal outbreak, travel to/from hyper-endemic countries.

Other Childhood Vaccines MMR and Varicella Vaccines – separate doses or

combined vaccine (ProQuad)Increased risk (2X) for febrile seizures for ages 12-

24 months when ProQuad used, compared to separate vaccines. This risk is NOT present at 4-6 years of age

Rotavirus vaccines: big drop in hospitalizations for gastroent/dehydration. New contraindication is hx of Severe Combined Immunodefic. Disease (2/10)

Polio (IPV) – final dose on or after 4th birthday and at least 6 mos. after previous dose.

Barriers to Adult Vaccination

Lack of awareness of recommendations by patients and providers

Adults may see only specialists, preventive care not a priority

Out-of-pocket costsAdult vaccine schedule complexAdult vaccine through public health is under-

funded, compared to Vaccines For Children program

Evidence-Based Strategies to Improve Adult Coverage Rates Patient-Related Strategies:

Enhance access – home visits, referral to providers, decrease out of pocket costs for patients

Rx for vaccine administration at local pharmacyIncrease community demand for vaccines –

patient incentives, reminder/recall methodsCommunity-based interventions – combos of

above

Strategies to Improve Coverage RatesHealth Care Provider or System-Based:

Provider reminders – electronic, printProvider assessment and feedback – CASA-AFIX,

benchmarks for preventive care Standing orders – protocols, see Adult

Immunization Standing Order Toolkit (Univ. of Pittsburgh)

Immunization registries (IIS): CHIRP is the Children and Hoosiers Immunization Registry Program

Really ImportantHEALTH CARE PROVIDER

RECOMMENDATION FOR VACCINATIONThink of/review immunization status at every

visitHave an “immunization champion” in your

officeEmbrace new technologies

Consider text messaging and/or e-mails for reminder/recall

But keep HIPAA rules in mind

Resourceswww.immunize.org (Immunization Action

Coalition)www.cdc.gov/vaccineswww.vaccinateindiana.orgwww.healthychildren.org (AAP)www.tdapvac.comwww.immunizationed.org (smartphone app

by STFM)www.immunizationinfo.org (National

Network for Immunization Information)