May 6, 2012 Charlene Graves, MD, FAAP Former 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 Topics

 Vaccination to protect adults against:  Pertussis  Influenza  Pneumococcal infection  Shingles  Other: Human papillomavirus, Hepatitis B, measles  Update on childhood and teen vaccination new recommendations from 2011 and 2012  Strategies to improve adult vaccination rates

Recent Data on Adult Vaccination Rates

MMWR, Feb. 3, 2012 Tetanus, 19-49 years Tetanus, 50-64 years Tetanus, 65 years and older Tdap, 19-64 years Pneumococcal, 19-64 yrs, high-risk Pneumococcal, 65 years and older Hepatitis B, 19-49 years, high-risk Hepatitis B, 19-59 years with diabetes Hepatitis B, 60 years +, with diabetes Hepatitis B, 19-49 years, not high-risk 64.0% 63.4% 53.4% 8.2% 18.5% 2020 goal = 60% 59.7% 2020 goal = 90% 42.0% 22.8% 10.9% 10.9%

Pertussis Infection Update

Year CDC Reported Cases

2004 25,800+ 2007 2009 2010 10,000+ 16,858 27, 000+ (744 cases in Indiana)

More on Pertussis

 48% 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 Pertussis

 Adults with pertussis: 61% missed work, for an average, of 10 days  66% required 2 or more medical visits during their illness  Complications: 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 Management

 Evaluate anyone with a cough lasting 2 weeks of longer  N-P specimen for PCR +/- culture  Antibiotics 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 Vaccination

    Two 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 20 hospital). th week of pregnancy. (revised from previous post-partum, before leaving

Tdap Vaccination

 There is NO MINIMUM INTERVAL between Td vaccination and receiving Tdap vaccine  Tdap should be used to replace Td booster in wound management situations  Immunogenicity and safety records for both Tdap vaccines are excellent.  Injection site reactions: pain in 60%, redness and/or swelling in 20%

Tdap Vaccination Coverage Rates

 As of 2010, only 8.2% of U.S. adults had Tdap vaccine**  In contrast, 68.7% of U.S. teens have had Tdap  Indiana: 72.3% of teens have had Tdap   Why is Tdap vaccine so under-utilized?

 Role of health care provider recommendation  Need 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 older  Pediatric deaths : 282 in 2009-10, 122 in 2010-11  225,000 hospitalization per year (U.S.)  Risk of hospitalization equal in young children compared to the elderly  Racial and ethnic disparities in adult vaccination

Influenza Vaccination Basics

 Everyone 6 months of age and older should be vaccinated  For 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) = injection  Live attenuated influenza vaccine (LAIV) = FluMist  Long 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 U.S. Data 19.7% 20.9% 21.8% 37.5% 46.7% 270,000 hospitaliz ations 1,270 deaths Vaccinati on rates 12,270 deaths, all ages

Fluzone High-Dose Vaccine

 Licensed by FDA in December of 2009  Alternative for 65 years or older  60 micrograms of hemaglutinin vs. usual 15 mcg for each flu strain  Increased local reactions at injection site (36%) compared to Fluzone (24%)  Increased antibody levels, clinical efficacy unknown

Fluzone Intradermal Vaccine

 Licensed in May of 2011  For 18-64 years of age  0.1 ml microinjection syringe  Administration in deltoid preferred  More local reactions, including itching, but resolve in 3 to 7 days

FluMist vaccine (LAIV)

 Licensed for 2-49 years of age, non-pregnant  Not 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 LAIV   Licensed in March 2012, available for 2012-13 flu season 2 strains each flu A and flu B  Improved protection against B strains

Flu Vaccine and Egg Allergy

 Use 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-vaccination  Angioedema, 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 Vaccination

 Data 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 Vaccines

 Pneumococcal 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, continued

 PCV13 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  4 th dose of PCV13 for children is underutilized

PCV-13 Considerations for Adults

 FDA-licensed for 50 yrs.+…..but not yet recommended by the ACIP – why?

 Data is insufficient for this recommendation at this time  Awaiting 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 Zoster

 Shingles is a common and painful disease  Over 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 Zostavax

 FDA 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 Basics

 HPV infection acquired soon after sexual initiation  Persistent infection of 1-2 years leads to precancerous cell changes  HPV types 16 and 18 involved in 70% of cervical cancers  HPV types 6 and 11 involved in 90% of genital warts  HPV 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 males  Estimated 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 Recommendations

 Quadrivalent 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 period  Vaccinate 11-12 year-old females routinely with either vaccine (2006)  Vaccinate 11-12 year-old males routinely with Gardasil  Catch-up vaccination for females, through age 26, for males through age 21  MSM and HIV-infected vaccinate through age 26

Improving HPV Vaccination Rates

 HPV 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 Rates

 Provider 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 infection  HPV 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 diabetes

 Studies 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 outbreaks  From 2001-10, annually 37-140 cases, 2-10 outbreaks  Median age of 14 years  32% hospitalized  90% of cases were import-associated  86% of patients were unvaccinated/unknown status  46% 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 1967  Could affect people now 42 to 50 years of age  If received killed measles vaccine, NOT immune  If 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 Rotavir us, 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 Updates

 Meningococcal conjugate vaccines (MCV4)  Menactra or Menveo  1/11 – 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 4 th least 6 mos. after previous dose.

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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 costs  Adult vaccine schedule complex  Adult 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 pharmacy  Increase community demand for vaccines – patient incentives, reminder/recall methods  Community-based interventions – combos of above

Strategies to Improve Coverage Rates

 Health Care Provider or System-Based:  Provider reminders – electronic, print  Provider 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 Important

 HEALTH CARE PROVIDER RECOMMENDATION FOR VACCINATION  Think of/review immunization status at every visit  Have an “immunization champion” in your office  Embrace new technologies  Consider text messaging and/or e-mails for reminder/recall  But keep HIPAA rules in mind

Resources

 www.immunize.org (Immunization Action Coalition)  www.cdc.gov/vaccines  www.vaccinateindiana.org

 www.healthychildren.org

(AAP)  www.tdapvac.com

 www.immunizationed.org

STFM) (smartphone app by  www.immunizationinfo.org

(National Network for Immunization Information)