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PROTECT TM SupPorting AppROpriate ImmunizaTions Across the AgE SpeCTrum.

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Presentation on theme: "PROTECT TM SupPorting AppROpriate ImmunizaTions Across the AgE SpeCTrum."— Presentation transcript:

1 PROTECT TM SupPorting AppROpriate ImmunizaTions Across the AgE SpeCTrum

2 FPO-Faculty Disclosure Click to add subtitle

3 Table of Contents PROTECT TM SupPorting AppROpriate ImmunizaTions Across the AgE SpeCTrum Childhood –Childhood VaccinesChildhood Vaccines –Combination VaccinesCombination Vaccines –Addressing Parental ConcernsAddressing Parental Concerns –Strategies for Improving Childhood Immunization RatesStrategies for Improving Childhood Immunization Rates Adolescent –Adolescent VaccinesAdolescent Vaccines –Strategies for Improving Adolescent Immunization RatesStrategies for Improving Adolescent Immunization Rates Adult –Adult VaccinesAdult Vaccines –Strategies for Improving Adult Immunization RatesStrategies for Improving Adult Immunization Rates General Immunization Information for All Age Groups –Vaccine-preventable DiseasesVaccine-preventable Diseases –General Strategies for Improving Immunization RatesGeneral Strategies for Improving Immunization Rates –ResourcesResources

4 Educational Learning Objectives At the conclusion of this presentation, the participant should be able to: Discuss the indications and recommendations for the most current immunization schedules for childhood, adolescent, and adult populations Respond to frequently encountered questions and situations during patient discussions including safety, efficacy, and possible misinformation Implement strategies for improving immunization rates within one’s clinical practice, taking into account current immunization schedules and guidelines

5 Childhood Vaccines

6 Routine Childhood Immunization Schedule, 1983 Birth1 mo 2 mo 4 mo 6 mo 12 mo15 mo18 mo 24 mo 4-6 y 11-12 y 14-16 y DTP MMR OPV OPV * OPV Td *A third dose of OPV is optional but may be given in areas of high endemicity for poliomyelitis CDC. MMWR Morb Mortal Wkly Rep. 1983;32(1):1-8,13-17. DTP = Diphtheria, tetanus, pertussis OPV = Oral polio (trivalent) MMR = Measles, mumps, rubella VACCINE

7 2010 Child Immunization Schedule HepB = Hepatitis B; RV = Rotavirus; DTaP = Diphtheria, Tetanus, Pertussis; Hib = Haemophilus influenzae type b; PCV = Pneumococcal; IPV = Inactivated Poliovirus; MMR = Measles, Mumps, Rubella; HepA = Hepatitis A; MCV = Meningococcal; PPSV = Pneumococcal Polysaccharide ACIP Schedules. http://www.cdc.gov/vaccines/recs/schedules/default.htm. Accessed Jan 2010.

8 Childhood Catch-up Schedule ACIP Schedules. http://www.cdc.gov/vaccines/recs/schedules/default.htm. Accessed Jan 2010.

9 Vaccination Coverage Children 19–35 Months, United States, N = 18,430 CDC. MMWR Morb Mortal Wkly Rep. 2009;58(33):913-940. 0 10 20 30 40 50 60 70 80 90 100 DTaP/DT ≥ 3 Doses PoliovirusMMR ≥ 1 Dose Hib ≥ 3 Doses Hepatitis B ≥ 3 Doses Varicella ≥ 1 Dose PCV7 ≥ 4 Doses Hepatitis A ≥ 2 Doses Vaccination Coverage (%) 2004 2005 2006 2007 2008 ≥ 3 Doses≥ 4 Doses * *Data for previous years not available DTaP/DT

10 2008–2010 Changes in Child Schedule Influenza –Universal annual vaccination ≥ 6 months Rotavirus –Two schedules available: age 2, 4 mos and age 2, 4, and 6 months Polio –Emphasize importance of booster dose at age ≥ 4 yrs Meningococcal Conjugate Vaccine –Two vaccines now approved; MCV4-D (Menactra ® ) and MenACWY- CRM 197 (Menveo ® ) – Booster Hib –Booster reinstatement, shortage issues are over Pneumococcal –Addition of PCV13 –Booster for PPSV23

11 Immunization Timelines 8% of children immunized too early to be valid 58% of children received at least one vaccine later than recommended Thirty-five million adolescents may be missing at least one recommended vaccination Luman ET, et al. Pediatrics. 2002;110:935-939.

12 Hepatitis B Dose # Recommended Age Minimum Age Recommended Interval Minimum Interval 1 Birth*Birth1-4 mo4 wk 2 1-2 mo4 wk2-17 mo8 wk 3 6-18 mo24 wk Dose 3 should be administered ≥ 16 wk after dose 1 Combination vaccines cannot be used for the birth dose Adapted from Table 1, ACIP General Recommendations on Immunization: MMWR Recomm Rep. 2006;55(RR-15):1-48. * HB Immunoglobulin should also be administered at birth for infants whose mothers are HBsAg positive

13 Hepatitis B Perinatal Transmission* If mother positive for HBsAg and HBeAg –70%–90% of infants infected –90% of infected infants become chronically infected If positive for HBsAg only –5%–20% of infants infected –90% of infected infants become chronically infected *in the absence of postexposure prophylaxis

14 Why Rotavirus? > 400,000 physician visits > 200,000 ED visits > 50,000 hospitalizations > $1 billion in total health care costs CDC. MMWR Recomm Rep. 2006;55(RR12):1-13.

15 Rotavirus Vaccines and Schedules CDC. MMWR Recomm Rep. 2009;58(RR2):1-25.

16 Rotavirus Vaccine Harmonized Recommendations Dose #RV1 (Rotarix) RV5 (RotaTeq) ACIP Recommendation Usual schedule2, 4 mo2, 4, 6 moSame 1 Earliest Latest 6 wk 20 wk 6 wk 12 wk 6 wk 14 wk 6 day 2 Earliest Latest 10 wk 24 wk 10 wk 32 wk 10 wk 8 mo 0 day 3 Earliest Latest --- 14 wk 32 wk 14 wk 8 mo 0 day “..vaccination should not be deferred because the product used for previous dose(s) is not available or is unknown. In these situations, the provider should continue or complete the series with the product available. If any dose in the series was RV5, or the vaccine product is unknown for any dose in the series, a total of 3 doses of rotavirus vaccine should be administered.”

17 The FDA is recommending that health care providers temporarily suspend the use of Rotarix vaccine for rotavirus immunization in the United States while the agency learns more about components of an extraneous virus detected in the vaccine. An independent research team using a novel technique found DNA from porcine circovirus 1 (PCV1) in Rotarix. PCV1 is not known to cause illness in humans or other animals. Rotarix has been studied extensively before and after approval, and found to have an excellent safety record. There is no current evidence of a safety risk; the temporary suspension is a precautionary move. Children with incomplete Rotarix series should complete the series with RV5 (RotaTeq). This will require 3 total rotavirus vaccine doses to be a complete series. FDA. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205625.htm. Accessed March 2010. Rotarix−FDA Advisory

18 Rotavirus Contraindications –History of serious allergic reaction to a previous dose of vaccine –History of severe hypersensitivity to any component of the vaccine Precautions – Altered immunocompetence – Moderate to severe illness, including acute gastroenteritis – Preexisting chronic gastrointestinal disease – Previous history of intussusception CDC. MMWR Recomm Rep. 2009;58(RR2):1-25.

19 Family Physicians and Rotavirus Vaccine 2008 Survey* –45% provided rotavirus vaccine on site ½ rate of other vaccines –35% referred elsewhere –24% did neither 3x rate of other vaccines *Campos-Outcalt D, et al. Immunization Practices of Family Physicians. 43 rd National Immunization Conference, Dallas TX, March 31, 2009. Abstract PS19.

20 DTaP Dose # Recommended Age Minimum Age Recommended Interval Minimum Interval 12 mo6 wk2 mo4 wk 24 mo10 wk2 mo4 wk 36 mo14 wk6-12 mo6 mo 415-18 mo12 mo3 yr6 mo 54-6 yr4 yr Dose 5 not needed if dose 4 is given after age 4 yrs Adapted from Table 1, ACIP General Recommendations on Immunization. CDC. MMWR Recomm Rep. 2006;55(RR15):1-48.

21 Hib Dose # Recommended Age Minimum Age Recommende d Interval Minimum Interval 12 mo6 wk2 mo4 wk 24 mo10 wk2 mo4 wk 36 mo14 wk6-9 mo8 wk 412-15 mo12 mo Dose at 6 mo of age not necessary if first 2 doses are PRP-OMP Fewer doses required if series initiated at ≥ 7 mo of age Supply shortage over, reinstate 12-15 mo booster and catch-up Approved products – PedvaxHib (Merck) – ActHIB (Sanofi) – Hiberix (GSK)---booster only CDC. MMWR Morb Mortal Wkly Rep. 2009;58(24):673-674.

22 Summer 2009 HIB Updated Recommendations Re-institute routine booster Catch up on those who missed their booster at their next regular check up No recall of all those who missed booster immediately Changed in late summer to recall of those who missed CDC. http://www.cdc.gov/vaccines/vac-gen/shortages/downloads/hib-hcp-ltr-7-30-09.pdf. Accessed September 2009. CDC, personal communication.

23 Hib Products ProductDescriptionPrimary SeriesBooster PedvaxHIB (Merck) Monovalent Hib vaccine2,4 months12-15 months* Comvax (Merck) Combined Hib/hepatitis B vaccine 2,4 months12-15 months* Act HIB (Sanofi Pasteur) Monovalent Hib vaccine2,4,6 months12-15 months* TriHIBit (Sanofi Pasteur) DTaP/Hib vaccine Not licensed for this age group 15-18 months* HIBERIX (GSK) Hib conjugate (tetanus toxoid conjugate) ---15 months* *Can immunize through age 59 months Haemophilus influenzae type b. http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/hib.pdf. Accessed September 2009. HIBERIX PI. http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ ApprovedProducts/UCM179530.pdf. Accessed September 2009.

24 PCV7 Dose # Recommended Age Minimum Age Recommended Interval Minimum Interval 12 mo6 wk2 mo4 wk 24 mo10 wk2 mo4 wk 36 mo14 wk6 mo8 wk 412-15 mo12 mo ACIP Schedules. http://www.cdc.gov/vaccines/recs/schedules/default.htm. Accessed Sept 2009.

25 13-Valent Pneumococcal Conjugate Vaccine (PCV13) Licensed by FDA on February 24, 2010 Serotypes in PCV13 –PCV7 types: 4, 6B, 9V, 14, 18C, 19F, 23F –Additional serotypes: 1, 3, 5, 6A, 7F, 19A Approved for use in children 6 weeks through 5 years (before the 6 th birthday) –4-dose series at ages 2, 4, 6, and 12-15 months Indications –Prevention of invasive pneumococcal disease (IPD) caused by the 13 vaccine serotypes –Prevention of otitis media caused by PCV7 serotypes CDC. MMWR Morb Mortal Wkly Rep. 2010;59(9):258-261.

26 PCV13 Recommended Schedules for Children < 24 months CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-mar-2010-508.pdf. Accessed March 2010. Age at Examination (mos) Vaccination History: Total PCV7 and/or PCV13 Doses Received Previously Recommended PCV13 Regimen 2 through 6 mos 0 doses3 doses, 8 wks apart; 4 th dose at age 12-15 mos 1 dose2 doses, 8 wks apart; 4 th dose at age 12-15 mos 2 doses 1 dose, 8 wks after the most recent dose; 4 th dose at age 12-15 mos 7 through 11 mos 0 doses2 doses, 8 wks apart; 3 rd dose at 12-15 mos 1 or 2 doses before age 7 mo 1 dose at age 7-11 mos, 2 nd dose at 12-15 mos, ≥ 8 wks later 12 through 23 mos 0 doses2 doses, ≥ 8 wks apart 1 dose before age 12 mo2 doses, ≥ 8 wks apart 1 dose at ≥ 12 mo1 dose, ≥ 8 wks after the most recent dose 2 or 3 doses before age 12 mo1 dose, ≥ 8 wks after the most recent dose 4 doses of PCV 7 or other age-appropriate, complete PCV7 schedule 1 supplemental dose, ≥ 8 wks after the most recent dose

27 Transition from PCV7 to PCV13 According to Number of Doses Previously Received Primary Infant SeriesBooster Dose Supplemental PCV13 Dose 2 mos4 mos6 mos≥ 12 mos*14-59 mos** PCV7PCV13 -- PCV7 PCV13 -- PCV7 PCV13-- PCV7 PCV13 *No additional PCV13 doses are indicated for children 12-23 months who received 2 or 3 doses or PCV7 before age 12 months and at least 1 dose of PCV13 at age ≥ 12months **For children with underlying medical conditions, a supplemental PCV13 dose is recommended through 71 months of age CDC. MMWR Morb Mortal Wkly Rep. 2010;59(9):258-261.

28 PCV13 Recommended Schedules for Children ≥ 24 months CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-mar-2010-508.pdf. Accessed March 2010. Age at Examination (mos) Vaccination History: Total PCV7 and/or PCV13 Doses Received Previously Recommended PCV13 Regimen Healthy children 24 through 59 mos Unvaccinated or any incomplete schedule 1 dose, ≥ 8 wks after the most recent dose 4 doses of PCV7 or other age- appropriate, complete PCV7 schedule 1 supplemental dose, ≥ 8 wks after the most recent dose Children 24 through 71 mos with underlying medical conditions Unvaccinated or any incomplete schedule of < 3 doses 2 doses, one ≥ 8 wks after the most recent dose and another dose ≥ 8 wks later Any incomplete schedule of 3 doses1 dose, ≥ 8 wks after the most recent dose 4 doses of PCV 7 or other age- appropriate, complete PCV7 schedule 1 supplemental dose, ≥ 8 wks after the most recent dose* *For children who have underlying medical conditions, a supplemental PCV13 dose is recommended through 71 months of age

29 PCV13 – Children 6 through 18 Years of Age with High-risk Conditions A single dose of PCV13 may be administered for children 6 through 18 years of age who are at increased risk for invasive pneumococcal disease because of their sickle cell disease, HIV infection or other immunocompromising condition, cochlear implant or cerebrospinal fluid leaks, regardless of whether they have previously received PCV7 or PPSV23 CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-mar-2010-508.pdf. Accessed March 2010. This recommendation is an off-label use of PCV13, which is indicated for children 6 weeks through 5 years of age (prior to the 6 th birthday)

30 PPSV23 After PCV13 for Children ≥ 2 years of Age with Underlying Medical Conditions GroupSchedule for PPSV23 Revaccination with PPSV23 Children who have sickle cell disease, functional or anatomic asplenia, HIV- infection, or other immunocompromising condition 1 dose of PPSV23 administered at age ≥ 2 yrs and ≥ 8 weeks after last indicated dose of PCV13 1 dose 5 years after the 1 st dose of PPSV23 Immunocompetent children with chronic illness 1 dose of PPSV23 administered at age ≥ 2 yrs and ≥ 8 weeks after last indicated dose of PCV13 Not recommended Doses of PCV13 should be completed before PPSV23 is given. No more than 2 PPSV23 doses are recommended. CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-mar-2010-508.pdf. Accessed March 2010.

31 Transition from PCV7 to PCV13 When PCV13 is available in office, unvaccinated and incompletely vaccinated children should receive PCV13 (not PCV7) If only PCV7 is available in office, unvaccinated and incompletely vaccinated children should receive PCV7; these children should complete the series with PCV13 at subsequent visits Children for whom the supplemental PCV13 dose is recommended should receive it at their next medical visit. Active recall is not being recommended CDC. MMWR Morb Mortal Wkly Rep. 2010;59(9):258-261.

32 PPSV23 Dose # Recommended Age Minimum Age Recommended Interval Minimum Interval 12 yr5 yr 27 yr Second dose recommended for individuals at highest risk Second dose is recommended 5 years after first dose in age ≥ 2 years who are immunocompromised, have sickle cell disease, or functional or anatomic asplenia Routine use not recommended for Alaskan Native or American Indian children ages 24-59 months – May be recommended by local health departments based on community epidemiology Adapted from Table 1, ACIP General Recommendations on Immunization. MMWR Recomm Rep.2006;55(RR15):1-48. ACIP Provisional Recommendations.www.cdc.gov/vaccines/recs/provisional/ downloads/pneumo-Oct-2008-508.pdf. Accessed September 2009.

33 IPV Dose # Recommended Age Minimum Age Recommende d Interval Minimum Interval 12 mo6 wk2 mo4 wk* 24 mo10 wk2-14 mo4 wk* 36-18 mo14 wk3-5 yr6 mo 44-6 yr18 wk *In first 6 months of age, 2 mo intervals are recommended unless accelerated dosing is needed (eg, travel) Last dose after age 4 - 6 mo minimum interval from penultimate dose DTaP-IPV-Hib (Pentacel): 4 doses at age 2, 4, 6, and 15-18 mos will require a 5 th dose at 4-6 years with an age-appropriate IPV vaccine Adapted from Table 1, ACIP General Recommendations on Immunization. MMWR Recomm Rep.2006;55(RR15):1-48. CDC. MMWR Morb Mortal Wkly Rep. 2009;58(30):829-830.

34 Annual Influenza Vaccine is Recommended for: All people age 6 months and older! CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/flu-vac-mar-2010-508.pdf. Accessed March 2010.

35 Seasonal Influenza Vaccination Status of Children 6–23 mos & 2–4 yrs, United States CDC. MMWR Morb Mortal Wkly Rep. 2009;58(38):1059-1090. 2007–08 season: 6–23 months, N = 302,333; 2–4 years, N = 808,711 2008–09 season: 6–23 months, N = 263,597; 2–4 years, N = 767,422

36 TIV Dose # Recommended Age Minimum Age Recommended Interval Minimum Interval 1Yearly6 mo4 wk4 wk* 2 *Two doses (4 wks apart) are given for children 6 mo through 8 yr of age who are receiving influenza vaccine for the first time – If 2 nd dose is missed during first vaccination season, administer two doses during next season Seasonal influenza products will not confer protection against pandemic H1N1 strains – Pandemic H1N1 vaccine available CDC. MMWR Recomm Rep. 2009;58(RR8):1-52.

37 LAIV Dose # Recommended Age Minimum Age Recommended Interval Minimum Interval 1Yearly2 yr4 wk4 wk* 2 * Two doses are given for children 2 through 8 yr of age who are receiving influenza vaccine for the first time – If 2 nd dose is missed during first vaccination season, administer two doses during next season CDC. MMWR Recomm Rep. 2009;58(RR8):1-52.

38 Trivalent Inactivated (TIV) and Live Attenuated Influenza Virus (LAIV) Vaccines CategoryTIVLAIV AdministrationIMIntranasal Primary immune responseSerum antibodies Serum & mucosal antibodies FormulationInactivatedLive attenuated Approved age and risk groups ≥ 6 mo (healthy & high risk) 2–49 yrs (healthy) StorageRefrigerated CDC. MMWR Recomm Rep. 2009;58(RR8):1-52.

39 Two Doses for Children Under 9 Years of Age Regardless of whether a child receives LAIV or TIV, those younger than 9 years of age who are receiving influenza vaccine for the first time should receive 2 doses, 4 weeks apart. If a child received only 1 dose in the first year, he or she should receive 2 doses, 4 weeks apart, the following year. CDC. MMWR Recomm Rep. 2009;58(RR8):1-52.

40 Trivalent Inactivated Virus (TIV) versus Live Attenuated Influenza Virus (LAIV) Vaccines TIV Licensed for use in persons age ≥6 mos Intramuscular injection TIV contains purified viral particles that have been chemically inactivated –Purified components from 3 WHO-recommended annual strains –Immunity developed against disrupted/denatured viral proteins, not against intact virus LAIV Licensed for use among nonpregnant persons aged 2-49 years Administered by nasal spray LAIV contains intact virus that has been propogated in eggs at 25ºC –Cold-adaptation results in restricted replication at body temp –More mild flu symptoms –Contains same 3 WHO-recommended annual strains as TIV CDC. MMWR Recomm Rep. 2009;58(RR8):1-52. Flumist Prescribing Information. www.flumist.com. Accessed Oct 2009.

41 2009–2010 Seasonal Influenza Vaccines 2009–2010 seasonal influenza vaccine formulation: –A/Brisbane/59/2007(H1N1)-like virus –A/Brisbane/10/2007 (H3N2)-like virus –B/Brisbane/60/2008-like antigens Vaccines Trivalent Inactivated, Injectable Influenza Vaccine  Fluzone ® (sanofi): age ≥ 6 months  Fluvirin ® (Novartis): age ≥ 4 years  Fluarix ® (GSK): age ≥ 3 years  FluLaval™ (ID Biomedical/GSK): age ≥ 18 years  Afluria ® (CSL): age ≥ 6 months Live Attenuated, Nasal Spray Influenza Vaccine  FluMist ® (MedImmune): age 2 through 49 years (healthy, non-pregnant) Seasonal 2009 influenza vaccine does not protect against 2009 (pandemic) H1N1 influenza CDC. MMWR Recomm Rep. 2009;58(RR8):1-52. CDC. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094045.htm. Accessed March 2010.

42 2009 H1N1 (Pandemic) Influenza Vaccines As of November 11, 2009: 4 monovalent inactivated vaccines approved CSL Limited –Age 6-35 mos: Two 0.25 mL IM doses (4 wk interval) –Age 36 mos to 9 yrs: Two 0.5 mL IM doses (4 wk interval) –Age ≥ 10 yrs: Single 0.5 mL IM injection –Adults ≥ 18 yrs: Single 0.5 mL IM injection Novartis Vaccines and Diagnostics Limited –Age 4-9 yrs: Two 0.5 mL IM doses (4 wk interval) –Age 10-17 yrs: Single 0.5 mL IM injection –Age ≥ 18 yrs: Single 0.5 mL IM injection Sanofi Pasteur, Inc. –Age 6-35 mos: Two 0.25 mL IM doses (4 wk interval) –Age 36 mos to 9 yrs: Two 0.5 mL IM doses (4 wk interval) –Age ≥ 10 yrs: Single 0.5 mL IM injection –Adults ≥ 18 yrs: Single 0.5 mL IM injection ID Biomedical/GSK –Adults ≥ 18 yrs: Single 0.5 mL IM injection 1 live attenuated (nasal administration) MedImmune LLC –Age 2-9 yrs: Two 0.2 mL doses (0.1 mL per nostril), 4 week interval –Age 10-49 yrs: Single 0.2 mL dose (0.1 mL per nostril) Prescribing information available at: http://www.cdc.gov/h1n1flu/vaccination/dosage.htm#table1. Accessed December 2009.

43 2010–2011 Influenza Season Universal Influenza Vaccination –All people 6 months and older are now recommended to receive annual influenza vaccination 2010-2011 Trivalent Influenza Vaccines: –A/California/7/2009(H1N1)-like virus Same strain as in the 2009 H1N1 monovalent vaccine – A/Perth/16/2009(H3N2)-like virus New strain for northern hemisphere vaccine Same strain as 2010 southern hemisphere seasonal strain –B/Brisbane/60/2008-like virus No change CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/flu-vac-mar-2010-508.pdf. March 2010.

44 Continued Emphasis on High-risk Groups: –Children aged 6 months through 4 years –Adults ≥ 50 years –Women who will be pregnant during the influenza season –Persons who have chronic pulmonary, cardiovascular, renal, hepatic, neurological, neuromuscular, hematological or metabolic disorders –Persons who have immunosuppression (including caused by medication or HIV) –Residents of nursing homes and other chronic-care facilities –Health care personnel –Household contacts and caregivers of children aged < 5 year and adults aged ≥ 50 years, with particular emphasis on vaccinating contacts of children < 6 months –Household contacts and caregivers of persons with medical conditions that put them at higher risk for severe complications from influenza 2010–2011 Influenza Season CDC. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb10/05-7-flu-vac.pdf. Accessed March 2010.

45 MMR Dose # Recommended Age Minimum Age Recommended Interval Minimum Interval 112-15 mo12 mo3-5 yr4 wk 24-6 yr13 mo May be administered as MMRV if 12 mo-12 yr of age, but minimal interval is 3 mo ACIP Summary Recommendations. www.immunize.org/catg.d/p2010.pdf. Accessed Oct 2009.

46 Varicella Varicella photo. http://www.cdc.gov/vaccines/vpd-vac/varicella/photos.htm. Accessed September 2009.

47 Varicella Dose # Recommended Age Minimum Age Recommended Interval Minimum Interval 112-15 mo12 mo3-5 yr12 wk (age < 13) 4-8 wk (age ≥ 13) 24-6 yr15 mo Second dose At ≥ 3 months if 1 st dose for age < 13 yrs At ≥ 4 weeks if 1 st dose for age > 13 yrs “MMRV vaccine can be used in place of trivalent MMR vaccine and monovalent varicella vaccine to implement the recommended 2-dose vaccine policies for prevention of measles, mumps, rubella, and varicella” Note: a two-fold increase in the risk of febrile seizures is associated with MMRV versus MMR and Varicella vaccines administered separately and simultaneously CDC MMWR Recomm Rep. 2007;56(RR04):1-40. CDC. MMWR Morb Mortal Wkly Rep. 2008;57(10);258-260 Broder K, et al. Presented at the ACIP June 25, 2009.

48 Hepatitis A Dose # Recommended Age Minimum Age Recommended Interval Minimum Interval 112-23 mo12 mo6-18 mo6 mo 218-41 mo18 mo New recommendations for families of international adoptees ACIP Summary Recommendations. http://www.immunize.org/catg.d/p2010.pdf. Accessed September 2009. CDC. MMWR Morb Mortal Wkly Rep. 2009;58(36):1006-1007.

49 Hepatitis A: Families of International Adoptees –Hepatitis A vaccination is recommended for all previously unvaccinated persons who anticipate close personal contact with an international adoptee from countries of high or intermediate endemicity during the first 60 days following arrival in the US. –The first dose of hepatitis A vaccine should be administered as soon as adoption is planned. Ideally, the first dose of hepatitis A vaccine should be administered at least two weeks prior to the arrival of the adoptee. CDC. MMWR Morb Mortal Wkly Rep. 2009;58(36):1006-1007.

50 General Principles The only vaccines that cannot be given at the same time are smallpox and varicella Minimal intervals apply to –Doses of the same inactivated vaccine –Doses of the same live vaccine –Doses of different live vaccines not given simultaneously, except Oral typhoid Ty21a vaccine Rotavirus vaccine Minimal intervals do not apply to doses of different inactivated vaccines Minimal intervals define catch-up schedules A 4-day grace period is granted to all vaccine doses –Rabies vaccine is an exception –Local regulations may not allow a grace period Marshall, GS. The Vaccine Handbook: A Practical Guide for Clinicians. West Islip, NY: Professional Communications, Inc.;2008.

51 Principles of Catch-up Schedules Age –Doses administered prior to minimum age should not be considered valid –Reduce number of doses according to age and schedule (eg, Hib, PCV) –Do not administer beyond maximum age Dose intervals –Minimum Do not administer subsequent doses at less than minimum intervals Unnecessary to repeat series; diminution of immunity is not expected in the short term Check formula interchangeability

52 Erroneous Contraindications The following are NOT contraindications: Mild acute illness Mild-moderate local reaction Concurrent antibiotic therapy Convalescent phase of illness Prematurity Recent exposure to illness History of non-vaccine allergies Family history of allergies, SIDS, seizures Desensitization shots Breastfeeding Positive TST Pregnant household contact (except OPV and smallpox) Asymptomatic or mildly symptomatic HIV infection Allergic to eggs but can eat egg-containing products Mild latex allergy Autoimmune disease

53 Combination Vaccines

54 MMRV: New Issues Increased risk of febrile seizures among 12- to 23-month-olds receiving dose 1 of MMRV vs MMR and varicella vaccines at the same visit Limited availability of MMRV due to manufacturing constraints ACIP position –Age 12 through 47 months for first dose: no preference –Dose 2 and any dose at age > 48 months The use of combinations generally is preferred. Considerations should include provider assessment, patient preference, and the potential for adverse events. Footnote= Provider assessment should include storage costs, number of injections, vaccine availability, vaccination status, likelihood of improved coverage, and likelihood of patient return visits. CDC. MMWR Morb Mortal Wkly Rep. 2008;57(10):258-260. Resolution No. 06/09-3. http://www.cdc.gov/vaccines/programs/vfc/downloads/ resolutions/0606mmrv.pdf. Accessed September 2009.

55 Current US Combination Vaccines ProductTriHIBitComvaxTwinrixPediarixProQuad DTaPTripediaInfanrix IPV Hib conjActHIBPedvaxHIB Hep-AHavrix Hep-BRecom-HBEngerix-B Measles MMR II Mumps Rubella VaricellaVarivax

56 Current US Combination Vaccines ProductPentacelKinrix DTaP(Daptacel)Infanrix IPVPoliovaxIPV Hib conjActHIB Hep-A Hep-B Measles Mumps Rubella Varicella

57 Combination Vaccine Rule The minimum intervals between doses of a combination vaccine are dictated by the single antigen with the longest minimum intervals

58 Addressing Parental Concerns Safety

59 Public Confidence in Vaccines Public confidence in vaccines is affected by a number of factors, including: –Product safety and efficacy –Anecdotal experience/information –Prevalence of disease –Recommendations by governmental committees and professional societies –Physician recommendations –Media coverage –Vaccine monitoring and surveillance systems

60 Alternative Vaccination Schedules The Dr. Bob Sears’ alternative schedule –Dr. Bob Sears’ strategy for addressing parent concerns –Dr. Paul Offit’s analysis of this strategy

61 Dr. Bob Sears’ Alternative Vaccine Schedule Sears RW. The Vaccine Book. New York, NY: Little Brown & Company: 2007.

62 Dr. Bob Sears’ Alternative Vaccine Schedule ParameterDr. Bob SearsACIP Total visits to completion15 visits4 or 5 visits Age at completion42 months15 or 18 months Marshall G. The Vaccine Quarterly. 2009;3[1]:17.

63 ArgumentThe Truth Doctors do not understand vaccines. Parents can educate themselves to know more than doctors. Doctors may not always review the primary data, but the advisory committees that do are composed of experts whose record has been spot-on. Government and pharmaceutical companies conspire to misrepresent data. There is no evidence of conspiracy. Vaccine-preventable diseases are not that serious and are often not seen in practice. Vaccine-preventable diseases are serious and can result in death. Anecdotal experience in practice does not trump national surveillance data. Natural immunity is better than vaccine-induced immunity. The cost of natural immunity is the risk of serious disease or death. Vaccines are not adequately tested for safety.Vaccines are among the most thoroughly tested pharmaceuticals. The post-licensure safety net is robust. Offit PA, Moser CA. Pediatrics. 2009;123(1):e164-e169. Critique of Dr. Bob Sears’ Alternative Schedule

64 ArgumentThe Truth Vaccines are recommended for protection of the public at large, not individuals. Every individual benefits from receiving vaccines– they become immune to the disease and, as long as others are immunized, they have less chance of exposure. Parents’ fears should be indulged by offering alternative schedules. Parents’ fears should be assuaged by explaining the scientific findings. Reports in VAERS and language in the Package Insert (PI) constitute accurate profiles of vaccine side effects. VAERS reports do not establish causality and the PI lists any reported events, whether causally related or not. There is a middle ground between causality and coincidence. This logic is flawed–either vaccines do or don’t cause certain adverse events. Science fails because it cannot prove there is no connection between vaccines and certain adverse events. Science doesn’t work that way– one can only reject or fail to reject the null hypothesis. Offit PA, Moser CA. Pediatrics. 2009;123(1):e164-e169. Critique of Dr. Bob Sears’ Alternative Schedule For more discussion on this alternative schedule, visit http://www.immunize.org/concerns/drsears.asp

65 Institute of Medicine Immunization Safety Reviews 2004 “…the body of epidemiological evidence favors rejection of a causal relationship between the MMR vaccine and autism… [and] favors rejection of a causal relationship between thimerosal-containing vaccines and autism.” 1. Immunization Safety Review: http://www.nap.edu/catalog.php?record_id=10101#toc. Accessed September 2009. 2. Immunization Safety Review: http://www.nap.edu/catalog.php?record_id=10208#toc. Accessed September 2009. 3. Immunization Safety Review: http://www.nap.edu/catalog.php?record_id=10997#toc. Accessed September 2009.

66 US Measles Cases Measles increase in 2008 not due to a greater number of imported cases, but was the result of greater transmission after importation CDC. MMWR Morb Mortal Wkly Rep. 2008;57(33):893-896. Cases of imported measles* as a proportion of all measles cases–US 1997 to July 2008 Cases of measles by vaccination status (2008)

67 Madsen KM, et al. N Engl J Med. 2002;347:1477-1482. Danish Cohort Study Population of Denmark Children born between 01/01/91 and 12/31/98 The Past MMR 1,647,504 person-yr No MMR 482,360 person-yr The Present Autism: 263 ASD: 345 Autism: 53 ASD: 77 Relative risk: Autism: 0.92 (0.68-1.24) ASD: 0.83 (0.65-1.07)

68 Hviid A, et al. JAMA. 2003;290:1763-1766. Danish Cohort Study Population of Denmark Children born between 01/01/90 and 12/31/96 The Past Thimerosal 1,220,006 person-yr No thimerosal 1,660,159 person-yr The Present Autism: 104 ASD: 321 Autism: 303 ASD: 430 Relative risk: Autism: 0.85 (0.60-1.20) ASD: 1.12 (0.88-1.43)

69 2-month-old infants Pichichero ME, et al. Pediatrics. 2008;121:e208-e214. Mercury Levels After Thimerosal-Containing Vaccines

70 Madsen KM, et al. Pediatrics. 2003;112:604-606. Autism Incidence After Vaccine Formulation Changes Thimerosal-containing vaccines removed Autism Incidence per 10,000 Persons

71 Schechter R, Grether JK. Arch Gen Psychiatry. 2008;65:19-24. Autism in California

72 Thimerosal in Vaccines. www.fda.gov/cber/vaccine/thimerosal.htm. Accessed September 2009. Thimerosal Status of Current Vaccines VaccineTrade NameStatus Diphtheria, tetanus, pertussis Infanrix Daptacel Tripedia Free ≤ 0.3 mcg Hg/0.5mL PCV-7PrevnarFree PolioIPOLFree Hepatitis BRecombivax HB Engerix-B Free Hib conjugateActHIB PedvaxHIB HibTITER Free Free (single dose) Hib/Hepatitis BComvaxFree MMRM-M-R-IIFree VaricellaVarivaxFree DTaP/Hep-B/IPVPediarixFree InfluenzaFluzone T-freeFree Fluvirin P-free< 1.0 mcg Hg/0.5 mL FluMistFree Hepatitis A* *updated 3/14/08 VaqtaFree HavrixFree

73 Marshall GS, et al. The Vaccine Handbook. Lippincott Williams + Wilkins; 2004. VAERS reporting. http://www.cdc.gov/vaccines/Pubs/surv-manual/chpt21-surv-adverse-events.htm#4. Accessed September 2009. CDC. MMWR Morb Mortal Wkly Rep. 1988;37(13):197-200. Vaccine Adverse Event Reporting System Postmarketing surveillance system Mandatory reporting by health care providers –Occurrence of events listed as contraindications –Occurrence of events listed in the Reportable Events Table Voluntary reporting: any event by any one Intent: hypothesis generation not hypothesis testing

74 Vaccine Safety Datalink Study MMRVMMR plus V Number of subjects43,353314,599 Rate of febrile seizures9 per 10,0004 per 10,000 CDC. MMWR Morb Mortal Wkly Rep. 2008;57(10):258-260.

75 Adjudication of Febrile Seizure Incidence Following MMRV Pre-adjudicated Seizure ReportsAdjudicated Seizure Data Adjudication panel: Drs S. Michael Marcy, Robert Riewerts, and Suresh Gurbani – Reviewed medical records (blinded to vaccination dates) – Confirmed seizure diagnosis based on Brighton Collaboration criteria Post-adjudication seizure data for days 5-12 postvaccination: – MMRV: 0.70/1000 – MMR + V: 0.32/1000 – Relative risk = 2.2 (95% CI = 1.04, 4.65) Jacobsen SJ, et al. Vaccine. 2009;27:4656-4661.

76 Aluminum Adjuvants: Review of the Evidence Jefferson T, et al. Lancet Infect Dis. 2004;4:84-90. Aluminum Hydroxide vs No Adjuvant (children up to 18 months of age) Any Aluminum vs No Adjuvants (children 10-16 years)

77 Strategies for Improving Childhood Immunization Rates

78 The Community Guide.http://www.thecommunityguide.org/vaccines/universally/index.html. Accessed September 2009. Briss PA, et al. Am J Prev Med. 2000;18(suppl 1):35-43. Evidence-based Methods for Improving Immunization Rates Community Preventive Services Task Force Recommended Strategies –Reducing client out-of-pocket costs –Vaccination programs in schools –Vaccination programs in WIC settings –Client reminder and recall systems –Vaccination requirements for child care, school, and college attendance –Provider reminder systems when used alone –Standing orders when used alone –Provider assessment and feedback The above recommendations have all been upgraded to ‘strong evidence’ based on systematic reviews

79 Adolescent Vaccines

80 Definition of ‘Adolescent’ 7 th birthday until the 19 th birthday –Per CDC adolescent immunization schedule Society of Adolescent Medicine defines adolescent as 10-25 yrs

81 2010 ACIP Adolescent Immunization Schedule ACIP Schedules. www.cdc.gov/vaccines/recs/schedules/default.htm. Accessed Jan 2010. Minimum age 9 years

82 Adolescent Catch-up Schedule ACIP Schedules. www.cdc.gov/vaccines/recs/schedules/default.htm. Accessed Jan 2010.

83 Adolescent (13–17 yrs) Vaccination Coverage, United States 2007–2008 CDC. MMWR Morb Mortal Wkly Rep. 2009;58(36):993-1001. 0 10 20 30 40 50 60 70 80 90 100 MMR ≥ 2 Doses Hepatitis B ≥ 3 Doses Varicella ≥ 1 Dose VaricellaTd or Tdap ≥ 1 Dose Tdap ≥ 1 Dose MCV4HPV4* ≥ 1 Dose HPV4* ≥ 3 Doses Vaccination Coverage (%) 2007 N = 2947 2008 N = 17,835 ≥ 2 Doses≥ 1 Dose * Percentages for females only

84 Tdap 7–10 years11-12 years13–18 years ---recommendedcatch-up Two FDA-approved Tdap vaccines available Both contain the same acellular pertussis component as their respective DTaP products FDA recommended one-time use of Tdap only –For 11-12 year olds, replaces Td booster if no previous Tdap –Catch-up for 13-18 yrs (5-year interval from last Td encouraged) MCV4 contains diphtheria conjugate protein carrier –If both are indicated, administer MCV4 and Tdap simultaneously Boostrix Approved for use ages 10-64 years Adacel Approved for use ages 11-64 years CDC. MMWR Recomm Rep. 2006;55(RR03):1-34.

85 Tdap 10 to 18 years of age19 to 64 years of age Replaces Td booster for 11 ­ 12-year-olds Catch-up for 13-18 yrs (5-year interval from Td encouraged) If no previous DPT series, give as 1 Tdap + 2 Td Give with MCV4 if both vaccines are indicated Replaces Td booster; wound management* 2-year interval from Td for adults in contact with infants; health care workers Anyone who wants to decrease risk of disease The safety and effectiveness of Tdap have not been established in pregnant women CDC. MMWR Recomm Rep. 2006;55(RR3):1-34. CDC. MMWR Recomm Rep. 2006;55(RR17):1-33. CDC. MMWR Morb Mortal Wkly Rep. 2009;58(14):374-375. If overall risk/benefit is favorable, discount risk of local rxns and immunize * Only if no previous Tdap received

86 Available HPV Vaccines Quadrivalent Merck - Gardasil ® Bivalent GSK - Cervarix ® Licensed in the US 20062009 Virus-like Particle TypesHPV 6, 11, 16, 18HPV 16, 18 Protection against HPV 16/18 related CIN2+ ≥ 98%≥ 93% Protection against HPV 6/11 related genital lesions ~99%--- Hypersensitivity-related contraindication YeastLatex Age ranges Routine 11 or 12 yrs, as young as 9 yrs; catch-up 13-26 yrs Routine 11 or 12 yrs, as young as 10 years; catch-up 13-25 yrs Schedule 0, 2, 6 months0, 1, 6 months Markowitz L. ACIP Meeting Oct 2009. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides- oct09/02-2-hpv.pdf. Accessed Oct 2009. CIN2+: cervical intraepithelial neoplasia grade 2 or higher and adenocarcinoma in situ

87 HPV – ACIP Recommendations Quadrivalent HPV (HPV4) and Bivalent HPV (HPV2) Routine vaccination of females aged 11-12 years with 3 doses of HPV vaccine –Catch-up 13-26 yrs (HPV4); 13-25 yrs (HPV2) ACIP: no preference for either vaccine HPV4 or HPV2 vaccination for prevention of HPV 16/18- related cervical cancers, precancers and dysplastic lesions Vaccination with HPV4 for additional prevention against genital warts Monitor patients for 15 minutes following vaccination for syncopal episodes ACIP Schedules. www.cdc.gov/vaccines/recs/schedules/default.htm. Accessed Jan 2010.

88 HPV Vaccination and Pregnancy HPV vaccines are not recommended for use in pregnant women Initiation of the vaccine series should be delayed until after completion of pregnancy If a woman is found to be pregnant after initiating the vaccination series, delay remaining doses until after the pregnancy If a vaccine dose has been administered during pregnancy, there is no indication for intervention Two vaccine in pregnancy registries have been established. Patients and health care providers should report: –Quadrivalent HPV vaccine/pregnancy: 800-986-8999 –Bivalent HPV vaccine/pregnancy: 888-452-9622 CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/hpv-vac-dec2009-508.pdf. Accessed March 2010.

89 HPV Quadrivalent Vaccine in Males FDA approved quadrivalent HPV vaccine for prevention of genital warts due to HPV types 6 and 11 in boys and men ages 9 through 26 ACIP: Permissive HPV vaccine for males –Cost effectiveness –Priority vaccinating females to reduce overall disease/cancer burden –Quadrivalent HPV vaccine most effective when given before exposure to HPV through sexual contact FDA News Release. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187003.htm. Accessed Oct 2009. Dunne E. ACIP Meeting Oct 2009. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-oct09/02-9-hpv.pdf. Accessed Oct 2009.

90 HPV-associated* Invasive Squamous Cell Carcinomas in Women and Men, 1998–2003 Anatomic AreaAvg Annual Incidence (#) Incidence (per 100,000) 95% CI Cervix10,8468.98.9,9.0 Vagina6010.50.4,0.5 Vulva22661.71.7,1.7 Anus/Rectum19351.51.5,1.5 Oropharynx/OC17021.31.3,1.4 Total Females17,35014.013.8,14.0 Penis8280.80.8,0.8 Anus/Rectum10831.01.0,1.0 Oropharynx/OC56585.25.1,5.2 Total Males75687.06.9,7.0 *Defined by histology and anatomic site Watson M, et al. Cancer. 2008;113(10suppl):2855-2864. Data source: National Program of Cancer Registries and SEER, covering 83% coverage of US population. ACIP Meeting February 2009. http://www.cdc.gov/vaccines/recs/acip/downloads/min-feb09.pdf. Accessed Oct 2009.

91 HPV Vaccine Parental Concerns Many parents uncomfortable addressing subjects related to child sexuality, especially at such young ages –Be sensitive to discussing this issue –Communicate the importance of completing the 6-month immunization series before the adolescent becomes sexually active Vaccination does not imply current sexual activity, nor will it encourage it Protection against HPV acquired by involuntary sexual intercourse –Improved immunogenicity at younger ages Educate parents and adolescents regarding the ubiquitous nature of HPV and its association with cervical dysplasia and cancer –Parents who received education on human papillomavirus and HPV vaccine more likely to accept vaccination of their child than those who received no educational intervention Communicate the universality of the vaccine recommendation to avoid feelings of being stigmatized/singled out Rosenthal SL. J Adolesc Health. 2005;37:177-178.

92 HPV Postlicensure Safety Data- VAERS Review of 12,424 adverse event reports following immunization (AEFI) with quadrivalent HPV Vaccine from the Vaccine Adverse Event Reporting System (VAERS): 6/31/06 through 12/31/08 Disproportional reporting of syncope and venous thromboembolism –Increased risk among teens 11-18 yrs –Serious injuries have resulted –Providers should strongly consider observing patients for 15 minutes after they are vaccinated Quadrivalent HPV was the only vaccine administered in: –74% of syncope/vasovagal reports –73% of dizziness reports –78% of nausea reports Slade BA, et al. JAMA. 2009;302(7):750-757. Calugar A. Oct 2008 ACIP meeting. http://cdc.gov/vaccines/recs/acip/downloads/min-oct08.pdf. Accessed Oct 2009.

93 Meningococcal Conjugate Vaccines Recommended for adolescents aged 11-18 years and others at increased risk for meningococcal disease –MCV4-D (Menactra ®, Sanofi): licensed for persons 2-55 years; Serogroups A, C, Y, W-135; diphtheria toxoid conjugate –MenACWY-CRM 197 (Menveo ®, Novartis): licensed for persons 11-55 years; Serogroups A, C, Y, W-135; diphtheria CRM 197 conjugate Revaccination for Persons at Increased Risk –Previous vaccination (meningococcal conjugate vaccine or MPSV4) at 2-6 years, revaccinate 3 years after initial meningococcal vaccine –Previous vaccination (meningococcal conjugate vaccine or MPSV4) at ≥ 7 years, revaccinate 5 years after initial meningococcal vaccine –This includes: Persons with persistent complement component deficiencies Persons with anatomic or functional asplenia Microbiologists who are routinely exposed to isolates of N. meningitidis Frequent travelers to or people living in areas with high rates of meningococcal disease (African meningitis belt) Meissner HC. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb10/08-1- mening.pdf. Accessed March 2010. CDC. MMWR Morb Mortal Wkly Rep. 2009;58(37):1042-1043.

94 Annual Influenza Vaccine is Recommended for: All people age 6 months and older! CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/flu-vac-mar-2010-508.pdf. Accessed March 2010.

95 Trivalent Inactivated Virus (TIV) versus Live Attenuated Influenza Virus (LAIV) Vaccines TIV Licensed for use in persons age ≥6 mos Intramuscular injection TIV contains purified viral particles that have been chemically inactivated –Purified components from 3 WHO-recommended annual strains –Immunity developed against disrupted/denatured viral proteins, not against intact virus LAIV Licensed for use among nonpregnant persons aged 2-49 years Administered by nasal spray LAIV contains intact virus that has been propogated in eggs at 25ºC –Cold-adaptation results in restricted replication at body temp –More mild flu symptoms –Contains same 3 WHO-recommended annual strains as TIV CDC. MMWR Recomm Rep. 2009;58(RR8):1-52. Flumist Prescribing Information. www.flumist.com. Accessed Oct 2009.

96 2009–2010 Seasonal Influenza Vaccines 2009–2010 seasonal influenza vaccine formulation: –A/Brisbane/59/2007(H1N1)-like virus –A/Brisbane/10/2007 (H3N2)-like virus –B/Brisbane/60/2008-like antigens Vaccines Trivalent Inactivated, Injectable Influenza Vaccine  Fluzone ® (sanofi): age ≥ 6 months  Fluvirin ® (Novartis): age ≥ 4 years  Fluarix ® (GSK): age ≥ 3 years  FluLaval™ (ID Biomedical/GSK): age ≥ 18 years  Afluria ® (CSL): age ≥ 6 months Live Attenuated, Nasal Spray Influenza Vaccine  FluMist ® (MedImmune): age 2 through 49 years (healthy, non-pregnant) Seasonal 2009 influenza vaccine does not protect against 2009 (pandemic) H1N1 influenza CDC. MMWR Recomm Rep. 2009;58(RR8):1-52. CDC. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094045.htm. Accessed March 2010.

97 2009 H1N1 (Pandemic) Influenza Vaccines As of November 11, 2009: 4 monovalent inactivated vaccines approved CSL Limited –Age 6-35 mos: Two 0.25 mL IM doses (4 wk interval) –Age 36 mos to 9 yrs: Two 0.5 mL IM doses (4 wk interval) –Age ≥ 10 yrs: Single 0.5 mL IM injection –Adults ≥ 18 yrs: Single 0.5 mL IM injection Novartis Vaccines and Diagnostics Limited –Age 4-9 yrs: Two 0.5 mL IM doses (4 wk interval) –Age 10-17 yrs: Single 0.5 mL IM injection –Age ≥18 yrs: Single 0.5 mL IM injection Sanofi Pasteur, Inc. –Age 6-35 mos: Two 0.25 mL IM doses (4 wk interval) –Age 36 mos to 9 yrs: Two 0.5 mL IM doses (4 wk interval) –Age ≥10 yrs: Single 0.5 mL IM injection –Adults ≥ 18 yrs: Single 0.5 mL IM injection ID Biomedical/GSK –Adults ≥ 18 yrs: Single 0.5 mL IM injection 1 live attenuated (nasal administration) MedImmune LLC –Age 2-9 yrs: Two 0.2 mL doses (0.1 mL per nostril), 4 week interval –Age 10-49 yrs: Single 0.2 mL dose (0.1 mL per nostril) Prescribing information available at: http://www.cdc.gov/h1n1flu/vaccination/dosage.htm#table1. Accessed December 2009.

98 2010–2011 Influenza Season Universal Influenza Vaccination –All people 6 months and older are now recommended to receive annual influenza vaccination 2010-2011 Trivalent Influenza Vaccines –A/California/7/2009(H1N1)-like virus Same strain as in the 2009 H1N1 monovalent vaccine – A/Perth/16/2009(H3N2)-like virus New strain for northern hemisphere vaccine Same strain as 2010 southern hemisphere seasonal strain –B/Brisbane/60/2008-like virus No change CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/flu-vac-mar-2010-508.pdf. March 2010.

99 Continued Emphasis on High-risk Groups: –Children aged 6 months through 4 years –Adults ≥ 50 years –Women who will be pregnant during the influenza season –Persons who have chronic pulmonary, cardiovascular, renal, hepatic, neurological, neuromuscular, hematological or metabolic disorders –Persons who have immunosuppression (including caused by medication or HIV) –Residents of nursing homes and other chronic-care facilities –Health care personnel –Household contacts and caregivers of children aged < 5 year and adults aged ≥ 50 years, with particular emphasis on vaccinating contacts of children < 6 months –Household contacts and caregivers of persons with medical conditions that put them at higher risk for severe complications from influenza 2010–2011 Influenza Season CDC. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb10/05-7-flu-vac.pdf. Accessed March 2010.

100 PPSV23 7–10 years11-12 years13–18 years for certain high-risk groups Single dose recommended for: All ≥ 65 years 2–64 years: chronic cardiovascular disease, chronic pulmonary disease, diabetes, alcoholism, chronic liver disease, CSF leaks, asplenia, cochlear implants >2 years and immunocompromised Asthmatics and smokers age 19-64 years Proposed language for one-time revaccination: “A second dose of PPSV23 is recommended 5 years after the first dose of PPSV23 for persons aged >2 years who are immunocompromised, have sickle cell disease, or functional or anatomic asplenia” ACIP Summary Recommendations. http://www.immunize.org/catg.d/p2010.pdf. Accessed Oct 2009. ACIP Provisional Recommendations. http://www.cdc.gov/vaccines/recs/provisional/downloads/pneumo- Oct-2008-508.pdf. Accessed Oct 2009.

101 PPSV23 and Alaskan Natives, American Indians “Routine use of PPSV23 is not recommended for Alaska Native or American Indian persons younger than 65 years old unless they have underlying medical conditions that are PPSV23 indications. However, in special situations, public health authorities may recommend PPSV23 for Alaska Natives and American Indians aged 50 through 64 years who are living in areas in which the risk of invasive pneumococcal disease is increased." ACIP Provisional Recommendations. http://www.cdc.gov/vaccines/recs/provisional/downloads/pneumo-Oct-2008-508.pdf. Accessed Oct 2009.

102 HepA 7–10 years11-12 years13–18 years for certain high-risk groups CDC. MMWR Morb Mortal Wkly Rep. 2006;55(RR7):1-23. CDC Resolution No. 06/07-1. http://cdc.gov/vaccines/programs/vfc/downloads/resolutions/0607-1hepa.pdf Accessed Oct 2009. Routine vaccination recommended for all children ages 12-23 mos In areas without existing Hep A vaccination programs, catch-up of unvaccinated children 2-18 yrs old may be considered Recommendations for age ≥2 yrs depend on risk and vary according to state programs Dosing: VAQTA ® –For all persons age ≥12 mos 2 doses at 0 and 6-18 mos HAVRIX ® –For all persons age ≥12 mos 2 doses at 0 and 6-12 mos

103 Hepatitis A Vaccine International Travel For healthy persons 40 years of age or younger –2 doses 6 months apart prior to departure –The first dose of Hepatitis A vaccine should be administered as soon as travel is considered –1 dose of single-antigen vaccine administered at any time before departure Consider both HAV and Ig for –Persons age > 40 with chronic illness traveling in less than 2 weeks and only receiving one dose of HAV –Persons at risk of severe disease from hepatitis A virus planning to travel in 2 weeks or sooner CDC. MMWR Morb Mortal Wkly Rep. 2007;56(41):1080-1084.

104 Hepatitis A Postexposure Prophylaxis For healthy persons 12 months through 40 years of age who have not previously received HepA vaccine –Take into account patient characteristics, including chronic liver disease Immunoglobulin and/or single-antigen hepatitis A vaccine should be administered as soon as possible after exposure –Vaccine preferred for those of age 12 mos to 40 yrs –Ig preferred for age <12 mos, those with vaccine allergies, or those with immunosuppression or liver disease –Ig preferred for age >40 but vaccine may be used if Ig unavailable –HepA and Ig may be administered simultaneously Efficacy of Ig or HepA when administered >2 weeks postexposure is unknown CDC. MMWR Morb Mortal Wkly Rep. 2007;56(41):1080-1084. CDC. MMWR Morb Mortal Wkly Rep. 2009;58(36):1006-1007.

105 Hepatitis A: Families of International Adoptees –Hepatitis A vaccination is recommended for all previously unvaccinated persons who anticipate close personal contact with an international adoptee from countries of high or intermediate endemicity during the first 60 days following arrival in the US. –The first dose of hepatitis A vaccine should be administered as soon as adoption is planned. Ideally, the first dose of hepatitis A vaccine should be administered at least two weeks prior to the arrival of the adoptee. CDC. MMWR Morb Mortal Wkly Rep. 2009;58(36):1006-1007.

106 HepB 7–10 years11-12 years13–18 years catch-up Multiple schedules –Children 1-10 yrs 0, 1, and 6 mos 0, 2, and 4 mos 0, 1, 2, and 12 mos –Adolescents 11-19 yrs 0, 1, and 6 mos 0, 1, and 4 mos* 0, 2, and 4 mos* 0, 12, and 24 mos* 0 and 4-6 mos (2 dose schedule uses adult 10ug formulation, Recombivax-HB)** 0, 1, 2, and 12 mos No combination HepB vaccines approved for use in ages 11-17 yrs * These schedules provide equivalent seroprotection in adolescents **No long-term data are available for antibody persistence- when second dose is to be administered at age >15 yrs, consider switching to a 3-dose schedule using pediatric formulation CDC. MMWR Recomm Rep. 2005;54(RR16):1-23.

107 HepA-HepB Combination Vaccine (Twinrix) Approved for persons 18 years and older –Combination HepA vaccine (pediatric dose) and HepB (adult dose) First licensed schedule: 0, 1, and 6 months –Alternate schedule 2007: Doses at 0, 7, 21-30 days and a booster dose at 12 months The first 3 doses of the new schedule provide equivalent protection to: –The first dose in the standard single-antigen adult hepatitis A vaccine series –The first 2 doses in the standard adult hepatitis B vaccine series Seroconversion is nearly 100% after either 3 doses of the combination vaccine on the new schedule or a single dose of single-antigen adult hepatitis A vaccine –Duration of protection 4 yrs against HepA No increased benefit of the new schedule for the hepatitis B component compared to administration of 2 hepatitis B vaccine doses 1 to 2 months apart CDC. MMWR Morb Mortal Wkly Rep. 2007;56(40):1057.

108 Varicella 7–10 years11-12 years13–18 years catch-up Universal recommendation for routine vaccination is 2 doses –Given 3 months apart for those under 13 years old –4 to 8 weeks apart for those ≥ 13 years old Second dose is still valid if >8 week interval Formulations –Varivax licensed ages 12 mos and older –Proquad (Combination MMRV) not licensed ≥13 years CDC. MMWR Recomm Rep. 2007;56(RR04):1-40.

109 Adolescent Immunization: Goals and Objectives Effective adolescent vaccine delivery and monitoring are critical Adolescents lag far behind preschoolers in immunization coverage Healthy People 2010 objective for adolescents aged 13-15 years is 90% coverage with the following: –3 or more doses of hepatitis B vaccine –2 or more doses of MMR vaccine –1 or more doses of Td* vaccine –1 or more doses of varicella vaccine *Healthy People 2010 objectives were set prior to licensure of Tdap, meningococcal, and HPV vaccines.

110 Strategies for Improving Adolescent Immunization Rates

111 Healthy People 2010 Adolescent Immunization Goals 14-24. Increase the proportion of young children and adolescents who receive all vaccines that have been recommended for universal administration for at least 5 years 14-27. Increase routine vaccination coverage levels for adolescents –For 13-15 yrs olds, 90% coverage rates for ≥ 3 hepatitis B, ≥ 2 MMR, ≥ 1 varicella, ≥ 1 TD –Flu vaccine recommendation is new; no specific goal established Healthy People 2010. http://www.healthypeople.gov/document/html/objectives/ 14-27.htm. Accessed September 2009.

112 Parents Are a Key Influence Parental perception of vaccination is an important factor in adolescents’ vaccination decisions 1,2 –Parents influence adolescent acceptance –Providers influence parental acceptance Parental consent for immunization is the most cited barrier to immunizing students at school-based vaccination initiatives 3,4 1.Rosenthal SL, et al. J Adolesc Health. 1995;17:248-254. 2.Rosenthal SL. J Adolesc Health. 2005;37:177-178. 3.Guajardo AD, et al. J Sch Health. 2002;72:128-130. 4.Deeks SL, Johnson IL. Can J Public Health. 1998;89:98-101.

113 Patient and Provider Factors That Influence Adolescent Immunization Education/ Knowledge Self-Efficacy Insurance/ Reimbursement Time Provider likelihood to administer immunization ADOLESCENT IMMUNIZATION Patient likelihood to access immunization Provider Patient Middleman AB. J Adolesc Health. 2007;41:109-118.

114 Available Reimbursement for Adolescent Vaccination Public funding for eligible children up to but not including the 19 th birthday –Vaccines for Children Program (VFC)  Many insurers follow VFC lead –State Children’s Health Insurance Program (SCHIP) Funding for adolescents > 19 years: –Federal Vaccination Assistance Act, Section 317  Inadequate for large-scale immunization strategies

115 Establishing Adolescent Immunization Platforms Need exists for standard immunization visits during adolescence ACIP recommendations geared to 11- to 12-year-old age group –Younger adolescents have higher rates of accessing preventive health care than older adolescents Rand CM, et al. J Adolesc Health. 2005;37:87-93.

116 Establishing Adolescent Immunization Platforms (cont) Society for Adolescent Medicine position statement –11- to 12-year visit: primary immunization platform –14- to 15-year visit: catch up on missed vaccines or complete multidose regimens –17- to 18-year visit: update vaccinations that were missed or are newly recommended Middleman AB, et al. J Adolesc Health. 2006;38:321-327. IDSA. Clin Infect Dis. 2007;44:e104-e108.

117 Advantages of Building an Adolescent Immunization Platform Structure Puts focus on disease prevention among this age group Presents opportunities for improved comprehensive care that includes other health issues (eg, screening and prevention of risk behaviors) Creates parental and provider expectation of compliance with established adolescent immunization visits IDSA. Clin Infect Dis. 2007;44:e104-e108.

118 Adolescent Vaccination Coverage: Who Is Measuring? The National Committee for Quality Assurance (NCQA) Healthcare Effectiveness Data and Information Set (HEDIS) update: –NCQA eliminated measures in 2008; Web site indicates development of updated measures for 2009 National Immunization Survey (NIS) 2006: First year of data collection for adolescents 13 to 17 years of age NIS-Teen: –Includes provider-reported information –HPV not reported (recommended in 2007) –Now conducted annually

119 NIS-Teen Results Vaccine Coverage 2006 + Coverage 2007 ^ Coverage 2008* ≥ 1 dose Tdap after 10 years of age 10.8%30.4%40.8% ≥ 1 dose Td/Tdap after 10 years of age 60.1%72.3%72.2% ≥ 3 doses HepB vaccine 81.3%87.6%87.9% ≥ 2 doses MMR vaccine 86.9%88.9%89.3% ≥ 1 dose of Varicella vaccine (no disease history) 65.5%75.7%81.9% ≥ 2 doses of Varicella vaccine (no disease history) –18.8%34.1% MCV4 vaccine 11.7%32.4%41.8% HPV 4 ≥ 1 dose –25.1%37.2% CDC. MMWR Morb Mortal Wkly Rep. 2008;57(40):1100-1103. CDC. MMWR Morb Mortal Wkly Rep. 2009;58(36):997-1001. + n = 2882 adolescents ^ n = 2947 adolescents *n = 17,835 adolescents

120 Public Policy Use of standing orders Use of recall systems Use of immunization information systems Use of screening tools Development of specific vaccination “quick visits” if other services not needed Education re: provision of preventive care for adolescents Education re immunizations Providers Patients Use of alternative site if no medical home or if need to complete a series of vaccinations Attend vaccination “quick visits” if other preventive services not required Education re need for preventive care of adolescents Education re: immunizations Enrollment in immunization information systems National Development of standard immunization platforms by ACIP, professional organizations Reimbursement/ funding (currently VFC, 317) Funding and support for immunization information systems Insurance reform Mandates for school entry Reimbursement/ funding (currently SCHIP) Funding and support for immunization information systems State legislation allowing immunization at alternative sites State review of “consent” procedures Bull’s-eye! Shots in Adolescent Arms Adolescent Immunization Rates: Strategies to Hit the Target State Middleman AB. J Adoles Health. 2007;41:109-118.

121 Benefits of Using a Computerized Immunization Information System (IIS) Recommended by National Vaccine Advisory Committee (NVAC) and National Immunization Program (NIP) Consolidates fragmented records Keeps track of patients needing recommended or catch-up vaccination Provides automated reminder and recall Assists in management of vaccine supply Generates vaccination records for parents, schools, other Yawn BP, et al. Am J Manag Care. 1998;4:185-192. Glazner JE, et al. Ambul Pediatr. 2004;4:34-40.

122 Are Providers Seeing Adolescents? HEDIS data: 34% of adolescents who participate in health plans have annual preventive visits 1 NCHS (CDC) data: 86% of 6- to 17-year-olds and 76% of 18- to 24-year-olds report at least one doctor’s office, ED, or home visit within past year 2 88–92% of adolescents report having an identified source of primary care 3,4 HEDIS = Health Plan Employer Data and Information Set; NCHS = National Center for Health Statistics McInerny TK, et al. Pediatrics. 2005;115:833-838. National Center for Health Statistics. Health, United States, 2005. Klein JD, et al. Arch Pediatr Adolesc Med. 1998;152:676-682. Klein JD, et al. J Adolesc Health. 1999;25:120-130.

123 Provider-based Strategies to Improve Adolescent Immunization Rates Standing orders –Recommended by CDC (strong evidence) to increase adult immunization –Would likely decrease missed vaccination opportunities in adolescents Screening tools (NVAC recommends annual review) Reminder/recall systems (often with IIS) –Recommended (strong evidence) by CDC to increase adult, adolescent, and childhood immunizations –Complex for adolescents (eg, changing phone numbers, waning effect of calls) Vaccination “quick visits” Understanding other adolescent issues/care The Community Guide. www.thecommunityguide.org/vaccine/vpd.pdf. Accessed September 2009. Szilagyi PG, et al. Arch Pediatr Adolesc Med. 2006;160:157-163. IIS: immunization information systems

124 The Goal: To Increase the Adolescent Immunization Rate Healthy People 2010 –Adolescent immunization coverage goal: 90% –Increase number of providers who measure vaccination coverage level every 2 years among children in their practice Free assistance from public health departments (CoCASA software) Vaccines for Children quality improvement activities (eg, AFIX) Healthy People 2010 Immunization and Infectious Disease. http://www.healthypeople.gov/Document/HTML/Volume1/14Immunization.htm. Accessed Oct 2009. CoCASA. http://www.cdc.gov/vaccines/programs/cocasa/default.htm. Accessed Oct 2009. AFIX. http://www.cdc.gov/vaccines/programs/afix/default.htm. Accessed Oct 2009.

125 Standing Orders Are Among the Most Effective Strategies Nonphysicians offer and administer vaccinations –No direct MD involvement at the time of the visit Established with physician approved policies and protocols Locations: –Clinics and hospitals CDC. http://www.cdc.gov/vaccines/recs/rate-strategies/adultstrat.htm. Accessed September 2009. McKibbin LJ, et al. MMWR Recomm Rep. 2000;49 (RR1):15-26.

126 Success of Standing Orders as Part of a Multifaceted Program Education Standing Orders Nichol KL. Am J Med. 1998;105:385-392. Influenza Vaccination Rates for Elderly Patients in General Medicine Clinics

127 Adult Vaccines

128 Adult Immunization Schedule: US 2010 CDC. MMWR Morb Mortal Wkly Rep. 2010;59(1).

129 Gaps Persist Between Vaccination Rates and Goals US Goals: Elderly: 90% HR < 65: 60% HR denotes High Risk Schiller J, et al. http://www.cdc.gov/nchs/data/hestat/vaccine_coverage.htm. Accessed September 2009.

130 Adult Immunization Schedule: US 2010 CDC. MMWR Morb Mortal Wkly Rep. 2010;59(1).

131 Tdap 10 to 18 years of age19 to 64 years of age Replaces Td booster for 11 ­ 12-year-olds Catch-up for 13-18 yrs (5-year interval from Td encouraged) If no previous DPT series, give as 1 Tdap + 2 Td Give with MCV4 if both vaccines are indicated Replaces Td booster; wound management* 2-year interval from Td for adults in contact with infants; health care workers Anyone who wants to decrease risk of disease The safety and effectiveness of Tdap have not been established in pregnant women CDC. MMWR Recomm Rep. 2006; 55(RR3):1-34. CDC. MMWR Recomm Rep. 2006;55(RR17);1-33. CDC. MMWR Morb Mortal Wkly Rep. 2009;58(14):374-375. If overall risk/benefit is favorable, discount risk of local rxns and immunize * Only if no previous Tdap received

132 Pertussis Challenges for Those Providing Care for Adults Modified, less “classic” illness –Respiratory infection –Persistent cough Laboratory diagnosis inadequate Treatment reduces severity only if given very early (usually before pertussis is considered) Out of sight; out of mind

133 Adult Immunization Schedule: US 2010 CDC. MMWR Morb Mortal Wkly Rep. 2010;59(1).

134 Available HPV Vaccines Quadrivalent Merck - Gardasil ® Bivalent GSK - Cervarix ® Licensed in the US 20062009 Virus-like Particle Types HPV 6, 11, 16, 18HPV 16, 18 Protection against HPV 16/18 related CIN2+ ≥ 98%≥ 93% Protection against HPV 6/11 related genital lesions ~99%--- Hypersensitivity-related contraindication YeastLatex Age ranges Routine 11 or 12 yrs, as young as 9 yrs; catch-up 13-26 yrs Routine 11 or 12 yrs, as young as 10 years; catch-up 13-25 yrs Schedule 0, 2, 6 months0, 1, 6 months Markowitz L. ACIP Meeting Oct 2009. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-oct09/02-2-hpv.pdf. Accessed Oct 2009. CIN2+: cervical intraepithelial neoplasia grade 2 or higher and adenocarcinoma in situ

135 HPV – ACIP Recommendations Quadrivalent HPV (HPV4) and Bivalent HPV (HPV2) Routine vaccination of females aged 11-12 years with 3 doses of HPV vaccine –Catch-up 13-26 yrs (HPV4); 13-25 yrs (HPV2) ACIP: no preference for either vaccine HPV4 or HPV2 vaccination for prevention of HPV 16/18- related cervical cancers, precancers and dysplastic lesions Vaccination with HPV4 for additional prevention against genital warts Monitor patients for 15 minutes following vaccination for syncopal episodes ACIP Schedules. www.cdc.gov/vaccines/recs/schedules/default.htm. Accessed Jan 2010.

136 HPV Vaccination and Pregnancy HPV vaccines are not recommended for use in pregnant women Initiation of the vaccine series should be delayed until after completion of pregnancy If a woman is found to be pregnant after initiating the vaccination series, delay remaining doses until after the pregnancy If a vaccine dose has been administered during pregnancy, there is no indication for intervention Two vaccine in pregnancy registries have been established. Patients and health care providers should report: –Quadrivalent HPV vaccine/pregnancy: 800-986-8999 –Bivalent HPV vaccine/pregnancy: 888-452-9622 CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/hpv-vac-dec2009-508.pdf. Accessed March 2010.

137 HPV Quadrivalent Vaccine in Males FDA approved quadrivalent HPV vaccine for prevention of genital warts due to HPV types 6 and 11 in boys and men ages 9 through 26 ACIP: Permissive HPV vaccine for males –Cost effectiveness –Priority vaccinating females to reduce overall disease/cancer burden –Quadrivalent HPV vaccine most effective when given before exposure to HPV through sexual contact FDA News Release. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187003.htm. Accessed Oct 2009. Dunne E. ACIP Meeting Oct 2009. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-oct09/02-9-hpv.pdf. Accessed Oct 2009.

138 Quadrivalent HPV Vaccine for Women 27–45 years Under FDA Review ACIP Considerations As women age from their mid 20s –HPV prevalence decreases –HPV incidence decreases –Likelihood of having acquired HPV infection increases Disease outcomes (genital warts, CIN 2/3) peak among women in their mid to late 20s, potential benefit of vaccinating women in late 20s to early 40s would be minimal Questions on natural history of incident infections in adult women Greatest benefit from vaccinating females in early adolescence Clinical trial data (women 24–45 years) –Efficacy against HPV 6/11/16/18-related persistent infection, CIN, external genital lesions –Well tolerated Dunne E. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb10/02-3-hpv.pdf. Accessed March 2010. Haupt R. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb10/02-2-hpv.pdf. Accessed March 2010. CIN: cervical intraepithelial neoplasia

139 Adult Immunization Schedule: US 2010 CDC. MMWR Morb Mortal Wkly Rep. 2010;59(1).

140 Shingles (Herpes Zoster) CDC. http://www.cdc.gov/vaccines/vpd-vac/shingles/photos.htm. Accessed September 2009.

141 Zoster (Shingles) Vaccine Single-dose vaccine licensed for persons 60+ years of age –High potency live, attenuated varicella vaccine –Boosts immunity –Off-label use in patients under 60 Shingles – localized rash due to reactivation of latent chicken pox (varicella) virus Postherpetic neuralgia – extreme, debilitating pain lasting for months CDC. MMWR Recomm Rep. 2008;57(RR5):1-30.

142 Zoster Vaccine Contraindications and Precautions Single dose vaccine Contraindications –Previous severe allergic reaction to a vaccine component –Immunocompromised persons Persons with HIV, AIDS, leukemia, lymphoma, or other malignant neoplasms Persons on immunosuppressive therapy, including high-dose corticosteroids Persons receiving immune mediators/modulators, such as etanercept, infliximab, and adalimumab –Pregnancy or planned pregnancy within 4 weeks Precautions –Moderate or severe acute illness CDC. MMWR Recomm Rep. 2008;57(RR5):1-30.

143 Zoster Vaccine Cost Issues Routine vaccination not covered by Medicare part B –Eligible for reimbursement by Medicare part D  In the office, check that insurance can be billed directly through the computer billing system or through pharmacy, otherwise patient will have to pay full amount and claim for reimbursement  Outside the office, ensure vaccine administered at a pharmacy or other location covered by insurance CDC. http://www.cdc.gov/vaccines/vpd-vac/shingles/vac-faqs.htm. Accessed September 2009. AAFP. http://www.aafp.org/fpm/20070700/33bill.html. Accessed September 2009.

144 Varicella-Zoster Vaccine Shingles Prevention Study Randomized, placebo-controlled, double-blind vaccine trial –Study population  38,546 volunteers at 22 sites; adults 60+ years  95% of volunteers completed study –Follow-up: median duration 3.12 years Vaccine recipients:  Overall incidence of herpes zoster reduced by 51% 60-69 years ↓64% ≥ 70 years ↓38%  Incidence of post-herpetic neuralgia reduced by 67%  Injection site reactions were more frequent in the vaccine group Oxman MN, et al. N Engl J Med. 2005;352:2271-2284.

145 Adult Immunization Schedule: US 2010 CDC. MMWR Morb Mortal Wkly Rep. 2010;59(1).

146 Seasonal Influenza Has a Huge Annual Impact in the United States *Average of all causes, 1976-77 through 1998-99. † Average of all causes, 1990-91 through 1998-99. CDC. MMWR Recomm Rep. 2003;52(RR-8):1-36. Thompson WW, et al. JAMA. 2003;289:179-186. Adams PF, et al. Vital Health Stat 10. 1999;200:1-203. Cases25–55 million+ cases Days of Illness100–200 million days Work loss days10’s of millions Hospitalizations100,000–300,000 Deaths35,000*–50,000 † CostsBillions of dollars

147 Annual Influenza Vaccine is Recommended for: All people age 6 months and older! CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/flu-vac-mar-2010-508.pdf. Accessed March 2010.

148 Trivalent Inactivated Virus (TIV) versus Live Attenuated Influenza Virus (LAIV) Vaccines TIV Licensed for use in persons age ≥6 mos Intramuscular injection TIV contains purified viral particles that have been chemically inactivated –Purified components from 3 WHO-recommended annual strains –Immunity developed against disrupted/denatured viral proteins, not against intact virus LAIV Licensed for use among nonpregnant persons aged 2-49 years Administered by nasal spray LAIV contains intact virus that has been propogated in eggs at 25ºC –Cold-adaptation results in restricted replication at body temp –More mild flu symptoms –Contains same 3 WHO-recommended annual strains as TIV CDC. MMWR Recomm Rep. 2009;58(RR08):1-52. Flumist Prescribing Information. www.flumist.com. Accessed Oct 2009.

149 Influenza Vaccination During Most Recent Pregnancy – Georgia & Rhode Island § 95% confidence Interval † 2007 data for Georgia were not available CDC. MMWR Morb Mortal Wkly Rep. 2009;58(35):969-992. N = 5499 N = 5231 Year Percentage

150 2009–2010 Seasonal Influenza Vaccines 2009–2010 seasonal influenza vaccine formulation: –A/Brisbane/59/2007(H1N1)-like virus –A/Brisbane/10/2007 (H3N2)-like virus –B/Brisbane/60/2008-like antigens Vaccines Trivalent Inactivated, Injectable Influenza Vaccine  Fluzone ® (sanofi): age ≥ 6 months  Fluvirin ® (Novartis): age ≥ 4 years  Fluarix ® (GSK): age ≥ 3 years  FluLaval™ (ID Biomedical/GSK): age ≥ 18 years  Afluria ® (CSL): age ≥ 6 months Live Attenuated, Nasal Spray Influenza Vaccine  FluMist ® (MedImmune): age 2 through 49 years (healthy, non-pregnant) Seasonal 2009 influenza vaccine does not protect against 2009 (pandemic) H1N1 influenza CDC. MMWR Recomm Rep. 2009;58(RR8):1-52. CDC. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094045.htm. Accessed March 2010.

151 2009 H1N1 (Pandemic) Influenza Vaccines As of November 11, 2009: 4 monovalent inactivated vaccines approved CSL Limited –Age 6-35 mos: Two 0.25 mL IM doses (4 wk interval) –Age 36 mos to 9 yrs: Two 0.5 mL IM doses (4 wk interval) –Age ≥ 10 yrs: Single 0.5 mL IM injection –Adults ≥ 18 yrs: Single 0.5 mL IM injection Novartis Vaccines and Diagnostics Limited –Age 4-9 yrs: Two 0.5 mL IM doses (4 wk interval) –Age 10-17 yrs: Single 0.5 mL IM injection –Age ≥ 18 yrs: Single 0.5 mL IM injection Sanofi Pasteur, Inc. –Age 6-35 mos: Two 0.25 mL IM doses (4 wk interval) –Age 36 mos to 9 yrs: Two 0.5 mL IM doses (4 wk interval) –Age ≥ 10 yrs: Single 0.5 mL IM injection –Adults ≥ 18 yrs: Single 0.5 mL IM injection ID Biomedical/GSK –Adults ≥ 18 yrs: Single 0.5 mL IM injection 1 live attenuated (nasal administration) MedImmune LLC –Age 2-9 yrs: Two 0.2 mL doses (0.1 mL per nostril), 4 week interval –Age 10-49 yrs: Single 0.2 mL dose (0.1 mL per nostril) Prescribing information available at: http://www.cdc.gov/h1n1flu/vaccination/dosage.htm#table1. Accessed December 2009.

152 2009 H1N1 Influenza Summary Between April 2009 and February 13, 2010 Cases of H1N1 Influenza  42–86 million  Mid-level: 59 million H1N1-related Hospitalizations  188,000–389,000  Mid-level: 265,000 H1N1-related Deaths  8,520–17,620  Mid-level: 12,000 Vaccination Coverage  ~86 million people received 97 million doses of H1N1 vaccine CDC. http://www.cdc.gov/h1n1flu/estimates_2009_h1n1.htm. Accessed March 2010.

153 Percentage of Visits for Influenza-like Illness; National Summary Oct 2006–Feb 2010 Finelli L, et al. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb10/05-2-flu-vac.pdf. Accessed March 2010.

154 2009–2010 College Influenza-like Illness Finelli L, et al. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb10/05-2-flu-vac.pdf. Accessed March 2010.

155 Influenza Hospitalizations, Sep 2009–Feb 2010 Finelli L, et al. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb10/05-2-flu-vac.pdf. Accessed March 2010.

156 Aggregate Hospitalizations 2009–H1N1 April 2009–Feb 2010 Finelli L, et al. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb10/05-2-flu-vac.pdf. Accessed March 2010.

157 Influenza Deaths, Sep 2009–Feb 2010

158 Deaths 2009–H1N1 Influenza April 2009–Feb 2010 Finelli L, et al. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb10/05-2-flu-vac.pdf. Accessed March 2010.

159 Influenza Vaccination (H1N1, Seasonal or Both) by mid-January 2010 Data from National 2009 H1N1 Flu Survey (NHFS) Singleton J. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb10/05-4-flu-vac.pdf Accessed March 2010.

160 2010–2011 Influenza Season Universal Influenza Vaccination –All people 6 months and older are now recommended to receive annual influenza vaccination 2010-2011 Trivalent Influenza Vaccines –A/California/7/2009(H1N1)-like virus Same strain as in the 2009 H1N1 monovalent vaccine – A/Perth/16/2009(H3N2)-like virus New strain for northern hemisphere vaccine Same strain as 2010 southern hemisphere seasonal strain –B/Brisbane/60/2008-like virus No change CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/flu-vac-mar-2010-508.pdf. March 2010.

161 Continued Emphasis on High-risk Groups: –Children aged 6 months through 4 years –Adults ≥ 50 years –Women who will be pregnant during the influenza season –Persons who have chronic pulmonary, cardiovascular, renal, hepatic, neurological, neuromuscular, hematological or metabolic disorders –Persons who have immunosuppression (including caused by medication or HIV) –Residents of nursing homes and other chronic-care facilities –Health care personnel –Household contacts and caregivers of children aged < 5 year and adults aged ≥ 50 years, with particular emphasis on vaccinating contacts of children < 6 months –Household contacts and caregivers of persons with medical conditions that put them at higher risk for severe complications from influenza 2010–2011 Influenza Season CDC. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb10/05-7-flu-vac.pdf. Accessed March 2010.

162 Flu Shots May Also Reduce Hospitalizations for Cardiovascular Disease 2-year cohort study of elderly members of 3 HMOs –1998–1999 and 1999–2000 seasons with > 140,000 elderly members in each year’s cohort After multivariable analysis, vaccination cohort showed a reduced risk of death and hospitalization Nichol KL, et al. N Engl J Med. 2003;348:1322-1332.

163 Rationale for Vaccinating HCWs “First do no harm” –Reduce the risk for nosocomial transmission from staff to patient Reduce staff absenteeism and preserve health care capacity –May be cost saving for the health care org Personal benefits to HCWs (? Increase awareness & likelihood of HCWs vaccinating patients)

164 Nosocomial Influenza Is Well Documented Nosocomial outbreaks documented on –Solid organ transplant units –Oncology units –Neonatal ICU –Pediatric units –Long term care facilities –General medical wards Results: morbidity for patients & staff, increased costs for institution & impaired capacity to provide care Vectors for transmission include staff, visitors, patients Stott DJ, et al. Occup Med (Lond). 2002;52:249-253. Encourage hygiene etiquette amongst staff and patients

165 Health Care Workers Should Be Immunized HCW Influenza Vaccination Rates NHIS, 2003 Vaccinated 40.1 Not Vaccinated 59.9

166 Pneumococcal Polysaccharide Vaccine (PPSV23) Contains polysaccharide surface antigens expressed on S. pneumoniae –Over 90 known serotypes Vaccine contains 23 polysaccharide serotypes from S. pneumoniae –1-4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B –17F, 18C, 19F, 19A, 20, 22F, 23F, 33F Included in PCV7 New conjugate vaccine –PCV13 (Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V,14,18C,19A,19F, 23F) CDC. http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/pneumo.pdf. Accessed March 2010. CDC. MMWR Morb Mortal Wkly Rep. 2010;59(9):258-261.

167 Pneumococcal Polysaccharide Vaccine (PPSV23) Single dose recommended for: All ≥ 65 years 2–64 years: chronic cardiovascular disease, chronic pulmonary disease, diabetes, alcoholism, chronic liver disease, CSF leaks, asplenia, cochlear implants > 2 years and immunocompromised Asthmatics and smokers age 19-64 years Proposed language for one-time revaccination: “A second dose of PPSV23 is recommended 5 years after the first dose of PPSV23 for persons aged ≥ 2 years who are immunocompromised, have sickle cell disease, or functional or anatomic asplenia” ACIP Schedules. http://www.cdc.gov/vaccines/recs/schedules/default.htm. Accessed September 2009. CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/pneumo-oct-2008-508.pdf. Accessed Oct 2009.

168 PPSV23 and Smokers Higher RR of invasive pneumococcal disease among smokers. Current smoker RR = 4.1. Passive exposure RR = 2.5. There is a dose response relation to number of cigarettes per day and pack years smoked Risks among smokers comparable to those of diabetes, asthma and other known risks 50/100,000/yr incidence rate NNV is 10,700 for age 18-44, 4000 for age 45-64 Nuorti J, et al. N Engl J Med. 2000;342:681-689. ACIP Meeting Oct 2008. http://www.cdc.gov/vaccines/recs/acip/downloads/min-oct08.pdf. Accessed September 2009.

169 Effectiveness of Pneumococcal Polysaccharide Vaccine in Older Adults: The VSD Cohort Study 3-year cohort study of 47,365 members of Group Health Coop (Seattle) PPV was associated with lower rates of bacteremia: –HR 0.56 (95% CI 0.33 to 0.93) PPV was not associated with lower rates of pneumonia –HR 1.07 (95% CI 0.99 to 1.14) HR = hazard ratio. Jackson LA, et al. N Engl J Med. 2003;348:1747-1755.

170 Adult Immunization Schedule: US 2010 CDC. MMWR Morb Mortal Wkly Rep. 2010;59(1).

171 Hepatitis A Postexposure Prophylaxis For healthy persons 12 months through 40 years of age who have not previously received HepA vaccine –Take into account patient characteristics, including chronic liver disease Immunoglobulin and/or single-antigen hepatitis A vaccine should be administered as soon as possible after exposure –Vaccine preferred for those of age 12 mos to 40 yrs –Ig preferred for age < 12 mos, those with vaccine allergies, or those with immunosuppression or liver disease –Ig preferred for age > 40 but vaccine may be used if Ig unavailable –HepA and Ig may be administered simultaneously Efficacy of Ig or HepA when administered > 2 weeks postexposure is unknown CDC. MMWR Morb Mortal Wkly Rep. 2007;56(41):1080-1084. CDC. MMWR Morb Mortal Wkly Rep. 2009;58(36):1006-1007.

172 Hepatitis A Vaccine International Travel For healthy persons 40 years of age or younger –2 doses 6 months apart prior to departure –The first dose of Hepatitis A vaccine should be administered as soon as travel is considered –1 dose of single-antigen vaccine administered at any time before departure Consider both HAV and Ig for –Persons age > 40 with chronic illness traveling in less than 2 weeks and only receiving one dose of HAV –Persons at risk of severe disease from hepatitis A virus planning to travel in 2 weeks or sooner CDC. MMWR Morb Mortal Wkly Rep. 2007;56(41):1080-1084.

173 Hepatitis B Vaccine Expanded Indications A patient’s “acknowledgment of a specific risk factor should not be a requirement for vaccination” For all “sexually active persons who are not in a long- term mutually monogamous relationship” Past indications: –Universal for ages birth–18 years –Being evaluated for STD –Being treated for STD –Men who have sex with men –Sex partners of HBs Ag-positive persons –Prisoners –Health care workers CDC. MMWR Recomm Rep. 2006;55(RR16):1-33.

174 Hepatitis B Vaccine CompositionRecombinant HBsAg Efficacy95% (Range, 80%-100%) Duration of immunity20 years or more Schedule3 doses Hepatitis B. http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/hepb.pdf. Accessed Oct 2009.

175 DoseInfants**Teens and Adults*** 116%-40%20%-30% 280%-95%75%-80% 398%-100%90%-95% HBV Protection* by Age Group and Dose *Anti-HBs antibody titer of 10 mIU/mL or higher **Preterm infants less than 2 kg have been shown to respond to vaccination less often ***Factors that may lower vaccine response rates are older than 40 years, male gender, smoking, obesity, and immune deficiency Hepatitis B. http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/hepb.pdf. Accessed Oct 2009.

176 Hepatitis B Vaccine Adult Schedule * Approved Twinrix schedule ** A 4-dose schedule of Engerix-B is licensed for all age groups CDC. MMWR Recomm Rep. 2006;55(RR16):1-25. Several approved 3-dose schedules for adults age ≥ 20 years –0, 1, and 6 months* –0, 1, and 4 months –0, 2, and 4 months –0, 1, 2, and 12 months** “Providers should select the vaccine schedule they consider necessary to achieve completion of the vaccine series” No apparent effect on immunogenicity has been documented when minimum spacing of doses (ie, 4 weeks between doses 1 and 2, 8 weeks between doses 2 and 3, and 16 weeks between doses 1 and 3) is not achieved precisely.

177 HepA-HepB Combination Vaccine (Twinrix) Approved for persons 18 years and older –Combination HepA vaccine (pediatric dose) and HepB (adult dose) First licensed schedule: 0, 1, and 6 months –Alternate schedule 2007: Doses at 0, 7, 21-30 days and a booster dose at 12 months The first 3 doses of the new schedule provide equivalent protection to: –The first dose in the standard single-antigen adult hepatitis A vaccine series –The first 2 doses in the standard adult hepatitis B vaccine series Seroconversion is nearly 100% after either 3 doses of the combination vaccine on the new schedule or a single dose of single-antigen adult hepatitis A vaccine –Duration of protection 4 yrs against HepA No increased benefit of the new schedule for the hepatitis B component compared to administration of 2 hepatitis B vaccine doses 1 to 2 months apart CDC. MMWR Morb Mortal Wkly Rep. 2007:56(40):1057.

178 Adult Immunization Schedule: US 2010 CDC. MMWR Morb Mortal Wkly Rep. 2010;59(1).

179 Meningococcal Conjugate Vaccines Recommended for adolescents aged 11-18 years and others at increased risk for meningococcal disease –MCV4-D (Menactra ®, Sanofi): licensed for persons 2-55 years; Serogroups A, C, Y, W-135; diphtheria toxoid conjugate –MenACWY-CRM 197 (Menveo ®, Novartis): licensed for persons 11-55 years; Serogroups A, C, Y, W-135; diphtheria CRM 197 conjugate Revaccination for Persons at Increased Risk –Previous vaccination (meningococcal conjugate vaccine or MPSV4) at 2-6 years, revaccinate 3 years after initial meningococcal vaccine –Previous vaccination (meningococcal conjugate vaccine or MPSV4) at ≥ 7 years, revaccinate 5 years after initial meningococcal vaccine –This includes:  Persons with persistent complement component deficiencies  Persons with anatomic or functional asplenia  Microbiologists who are routinely exposed to isolates of N. meningitidis  Frequent travelers to or people living in areas with high rates of meningococcal disease (African meningitis belt) Meissner HC. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb10/08-1- mening.pdf. Accessed March 2010. CDC. MMWR Morb Mortal Wkly Rep. 2009;58(37):1042-1043.

180 MMR Evidence of Immunity for Health Care Personnel: Mumps, Measles & Rubella Documented administration of two doses of live measles virus vaccine or Laboratory evidence of immunity or laboratory confirmation of disease or Born before 1957* ACIP Provisional Recommendations. http://www.cdc.gov/vaccines/recs/provisional/downloads/mmr-evidence- immunity-Aug2009-508.pdf. Accessed September 2009. *For unvaccinated personnel with no documentation or laboratory evidence of immunity, facilities should consider 2 doses of MMR for measles/mumps, and 1 MMR dose for rubella. Recommended during outbreaks.

181 Strategies for Improving Adult Immunization Rates

182 The Community Guide. http://www.thecommunityguide.org/vaccines/universally/index.html. Accessed September 2009. Briss PA, et al. Am J Prev Med. 2000;18(suppl 1):35-43. Evidence-based Methods for Improving Immunization Rates Community Preventive Services Task Force Recommended Strategies –Reducing client out-of-pocket costs –Vaccination programs in schools –Vaccination programs in WIC settings –Client reminder and recall systems –Vaccination requirements for child care, school, and college attendance –Provider reminder systems when used alone –Standing orders when used alone –Provider assessment and feedback The above recommendations have all been upgraded to ‘strong evidence’ based on systematic reviews

183 Provider Recommendation Can Overcome Negative Attitudes Among Patients Vaccination Rates Among High Risk Patients With Negative Attitudes Nichol KL, et al. J Gen Intern Med. 1996;11:673-677.

184 Improving Vaccination Rates – Provider Issues Know the facts Recommend vaccinations to your patients Get organized and use systems approaches –Ensure offering and administration of vaccine Automatic processes that empower nurses are effective Address convenience, efficiency, durability Evaluate and provide feedback Consider new paradigms –New venues –Extend vaccination season Practice what we preach (get vaccinated!) Nichol KL. Cleve Clin J Med. 2006;73:1009-1015.

185 Clinician Barriers to Adult Immunizations Knowledge about bad diseases, good vaccines –Generally OK May underestimate disease burden and overestimate side effects Don’t always strongly recommend Frequently don’t use proven systems strategies Core elements for success: –Education, measurement, systems approaches –Other issues Ultimate success may require collaboration of many stakeholders and new paradigms

186 Factors Associated With Very Strongly Recommending Vaccinations to Elderly Patients Adjusted OR Influenza Vacc. Adjusted OR PPV Monitor vaccination rates in practice as part of CI1.791.72 Vaccination cost saving2.022.92 Having received flu shot1.912.41 Indicating that systemic symptoms uncommon1.57— Number of system strategies used in practice—2.03 V important for HCW to get flu shot3.41.94 Male sex0.580.57 Generalist physician (vs subspecialist)—1.53 Patients risk for disease2.422.38 Concerns about drug resistance—1.46 Vaccine effectiveness1.42— Expert group recommendations—1.43 Having sufficient time to counsel—1.43 Liability issues2.041.64 Ease of targeting high risk groups1.73— Nichol KL, et al. Arch Intern Med. 2001;161:2702-2708.

187 Missed opportunities and lack of system approaches Why Don’t Health Care Providers Use These Strategies? No time / forget / logistics / resources I am already doing it –Not included in CI activities / not measured PCPs should be doing it Lack of knowledge about effective strategies

188 Other Issues Reimbursement levels State laws –In some states, pharmacists and other health care workers can immunize under standing orders –Regulations for vaccinations in long term care facilities Patient concerns for vaccine safety Vaccine immunogenicity (especially for inpatients) Nontraditional settings

189 Where Flu Shots Are Received (Often Not the Doctor’s Office) Singleton J, et al. Am J Infect Control. 2005;33:563-570.

190 Vaccinations in Nontraditional Settings Potential advantages –Cost –Access/convenience –Increased public awareness and demand –New providers and new strategies –For flu, pneumo, ??? other vaccines CDC. MMWR Recomm Rep. 2000;49 (RR1):1-13.

191 Standing Orders Are Among the Most Effective Strategies Nonphysicians offer and administer vaccinations –No direct MD involvement at the time of the visit Established with physician approved policies and protocols Locations: –Clinics and hospitals CDC. http://www.cdc.gov/vaccines/recs/rate-strategies/adultstrat.htm. Accessed September 2009. McKibbin LJ, et al. MMWR Recomm Rep. 2000;49 (RR1):15-26.

192 Multifaceted Program Improved Success and Sustainability Increase DemandAnnual reminder to pts Enhance AccessWalk-in Clinics Address Provider BarriersInstitutional Policy Standing Orders Standardized Forms Efficient Clinic Flow Ongoing Measurement and Evaluation

193 Success of Standing Orders as Part of a Multifaceted Program Education Standing Orders Nichol KL. Am J Med. 1998;105:385-392. Influenza Vaccination Rates for Elderly Patients in General Medicine Clinics

194 Targeting Hospitalized Patients Makes Sense Hospitalization is a marker for increased risk Hospitalized patients may be less likely to be immunized –Providers often miss opportunities to immunize Organized programs work in the inpatient setting

195 General Immunization Information for All Age Groups

196 Vaccination Pearls There is no harm in vaccinating individuals who have had the disease –Poor immunogenicity of natural infection (Hib under 2 yr of age) –Waning immunity (pertussis) –Multiple serotypes (pneumococcus) –Didn’t really have the disease (varicella) There is no recommendation for maximum number of injections per limb –Each injection must be separated 1 inch on same limb There is no recommendation for maximum number of vaccinations per day

197 Erroneous Contraindications Mild acute illness Mild-moderate local reaction Concurrent antibiotic therapy Convalescent phase of illness Prematurity Recent exposure to illness History of non-vaccine allergies Family history of allergies, SIDS, seizures Desensitization shots Breastfeeding Positive Tuberculin Skin Test (TST) Pregnant household contact (except Oral polio Vaccine (OPV) and smallpox) Asymptomatic or mildly symptomatic HIV infection Allergic to eggs but can eat egg-containing products Mild latex allergy Autoimmune disease

198 General Safety Concerns Post vaccination syncope most common among adolescents/young adults Approximately 12% result in hospitalization Serious injuries include –Skull fractures –Cerebral bleeding –Car accidents 89% of episodes occur ≤ 15 minutes CDC. MMWR Recomm Rep. 2002;51(RR2);1-36.

199 Vaccine-preventable Diseases

200 Measles Clinical Presentation –Fever, runny nose, rash Complications –Ear infection 1 in 10 –Pneumonia 1 in 20 –Encephalitis 1 in 1000 –Death 1 in 1000 Transmission –Respiratory secretions Vaccine Formulations –MMR-II Live-attenuated measles virus Live B-level strain mumps virus Live-attenuated rubella virus Unvaccinated persons at increased risk for disease –College students –Health care workers –Women of childbearing age –International travelers CDC. http://www.cdc.gov/measles/about/overview.html. Accessed September 2009.

201 CDC. http://www.cdc.gov/ncphi/disss/nndss/annsum/2006/06graphs.htm. Accessed September 2009. Measles

202 Mumps Clinical Presentation –Swollen parotid salivary glands –Fever, headache, muscle aches, fatigue Complications –Encephalitis/meningitis –Permanent deafness –Spontaneous abortion –Orchitis, oophoritis, mastitis Transmission –Saliva, respiratory secretions, airborne Unvaccinated persons at increased risk for disease –College students –Health care workers –Women of childbearing age –International travelers CDC. http://www.cdc.gov/vaccines/vpd-vac/mumps/in-short-adult.htm. Accessed September 2009.

203 CDC. http://www.cdc.gov/ncphi/disss/nndss/annsum/2006/06graphs.htm. Accessed September 2009. Mumps

204 Rubella Clinical Presentation –2-3 day fever, rash Complications –Birth defects if acquired during pregnancy: deafness, cataracts, heart defects, mental retardation, liver/spleen damage Transmission –Respiratory secretions Unvaccinated persons at increased risk for disease –College students –Health care workers –Women of childbearing age –International travelers CDC. http://www.cdc.gov/vaccines/vpd-vac/rubella/in-short-adult.htm. Accessed September 2009. Rubella. http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/rubella.pdf. Accessed Oct 2009.

205 CDC. http://www.cdc.gov/ncphi/disss/nndss/annsum/2006/06graphs.htm. Accessed September 2009. Rubella

206 Tetanus Clinical Presentation –Early: lockjaw, stiffness in neck and abdomen, difficulty swallowing First symptoms may appear up to 3 weeks post-infection –Late: severe muscle spasms, generalized tonic seizure-like activity, severe autonomic system disorders Complications –Bone fractures, arrythmia, death in 10- 20% of cases Transmission –Bacterial infection, usually via exposure of a skin break to dust, soil, or manure Groups at increased risk for disease –Unvaccinated individuals CDC. http://www.cdc.gov/vaccines/vpd-vac/tetanus/in-short-both.htm. Accessed September 2009.

207 CDC. http://www.cdc.gov/ncphi/disss/nndss/annsum/2006/06graphs.htm. Accessed September 2009. Tetanus

208 Diphtheria Clinical Presentation –Sore throat, low-grade fever, fatigue –Membranous pharyngitis –Bull neck in 10% of cases –Occasional skin lesions Complications –Airway obstruction, cardiac complications, coma, death if untreated Transmission –Respiratory secretions Groups at increased risk for disease –Unvaccinated individuals CDC. http://www.cdc.gov/vaccines/vpd-vac/diphtheria/in-short-both.htm. Accessed September 2009. Dipnet.com http://www.dipnet.org/general.public.php. Accessed September 2009.

209 CDC. http://www.cdc.gov/ncphi/disss/nndss/annsum/2006/06graphs.htm. Accessed September 2009. Diptheria

210 Pertussis Clinical Presentation –Early: Runny nose, sneezing, low grade fever, cough, similar to common cold –1-2 weeks: Paroxysms, whooping cough Complications –Bacterial pneumonia, rib fracture –Infants are at highest risk for apnea, pneumonia, seizures, encephalopathy, death Transmission –Respiratory secretions Groups at increased risk for disease –Unvaccinated individuals CDC. http://www.cdc.gov/vaccines/vpd-vac/pertussis/in-short-both.htm. Accessed September 2009.

211 CDC. http://www.cdc.gov/ncphi/disss/nndss/annsum/2006/06graphs.htm. Accessed September 2009. Pertussis

212 Reported Pertussis Cases Cortese M, et al. Am J Prev Med. 2007;32(3):177-185.

213 Pertussis Is Increasingly an Adolescent and Adult Disease 1990-19931994-19961997-20002001-20032004 8000 9000 0 4000 1000 5000 2000 6000 3000 7000 <11-45-910-1920+ Average Number of Cases / Year Age Group (years) 18.8 fold 15.5 fold Güris D, et al. Clin Infect Dis. 1999;28:1230-1237. CDC. MMWR Morb Mortal Wkly Rep. 2005;54(50):1283-1286. Pertussis. http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/pert.pdf. Accessed Sept 2009.

214 CDC. http://www.cdc.gov/ncphi/disss/nndss/annsum/2006/06graphs.htm. Accessed September 2009. Viral Hepatitis

215 Reported Acute Hepatitis B Incidence By Age Group: United States, 1990–2004 ≥ 20 years 12-19 years < 12 years Year Cases per 100,000 CDC. MMWR Recomm Rep. 2005;54(RR16):1-31.

216 Age of Infection of Acute and Chronic Hepatitis B Virus Infection Acute infectionChronic infection CDC Sentinel Sites. 1989 data. Hepatitis B. http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/hepb.pdf. Accessed Oct 2009.

217 Risk Factors for Hepatitis B CDC. MMWR Recomm Rep. 2006;55(RR16):1-25.

218 CDC. http://www.cdc.gov/ncphi/disss/nndss/annsum/2006/06graphs.htm. Accessed September 2009. Haemophilus influenzae

219 Epidemic Influenza Has a Huge Annual Impact in the United States *Average of all causes, 1976-77 through 1998-99. †Average of all causes, 1990-91 through 1998-99. CDC. MMWR Recomm Rep. 2003;52(RR8):1-36. Thompson WW, et al. JAMA. 2003;289:179-186. Adams PF, et al. Vital Health Stat 10. 1999;200:1-203. Cases25–55 million+ cases Days of Illness100–200 million days Work loss days10’s of millions Hospitalizations100,000–300,000 Deaths35,000*–50,000 † CostsBillions of dollars

220 Influence of Influenza Epidemics on Seasonal Mortality Simonsen L, et al. Am J Public Health. 1997;87:1944-1950. P & I Mortality All Cause Mortality P&I: pneumonia and influenza

221 February is #1 for Peak Influenza Activity CDC. MMWR Recomm Rep. 2008;57(RR7):1-60.

222 Influenza Complications Pneumonia Ear infection Sinus infection Dehydration Worsening of chronic conditions “The number of pediatric influenza-associated deaths reported during 2006-07 was moderately higher than the number reported during the two previous surveillance years; the number of these deaths in which pneumonia or bacteremia due to S. aureus was noted represents a five-fold increase.” CDC. MMWR Recomm Rep. 2008;57(RR7):1-60. CDC Health Advisory. http://www2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00268. Accessed Oct 2009.

223 2009–2010 Seasonal Influenza Vaccines 2009–2010 seasonal influenza vaccine formulation: –A/Brisbane/59/2007(H1N1)-like virus –A/Brisbane/10/2007 (H3N2)-like virus –B/Brisbane/60/2008-like antigens Vaccines Trivalent Inactivated, Injectable Influenza Vaccine  Fluzone ® (sanofi): age ≥ 6 months  Fluvirin ® (Novartis): age ≥ 4 years  Fluarix ® (GSK): age ≥ 3 years  FluLaval™ (ID Biomedical/GSK): age ≥ 18 years  Afluria ® (CSL): age ≥ 6 months Live Attenuated, Nasal Spray Influenza Vaccine  FluMist ® (MedImmune): age 2 through 49 years (healthy, non-pregnant) Seasonal 2009 influenza vaccine does not protect against 2009 (pandemic) H1N1 influenza CDC. MMWR Recomm Rep. 2009;58(RR10):1-8. CDC. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094045.htm. Accessed March 2010.

224 2009 H1N1 (Pandemic) Influenza Vaccines As of November 11, 2009: 4 monovalent inactivated vaccines approved CSL Limited –Age 6-35 mos: Two 0.25 mL IM doses (4 wk interval) –Age 36 mos to 9 yrs: Two 0.5 mL IM doses (4 wk interval) –Age ≥ 10 yrs: Single 0.5 mL IM injection –Adults ≥ 18 yrs: Single 0.5 mL IM injection Novartis Vaccines and Diagnostics Limited –Age 4-9 yrs: Two 0.5 mL IM doses (4 wk interval) –Age 10-17 yrs: Single 0.5 mL IM injection –Age ≥ 18 yrs: Single 0.5 mL IM injection Sanofi Pasteur, Inc. –Age 6-35 mos: Two 0.25 mL IM doses (4 wk interval) –Age 36 mos to 9 yrs: Two 0.5 mL IM doses (4 wk interval) –Age ≥ 10 yrs: Single 0.5 mL IM injection –Adults ≥ 18 yrs: Single 0.5 mL IM injection ID Biomedical/GSK –Adults ≥ 18 yrs: Single 0.5 mL IM injection 1 live attenuated (nasal administration) MedImmune LLC –Age 2-9 yrs: Two 0.2 mL doses (0.1 mL per nostril), 4 week interval –Age 10-49 yrs: Single 0.2 mL dose (0.1 mL per nostril) Prescribing information available at: http://www.cdc.gov/h1n1flu/vaccination/dosage.htm#table1. Accessed December 2009.

225 2009 H1N1 Influenza Summary Between April 2009 and February 13, 2010 Cases of H1N1 Influenza  42–86 million  Mid-level: 59 million H1N1-related Hospitalizations  188,000–389,000  Mid-level: 265,000 H1N1-related Deaths  8,520–17,620  Mid-level: 12,000 Vaccination Coverage  ~86 million people received 97 million doses of H1N1 vaccine CDC. http://www.cdc.gov/h1n1flu/estimates_2009_h1n1.htm. Accessed March 2010.

226 Percentage of Visits for Influenza-like Illness; National Summary Oct 2006–Feb 2010 Finelli L, et al. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb10/05-2-flu-vac.pdf. Accessed March 2010.

227 2009–2010 College Influenza-like Illness Finelli L, et al. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb10/05-2-flu-vac.pdf. Accessed March 2010.

228 Influenza Hospitalizations, Sep 2009–Feb 2010 Finelli L, et al. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb10/05-2-flu-vac.pdf. Accessed March 2010.

229 Aggregate Hospitalizations 2009–H1N1 April 2009–Feb 2010 Finelli L, et al. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb10/05-2-flu-vac.pdf. Accessed March 2010.

230 Influenza Deaths, Sep 2009–Feb 2010

231 Deaths 2009–H1N1 Influenza April 2009–Feb 2010 Finelli L, et al. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb10/05-2-flu-vac.pdf. Accessed March 2010.

232 Influenza Vaccination (H1N1, Seasonal or Both) by mid-January 2010 Data from National 2009 H1N1 Flu Survey (NHFS) Singleton J. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb10/05-4-flu-vac.pdf Accessed March 2010.

233 2010–2011 Influenza Season Universal Influenza Vaccination –All people 6 months and older are now recommended to receive annual influenza vaccination 2010-2011 Trivalent Influenza Vaccines: –A/California/7/2009(H1N1)-like virus Same strain as in the 2009 H1N1 monovalent vaccine – A/Perth/16/2009(H3N2)-like virus New strain for northern hemisphere vaccine Same strain as 2010 southern hemisphere seasonal strain –B/Brisbane/60/2008-like virus No change CDC. http://www.cdc.gov/vaccines/recs/provisional/downloads/flu-vac-mar-2010-508.pdf. Accessed March 2010.

234 Continued Emphasis on High-risk Groups: –Children aged 6 months through 4 years –Adults ≥ 50 years –Women who will be pregnant during the influenza season –Persons who have chronic pulmonary, cardiovascular, renal, hepatic, neurological, neuromuscular, hematological or metabolic disorders –Persons who have immunosuppression (including caused by medication or HIV) –Residents of nursing homes and other chronic-care facilities –Health care personnel –Household contacts and caregivers of children aged < 5 year and adults aged ≥ 50 years, with particular emphasis on vaccinating contacts of children < 6 months –Household contacts and caregivers of persons with medical conditions that put them at higher risk for severe complications from influenza 2010–2011 Influenza Season CDC. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb10/05-7-flu-vac.pdf. Accessed March 2010.

235 Extending Vaccination Season Will Reduce Missed Opportunities Influenza cases Week Percent of Maximum Vaccine demand CDC. MMWR Morb Mortal Wkly Rep. 2007;56(31):789-794. Missed Opportunities

236 Changes in Overall Invasive Pneumococcal Disease, 1998–2007 Pilishvili T, et al. J Infect Dis. 2010;201:32-41. Cases/100,000 population 0 20 40 60 100 80 120 1998199920012000200220032004200520062007 Year PCV7 introduced Age Group 2007 vs baseline (years) (% reduction) < 5 5–17 18–49 50–64 ≥ 65 76 43 40 18 37

237 Direct Effect of Vaccination: Invasive Pneumococcal Disease Among Children < 5 Years, 1998/99–2007 Cases/100,000 population 0 10 20 30 40 50 60 70 80 90 1998199920012000200220032004200520062007 Year PCV7 introduced Serotype group PCV7 type Non-PCV7 type 19A Pilishvili T, et al. J Infect Dis. 2010;201:32-41. *100% reduction in PCV7 serotypes, 2007 vs baseline *

238 Invasive Pneumococcal Disease Among Adults ≥ 65 Years, 1998/99–2007 Pilishvili T, et al. J Infect Dis. 2010;201:32-41. Cases/100,000 population 0 5 10 15 20 25 30 35 40 1998199920012000200220032004200520062007 Year PCV7 introduced Serotype group PCV7 type Non-PCV7 type 19A *92% reduction in PCV7 serotypes, 2007 vs baseline *

239 Percentage of Deaths from Vaccine-preventable Diseases Among Children Aged < 5 Years, 2002 *Other VPDs: Diphtheria, HepB, Japanese encephalitis, meningococcal disease, poliomyelitis, and yellow fever. In 2002, an estimated 2.5 million deaths worldwide under the age of 5 were attributable to diseases for which vaccines were available CDC. MMWR Morb Mortal Wkly Rep. 2006;55(18):511-515.

240 HPV/Cancer Disease Burden in the United States Anogenital HPV is the most common sexually transmitted infection in the US 1 –Estimated 20 million currently infected –6.2 million new infections/year Common among adolescents and young adults –Estimated 80% of sexually active women will have been infected by age 50 –Infection also common in men The American Cancer Society estimates that in 2008 –11,070 new cervical cancer cases –3,870 cervical cancer deaths –Almost 100% of these cervical cancer cases will be caused by one of the 40 HPV types that infect the mucosa Burchell AN. Vaccine. 2006;24(suppl 3):52-61.

241 Human Papillomavirus Types and Disease Association nonmucosal/cutaneous (~60 types) skin warts (hands and feet) mucosal/genital (~40 types) high-risk types 16, 18, 31, 45 (and others) low-risk types 6, 11 (and others) Low grade cervical abnormalities Cancer precursors Anogenital cancers Low grade cervical abnormalities Genital warts Laryngeal papillomas

242 TypeWomenMen 16/1870% of cervical cancer 70% of anal/genital cancer 70% of anal cancer Transmission to women 6/1190% of genital warts 90% of RRP lesions 90% of genital warts 90% of RRP lesions Transmission to women HPV-Associated Disease CDC. MMWR Recomm Rep. 2007;56(RR-2):1-23. RRP: recurrent respiratory papillomatosis

243 CDC. http://www.cdc.gov/ncphi/disss/nndss/annsum/2006/06graphs.htm. Accessed September 2009. Meningococcal Disease

244 CDC. National Vital Statistics Reports. http://www.cdc.gov/nchs/products/nvsr.htm. Accessed Oct 2009. Age-Specific Fatalities From Meningococcal Disease, US, 1997–2002

245 Most Common Clinical Presentations of Meningococcal Disease Meningococcemia Rash Vascular damage Disseminated intravascular coagulation Multiorgan failure Shock Death can occur within 24 hours ~ 5% to 20% of cases Up to 40% fatality rate Meningitis Fever and headache (flu-like symptoms) Stiff neck Nausea Altered mental status Seizures ~ 50% of cases 3% to 10% fatality rate Rosenstein NE, et al. N Engl J Med. 2001;344:1378-1388.

246 CDC. http://www.cdc.gov/ncphi/disss/nndss/annsum/2006/06graphs.htm. Accessed September 2009. Varicella

247 General Strategies for Improving Immunization Rates

248 Standing Orders Are Among the Most Effective Strategies Nonphysicians offer and administer vaccinations –No direct MD involvement at the time of the visit Established with physician approved policies and protocols Locations: –Clinics and hospitals CDC. http://www.cdc.gov/vaccines/recs/rate-strategies/adultstrat.htm. Accessed September 2009. McKibbin LJ, et al. MMWR Recomm Rep. 2000;49(RR1):15-26.

249 Multifaceted Program Improved Success and Sustainability Increase DemandAnnual reminder to pts Enhance AccessWalk-in Clinics Address Provider BarriersInstitutional Policy Standing Orders Standardized Forms Efficient Clinic Flow Ongoing Measurement and Evaluation

250 Success of Standing Orders as Part of a Multifaceted Program Education Standing Orders Nichol KL. Am J Med. 1998;105:385-392. Influenza Vaccination Rates for Elderly Patients in General Medicine Clinics

251 Standing Orders More Effective than Education or MD Reminders for Inpatients Crouse B, et al. J Fam Pract. 1994;38:258-261.

252 Sample Standing Order Immunization Action Coalition. http:www.immunize.org/standingorders. Accessed September 2009.

253 Venues for Vaccination: Where Vaccine Recipients Were Immunized, 2005–2006

254 Physician Practice and Interest in Selected Strategies Doing AlreadyWould Try Patient reminders23%53% Walk-in Vax67%19% Policy to Assess48%31% Standing Orders33%36% Clearer Vax Guidelines33%51% Registry7%56% Szilagyi PG, et al. Prev Med. 2005;40:152-161.

255 Available Reimbursement for Adolescent Vaccination Public funding for eligible children up to but not including the 19 th birthday –Vaccines for Children Program (VFC)  Many insurers follow VFC lead –State Children’s Health Insurance Program (SCHIP) Funding for adolescents > 19 years: –Federal Vaccination Assistance Act, Section 317  Inadequate for large-scale immunization strategies

256 Reimbursement Rates Providers often not reimbursed adequately for administration costs “Float” costs are high Some states add taxes to the cost of vaccines Institute of Medicine recommended a universal federal reimbursement system – subsidized mandate for insurance companies Significant correlation between reimbursement rates and 8/16 studied HEDIS measures Childhood immunizations correlation 0.42 Strong relationship with rates of adolescent varicella vaccination (r = 0.53) Low reimbursement rates associated with lower rates of vaccination of adolescents McInerny TK, et al. Pediatrics. 2006;115:833-838.

257 Resources

258 PROTECT TM Website: http://www.francefoundation.com/protect/

259 Resources for Patients and Parents Guide to evaluating information on the web www.cdc.gov/vaccines/vac-gen/evalwebs.htm CDC Vaccine Information Statements (VISs) http://www.cdc.gov/vaccines/pubs/vis/default.htm Vaccine Safety www.cdc.gov/Features/VaccineSafety National Network for Immunization Information (NNII) www.immunizationinfo.org Allied Vaccine Group www.vaccine.org Immunization Action Coalition (IAC) www.immunize.org Vaccine Education Center at CHOP www.vaccine.chop.edu TCH Center for Vaccine Awareness and Research www.texaschildrens.org/carecenters/vaccine/default.aspx

260 Resources for Providers Immunization Schedules www.cdc.gov/vaccines/recs/schedules/ ACIP recommendations & provisional recommendations www.cdc.gov/vaccines/pubs/ACIP-list.htm www.cdc.gov/vaccines/recs/provisional/default.htm The Guide to Community Preventive Services. Vaccine recommendations www.thecommunityguide.org/vaccines/index.html Assessment, Feedback, Incentives, and Exchange (AFIX) www.cdc.gov/vaccines/programs/afix/default.htm National Foundation for Infectious Diseases www.nfid.org Centers for Medicare & Medicaid Services www.cms.hhs.gov

261 Resources for Providers, Parents, and Patients The Immunization Action Coalition: vaccine information for the public and health professionals www.vaccineinformation.org The Immunization Action Coalition: directory of immunization coalitions www.izcoalitions.org

262 Passive Surveillance: VAERS National reporting system Jointly administered by CDC and the Food and Drug Administration (FDA) since 1990 Designed to detect: –New, unusual or rare events –Changes in rates of previously reported AEs –Patient risk factors While the information provided is useful, it also may be somewhat limited Causality may not be determined because of limited data CDC. http://www.cdc.gov/vaccinesafety/vaers. Accessed September 2009.

263

264 Active Surveillance Vaccine Safety Datalink (VSD) Established in 1990 as collaborative effort between Centers for Disease Control and Prevention (CDC) and 8 geographically diverse health maintenance organizations 1,2 Large linked database which covers ~3% of the US population 1,2 Links vaccination and health records 1,2 Allows identification of possible AEs 1,2 1. Iskander J. Current CDC vaccine safety activities. http://www.hhs.gov/nvpo/documents/5Iskander.ppt. Accessed September 2009. 2. Pickering LK,Bocchini J. AAP News. 2008;29(5):1.

265 Useful Flu Vaccine Links/Resources The Childhood Influenza Immunization Coalition (CIIC) www.PreventChildhoodInfluenza.org The Childhood Influenza Immunization Coalition (CIIC) was established by the National Foundation for Infectious Diseases (NFID) to protect infants, children and adolescents from influenza by communicating with "one strong voice" the need to make influenza immunization a national health priority. The Coalition seeks to address and improve the low influenza immunization rates among children. Members, including SAM, represent more than 25 of the nation's leading public health, medical, patient and parent groups committed to protecting children's health and encouraging wellness. The CIIC Web site provides a variety of excellent educational materials to help promote childhood influenza immunization. Centers for Disease Control and Prevention (CDC) www.cdc.gov/flu/ The Centers for Disease Control and Prevention Web site offers of wealth of information and resources, including posters for your office, tracking of reported cases of flu and links to the full ACIP flu recommendations. The National Network for Immunization Information (NNii) www.immunizationinfo.org/vaccineInfo/vaccine_detail.cfv?id=6 The National Network for Immunization Information (NNii) provides up-to-date, science-based information to health care professionals, the media, and the public: everyone who needs to know the facts about vaccines and immunization. Families Fighting Flu (FFF) www.familiesfightingflu.org/ Families Fighting Flu (FFF) was established for the children who die each year due to the influenza virus (commonly called "the flu"). Each family has experienced first-hand the death of a child due to the flu or has had a child experience severe medical complications from the flu. This non-profit organization, made up of families and health care practitioners, is dedicated to educating people about the severity of influenza and the importance of vaccinating children against the flu every year.


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