7 th Annual Dell Childrens Medical Center Pediatric

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7 th Annual Dell Children’s Medical Center Pediatric Conference Current and Future Vaccine Recommendations

7 th Annual Dell Children’s Medical Center Pediatric Conference Current and Future Vaccine Recommendations from the ACIP Larry K. Pickering, MD, FAAP April 11, 2014 Austin, TX

Faculty Disclosure Information: In the past 12 months, I have had no relevant financial

Faculty Disclosure Information: In the past 12 months, I have had no relevant financial relationships with the manufacturer(s) of any commercial product(s) and/or provider(s) of commercial services discussed in this CME activity. I do not intend to discuss an unapproved/investigative use of a commercial product/device in my presentation.

OBJECTIVES • Describe recent changes to the pediatric and adult immunization schedules • Lessons

OBJECTIVES • Describe recent changes to the pediatric and adult immunization schedules • Lessons learned from vaccine surveillance systems • Highlight major vaccine issues and updates • Discuss future directions

q 1994 schedule from Red Book paper

q 1994 schedule from Red Book paper

The Fine Print

The Fine Print

Vaccines Recommended

Vaccines Recommended

Number of ACIP Vaccine Recommendations, by Year, Since 1995* * This chart takes into

Number of ACIP Vaccine Recommendations, by Year, Since 1995* * This chart takes into account General Recommendations on Immunization, recommendations for health care professionals, the annual recommended routine childhood immunization schedule (1995 -present), the annual recommended routine adult immunization schedule, and recommendations pertaining to vaccines such as those for rabies, yellow fever, smallpox, and Japanese encephalitis that are not part of any routine immunization schedule in the United States.

Changes to the 2014 Immunization Schedules • Infant meningococcal vaccination (January 2013) • Tdap

Changes to the 2014 Immunization Schedules • Infant meningococcal vaccination (January 2013) • Tdap in pregnant women (February 2013) • Meningococcal disease: Prevention and Control: RR (March 2013) • Interim influenza recommendations (May 2013) • MMR and congenital rubella syndrome: RR (June 2013) • PCV 13 and PPSV 23 vaccines for 6 -18 year olds with immunocompromising conditions (July 2013) • Update on use of Vari. ZIG (July 2013) • Influenza vaccines (2013/14 season): RR (September 2013) • Japanese encephalitis vaccine for children: (November 2013) • Haemophilus influenzae RR: (February 2014) http: //www. cdc. gov/vaccines/hcp/acip-recs/recs-by-date. html

Incidence Declines in All Age Groups ABCs cases from 1993 -2011 estimated to the

Incidence Declines in All Age Groups ABCs cases from 1993 -2011 estimated to the U. S. population with 18% correction for under reporting *In 2010, estimated case counts from ABCs were lower than cases reported to NNDSS and may not be representative

Incidence in All Serogroups, United States, 1993 -2012* *Source: ABCs cases from 1993 -2012

Incidence in All Serogroups, United States, 1993 -2012* *Source: ABCs cases from 1993 -2012 estimated to the U. S. population with 18% correction for under reporting 14

Meningococcal Vaccine Recommendations Vaccine FDA Routine High Risk Men. ACWY-D (Menactra) 9 mo. 55

Meningococcal Vaccine Recommendations Vaccine FDA Routine High Risk Men. ACWY-D (Menactra) 9 mo. 55 yr. 11 -21 yr. 9 mo. 55 yr. Men. ACWYCRM (Menveo) 2 mo. 55 yr. 11 -21 yr. 2 mo. 55 yr. Hib. Men. CY-TT (Men. Hibrix) 6 wk. 18 mo. Hib 6 wk. 18 mo. * *not for travelers

MMWR 2014; 63: 148 -54

MMWR 2014; 63: 148 -54

MMWR 2014; 63: 148 -54

MMWR 2014; 63: 148 -54

56% 61% 43% 40% 34%

56% 61% 43% 40% 34%

Influenza Deaths by Age Group 122 Cities Mortality Reporting System, Number of Influenza Deaths

Influenza Deaths by Age Group 122 Cities Mortality Reporting System, Number of Influenza Deaths by Age Group and Year * ** *Data from week 15, 2009 – week 39, 2010 **Data as of week 6, 2014

MMWR 2013; 62: 997 n o s a e s 3 1 2 1

MMWR 2013; 62: 997 n o s a e s 3 1 2 1 0 2 g n s i n r o u i t d a n z i o l i t a i n p i s c o c h a r e a w Flu v z e f n e 0 u 6 l 2 f , 9 in 7 f o n i s d e e s t ca r e resul w e f n o i l l i m and 6. 6

National Estimated Vaccination Coverage Levels among Adolescents 13 -17 Years, National Immunization Survey-Teen, 2006

National Estimated Vaccination Coverage Levels among Adolescents 13 -17 Years, National Immunization Survey-Teen, 2006 -2012 Tdap: tetanus, diphtheria, acellular pertussis vaccine. MCV 4: meningococcal conjugate vaccine HPV: human papillomavirus vaccine

Strength of HPV Vaccine Recommendation for Female Patients, Pediatricians and Family Physicians (N=609)

Strength of HPV Vaccine Recommendation for Female Patients, Pediatricians and Family Physicians (N=609)

IID-9: Children 19 -35 Months Who Received No Vaccinations, 2008 -2012, U. S. Tracking

IID-9: Children 19 -35 Months Who Received No Vaccinations, 2008 -2012, U. S. Tracking Measure- Program goal to sustain percentage of <1% Source: National Immunization Survey

MMWR 2013; 62(30): 607 -612

MMWR 2013; 62(30): 607 -612

Vaccination coverage among children in kindergarten- US, 2012 -2013. MMWR 2013; 62: 607.

Vaccination coverage among children in kindergarten- US, 2012 -2013. MMWR 2013; 62: 607.

“I’m pregnant. I was told that vaccines are now recommended for pregnant women but

“I’m pregnant. I was told that vaccines are now recommended for pregnant women but I don’t know. . . ”

Estimated Influenza Vaccination (trivalent) Coverage, Pregnant Women* * Behavioral Risk Factor Surveillance (BRFSS) data

Estimated Influenza Vaccination (trivalent) Coverage, Pregnant Women* * Behavioral Risk Factor Surveillance (BRFSS) data from December-February interviews only, for women 18 -44 years pregnant or not pregnant when interviewed; sample sizes for pregnant women per season ranged from 400 -800. Differences in influenza vaccination coverage between pregnant and not pregnant women were statistically significant (p<0. 05) for 2005 -06 and 2008 -09 through 2012 -13 seasons (age adjusted), p<0. 05). Other estimates for pregnant women from PRAMS (MMWR February 24, 2012 / 61(07); 113 -118); NHFS (Ding et al. Am. J. Obstetrics & Gynecology, June 2011 Supplement); and internet panel survey (MMWR August 19, 2011 / 60(32); 1078 -1082, MMWR September 28, 2012 / 61(38 ): 758 – 763, MMWR September 27, 2013 / 62(38): 787 -792)

Vaccination coverage by provider recommendation and/or offer *Women who didn't visit a provider since

Vaccination coverage by provider recommendation and/or offer *Women who didn't visit a provider since August 2012 (n=27) or women who didn't know whether they received provider recommendation or offer (n=55) were excluded from this analysis.

AAP 2013 Tdap Recommendations § Tdap vaccine is recommended for every pregnancy administered from

AAP 2013 Tdap Recommendations § Tdap vaccine is recommended for every pregnancy administered from week 27 to 36 of gestation § “Cocooning“ is still important since Tdap effectiveness is only 65 -81% and ineffective in small premature infants § Tdap-induced pertussis antibodies transferred to newborn in high concentrations and persist for 2 months

Maternal Immunization: Benefits Safe for mother and infant • Recommended to protect pregnant women

Maternal Immunization: Benefits Safe for mother and infant • Recommended to protect pregnant women and their infants • • Optimal timing is important Influenza (any trimester) § Pertussis (every pregnancy from week 27 -36) § Only potential strategy to prevent young infant deaths and hospitalizations § Clin Obstet Gynecol. 2012; 55: 474 -86

Conclusions q No new unexpected vaccine safety concerns noted among pregnant women who received

Conclusions q No new unexpected vaccine safety concerns noted among pregnant women who received Tdap (or their infants) q Limited number of pregnancy reports with repeat Tdap doses received by VAERS q CDC will continue to monitor the safety of Tdap vaccine during pregnancy, with special emphasis on repeated doses of Tdap Ø ACIP meeting: February 26 -27, 2014 33

Human Papillomavirus: Types and Disease Association Non-mucosal/cutaneous (~60 types) Mucosal/genital (~40 types) High-risk: types

Human Papillomavirus: Types and Disease Association Non-mucosal/cutaneous (~60 types) Mucosal/genital (~40 types) High-risk: types 16, 18, 31, 45 (and others) Low-risk: types 6, 11 (and others) Skin warts (hands and feet) Low-grade cervical abnormalities Cancer precursors Anogenital cancers Low-grade cervical abnormalities Genital warts Laryngeal papillomas Muñoz N et al. N Engl J Med 2003; 348: 518 -527.

Type Attribution by Cancer Site 100 HPV 16/18 HPV 31/33/45/52/58 90 Other HPV 79

Type Attribution by Cancer Site 100 HPV 16/18 HPV 31/33/45/52/58 90 Other HPV 79 80 70 HPV Negative 66 60 60 60 Percent 55 49 50 48 37 40 31 30 30 25 21 20 10 18 18 15 14 10 9 2 1 9 8 6 3 9 6 6 4 0 Cervical In Situ Cervical Vulvar Vaginal Cancer Site Saraiya et al, presented at AACR Health Disparities in Cancer, 2013 Anal Penile Oropharyngeal

Revised Estimated Percentages of Cancers Attributed to HPV in the U. S. Cancer HPV

Revised Estimated Percentages of Cancers Attributed to HPV in the U. S. Cancer HPV attributable % (95% CI) HPV 16/18 attributable % (95% CI) HPV 31/33/45/52/58 attributable % (95% CI) Cervical 91 (88 -92) 66 (63 -69) 15 (12 -17) Vaginal 75 (63 -84) 55 (43 -67) 18 (11 -30) Vulvar 69 (62 -75) 49 (41 -56) 14 (10 -20) Anal Male Female 89 (77 -95) 92 (85 -96) 79 (66 -88) 80 (70 -87) 4 (1 -13) 11 (6 -19) Penile 63 (52 -73) 48 (37 -59) 9 (4 -17) Oropharyngeal Male Female 72 (68 -76) 63 (55 -71) 63 (59 -68) 51 (43 -59) 4 (3 -7) 9 (6 -15)

Average Number of New HPV-Associated Cancers by Sex, in the United States, 2005 -2009

Average Number of New HPV-Associated Cancers by Sex, in the United States, 2005 -2009 n=694 n=3039 n=1003 n=2317 n=1687 n=3084 Oropharynx n=11279 Jemal A et al. J Natl Cancer Inst 2013; 105: 175 -201 n=9312

HPV Vaccines Quadrivalent (Gardasil) Bivalent (Cervarix) Manufacturer Merck Glaxo. Smith. Kline VLP types 6,

HPV Vaccines Quadrivalent (Gardasil) Bivalent (Cervarix) Manufacturer Merck Glaxo. Smith. Kline VLP types 6, 11, 16, 18 Producer cells Saccharomyces cerevisiae (yeast) Baculovirus infected Trichoplusia in insect cell line Schedule (IM) 3 dose series Estimated to Protect (%) Genital Warts 90% -- Cervical and other cancers 70% VLP – virus like particle; IM - Intramuscular

Evolution of recommendations for HPV vaccination in the United States Quadrivalent Routine, females 11

Evolution of recommendations for HPV vaccination in the United States Quadrivalent Routine, females 11 or 12 yrs* and 13 -26 yrs not previously vaccinated Quadrivalent or Bivalent Routine, females 11 or 12 yrs* and 13 -26 yrs not previously vaccinated Quadrivalent May be given, males 9 -26 yrs* Quadrivalent Routine, males 11 or 12 yrs* and 13 -21 yrs not previously vaccinated May be given, 22 -26 yrs** June October Quadrivalent (HPV 6, 11, 16, 18) vaccine; Bivalent (HPV 16, 18) vaccine * Can be given starting at 9 years of age; ** For MSM and immunocompromised males, quadrivalent HPV vaccine through 26 years of age 40

Disease Associations with Most Frequent Types of HPV Diseases Cutaneous warts HPV type 1,

Disease Associations with Most Frequent Types of HPV Diseases Cutaneous warts HPV type 1, 2, 3, 4, 10, others Cancer (cervical, anal, penile, oropharyngeal) 16, 18, 31, 33, 45, 52, 58 Condyloma acuminata (anogenital warts) 6, 11 Recurrent respiratory papillomatosis 6, 11 Burd. Clin Microbiol Rev 2003; 16: 1 -17

Oropharyngeal Cancer • HPV 16 causes head and neck cancers • Molecular, epidemiologic, and

Oropharyngeal Cancer • HPV 16 causes head and neck cancers • Molecular, epidemiologic, and clinical evidence • suggest these tumors are distinct from HPVnegative oropharyngeal cancers Risk factors for HPV-positive and HPV-negative oropharyngeal cancers differ: § HPV-positive cancers: tobacco, sexual behaviors (typically younger victims) § HPV-negative cancers: tobacco, alcohol (typically older victims)

Comparison of 9 v. HPV Vaccine and q. HPV Vaccine ADJUVANT AAHS 225μg q.

Comparison of 9 v. HPV Vaccine and q. HPV Vaccine ADJUVANT AAHS 225μg q. HPV vaccine 6 11 16 18 20μg 40μg 20μg AAHS 500μg 9 v. HPV vaccine 6 11 16 18 31 33 45 52 58 30μg 40μg 60μg 40μg 20μg 20μg AAHS =Amorphous aluminum hydroxyphosphate sulfate 44

Why Parents Say “No” to HPV Vaccine Parents who do not intend to vaccinate

Why Parents Say “No” to HPV Vaccine Parents who do not intend to vaccinate daughter in next 12 months, NIS-Teen 2008 -2009 * Not mutually exclusive. ** Did not know much about HPV or HPV vaccine. 2011 NIS-Teen available at http: //www. cdc. gov/vaccines/stats-surv/nis-2011 -released. htm#nisteen

Actual and Achievable Vaccination Coverage if Missed Opportunities Were Eliminated: Adolescents 13 -17 Years,

Actual and Achievable Vaccination Coverage if Missed Opportunities Were Eliminated: Adolescents 13 -17 Years, NIS-Teen 2012 Among girls unvaccinated for HPV, 84% had a missed opportunity Missed opportunity: Healthcare encounter when some, but not all ACIP-recommended vaccines are given. HPV-1: Receipt of at least one dose of HPV.

HPV Vaccine Communications During the Healthcare Encounter • HPV vaccine is often presented as

HPV Vaccine Communications During the Healthcare Encounter • HPV vaccine is often presented as ‘optional’ whereas other adolescent vaccines are recommended • Some expressed mixed or negative opinions about the vaccine: ‘new vaccine’; concerns over safety/efficacy • When parents expressed reluctance, providers were hesitant to engage in discussion • Some providers shared parent’s views that teen was not at risk for HPV and could delay vaccination until older Goff et al. Vaccine (2011). doi: 10. 1016/i. vaccine. 2011. 07. 082 Hughes et al. BMC Pediatrics. 2011; 11: 74. www. biomedcentral. com/1471 -2431/11/74

HPV Vaccine Safety Summary • Six years of post-marketing safety surveillance in females demonstrating

HPV Vaccine Safety Summary • Six years of post-marketing safety surveillance in females demonstrating safety of Gardasil • Syncope has been reported after HPV vaccine • Ongoing safety studies for males and bivalent vaccine • CDC and FDA are continuing to monitor HPV vaccine safety

HPV vaccine safety concerns • Safety questions for any new vaccine § More due

HPV vaccine safety concerns • Safety questions for any new vaccine § More due to high visibility of HPV vaccine • Anecdotes in press due to events temporally related to vaccination • Anti-vaccine websites

Accelerating HPV Vaccine Uptake in the United States: Goals • Goal 1: Reduce missed

Accelerating HPV Vaccine Uptake in the United States: Goals • Goal 1: Reduce missed clinical opportunities to recommend administer HPV vaccines • Goal 2: Increase parents’, caregivers’, and adolescents’ acceptance of HPV vaccines • Goal 3: Maximize access to HPV vaccination services • Goal 4: Promote global HPV vaccination uptake

IOM Report - 2011 • • • Evaluated a list of adverse events and

IOM Report - 2011 • • • Evaluated a list of adverse events and their association with 8 different vaccines covered by the National Vaccine Injury Compensation Program (VICP) Benefits or effectiveness were not assessed Based on scientific evidence, the committee developed 158 causality conclusions and assigned each to one of four categories

MMWR 2013; 62: 591 -95

MMWR 2013; 62: 591 -95

Predicted numbers of coincident, temporally associated events after a single dose of a hypothetical

Predicted numbers of coincident, temporally associated events after a single dose of a hypothetical vaccine, based upon background incidence rates Number of coincident events since a vaccine dose Baseline rate used for estimate Within 1 day Within 7 days Within 6 weeks GBS (per 10 million vaccinated people) 0. 51 3. 58 21. 50 1. 87 per 100, 000 personyears (all ages: UK Health Protection Agency data) Optic neuritis (per 10 million female vaccinees 2. 05 14. 40 86. 30 7. 5 per 100, 000 personyears in US females Spontaneous abortions (per 1 million vaccinated pregnant women) 397 2780 16, 684 Based on date from the UK (12% of pregnancies) Sudden death within 1 h of onset of any symptoms (per 10 million vaccinated) 0. 14 0. 98 5. 75 Based upon UK background rate of 0. 5 per 100, 000 person-years Lancet 2009; 374: 2115 -22

Comparison of 20 th Century Annual Morbidity and Current Morbidity: Vaccine-Preventable Diseases Disease 20

Comparison of 20 th Century Annual Morbidity and Current Morbidity: Vaccine-Preventable Diseases Disease 20 th Century Annual Morbidity† 2013 Reported Cases † † Percent Decrease Smallpox 29, 005 0 100% Diphtheria 21, 053 0 100% Measles 530, 217 184 > 99% Mumps 162, 344 438 > 99% Pertussis 200, 752 24, 231 88% Polio (paralytic) 16, 316 0 100% Rubella 47, 745 9 > 99% Congenital Rubella Syndrome 152 0 100% Tetanus 580 19 97% † JAMA. 2007; 298(18): 2155 -2163 Haemophilus influenzae 20, 000 † † CDC. MMWR January 3, 2014; 62(52); ND-719 -ND-732. 18* data) > 99% (MMWR week 52 provisional * Haemophilus influenzae type b (Hib) < 5 years of age. An additional 13 cases of Hib are estimated to have occurred among the 212 reports of Hi (< 5 years of age) with unknown serotype.

Figure 1. Estimated incidence of invasive Hib infection in <5 year olds, United States,

Figure 1. Estimated incidence of invasive Hib infection in <5 year olds, United States, 1980 -2011* Bacterial Core Surveillance (ABCs) data; 2010 -2011 **Among those with known vaccination status (n=241/288)

FIGURE 3. Percentage of children aged <5 years with cases of invasive Haemophilus influenzae

FIGURE 3. Percentage of children aged <5 years with cases of invasive Haemophilus influenzae type b (Hib) disease, * by vaccine status — United States 2002– 2012

MMWR 2013; 62(12): 226 -229 ers h t o m l l. A S.

MMWR 2013; 62(12): 226 -229 ers h t o m l l. A S. U e h t ts n in r n o a f b n i S l l R. A h. C a t i c i r w f s A t n n i ella 3 infa b u r o t ts. d c e e f s e o d p x e e er had sev

MMWR 2013; 62(12): 226 -229

MMWR 2013; 62(12): 226 -229

MMWR 2010; 59: 1305 -1308

MMWR 2010; 59: 1305 -1308

http: //www. cdc. gov/vaccines/hcp/patient-ed/conversations/index. html

http: //www. cdc. gov/vaccines/hcp/patient-ed/conversations/index. html

Conclusions • Routine immunizations provide a tremendous benefit to infants, children, adolescents, adults and

Conclusions • Routine immunizations provide a tremendous benefit to infants, children, adolescents, adults and to society • Immunization is a shared public / private responsibility • During visits, vaccines and other evidence-based preventive services should be provided • Continue monitoring adolescent vaccination coverage among different groups to assess coverage by race/ethnicity and other sociodemographic factors to identify barriers • Every day, 11, 000 births occur in the U. S.

Future Considerations • • • Duration of protection of Tdap repeat doses in pregnancy

Future Considerations • • • Duration of protection of Tdap repeat doses in pregnancy Use of PCV 13 in adults and integration with PPSV 13 PCV 13 dose reduction in children Use of zoster vaccine in adults beginning at 50 years of age, and duration of protection HPV vaccine: integration of HPV 9 and number of doses Meningococcal B-containing vaccines Several influenza vaccine preparations Vaccine hesitancy and pseudoscience