1

Pediatric and Adolescent Immunization Update

Jonathan Temte, MD, PhD

ACTIVITY DISCLAIMERThe material presented here is being made available by the American Academy of Family Physicians for educational purposes only. Please note that medical information is constantly changing; the information contained in this activity was accurate at the time of publication. This material is not intended to represent the only, nor necessarily best, methods or procedures appropriate for the medical situations discussed. Rather, it is intended to present an approach, view, statement, or opinion of the faculty, which may be helpful to others who face similar situations.

The AAFP disclaims any and all liability for injury or other damages resulting to any individual using this material and for all claims that might arise out of the use of the techniques demonstrated therein by such individuals, whether these claims shall be asserted by a physician or any other person. Physicians may care to check specific details such as drug doses and contraindications, etc., in standard sources prior to clinical application. This material might contain recommendations/guidelines developed by other organizations. Please note that although these guidelines might be included, this does not necessarily imply the endorsement by the AAFP.

2

DISCLOSUREIt is the policy of the AAFP that all individuals in a position to control content disclose any relationships with commercial interests upon nomination/invitation of participation. Disclosure documents are reviewed for potential conflict of interest (COI), and if identified, conflicts are resolved prior to confirmation of participation. Only those participants who had no conflict of interest or who agreed to an identified resolution process prior to their participation were involved in this CME activity.

The following individual(s) in a position to control content for this session have disclosed the following relevant financial relationships

Jonathan Temte, MD, PhD• Consultant or Advisory Board: TBWA World Health (Influenza); GLG (Vaccine); LEK (Vaccine);

Market Plus (Vaccine); Putnam and Associates (Vaccine); Guidepoint Global (Vaccine); RecknerHealthcare (Vaccine); GSK Vaccine (Vaccine); Sanofi Pasteur (Vaccine); and Deallus (Vaccine)

• Other personal or professional relationships: Merck Vaccines (Expert Witness - mumps vaccine)

All other individuals in a position to control content for this session have indicated they have no relevant financial relationships to disclose.

The content of my material/presentation in this CME activity will not include discussion of unapproved or investigational uses of products or devices.

Jonathan Temte, MD, PhDProfessor, Madison Family Medicine Residency Program, University of Wisconsin (UW)

Dr. Temte earned his medical degree from the UW School of Medicine and Public Health (formerly UW-Madison Medical School) and completed his family medicine residency at the Madison Family Medicine Residency, where he is now a professor. He teaches family medicine residents and provides full-spectrum primary care for an underserved, diverse community at Wingra Family Medical Center in Madison, Wisconsin. In 2015, he completed his tenure as chair of the U.S. Advisory Committee on Immunization Practices (ACIP), being the first family physician to serve in this capacity. From 2004-2008, he served as AAFP liaison to the ACIP. He was appointed twice to a four-year term as a voting member of the ACIP and chaired ACIP working groups on MMRV safety, evidence-based recommendations, and the MMR vaccine. Dr. Temte represented the AAFP at the Centers for Disease Control and Prevention’s (CDC’s) Measles Elimination Meeting in 2000 and the Rubella and CRS Elimination Meeting in 2004, and he chaired the AAFP Commission on Science in 2008. He currently chairs the Wisconsin Council on Immunization Practices (WCIP) and is the principal investigator for the Wisconsin Acute Respiratory Infection Epidemiology and Surveillance (ARIES) project; the Oregon Child Absenteeism due to Respiratory Disease Study (ORCHARDS); and the Rapid Assessment of and Prophylaxis for Influenza in Dwellers of Long-Term Care Facilities (RAPID-LTCF) project. In addition, he has participated on pandemic influenza and bioterrorism working groups for the state of Wisconsin. His current research interests include viral disease surveillance in primary care and communities, seasonality and epidemiology of influenza, and attitudes toward immunization.

3

Learning Objectives1. Identify available vaccine administration strategies and resources, available patient

education resources or programs, vaccine alert systems, current immunization schedules, for child and adolescent patients.

2. Use evidence-based recommendations and guidelines to establish standardized vaccine administration procedures, including standardized protocols to screen for immunizations during child and adolescent patient encounters.

3. Counsel parents of children and adolescents, using available patient education resources and motivational interviewing about vaccine safety and efficacy.

4. Participate in available childhood immunization programs, and administer using a standardized process.

Audience Engagement SystemStep 1 Step 2 Step 3

4

Vaccines are EffectiveAmong the 78.6 million children born during 1994–2013 routine childhood immunization was estimated to prevent:

– 322 million illnesses

• (Average = 4.1 illnesses per child: NNV = 0.24)

– 21 million hospitalizations over the course of their lifetimes

• (Average = 0.27 per child: NNV = 3.7)

– 732,000 premature deaths from vaccine-preventable illnesses

• (Average = 0.01 per child: NNV = 107.4)

CDC. Benefits from Immunization During the Vaccines for Children Program Era — United States, 1994–2013. MMWR 2014; 63(16):352-5.

Number of Deathschildren, adolescents and young adults (0—24 years)

0

50

100

150

200

Number of Deaths United States – 2014

Kochanek KD, et al.  Deaths: Final Data for 2014.  National Vital Statistics Reports Volume 65, Number 4 June 30, 2016

5

ACIP Immunization

Scheduleswww.cdc.gov/vaccines/schedules/

• Childhood (0 -18 years

• Adult

• Catch-up schedules

• Footnotes

ACIP Recommended Immunization Schedules are available at:www.cdc.gov/vaccines/recs/schedules/default.htm

Why do we use the schedules?• Only schedule for which we have sufficient evidence for safety and efficacy• Risk periods

– rotavirus

• Response periods– immunogenicity

• Convenience– grouping immunizations with well care

• Collaborative Activity with Organizational Support– child and adolescent

• CDC – ACIP• American Academy of Family Physicians• American Academy of Pediatrics

6

The Medical Board of California ordered a 35 months probation for Dr. Bob Sears. In 2016, the board threatened to revoke Sears’ medical license for wrongly writing a note for a 2-year-old boy exempting him from all childhood vaccinations.

Sears can keep practicing medicine but will be required to take 40 hours of medical education courses a year, as well as an ethics class, and also be monitored by a fellow doctor.

Alternative Schedules?

Young Children

Reprinted from Centers for Disease Control and Prevention. Recommended immunization schedule for persons aged 0 through 18 years – United States, 2016https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf

7

PRECONCEPTION / PRENATAL

Protecting children with vaccines begins before birth

Preconception…  MMR and Varicella

Prenatal Immunization for Healthy Moms and Infants

• Influenza Vaccine– Indicated for all moms

– Any trimester

• Pertussis (Tdap)– 27 to 36 weeks gestation

8

Maternal Influenza Vaccination• Randomized controlled study of 340 mothers (3rd Trimester)

– Infants of vaccinated mothers had less influenza• Vaccine effectiveness of 63% (95% CI, 5 to 85)

– Mothers had less respiratory illness with fever • Vaccine effectiveness of 36% (95% CI, 4 to 57)

• RCT of 4193 mothers in Mali– VE for 1st 4 months of follow-up was 67ꞏ9% (95% CI 35ꞏ1-85ꞏ3)– VE for five month period was 57ꞏ3% (30ꞏ6-74ꞏ4)– VE of 6 month period was 33ꞏ1% (95% CI 3ꞏ7-53ꞏ9)– No serious adverse events were related to vaccination.

Zaman K, et al. Effectiveness of maternal influenza immunization in mothers and infants. N Engl J Med. 2008;359:1555-1564. Tapia MD, et al. Maternal immunisation with trivalent inactivated influenza vaccine for prevention of influenza in infants in Mali: a prospective, active-controlled, observer-blind, randomised phase 4 trial. Lancet Infect Dis. 2016 Sep;16(9):1026-35.

Reduction in Stillbirths• Australian cohort of 58,008 births

– between April 2012 and December 2013

• Evaluation of Stillbirths (≥20 weeks gestation)– Vaccinated: 3.0 per 100,000 pregnancy days

– Unvaccinated: 5.0 per 100,000 pregnancy days

– 51% reduction for all births

– 67% reduction for births occurring just after influenza seasonRegan AK et al. Seasonal trivalent influenza vaccination during pregnancy and the incidence of stillbirth: population-based retrospective cohort study. Clinical Infectious Diseases 2016. DOI: 10.1093/cid/ciw082

9

• VAERS Study– No new unexpected vaccine safety concerns

• VSD study– Increased risk for chorioamnionitis

• RR = 1.11 (1.03-1.21) 5.5% of unvaccinated; 5.6% of vaccinated

– Decreased risk of pre-term labor• RR = 0.83 (0.77-0.90) 7.8% of unvaccinated; 5.3% of vaccinated

• New Zealand Study showed no serious adverse effects of Tdap

• UK Study: Vaccine Effectiveness = 91% (95% CI 84 to 95)

Safety and Efficacy of Tdap

Moro P.  Safety of Tdap vaccine during pregnancy: enhanced surveillance in VAERS. www.cdc.gov/vaccines/acip/meetings/downloads/slides‐2014‐02/02‐Tdap‐Moro.pdf Kharbanda EO et al. Receipt of pertussis vaccine during pregnancy across 7 Vaccine Safety Datalink Sites.  PrevMed. 2014. doi: 10.1016/j.ypmed.2014.05.025.   Petousis‐Harris H et al.,  Safety of Tdap vaccine in pregnant women: an observational study. BMJ Open. 2016; 6(4): e010911. Amirthalingam G et al.   Effectiveness of maternal pertussis vaccination in England: an observational study.  Lancet. 2014; doi: 10.1016/S0140‐6736(14)60686‐3. 

Image:  CDC

BIRTH

Protecting children with vaccines at birth

10

Hepatitis B Vaccine• First dose at birth

– Protects from lateral transmission from household contact

– coverage estimate for 2016 was 71.1% at 3 days for U.S.

• If Mother is Hepatitis B (+)– HB-Immunoglobulin at birth

– Birth dose of vaccine

– 85-98% effective in preventing development of the HBV carrier state

Vaccination Coverage Among Children Aged 19–35 Months — United States, 2016  MMWR 2017  66(43);1171–1177.  Umar M et al.  HBV Perinatal Transmission.  International Journal of Hepatology 2013; http://dx.doi.org/10.1155/2013/875791.  Stevens CE, et al. : Perinatal Hepatitis B virus transmission in the United States: Prevention by passive‐active immunization. JAMA 1985; 253:1740‐1745.

EARLY INFANCY

Protecting children with vaccines in early infancy

11

Vaccines at 2, 4 and 6 Months9 targeted diseases

• Hepatitis B (HepB)

• Rotavirus (RV1 or RV5)

• Diphtheria, Tetanus, acellular Pertussis (DTaP)

• Haemophilus influenzae type b (Hib)

• Pneumococcal conjugate (PCV13)

• Inactivated Poliovirous (IPV)

• Influenza (IIV) (but not until 6 months)

HepB• 2 additional doses

– 1-2 months

– 6 months

• Overall 3-dose coverage rate for U.S. = 90.5%

Vaccination Coverage Among Children Aged 19–35 Months — United States, 2016  MMWR 2017  66(43);1171–1177

12

RV1 or RV5• Cochrane 2012: Vaccines are effective

– Prevention of rotavirus diarrhea, office visits, hospitalizations

• Two options available:– RV1: Rotarix®—2 dose series at 2 and 4 months

– RV5: RotaTeq®—3 dose series at 2, 4, and 6 months

Soares-Weiser et al., Vaccines for preventing rotavirus diarrhea: vaccines in use. Cochrane Database Syst Rev 2012; Published Online: 15 FEB 2012

Image:CDC/Dr. Erskine Palmer

0

10

20

30

40

50

60

70

80

90

Jan-

00

Mar

-00

Jun-

00

Aug

-00

Nov

-00

Jan-

01

Apr

-01

Jun-

01

Sep

-01

Nov

-01

Feb

-02

Apr

-02

Jul-0

2

Sep

-02

Dec

-02

Mar

-03

May

-03

Aug

-03

Oct

-03

Jan-

04

Mar

-04

Jun-

04

Aug

-04

Nov

-04

Jan-

05

Apr

-05

Jun-

05

Sep

-05

Nov

-05

Feb

-06

Apr

-06

Jul-0

6

Sep

-06

Dec

-06

Mar

-07

May

-07

Aug

-07

Oct

-07

Jan-

08

Mar

-08

Jun-

08

Week of admission

Num

ber of hospitaliza

tions

0

500

1000

1500

2000

2500

3000

3500

Weekly Rotavirus HospitalizationsWisconsin 2000–2008

2000 2001 2002 2003 2004 2005 2006 2007 2008

13

DTaP• Diphtheria: Number of cases in U.S. (2015) = 0

– Pharyngeal and tonsillar diphtheria with exudative pharyngitis• Adherent membrane contributed to airway obstruction

– Diphtheria toxoid has clinical efficacy of 97%

• Tetanus: Number of cases in U.S. (2015) = 30

– Most common form is generalized tetanus• Lockjaw, muscle rigidity, and spasms

– Neonatal tetanus (2015 U.S. cases = 0) • resulted in ~260,000 global deaths in 2000-2003

WHO vaccine‐preventable diseases: monitoring system. 2018 global summary. http://apps.who.int/immunization_monitoring/globalsummaryMoro PL et al.  Safety Surveillance of Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) Vaccines  Pediatrics 2018;142(1)e20174171 

Image: CDC

• Pertussis– Significant Cough

Illness

– can last weeks to months

– highly transmissible

– respiratory droplets

– Serious clinicalconsequences in infants and elders

– Vaccine prevents80-85% of casesafter 3 doses

14

Hib• Two different vaccine types

– PRP-T • ACTHIB, DTaP-IPV/Hib (Pentacel) and Hib-MenCY (MenHibrix)

– PRP-OMP • PedvaxHIB or COMVAX

• 2-dose or 3-dose Hib vaccine primary series – 3 doses of PRP-T containing vaccine: 2, 4, and 6 months of age

– 2 doses of PRP-OMP containing vaccine: 2 and 4 months of age

Hib

Source:  http://www.cdc.gov/vaccines/pubs/pinkbook/images/hib‐fig‐03.jpg

Incidence of Hib – U.S. 1990 to 2010

Image: CDC

Hib Meningitis

15

PCV13• 3 doses of PCV13

– ages 2, 4, and 6 months• Disease outcomes

– Invasive Pneumococcal Disease • 89% effective for vaccine serotypes

– 63% to 74% effective for all serotypes

– Otitis media• 55% effective for vaccine serotypes

– 29% effective for all serotypes

• Direct and indirect effects

CDC.  Invasive Pneumococcal Disease in Children 5 Years After Conjugate Vaccine Introduction ‐‐‐ Eight States, 1998—2005.   MMWR2008; 57;144‐148.

Source CDC/Charles Farmer

Polio (IPV)• 3 doses at 2, 4, and 6—18 months

• US Polio Elimination in 1979

• Nearing Global Eradication

– 13 wild-type cases in 2018

• Wild-type Polio is circulating in only two nations:

– Afghanistan

– Pakistan

See:   www.who.int/features/factfiles/polio/en/http://polioeradication.org/polio‐today/

16

Source: http://www.cdc.gov/flu/weekly/

Influenza‐associated pediatric deaths

Season No. Deaths

2014‐2015 148

2015‐2016 93

2016‐2017 110

2017‐2018 178

IIV

• Recommended for all children (≥6 months) annually– Provide 2 doses at least 4 weeks apart

• If child did not receive 2 doses in the previous season

• LAIV not licensed below 24 months of age

17

LATE INFANCY – EARLY TODDLER

Protecting children with vaccines in late infancy and early toddlerhood

• DTaP

• Hib

• PCV13

• IPV

• IIV

• Measles, mumps, rubella (MMR)

• Varicella (VAR)

• Hepatitis A (HepA)

Vaccines at 9 through 18 months12 targeted diseases

18

DTaP, Hib, PCV13 and IPV• 4th dose of DTaP at age 12 through 18 months

• 3rd or 4th dose of Hib at age 12 through 15 months– 4th dose of PRP-T

• ACTHIB, DTaP-IPV/Hib (Pentacel) and Hib-MenCY (MenHibrix)

– 3rd dose of PRP-OMP • PedvaxHIB or COMVAX

• 4th dose of PCV13 at age 12 through 15 months

• 3rd dose of IPV at age through 18 months,– if not received earlier

IIV

• Recommended for all children (≥6 months) annually– Provide 2 doses at least 4 weeks apart

– If child did not receive 2 doses in the previous season

• LAIV not licensed below 24 months of age

19

MMR

• One dose at ages 12 through 15 months – Provide MMR to children aged 6 through 11 months who plan to

travel or live abroad should receive MMR before travel• This dose does not count as one of the routine doses

• MMRV is also licensed for 1st dose at age 12—15 months– Associated with a 2-fold increased risk in febrile seizures

• Rate = 1 in 2,500 vaccinees

MMR• Measles eliminated from the United States in 2000

– 2918: 93 cases in 19 states (so far)

– 2017: 118 cases in 15 states

– 2016: 86 cases in 19 states.

– 2015: 188 cases in 24 states

– 2014: 667 cases in 27 states

– 2014: 667 cases and 23 outbreaks

• Rubella eliminated from the United States in 2004– eliminated from the Americas in 2015

20

Source CDC/Barbara Rice

Measles (MMR)• The majority of people who contract

measles are unvaccinated

• Measles is still common in many parts of the world including some countries in Europe, Asia, the Pacific, and Africa.

MenACWY

• 2, 4, 6 and 12 through 15 months• Infants at high risk for meningococcal

disease– Persistent complement pathway deficiencies– Anatomic or functional asplenia

• Including sickle cell disease

– HIV

21

VAR

• 1st dose of VAR vaccine at age 12 through 15 months

• MMRV is also licensed for 1st dose at age 12—15 months– Associated with a 2-fold increased risk

in febrile seizures• Rate = 1 in 2,500 vaccinees

Source: CDC

HepA• 2-doses of HepA at 12 through 23 months

– separate the 2 doses by 6 to 18 months.

• Vaccination of all children for hepatitis A will eventually protect against endemic and imported viruses– Hepatitis A has devastating consequences when superimposed

on chronic hepatitis C infection.

– About 3.5 million Americans have chronic hepatitis C infection

– reducing hepatitis A infections in children should benefit this vulnerable group

Temte JL.  Should all children be immunised against hepatitis A? BMJ 2006;332:715 

22

OLDER TODDLER

Protecting children with vaccines in toddlerhood

Vaccines at 19 through 47 months2 targeted diseases

• Influenza (IIV / LAIV) annually– 2 doses ≥4 weeks apart if child has not received 2 doses previously

– LAIV licensed for children over the age of 24 months

– Number needed to vaccinate (NNV) to prevent• Hospitalization between 24 to 59 months of age: 4,255 to 6,897

• Outpatient Visits: 12 to 42

• Hepatitis A (HepA)– 2nd dose 6 to 18 months after the first dose

Lewis EN, Griffin MR, Szilagyi PG, et al. Childhood influenza: number needed to vaccinate to prevent 1 hospitalization or outpatient visit. Pediatrics. 2007;120(3):467-472.

23

Influenza Vaccines (IIV and LAIV)

• Recommended for all children – 6 months through 18 years of age– 2 doses at least 4 weeks apart

• Children younger than 9 years of age• First time being vaccinated• Vaccinated in previous year with single dose

• LAIV has been recommended for 2018-2019– Live Attenuated Influenza Vaccine – ACIP recommendation June 20, 2018

• Use either IIV or LAIV

Image: CDC - Brian Judd

Photo: Nation al Institute of Allergy and Infectious Diseases (NIAID)

ACIP Recommendations for Influenza Vaccines

• 2014: preferential recommendation for LAIV in children 2--8 years

• 2015: removal of this preference

• 2016: recommended against use of LAIV

• 2018: recommended for use of LAIV– AAP Committee on Infectious Diseases has a preferential recommendation for IIV

• Recent study shows no evidence of lack of effectiveness of LAIV against influenza A[H1N1]pdm09

Photo: CDC/ Dr. Bill Atkinson

Buchan et al. JAMA Pediatr. Doi: 10.1001/jamapediatrics.2018.1514 July 2, 2018

24

Polling Question:How much of a problem do

fluctuating recommendations for LAIV cause in your practice?

a. No problem at allb. Slight problems in vaccinating childrenc. Moderate problems in vaccinating childrend. Major problems in vaccinating children e. I don’t even want to think about this…

ELEMENTARY SCHOOL

Protecting children with vaccines in elementary school children

25

Vaccines at 4 through 10 years9 targeted diseases

• Diphtheria, Tetanus, acellular Pertussis (DTaP)

• Inactivate Poliovirus (IPV)

• Influenza (IIV / LAIV)

• Measles, mumps, rubella (MMR)

• Varicella (VAR)

DTaP, IPV and IIV/LAIV

• Diphtheria, Tetanus, acellular Pertussis (DTaP)– 5th dose at ages 4 through 6 years

• Inactivated Poliovirus (IPV)– 4th dose at age 4 through 6 years

• Influenza (IIV / LAIV)– Recommended for all children an annual basis

• Provide 2 doses ≥ 4 weeks apart if child has not received 2 doses previously

26

MMR and VAR

• Measles, mumps, rubella (MMR)– 2nd dose at age 4 through 6 years

– MMRV is also licensed for 2nd dose at age 4 through 6 years• No increased risk for adverse events

• Varicella (VAR)– 2nd dose at age 4 through 6 years

– MMRV is also licensed for 2nd dose at age 4 through 6 years• No increased risk for adverse events

Polling Question:What percentage of your school-

aged patients (5-18 years) received influenza vaccine last year?

a. Less than 5%b. 5 - 10%c. 10 - 25%d. 25 - 50%e. More than 50%

27

Older Children and

Adolescents

Reprinted from Centers for Disease Control and Prevention. Recommended immunization schedule for persons aged 0 through 18 years – United States, 2016https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf

INTERMEDIATE / MIDDLE SCHOOL

Protecting children with vaccines in early adolescence

28

Vaccines at 11 through 13 years6 targeted disease

• Tetanus, Diphtheria, acellular Pertussis (Tdap)

• Influenza (IIV / LAIV)

• Human papillomavirus (HPV)

• Meningococcal (MenACWY)

Tdap

• Administer 1 dose of Tdap vaccine to all adolescents at age 11 through 12 years– Tdap may be administered regardless of the interval since the

last tetanus and diphtheria toxoid-containing vaccine.

– Administer 1 dose of Tdap vaccine to pregnant adolescents during each pregnancy (preferred during 27 through 36 weeks’ gestation) regardless of time since prior Td or Tdap vaccination

29

Consequences of a safer pertussis vaccine

Vaccine RegimenRate

Cases/100,000Risk Ratio

Pure Course DTwP 113.3 1 (reference)

Mixed Course 1st dose DTwP

201.9 1.78

Mixed Course1st dose DTaP

409.0 3.61

Pure course DTaP 373.1 3.29

Sheridan SL et al.  Number and order of whole cell pertussis  vaccines in infancy and disease protection.  JAMA. 2012;308(5):454‐6. doi: 10.1001/jama.2012.6364. 

Tdap Vaccine Efficacycohort modeling with adolescents within Kaiser Permanente Northern California

0

20

40

60

80

Year 1 Year 2 Year 3 Year 4+

Vaccine Efficacy

Time from Vaccination

Klein NP, Bartlett J, Fireman B, Baxter R.  Waning Tdap Effectiveness in Adolescents.  Pediatrics 2016; 137: e2 0153326

30

IIV / LAIV

• Influenza (IIV / LAIV)– Recommended for all adolescents on an annual basis

Polling Question: Do you offer to

put off HPV9 vaccine until later for your 11 and12 year-old patients?

a. Yes b. No

31

HPV• Three licensed vaccines

– Only one available in U.S. (HPV9)

– HPV9 (serotypes 6, 11, 16, 18,31, 33, 45, 52, 58) • Protects against types causing 74% of cervical cancer

– 2-dose schedule (0 and 6-12 months)• If started before age 15

• 3-dose schedules: 0, 1-2 months, 6 months if started after age 15

Image: CDC

HPV• HPV9 is licensed from age 9—26 years

• Female indication – age 11-12 years (9-26 years)• cervical pathology (cancers and pre-cancers)

• genital warts

• Male indication – age 11-12 years (9-21years)– genital warts

– anal cancer / precursors– Extended age range for high risk males from 22 through 26 years

• HIV infection and MSM

Image: CDC

32

Effects of HPV in U.S.pre-vaccine (2003-2006) vs. post-vaccine (2009-2012)

0

5

10

15

20

14‐19 years 20‐24 years 25‐29

Vaccine typ

e HPV 

prevalence (%)

PreVaccine

Post‐Vaccine

64%decline

34%decline

Markowitz et al, Prevalence of HPV after introduction of vaccination in the United States.  Pediatrics 2016; 137:e20151968

Effects of HPV in U.S.

0

5

10

15

20

14‐24 years

Vaccine typ

e HPV 

prevalence (%) not vaccinated

vaccinated

Markowitz et al, Prevalence of HPV after introduction of vaccination in the United States.  Pediatrics 2016; 137:e20151968

33

HPV Cochrane Review“There is high-certainty evidence that HPV vaccines protect against cervical precancer in adolescent girls and women who are vaccinated between 15 and 26 years of age. The protection is lower when a part of the population is already infected with HPV. Longer-term follow-up is needed to assess the impact on cervical cancer. The vaccines do not increase the risk of serious adverse events, miscarriage or pregnancy termination.”

Arbyn M, at al. Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors. Cochrane Database of Systematic Reviews 2018, Issue 5. Art. No.: CD009069. DOI: 10.1002/14651858.CD009069.pub3

Six Reasons to Give HPV9 Vaccine

https://www.cdc.gov/hpv/infographics/vacc‐six‐reasons.html

34

Six Reasons to Give HPV9 Vaccine

https://www.cdc.gov/hpv/infographics/vacc‐six‐reasons.html

Does HPV Vaccine invite early sexual activity?• Retrospective EHR cohort in a large managed care organization

– 1,398 girls, aged 11 through 12 years (7/06 to 12/07)

– up to 3 years follow-up

– Outcomes: pregnancy/STI testing/diagnosis; contraceptive counseling based on vaccine receipt

• 493 HPV vaccine-exposed and 905 HPV vaccine-unexposed

• Risk not significantly elevated with HPV vaccine– adjusted incidence rate ratio: 1.29 (95% CI: 0.92-1.80)

• Vaccination not associated with increased sexual activity-related outcome rates

Bednarczyk RA et al. Sexual activity-related outcomes after human papillomavirus vaccination of 11- to 12-year-olds. Pediatrics. 2012;130(5):798-805.

35

Improving the message• Most parent endorse the use of bike helmets• When do you want your child to put on his/her

helmet?A. Before getting on th e bikeB. When riding his/her bikeC. When s/he sees the car heading

directly at him/herD. After being hit by the car

Temte JL. Timing of HPV vaccine. [letter] Pediatrics 2014 http://pediatrics.aappublications.org/content/134/3/e666/reply#pediatrics_el_63882

Image: CDC

Estimated HPV vaccination coverage among adolescents aged 13-17 years

0 20 40 60 80 100

Girls 1+ doses

Girls 2+ doses

Girls 3 doses

Boys 1+ dose

Boys 2+ doses

Boys 3+ doses

Estimated Coverage Rate (%)

National Immunization Survey‐Teen, United States, 2015 

36

MenACWY

• Adolescent primary dose at age 11-12

• functional or anatomic asplenia– every 5 years

– Think sickle cell disease!

Source: CDC/ Mr. Gust

CDC. Prevention and Control of Meningococcal Disease  Recommendations of the Advisory Committee on Immunization Practices (ACIP).  MMWR 2005;54(No. RR‐7):1‐21

37

HIGH SCHOOL

Protecting children with vaccines in late adolescence

Vaccines at 14 through 18 years3 targeted diseases

• Influenza (IIV / LAIV)– Recommended for all adolescents on an annual basis

• Meningococcal (MenACWY)– Booster at age 16 years

• Meningococcal Serogroup B (MenB)

38

Polling Question: Are you recommending

Meningococcal B vaccine?

a. Yes b. No

MenB

• ACIP “Category B” Recommendation

• MenB vaccine series may be administered to adolescents and young adults 16 through 23 years of age to provide short term protection against most strains of serogroup B meningococcal disease

• The preferred age for MenB vaccination is 16 through 18 years of age

39

MenB• Two vaccines for serogroup B meningococcal disease have

been licensed for use in the United States. – Trumenba® (Pfizer)

• 2 dose series given at 0 and 6 months

– Bexsero® (Novartis)• 2 dose series given at 0 and ≥1 month

• Both licensed for use in people aged 10 through 25 years

• Series must be completed with same vaccine as initial dose– vaccines contain very different antigens

Vaccine Hesitancy

40

Where do concerns lie?A lot Some A little/not at all

0 10 20 30 40 50 60 70 80 90 100

weaken immune system

unlikely to encounter disease

thimerosal effects

autism

long-term complications

Percent of Responses

A lot

Some

Kempe et al., Prevalence of parental concerns about Childhood vaccines. AM J Prev Med 2011;40:548-55

Where do concerns not lie?A lot Some A little/not at all

0 20 40 60 80 100

vaccines not effective

drug company profits

immediate, short term effects

diseases not severe

Percent of Responses

A lotSomeA little / not at all

Kempe et al., Prevalence of parental concerns about Childhood vaccines. AM J Prev Med 2011;40:548-55

41

Vaccine Hesitancy• Model Behavior

– Make immunization a high priority at your clinic• Including health care workers

• Including yourself

• Explore Concerns– Sources of information (misinformation)

– Provide evidence-based recommendation

– Provide honest feedback

• www.cdc.gov/vaccines/conversations

42

Talking With Parents about Vaccines for Infants

• Take time to listen

• Solicit and welcome questions

• Keep the conversation going

• Science vs. anecdote

• Acknowledge risks and benefits

• Respect parents’ authority

• Reduce the stress of shots

• Follow-upPhoto:  CDC/ Jessie Blount

Vaccine are Safe• 2014: AHRQ-commissioned systematic review

Rigorous lack of Conflict of Interest

– No association: MMR and autism spectrum disorder

– high quality evidence

• 2013: Institute of Medicine Review“Upon reviewing stakeholder concerns and scientific literature regarding the entire childhood immunization schedule, the IOM committee finds no evidence that the schedule is unsafe. The committee’s review did not reveal an evidence base suggesting that the U.S. childhood immunization schedule is linked to autoimmune diseases, asthma, hypersensitivity, seizures, child developmental disorders, learning or developmental disorders, or attention deficit or disruptive disorders.”

Maglione et al. Safety of vaccines used for routine immunization of US children: a systematic review. Pediatrics 2014;134;325; DOI:10.1542/peds.2014-1079. The Childhood Immunization Schedule and Safety, Stakeholder Concerns, Scientific Evidence, and FutureStudies www.iom.edu/Reports/2013/The-Childhood-Immunization-Schedule-and-Safety.aspx

43

Great Source for Safety Information

• Vaccine Safety Reference List– Children’s Hospital of Philadelphia

• provides key references regarding vaccine safety to clinicians and others

• value to clinicians answering the questions of patients and parents concerning vaccine safety

https://www.chop.edu/centers‐programs/vaccine‐education‐center/vaccine‐safety‐references

• Aluminum and vaccines

• Autism and the MMR vaccine

• Diabetes and vaccines

• DNA and vaccines

• Formaldehyde and vaccines

Topics in Vaccine Safety Reference Library

• Multiple sclerosis and vaccines

• Thimerosal (mercury) and vaccines

• Too many vaccines, too soon

• Vaccine ingredients

https://www.chop.edu/centers‐programs/vaccine‐education‐center/vaccine‐safety‐references

44

Vaccine Safety Monitoringhttps://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/index.html

• CDC monitors the safety of vaccines by:– Performing high-quality vaccine safety research

– Making determinations about whether vaccines caused reactions in certain cases and helping to learn about preventable risk factors

– Identifying vaccine adverse events through public health surveillance

Four primary vaccine safety

activities conducted by

the CDC’s Immunization Safety Office

CDC. Vaccine Safety Monitoring.https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/index.html

45

It’s the message, stupid• Messaging about routine use, safety, and effectiveness resonates

– MMR: parents reported increased vaccine acceptance with information emphasizing MMR’s benefits

• directly to the child

• to both the child and society

• but not to society alone

– HPV: messaging about routine use, safety, and cancer prevention

• Provider Hesitancy– Become knowledgeable on vaccine safety and effectiveness

Hendrix KS. Vaccine Message framing and parents' intent to immunize their infants for MMR. Pediatrics 2014; DOI: 10.1542/peds.2013-4077. Perkins et al. Missed opportunities for HPV vaccination in adolescent girls: a qualitative study. Pediatrics 2014;134:e666-674.

ROUTINE

SAFE

EFFECTIVE

VACCINES

46

Polling Question: Do you routinely use an

immunization information system (registry)?

a. Yes b. No

Billing & CodingWhen services performed in conjunction with:Office Visit    992xx Preventive 9938x/9939xMCR IPPE/AWV   G0402/G0438MCR IPPE    G0402  

Additional tests to confirm or monitor:Specific vaccine codes to be provided based on presenter's information

90460Vaccine administration, through age of 18, with physician counseling, first component each vaccine

47

Billing & Coding (Continued)Additional tests to confirm or monitor (continued):

+90461Vaccine administration, through age of 18, with physician counseling, each additional component 

90471 Immunization administration, first vaccine90472 Immunization administration, each additional vaccine90473 Immunization administration, oral or intranasal, first vaccine90474 Immunization administration, oral or intranasal, each additionalG0008 Medicare immunization administration:  influenzaG0009 Medicare immunization administration:  pneumococcalG0010 Medicare immunization administration:  hepatits B

Summary Points

• Vaccines have been one of the most successful medical interventions (ever)– Highly effective

– Excellent record of safety

• Despite unparalleled safety, patients and clinicians are concerned about vaccine safety

• Multiple layers and mechanisms exist to ensure safety

48

Practice Recommendations

• Be familiar aware of the 2018 and 2019 ACIP Immunization Schedules, their footnotes and the catch-up schedules

• Have ready access to up to date information on vaccine safety and immunization safety mechanisms

• Engage your vaccine hesitant parents in conversation about vaccine safety and effectiveness

Questions

49

Contact:  Jon Temte, MD/PhDChair, Wisconsin Council on Immunization PracticesProfessor of Family Medicine and Community HealthUniversity of Wisconsin School of Medicine and Public 

Health,  Madison, Wisconsin 53715Jon.Temte@fammed.wisc.edu

Thanks