Vaccinating Every Adolescent Patient Vince LaPorte LaPorte, MD Adjunct Professor of Family Medicine University of Minnesota at Mankato
Funded by the Centers for Disease Control and Prevention via the Prevention and Public Health Fund Cooperative Agreement #3H23IP000737-01S1 DISCLAIMER: The findings and conclusions in this presentation are those of the author and do not necessarily represent the official position of the Centers for Disease Control and Prevention. 2
Disclosure Information Vaccinating Every Adolescent Patient April 17, 2015 Vince LaPorte, MD Disclosure of Relevant Financial Relationships I have no financial i relationships to disclose. Disclosure of Off-Label and/or Investigative Uses I will not discuss off-label or investigational uses in my presentation except to note that CDC recommends off-label administration of 9- valent HPV vaccine to males 16 and older and off-label administration of Tdap to children 7-9 years of age who were not fully immunized with DTaP before age 7. 3
About Dr. LaPorte M.D., University of Michigan Board-certified in Family Medicine U.S. Army Medical Corps, 1974-7676 Vietnamese refugee camp, Fort Chaffee, AR, 1975 Practiced 34 years in Marshall, MN Preceptor - University of Minnesota Family Medicine Residency - Mankato 4
Learning Objectives List the vaccines adolescents should receive and when they should receive them Confidently recommend vaccines to adolescents per the national consensus immunization schedule Select appropriate p tools for making adolescent immunization an integral part of your clinical routine 5
Our Agenda Today Thoughts about vaccination Useful information on adolescent vaccines HPV, meningococcal, Tdap Influenza, childhood catchup Toward higher vaccination rates Strategies to consider 6
Vaccination in Your Practice Adds value to visits made for other reasons Expresses physician s s concern for whole patient, engagement with lifetime journey Vaccine-friendly fi office culture can be cultivated 7
Tdap Vaccination Rates 100% 90% 80% Healthy People 2020 Goal Minnesota vs. US, 2008-2013 2013 70% 60% 50% 40% 30% 20% 10% 0% MN US MN US MN US MN US MN US MN US 2008 2009 2010 2011 2012 2013 9
Meningococcal Vaccination Rates 100% 90% 80% Healthy People 2020 Goal Minnesota vs. US, 2008-2013 2013 70% 60% 50% 40% 30% 20% 10% 0% MN US MN US MN US MN US MN US MN US 2008 2009 2010 2011 2012 2013 10
HPV #1 Vaccination Rates 100% 90% 80% Healthy People 2020 Goal Females, Minnesota vs. US, 2008-2013 2013 70% 60% 50% 40% 30% 20% 10% 0% MN US MN US MN US MN US MN US MN US 2008 2009 2010 2011 2012 2013 11
HPV #3 Vaccination Rates 100% 90% 80% Healthy People 2020 Goal Females, Minnesota vs. US, 2008-2013 2013 70% 60% 50% 40% 30% 20% 10% 0% MN US MN US MN US MN US MN US MN US 2008 2009 2010 2011 2012 2013 12
Current Minnesota Adolescent Rates 100% 90% 80% Males and females, ages 13-17 Per MIIC, February 2015 70% 60% 73% 50% 56% 40% 30% 36% 20% 10% 0% 12% 16% Tdap 1st MCV4 MCV4 Booster 1st HPV 3rd HPV 13
Communicating About Vaccines Provider recommendation predicts acceptance of pediatric vaccination generally [1] HPV vaccination specifically [2,3] Recommendation should be unequivocal and encompass full adolescent platform Use C.A.S.E. method [4] 14
Corroborate CASE C.A.S.E. Method Understand the question Find common ground About Me What Ive I ve done to understand this issue Science On this issue Explain/Advise How this leads to my recommendation 15
Adolescent Vaccination Generally Cost should rarely pose a barrier General vaccination resources: 16 Immunization Adolescent vaccination Pink Book schedule brochure
HPV: Cancer Burden 22,000 vaccine-type* cancers in the U.S. each year Oropharyngeal cancer** 7,000 annual deaths Penile cancer 300 annual deaths 16/18 HPV 16/18 Anal cancer HPV 16/18 900 annual deaths HPV 16/18 All cases [1] Caused by HPV [1] Caused by HPV 16/18 [ ] Cervical Caused by HPV 16/18 cancer [2] 4,000 annual deaths Vulvar cancer 16/18 HPV 16/18 Vaginal cancer 1,000 annual deaths 800 annual deaths 18 *This graphic only accounts for HPV types 16 and 18. **HPV vaccine is not indicated for the prevention of oropharyngeal cancer.
HPV Vaccine: Basics Catchup for women, immunecompromised men, and MSM; OK Best Catchup permissive for other men 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 Recommended schedule in years of age. Give to males and females Dose intervals: 0, 1-2 months, 6+ months 2/2015 ACIP vote changed 6 months to 6+ months 9-valent product: FDA approved 12/2014, ACIP voted to recommend 2/2015 19 Recommendation not official until published Use like quadrivalent product Even though FDA indication is narrower Don t miss opportunities to vaccinate by waiting for 9-valent OK to change products mid-series 9-valent dose(s) for those already fully vaccinated to be discussed in future Possible insurance coverage delay? Consider having patients check with insurers at first
HPV Vaccine: Necessity Pap testing does not substitute for HPV vaccination Not universal Only 73% of women tested [1] Cervical cancer persists in spite of Pap testing Only inspects cervix Doesn t protect males Doesn t protect against cancer at other sites Treats precancer, doesn t prevent infection Trauma Potential complications, cervical incompetence HPV vaccination does not substitute for Pap testing Vaccine does not prevent all oncogenic HPV types 20
HPV Vaccine: Effectiveness Strong performance in clinical trials [1] Vaccine Efficacy against CIN2 CIN3 Genital warts 9 valent 97 100%* 97%* Quadrivalent 100% 97% 96% (women) 90% (men) 96% (women) 90% (men) Bivalent 99% 100% NA Already having impact in the US [2] No evidence of waning immunity i [3,4] Antibody response stronger when given younger [5] *Demonstrated non inferior to quadrivalent product against types 16 and 18; 96.7% effective against CIN 2/3 attributable to additional 5 HPV types. 21
HPV Vaccine: Safety 62 million doses distributed to date in US [1] No association with long-term side effects Large studies of HPV vaccine find no link to serious adverse events [2-6] 22
HPV Vaccine: Potential Concerns Evidence-Based Syncope Can happen with any adolescent vaccination Observe for 15 minutes after any injection Injection site irritation [1] Rumors Impact on sexual activity Medical record indicators of sexual activity not higher among vaccinated girls [3,4] Media reports of HPV vaccine injuries The most common VAERS reports are fueled reported adverse event in by media coverage [5] clinical trials [2] 23
Misperceptions Parents ratings of the importance of vaccinating to prevent certain diseases How health care providers guessed parents would rate them Extremely 10.00 Important 8.0 60 6.0 9.4 9.5 9.5 9.3 9.3 9.2 9.2 9.3 7.0 4.0 5.2 Not Important 2.0 0.0 Meningococcal Hepatitis B Pertussis Influenza HPV 24
Talking About HPV Vaccine Reasons parents don t intend to vaccinate their daughters [1] Safety concerns Vaccine not recommended to them Don t know enough about the vaccine Child isn t sexually active Child is too young Effective provider recommendation can address misconceptions and knowledge gaps In CDC message testing, cancer messages were most powerful 25
Model HPV Conversation 26 More available at www.wevaxteens.org
Model HPV Conversation 27 More available at www.wevaxteens.org
HPV Vaccine: Perspective A conversation about HPV vaccination isn t difficult. A difficult conversation is one I have nearly every week when I have to look a young woman in the eye and tell her she may no longer be able to have children or even worse, that she may die from cervical cancer. That s a difficult conversation. [1] Daron Ferris, MD Professor, Department of OB/GYN Georgia Regents University Cancer Center 28
MCV4 Vaccine: Basics First Dose Booster Dose Permissive Best Option 11 12 13 14 15 16 17 18 19 20 Next Best Last Resort 11 12 13 14 15 16 17 18 19 20 11 12 13 14 15 16 17 18 19 20 First dose at 11-12, booster at 16 If first dose at 13-15, booster at 16-18 If first dose at 16+, no booster Extension for college students Vaccinate patients through age 21 if they will be first- year students living in college dormitories Meningococcal B vaccine Not (yet?) routinely recommended 30
Meningococcal Disease: Severity Meningococcal meningitis and sepsis Carriage common, invasive infections unpredictable About 1000 cases/yr in U.S. [1] Meningitis 9-12% fatal Sepsis up to 40% fatal Up to 20% of survivors have serious sequelae 31
Meningococcal Disease: Minnesota Mankato outbreak,, 1995[1] 9 cases, 1 death, 30,000 vaccinated 2012: 12 known cases invasive disease[2] 32
MCV4 Vaccine: Effectiveness Vaccine effectiveness wanes < 1 year = 95% 1 year = 91% 2-5 years = 58% Dose at 11-12 is important Adolescent platform presents opportunity Patient may not return for booster Booster dose is important Strengthens protection through highest-risk ages (16-21) 33
MCV4 Vaccine: Safety No serious safety concerns Hypothesized link between MCV4 and Guillain-Barré syndrome did not hold up in large study [1] Most common adverse events: Pain/redness at injection site (48%) Fever (3%) Headache/malaise in next 7 days (60%) 34
35 Meningococcal Disease Video
36 Meningococcal Disease Video
Tdap Vaccine: Basics Standard recommendation One dose at 11-12 No minimum interval between Td and Tdap; give adolescent dose of Tdap even if patient received Td recently 38
Tdap Diseases: Severity Pertussis: 48,277 reported pertussis cases in U.S. in 2012 [1] Pneumonia, rib fractures, missed school/work Risk of transmitting to infants can be fatal Tetanus: 37 cases in U.S. in 2012 [1] Not possible to eliminate exposures Diphtheria: i 0 cases in U.S. in 2012 [1] Still circulates in Eastern Europe, sporadic cases elsewhere [3] Confirmed and probable pertussis cases in Minnesota: [2] 2012: 4,144 2013: 865 2014: 1,120 39
Tdap Vaccine: Effectiveness High initial effectiveness 99% of vaccinees have antibodies against all three diseases after 1 year [1] Pertussis immunity wanes [2] Whole-cell vaccine protection was more durable but produced more reactions [3] Steady erosion of immunity each year after acellular vaccine is given 40
Tdap Vaccine: Safety No serious safety concerns Most common adverse events after vaccination Pain/redness (21-66%) Fever (1.4%) Comparable to rates after Td 41
Other Vaccines for Adolescents Influenza Annually Risk-Based Needs PCV13/PPSV23 Travel vaccines Childhood Catchup Hep B (2-3 doses) 2-dose alternative schedule for ages 11-15 MMR (2 doses) Varicella (2 doses) Polio (3+ doses) Hep A (2 doses) 43
45 Materials for Patients
Patient Outreach Strategies for Better Rates Patient education materials Keep on hand Existing communication channels Add immunization info to practice s web site, telephone hold recording, newsletter, Facebook page, etc. Reminder/recall notices Send to patients/parents Make sure MIIC is up to date 46 Clinic Operations Standard work flows Immunization screening At every visit Pop-up EHR reminders can help Routinize screening and administration Vaccination protocols can help Rate assessments Track over time MIIC or EHR All staff on board Everyone with patient contact Designate a vaccine champion Finances Reimbursement analysis Vaccines for Children Program Referral options
Question 1 Should a 10-year-old female be vaccinated against HPV? Choose one: a. Yes, without exception b. This is permissible, but waiting another year is the CDC recommendation c. No, unless she is in a special risk category d. No; vaccine is not licensed for 10-year-olds 48
Question 1 Should a 10-year-old female be vaccinated against HPV? Choose one: a. Yes, without exception b. This is permissible, but waiting another year is the CDC recommendation - CORRECT c. No, unless she is in a special risk category d. No; vaccine is not licensed for 10-year-olds 49
Question 2 What is the adolescent meningococcal vaccine recommendation? Choose one: a. Two doses, two months apart, when the adolescent turns 18 b. One dose just before college c. One dose at age 11-12 12 d. One dose at age 11-12 and a booster at age 16 50
Question 2 What is the adolescent meningococcal vaccine recommendation? Choose one: a. Two doses, two months apart, when the adolescent turns 18 b. One dose just before college c. One dose at age 11-12 12 d. One dose at age 11-12 and a booster at age 16 - CORRECT 51
Question 3 Which adolescents should receive influenza vaccine? Choose one: a. All of them b. Those with high-risk conditions such as asthma c. Those who live in households with infants or elderly people 52
Question 3 Which adolescents should receive influenza vaccine? Choose one: a. All of them - CORRECT b. Those with high-risk conditions such as asthma c. Those who live in households with infants or elderly people 53
Question 4 If an 11-year-old has received Td in the last few years, is Tdap still indicated? Choose one: a. Yes b. Yes, if pertussis incidence is high in the patient s area c. No 54
Question 4 If an 11-year-old has received Td in the last few years, is Tdap still indicated? Choose one: a. Yes - CORRECT b. Yes, if pertussis incidence is high in the patient s area c. No 55
Question 5 A 20-year-old woman with an abnormal Pap associated with HPV16 asks if she would benefit from HPV vaccine. What is your answer? Choose one: a. No; since she is already infected, it s too late. b. Yes, she should receive the bivalent vaccine as it is more potent. c. No, she is too old. d. Yes; she may benefit from protection ti against oncogenic type HPV18 and wart types HPV6 and 11. 56
Question 5 A 20-year-old woman with an abnormal Pap associated with HPV16 asks if she would benefit from HPV vaccine. What is your answer? Choose one: a. No; since she is already infected, it s too late. b. Yes, she should receive the bivalent vaccine as it is more potent. c. No, she is too old. d. Yes; she may benefit from protection ti against oncogenic type HPV18 and wart types HPV6 and 11. - CORRECT 57
Question 6 What is the strongest influence on whether an adolescent is vaccinated? Choose one: a. Financial barriers b. Strength of recommendation by health care provider c. Past history of timely vaccination d. Family s use of alternative medicine 58
Question 6 What is the strongest influence on whether an adolescent is vaccinated? Choose one: a. Financial barriers b. Strength of recommendation by health care provider - CORRECT c. Past history of timely vaccination d. Family s use of alternative medicine 59
Question 6 About what proportion of U.S. females ages 13-17 have received 3 doses of HPV vaccine? Choose one: a. One quarter b. One third c. One half d. Three quarters 60
Question 6 About what proportion of U.S. females ages 13-17 have received 3 doses of HPV vaccine? Choose one: a. One quarter b. One third - CORRECT c. One half d. Three quarters 61
Question 7 A 19-year-old male received HPV dose #1 at age 12. Now what should he do? Choose one: a. Start over with another dose #1 b. Continue with dose #2, then wait 4-6 months for dose #3 c. Forget the whole project d. Continue with dose #2, then wait 1-2 months for dose #3 62
Question 7 A 19-year-old male received HPV dose #1 at age 12. Now what should he do? Choose one: a. Start over with another dose #1 b. Continue with dose #2, then wait 4-6 months for dose #3 - CORRECT c. Forget the whole project d. Continue with dose #2, then wait 1-2 months for dose #3 63
Question 8 Which one has been substantiated as attributable to HPV vaccine? Choose one: a. Sexual promiscuity b. Irregular menstrual periods c. Infertility d. Syncope 64
Question 8 Which one has been substantiated as attributable to HPV vaccine? Choose one: a. Sexual promiscuity b. Irregular menstrual periods c. Infertility d. Syncope - CORRECT 65
Question 9 Which of the following produces lifetime immunity against pertussis? Choose one: a. Whole-cell pertussis vaccine b. Acellular pertussis vaccine c. Natural infection with pertussis d. None of the above 66
Question 9 Which of the following produces lifetime immunity against pertussis? Choose one: a. Whole-cell pertussis vaccine b. Acellular pertussis vaccine c. Natural infection with pertussis d. None of the above - CORRECT 67
Questions and Answers Thank You www.health.state.mn.us/wevaxteens t t t Minnesota county artwork by Todd Pitman