You are the Key to HPV Cancer Prevention Understanding the Burden of HPV Disease and the Importance of the HPV Vaccine Recommendation Speaker Name Speaker Affiliation Event Date of Event Disclosure Slide Objectives Express the importance of HPV vaccination for cancer prevention and the rationale for vaccinating at ages 11 or 12 Demonstrate concrete knowledge of all of the
indications for HPV vaccine for girls and for boys Provide useful and compelling information about HPV vaccine to parents to aid in making the decision to vaccinate Understanding the Burden HPV INFECTION & DISEASE Personal story In my practice, I HPV Infection Almost females and males will be infected with at least one type of HPV at some point in their lives
Estimated 79 million Americans currently infected 14 million new infections/year in the US HPV infection is most common in people in their teens and early 20s Jemal A et al. J Natl Cancer Inst 2013;105:175-201 HPV Transmission HPV exposure can occur with any type of intimate sexual contact Intercourse is not necessary to become infected Nearly 50% of high school students have already engaged in sexual (vaginal-penile) intercourse
1/3 of 9th graders and 2/3 of 12th graders have engaged in sexual intercourse 24% of high school seniors have had sexual intercourse with 4 or more partners Jemal A et al. J Natl Cancer Inst 2013;105:175-201 Infection From Time of First Rapid acquisition of HPV in following sexual debut Sexual Intercourse Study of 18-23 year-old males (n=240)
Study of female college students (N=603) Cumulative Incidence of HPV Infection 1 0.8 0.6 0.4 0.2 0
0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 Months Since First Intercourse From Winer RL, Lee S-K, Hughes JP, Adam DE, Kiviat NB, Koutsky LA. Genital human papillomavirus infection: incidence and risk factors in a cohort of female university students. Am J Epidemiol. 2003;157:218226. Reprinted with the permission of Oxford University Press. HPV is found in virgins Study examined the frequency of vaginal HPV and the association with non-coital sexual behavior in
longitudinally followed cohort of adolescent women without prior vaginal intercourse HPV was detected in 46% of women prior to first vaginal sex 70% of these women reported non-coital behaviors that may in part explain genital transmission Shew, J Infect Dis. 2012 Cervical Cancer Cervical cancer is the most common HPV-associated cancer among women 500,000+ new cases and 275,000 attributable deaths world-wide in 2008 12,000+ new cases and 4,000 attributable deaths in 2011 in the U.S.
25.9% cervical cancers occur in women who are between the ages of 35 and 44 14% between 20 and 34 23.9% between 45 and 54 HPV-Associated Cervical Cancer Rates by State, United States, 2009 United States Cancer Statistics: 19992009 Incidence and Mortality Web-based Report. Atlanta (GA): DHHS, CDC, and NCI; 2013. Available at: http://www.cdc.gov/uscs. HPV-Associated Cervical Cancer Rates by Race and Ethnicity, United States, 20042008 Jemal A et al. J Natl Cancer Inst 2013;105:175-201
Annual Report to the Nation on the Status of Cancer: HPV-Associated Cancers From 2000 to 2009, oral cancer rates increased 4.9% for Native American men 3.9% for white men 1.7% for white women 1% for Asian men Anal cancer rates doubled from 1975 to 2009 Vulvar cancer rates rose for white and AfricanAmerican women Penile cancer rates increased among Asian men 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=9312 n=11279 Jemal A et al. J Natl Cancer Inst 2013;105:175-201
HPV-Associated Oropharyngeal Cancers Prevalence increased from 16.3% (1984-89) to 71.7% (2000-04) Population-level incidence of HPV-positive cancers increased by 225% while HPV-negative cancers declined by 50% If trends continue, the annual number of HPV-positive oropharyngeal cancers is expected to surpass the annual number of cervical cancers by the year 2020 Chaturvedi, 2011, J Clin Oncol- data from SEER Economic Impact Related to HPV-Associated Disease, 2010 Event
Cost ($ billions) Cervical cancer screening* Cervical cancer Other anogenital cancers Oropharyngeal cancer Anogenital warts RRP** TOTAL 6.6 0.4 0.2 0.3 0.3 0.2
8.0 *Cervical cancer screening costs: ~ 80% routine screening, ~20% follow-up **RRP costs: ~ 70% juvenile-onset, ~ 30% adult-onset Chesson H et al. Vaccine 2012;30: 6016-19 RRP: recurrent respiratory papillomatosis Complications related to current methods of cervical cancer prevention Infertility due to treatment of cervical cancer by hysterectomy Cervical conization and loop electrosurgical excision procedure (LEEP) procedures associated with adverse obstetric morbidity Subsequent pregnancies are at risk of Perinatal mortality Severe and extreme preterm delivery (<32/34 or <28/30 weeks)
Severe and extreme low birth weight (< 2000g or 1500g) These outcomes have a considerable impactnot only on the mothers and infants concernedbut also on the cost of neonatal intensive care Recommendations, Safety, Impact, & Coverage Rates HPV VACCINE HPV Prophylactic Vaccines Recombinant L1 capsid proteins that form virus like particles (VLP) Non-infectious and nononcogenic Produce higher levels of
neutralizing antibody than natural infection HPV VLP HPV Vaccine Quadrivalent/HPV4 (Gardasil) Merck 6, 11, 16, 18 Females: Anal, cervical, vaginal and vulvar precancer and cancer; Genital warts Males: Anal precancer and cancer; Genital warts Pregnancy
Hypersensitivity to yeast 3 dose series: 0, 2, 6 months Name Manufacturer Types Indications Contraindications Schedule (IM) Bivalent/HPV2 (Cervarix) GlaxoSmithKline 16, 18 Females: Cervical precancer and
cancer Males: Not approved for use in males Pregnancy Hypersensitivity to latex (latex only contained in pre-filled syringes, not single-dose vials) 3 dose series: 0, 1, 6 months Evolution of recommendations for HPV vaccination in the United States Quadrivalent Quadrivalent or Bivalent Routine, females 11 or 12 yrs*
and 13-26 yrs not previously vaccinated Routine, females 11 or 12 yrs* and 13-26 yrs not previously vaccinated Quadrivalent Quadrivalent May be given, males 9-26 yrs* Routine, males 11 or 12 yrs* and 13-21 yrs not previously vaccinated May be given, 22-26 yrs**
June October 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 21 ACIP Recommendation and AAP Guidelines for HPV Vaccine
Routine HPV vaccination recommended for both males and females ages 11-12 years Catch-up ages 13-21 years for males; 13-26 for females Permissive use ages 9-10 years for both males and females; 22-26 for males Recommendation for Females Either bivalent HPV vaccine (Cervarix) or quadrivalent HPV vaccine (Gardasil) recommended for girls at age 11 or 12 years for prevention of cervical cancer and precancer Also for girls 13 through 26 who havent started or completed series Only quadrivalent HPV vaccine (Gardasil) also for
prevention of vaginal, vulvar, and anal cancers, as well as genital warts. Recommendation for Males Quadrivalent HPV vaccine (Gardasil) recommended for boys at age 11 or 12 years for prevention of anal cancer and genital warts Also for boys 13 through 21 who havent started or completed series Young men, 22 through 26 years of age, may get the vaccine Teen boys through age 26 who identify as gay or bisexual and havent started or completed series should be vaccinated
HPV Vaccine Safety The most common adverse events reported were considered mild For serious adverse events reported, no unusual pattern or clustering that would suggest that the events were caused by the HPV vaccine These findings are similar to the safety reviews of MCV4 and Tdap vaccines 57 million doses of HPV vaccine distributed in US since 2006 HPV Vaccine Safety Data Sources Post-licensure safety data (VAERS)1 Post-licensure observational comparative studies (VSD)2 Ongoing monitoring by CDC and FDA
Post-licensure commitments from manufacturers Vaccine in pregnancy registries Long term follow-up in Nordic countries Official reviews WHOs Global Advisory Committee on Vaccine Safety 3 Institute of Medicines report on adverse effects and vaccines, 2011 4 Vaccine Adverse Events Reporting System, http://vaers.hhs.gov/index Vaccine Safety Datalink, http://www.cdc.gov/vaccinesafety/Activities/VSD.html 3 http://www.who.int/vaccine_safety/Jun_2009/en/ 4http://www.iom.edu/Reports/2011/Adverse-Effects-of-Vaccines-Evidence-and-Causality.aspx 1 2
HPV Vaccine Impact: HPV Prevalence Studies NHANES Study National Health and Nutrition Examination Survey (NHANES) data used to compare HPV prevalence before the start of the HPV vaccination program with prevalence from the first four years after vaccine introduction In 14-19 year olds, vaccine-type HPV prevalence decreased 56 percent, from 11.5 percent in 2003-2006 to 5.1 percent in 2007-2010 Other age groups did not show a statistically significant difference over time The research showed that vaccine effectiveness for prevention of infection was an estimated 82 percent Cummings T, Zimet GD, Brown D, et al. Reduction of HPV infections through
vaccination among at-risk urban adolescents. Vaccine. 2012; 30:5496-5499. HPV Vaccine Impact: HPV Prevalence Studies, continued Clinic-Based Studies Significant decrease from 24.0% to 5.3% in HPV vaccine type prevalence in at-risk sexually active females 14-17 years of age attending 3 urban primary care clinics from 1999-2005, compared to a similar group of women who attended the same 3 clinics in 2010 Significant declines in vaccine type HPV prevalence in both vaccinated and unvaccinated women aged 13-26 years who attended primary care clinics from 2009-2010 compared to those from the pre-vaccine period (20062007) Kahn JA, Brown DR, Ding L, et al. Vaccine-Type Human Papillomavirus and Evidence of
Herd Protection After Vaccine Introduction. Pediatrics. 2012; 130:249-56. HPV Vaccine Impact: Genital Warts Studies Ecologic analysis used health claims data to examine trends in anogenital warts from 2003-2010 among a large group of private health insurance enrollees The study found significant declines after 2007 in females aged 15-19 year (38% decrease from 2.9/1000 PY in 2006 to 1.8/1000 PY in 2010) Smaller declines were observed among those 21-30 years but not in those over 30 years A similar study evaluated genital wart trends in males and females attending public family planning clinics and found Significant decrease of 35% (.94% to .61%) in females under 21 years of age
and a 19% decrease in males less than 21 years No decreases were reported in the older males or females HPV Vaccine Impact: High HPV Vaccine Coverage in Australia 80% of school-age girls in Australia are fully vaccinated High-grade cervical lesions have declined in women less than 18 years of age For vaccine-eligible females, the proportion of genital warts cases declined dramatically by 93% Genital warts have declined by 82% among males of the same age, indicating herd immunity Garland et al, Prev Med 2011
Ali et al, BMJ 2013 International uptake of 3 doses HPV vaccine 90 80 70 60 50 40 30 20 10 0 Australia
UK Canada Netherlands Brotherton, Lancet 2011; Cuzick BJC 2010; Ogilvie et al., 2010; Marc et al., 2010, NIS-Teen 2011 USA National Estimated Vaccination Coverage Levels among Adolescents 13-17 Years, National Immunization Survey-Teen, 2006-2012 90 80
26 32 1 HPV 3 HPV Boys Why We Need to Do Better in HPV Vaccination of 12 year olds Currently 26 million girls <13 yo in the US; If none of these girls are vaccinated then: 168,400 will develop cervical cancer and 54,100 will die from it Vaccinating 30% would prevent 45,500 of these
cases and 14,600 deaths Vaccinating 80% would prevent 98,800 cases and 31,700 deaths For each year we stay at 30% coverage instead of achieving 80%, 4,400 future cervical cancer cases and 1400 cervical cancer deaths will occur. 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
Vaccine Missed opportunity: Encounter when some, but not all ACIP-recommended vaccines are given. HPV-1: Receipt of at least one dose of HPV. Actual Achievable Avoid Missed Opportunities HPV vaccine can safely be given at the same time as the other recommended adolescent vaccines Provide HPV vaccine during routine sports, or camp physicals Review immunization record even at acute care visits Encourage parents to keep accurate vaccination records
and to review the immunization schedule Systems interventions depend on clinician commitment- determine what would work best for YOUR practice The Perfect Storm Why is HPV vaccine different? HPV vaccine issues sensationalized by popular media Different reasons for why some girls and boys dont get the first
shot and why some dont finish all 3 shots Parents think sexuality instead of cancer prevention Some clinicians arent giving strong recommendations Parents have questions that are seen as hesitation by some doctors Phased girls-then-boys recommendations initially confusing to parents Systems interventions to improve coverage rates depend on clinician commitment Talking about HPV vaccine FRAMING THE CONVERSATION Whats in a recommendation? Studies consistently show that a strong recommendation from you is the single best
predictor of vaccination In focus groups and surveys with moms, having a doctor recommend or not recommend the vaccine was an important factor in parents decision to vaccinate their child with the HPV vaccine Not receiving a recommendation for HPV vaccine was listed a barrier by mothers Strength of HPV Vaccine Recommendation for Female Patients, Pediatricians and Family Physicians (N=609) Allison et al. https://cdc.confex.com/cdc/nic2011/webprogram/Paper25181.html
Just another adolescent vaccine Successful recommendations group all of the adolescent vaccines Recommend the HPV vaccine series the same way you recommend the other adolescent vaccines Moms in focus groups who had not received a doctors recommendation stated that they questioned why they had not been told or if the vaccine was truly necessary Many parents responded that they trusted their childs doctor and would get the vaccine for their child as long as they received a recommendation from the doctor Top 5 reasons for not vaccinating daughter, among parents with no intention to vaccinate in the next 12 months, NIS-Teen
2012 Not sexually active Lack of knowledge Safety concerns/side effects Not recommended by provider Not needed or necessary** 0 5 Percent * Not mutually exclusive. ** Did not know much about HPV or HPV vaccine. 10
15 20 25 Try saying: Your child needs three shots today: HPV vaccine, meningococcal vaccine and Tdap vaccine. You child will get three shots today that will protect him/her from the cancers caused by HPV, as well as prevent tetanus, diphtheria, pertussis and meningitis. A case of vaccine hesitancy? Parents may be interested in vaccinating, yet still
have questions Many parents didnt have questions or concerns about HPV vaccine A question from a parents does not mean they are refusing or delaying Taking the time to listen to parents questions helps you save time and give an effective response CDC research shows these straightforward messages work with parents when discussing HPV vaccineand are easy for you or your staff to deliver An anti-cancer vaccine The HPV vaccine is cancer prevention message resonates strongly with parents In focus groups and online panels, mothers wanted
more information on the types of HPV cancers In focus groups mothers stated they were influenced to vaccinate their child because HPV vaccine prevents cancer, they had a family history of gynecological cancers (cervical, ovarian), and/or because they had a personal experience with cervical cancer Try saying: HPV vaccine is very important because it prevents cancer. I want your child to be protected from cancer. Thats why Im recommending that your daughter/son receive the first dose of the HPV vaccine series today.
Tell me doctor, how bad is it? Disease prevalence is not understood, and parents are unclear about what the vaccine actually protects against Parents in focus groups knew HPV vaccine can prevent cervical cancers, however they lacked knowledge about indications for HPV vaccine other than cervical cancer for girls, all HPV vaccine indications for boys, and the recommended ages to receive HPV vaccine Try saying: HPV can cause cancers of the cervix, vagina, and vulva in women, cancer of the penis in men, and cancers of the anus and the mouth or throat in both
women and men. There are about 26,000 of these cancers each year and most could be prevented with HPV vaccine. There are also many more precancerous conditions requiring treatment that can have lasting effects. Why at 11 or 12 years old? Parents want a concrete reason why 11-12 year olds should receive HPV vaccine In audience research with moms, almost all respondents were unaware of the correct age range the vaccine was recommended Respondents also missed the concept of vaccinating before sexual activity
Rationale for vaccinating early: Protection prior to exposure to HPV 82% 18 to 24 Markowitz MMWR 2007; Holl Henry J Kaiser Found 2003; Mosher Adv Data 2006 Try saying: We're vaccinating today so your child will have the best protection possible long before the start of any kind of sexual activity. We vaccinate people well before they are exposed to
an infection, as is the case with measles and the other routinely recommended childhood vaccines. Similarly, we want to vaccinate children long before they are exposed to HPV. A green light for sexual activity? Parents may be concerned that vaccinating may be perceived by the child as permission to have sex In focus groups, some parents expressed concern that in getting HPV vaccine for their child, they would be giving their child permission to have sex This was one of the top four reasons respondednts gave when asked why they would not vaccinate their daughter A few parents expressed that while they wanted their child to wait to have sex they understood that might
not be the case Receipt of HPV vaccine does not increase sexual activity or decrease age of sexual debut Kaiser Permanente Center for Health Research 1,398 girls who were 11 or 12 in 2006, 30% of whom were vaccinated, followed through 2010 No difference in markers of sexual activity, including pregnancies counseling on contraceptives testing for, or diagnoses of, sexually transmitted infections Bednarczyk Pediatrics Oct 2012
Try saying: Multiple research studies have shown that getting the HPV vaccine does not make kids more likely to be sexually active. These studies have also shown that getting the HPV vaccine does not make kids more likely to start having sex a younger age. But shes too young! Parents might believe their child won't be exposed to HPV because they aren't sexually active or may not be for a long time In focus groups, some moms couldnt understand how their child could become infected even if they waited until marriage to have sex
Some moms stated that they didnt think HPV infection was very common because they had never heard that it was or didnt know anyone who had an HPV infection or HPV disease Try saying: Even if your child waits until marriage to have sex or only has one partner in the future, he/she could still be exposed if his/ her future partner has engaged in any type of sexual activity with another person. We dont wait until exposure occurs to give any other routinely recommended vaccine. HPV vaccine is also given when kids are 11 or 12 years old because it produces a better immune response at that age. Thats why it is so important to start the shots now and finish them in the next 6 months.
Would you give it to your child? Emphasizing your personal belief in the importance of HPV vaccine helps parents feel secure in their decision Some respondents in focus groups stated that they would feel more comfortable knowing that the doctor had vaccinated their own child or was planning to (if the child was <11) Respondents in an online survey stated that knowing that oncologists supported the recommendation made them more likely to get their child vaccinated Try saying: I strongly believe in the importance of this cancerpreventing vaccine. I have given HPV vaccine to my son/daughter (or
grandchild/niece/nephew/friend's children). Experts, such as the American Academy of Pediatrics, cancer doctors, and the CDC, also agree that getting the HPV vaccine is very important for your child. Scared of side effects Understanding that the side effects are minor and emphasizing the extensive research that vaccines must undergo can help parents feel reassured Moms in focus groups stated concerns about both short term and long term vaccine safety as a reason that they would not vaccinate their child Respondents were not aware that HPV vaccine was tested in adolescents and adults and were concerned
that their childs fertility could be affected by the vaccine Try saying: HPV vaccine has been very carefully studied by scientific experts and its safety is continually monitored. This is not a new vaccine and for years HPV vaccine has been shown to be very effective and very safe. HPV vaccine has a similar safety profile to the meningococcal and Tdap vaccines. Like other shots, side effects can happen, but most are mild, primarily pain or redness in the arm. This should go away quickly, and HPV vaccine has not been associated with any long-term side effects. Try saying: Since 2006, about 57 million doses of HPV vaccine have been
distributed in the U.S., and in the years of HPV vaccine safety studies and monitoring, no serious safety concerns have been identified. There is no data to suggest that getting HPV vaccine will have an effect on future fertility. However, HPV can cause cervical cancer and the treatment of cervical cancer can leave women unable to have children. Even treatment for cervical pre-cancer can put a woman at risk for problems with her cervix during pregnancy which could cause preterm delivery or problems. When do we come back? Many parents do not know that the full vaccine series requires 3 shots Your reminder will help them to complete the series In focus groups, most respondents did not know
the dosing schedule for HPV vaccine Try saying: I want to make sure that your son/daughter receives all 3 shots of HPV vaccine to give them the best possible protection from cancer caused by HPV. Please make sure to make appointments for the second and third shots on the way out, and put those appointments on your calendar before you leave the office today! How Can Clinicians Help? 1. Give a STRONG recommendation Ask yourself, how often do you get a chance to prevent cancer?
2. Start conversation early and focus on cancer prevention Vaccination given well before sexual experimentation begins Better antibody response in preteens 3. Offer a personal story Own children/Grandchildren/Close friends children HPV-related cancer case 4. Welcome questions from parents, especially about safety Remind parents that the HPV vaccine is safe and not associated with increased sexual activity Provider and Parent
HPV VACCINE CONVERSATIONS Is she really too young? Take 1 (a conversation you may be familiar with) Doctor: Meghan is due for some shots today: Tdap and the meningococcal vaccine. There is also the HPV vaccine Parent: Why does she need an HPV vaccine? Shes only 11! Doctor: We want to make sure she gets the shots before she becomes sexually active. Parent: Well I can assure you Meghan is not like other girlsshes a long way off from that! Doctor: We can certainly wait if that would make you feel more comfortable. A Strong Recommendation at 11 Doctor: Meghan is due for some shots today: HPV, meningococcal vaccine, and Tdap.
Parent: Why does she need an HPV vaccine? Shes only 11! Doctor: HPV vaccine will help protect Meghan from cancer caused by HPV infection. And I want to make sure Meghan receives all 3 doses and develops protection long before she becomes sexually active. Parent: But it just seems so young Doctor: We dont wait until exposure occurs to give any other routinely recommended vaccine. HPV vaccine is also given when kids are 11 or 12 years old because it produces a better immune response at that age. Thats why it is so important to start the shots now and finish them in the next 6 months. Questions Should Be Encouraged, Not Interpreted as Refusal Doctor: Olivia needs her Tdap and meningococcal vaccines today. We could also give her the HPV vaccine.
Parent: Do you think she needs all of those today? Cant we just skip the HPV one? Im not sure she really needs that anyway. Doctor: Sure, we can wait until her next visit to give her that one. How to respond to Mom Doctor: Olivia needs the HPV, meningococcal, and Tdap vaccines today. Parent: Do you think she needs all of those today? Cant we just skip the HPV one? Im not sure she really needs that anyway. Doctor: HPV vaccination is very important to help prevent cancer caused by HPV infection. I want to help protect Olivia from cancer and I know you want that too. Thats why Im recommending that Olivia receive the first dose of HPV vaccine today. Parent: I didnt realize that.
Doctor: Shell need to come back in for the next 2 doses of the HPV vaccine for full protection. Please make your appointments at the front desk for the 2nd and 3rd doses of the HPV vaccine. What about boys? Take 1 Doctor: Henry is due for 3 vaccinations today: Tdap, MCV4 and HPV vaccine. Parent: Why does he need HPV vaccine- isnt that just for girls? Doctor: It could help protect his partners in the future. Parent: That seems like the girls responsibility. Henry is a nice boyif nothing will happen to him, then why bother? Doctor: Its completely up to you. Get it for your son, take 2
Doctor: Henry is due for 3 vaccinations today: Tdap, MCV4 and HPV vaccines. Parent: Why does he need HPV vaccine- isnt it just for girls? Doctor: Boys should also get HPV vaccine when they are 11 or 12 years old. HPV causes cancers in men too. Over 7000 men each year develop a cancer of the mouth, tongue or throat that is caused by HPV, and this number is rising. HPV also causes cancer of the penis and anus. Parent: Wow, I had no idea. Yes, lets him that one too! Doctor: Henry will need to come back for the second and third shotsmake an appointment today for those visits. For more information, including free resources for yourself and your patients, visit: cdc.gov/vaccines/teens Email questions or comments to
CDC Vaccines for Preteens and Teens: [email protected] Tell parents that almost everyone gets HPV and HPV can cause a variety of cancers in women and men Remind parents that vaccine is for cancer prevention HPV Provide a strong recommendation for HPV vaccine when patients are 11 or 12 years old Listen carefully to and welcome patient and parent questions especially about safety
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