BUST MYTHS WITH FACTS

Transcription

1 Death too early BUST MYTHS WITH FACTS Awkward Conversation Autism HPV FREE IDAHO

2 HPV FREE IDAHO Myth: The HPV Vaccine is Unsafe Tom Patterson, MD, FAAP, FABD

3 Vaccine Safety HPV FREE IDAHO

4 Safety Monitoring

5 VAERS: HPV Vaccine Safety Monitoring Ongoing safety monitoring has shown most reports are non-serious Among 7.6% of reports coded as serious, most frequently cited possible side effects are headache, nausea, vomiting, fever Syncope (fainting) continues to be reported following vaccination among adolescents Adherence to a 15 minute observation period after vaccination is encouraged.

6 Key Findings: CDC & Non-CDC Venous Thromboembolism (VTE) Study evaluating the risk of VTE in vaccinated persons age 9-26 years Found no increased risk of VTE following 4vHPV Autoimmune and neurologic conditions Study addressing concerns about autoimmune and neurologic disease following 4vHPV vaccination. Found no association between 4vHPV vaccination & 16 autoimmune conditions. Injection Site Reactions & Syncope 4vHPV vaccination may be associated with skin infections where the shot is given during the two weeks after vaccination and fainting on the day shot is received. No major safety concerns found HPV FREE ID

7 IOM Review: Syncope & Anaphylaxis IOM reviewed possible associations between 8 vaccines and adverse health events. Key Findings: Evidence favors acceptance of a causal relationship between HPV Vaccine and anaphylaxis (rare) Evidence convincingly supports a causal relationship between the injection of a vaccine and syncope Inadequate evidence was found for causal relationships between HPV vaccination and 12 other specific health events

8 9vHPV Vaccine Safety Seven pre-licensure studies including 15,000 males and females Generally Well Tolerated Adverse event profile similar to that of 4vHPV across age, gender, race, and ethnicity. More injection-site reactions expected among those who receive 9vHPV

9 HPV Vaccine Impact Monitoring Post licensure evaluations are important to evaluate real world effectiveness of vaccines Population impact against early and mid outcomes have been reported: HPV prevalence Australia, Norway, Denmark, Sweden, UK, US Genital Warts Australia, New Zealand, Denmark, Sweden, Germany, Quebec, US Cervical lesions Australia, British Columbia, Denmark, Sweden, US

10 A Parent s Concern and Provider Response HPV FREE IDAHO

11 I have some concerns about the safety of the Vaccine I keep reading things online that says the HPV Vaccination isn t safe. Do you really know if it is safe?

12 It sounds like you are generally in support of vaccines, but you have concerns about the safety of HPV. Is that right? So if you had information that convinced you the HPV vaccine was safe you might consider letting your daughter get it? I d like to share with you what I know about the safety of HPV vaccine

13 I know there are stories in the media and online about vaccines, and I can see how that could concern you. However, I want you to know that HPV vaccine has been carefully studied for many years by medical and scientific experts. Based on all of the data, I believe HPV vaccine is very safe. HPV FREE ID

14 Vaccines, like any medication, can cause side effects. With HPV vaccination this could include pain, swelling, and/or redness where the shot is given, or possibly headache. Sometimes kids faint when they get shots and they could be injured if they fall from fainting. We ll protect your child by having them stay seated after the shot.

15 The HPV Vaccine MUST Be Unsafe Over 200 million doses of HPV vaccine have been distributed worldwide. Over 80 million doses in the US. The safety is continually monitored in 80 countries. No serious safety concerns have been identified.

16 The HPV Vaccine Contains Harmful Ingredients HPV vaccines contain ingredients that have proven to be safe. Aluminum: boosts the body s immune response. Aluminum is also found in breast milk, infant formula, antacids and even fruits and vegetables. HPV FREE IDAHO

17 The HPV Vaccine will cause my child to have problems with infertility.

18 The HPV Vaccine Does NOT Cause Infertility No data to suggest that getting the HPV vaccine will have a negative effect on future fertility. Getting vaccinated and protecting against cervical cancer can help protect a women s ability to get pregnant and have healthy babies.

19 HPV FREE IDAHO Myth: Vaccinate if you are having sex William Atkinson, MD, MPH

20 HPV Vaccine Is Unnecessary Unless You re Sexually Active Does this mean Only sexually active people need to be vaccinated? Wait until sexual activity starts before being vaccinated? My child will not be sexually active until he/she is married and monogamous (so doesn t need the vaccine now)? HPV vaccine may encourage sexual behaviors in my child? HPV FREE

21 Only sexually active people need to be vaccinated HPV FREE

22 Audrey Hepburn, The Nun s Story, 1959 HPV FREE

23 Wait until sexual activity starts before being vaccinated HPV FREE

24 Cohorts Who Had Intercourse Age at Sexual Debut 70% 60% Behavior Reported in an Independent Study 50% 40% 40% 30% 28% 20% 19% 10% 0% 7% 2% 11 or Younger or Older Age at First Intercourse (y) In an analysis of 1552 adolescents and young adults, the subset (n = 1014) featured in this chart reported having engaged in sexual intercourse. The Henry J. Kaiser Family Foundation. national-survey-of-adolescents-and-young-adults.pdf. Accessed April 29, 2016.

25 Percent Percentage of Adolescents Who Have Had Vaginal Sex, By Gender and Age Female Male Age (years) National Survey of Family Growth, Mosher et al., 2005; Vital and Health Statistics: No. 362

26 Cumulative Incidence of Any HPV Infection Months after Sexual Initiation 4 years, > 50% 1 year, 30% Am J Epidemiol, 2003;157(3):218-26

27 When Should the Bike Helmet Go On?

28 When Should You Fasten Your Seat Belt?

29 When Should You Receive MMR Vaccine?

30 Age of Vaccination vs. Age of Exposure Vaccine Age of Vaccination Common Age of Exposure MMR months School-age Varicella months School-age Hepatitis B Birth-6 months Young adulthood* Polio months Child-adult *Perinatal exposure may occur from HBV-infected mother or household contact HPV FREE

31 My child is not sexually active and won t be until he/she is married and monogamous That is true, of course But the same cannot be said for his/her future wife/husband Better be safe than sorry

32 Earlier Vaccination Produces Higher Antibody Levels HPV FREE

33 HPV vaccine may encourage sexual behaviors in my child HPV FREE

34 Risk Homeostasis Theory (RHT) Individuals have innate set points for risk tolerance and that they change their behaviors based on perceived risk in order to maintain their set point According to RHT, then, if an individual believes that a measure protects him/her from a certain risk, then he/she would be more likely to engage in risky behaviors HPV vaccine could cause sexual disinhibition Wilde GJ. Risk homeostasis theory: an overview. Inj Prev 1998; 4:89 91 HPV FREE

35 Meta-analysis of 20 papers examining the relationship between receipt of HPV vaccine and sexual behavior Multiple study designs, populations, definitions and methods 522,000 total participants

36 Summary of Relationship of HPV Vaccination and Sexual Behavior Measure Sexual activity Age of sexual debut Self-reported number of sexual partners Condom use/contraception STI/HIV testing or diagnosis Pregnancy or abortion Difference between Vaccinated and Unvaccinated Groups No difference No difference No difference* No difference No difference No difference *some studies found that vaccinated women had fewer partners than vaccinated women Kasting ML et al. Tempest in a teapot: A systematic review of HPV vaccination and risk compensation research. Human Vaccines & Immunotherapeutics 2016, 12:6:

37 Allaying Parental/Patient Concerns for Not Wanting to Vaccinate Against HPV Vaccinate before exposure to an infection, just as with measles and other childhood vaccines Vaccinate early so your child will have the best protection possible long before the start of any sexual activity Better response in younger adolescents No evidence HPV vaccination increases sexual activity in adolescents

38 HPV FREE IDAHO Break

39 HPV FREE IDAHO Myth: Vaccine is only good for some Banu E. Symington, MD, MACP

40 MYTH: The HPV VACCINE IS RECOMMENDED FOR FEMALES ONLY HPV FREE IDAHO

41 WHY VACCINATE? 1) HPV is a ubiquitous virus that is transmitted by intimate and non-intimate skin to skin contact 2) HPV infection causes cancer 3) HPV infection prevention with vaccine prevents cancer HPV FREE IDAHO

42 HPV infection precedes cancer Most females and males will be infected with at least one type of mucosal 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 Most people will never know that they have been infected Jemal A et al. J Natl Cancer Inst 2013;105:

43 FACT Both males and females can get HPV. It s very common; the CDC estimates that between 80-90% of sexually active people would be infected with at least one type of HPV in their lifetime.11 Although cervical cancer is the most common type of cancer caused by HPV, persistent infection also causes cancers of the tongue and the base of the tonsils. These cancers are becoming more common, especially among men, and may be more common than cervical cancer by HPV can also cause penile and anal cancers affecting men. The HPV vaccine provides protection against most of the genital cancers in men caused by HPV infection.3

44 What cancers are caused by HPV infection?

45 Cancer site Cancers Caused by HPV, U.S. Average number of cancers per year probably caused by HPV Male Female Both Sexes Percentage per year Anus 1,400 2,600 4,000 91% Cervix 0 10,400 10,400 91% Oropharynx 7,200 1,800 9,000 72% Penis % Vagina % Vulva 0 2,200 2,200 69% TOTAL 9,300 17,600 26,900 HPV FREE IDAHO CDC, United States Cancer Statistics (USCS),

46 HPV FREE

47 Every year in the United States 27,000 people are diagnosed with a cancer caused by HPV That s 1 case every 20 minutes

48 HPV infection can cause cancers of the penis, anus, and throat in men and it can also cause genital warts. Getting HPV vaccine today for your son can help prevent the infection that can lead to these diseases.

49 Who should get the HPV vaccines? The FDA has approved Gardasil and Gardasil 9 for use in females ages 9 through 26 for the prevention of HPV-caused cervical, vulvar, vaginal, and anal cancers; precancerous cervical, vulvar, vaginal, and anal lesions; and genital warts. Gardasil and Gardasil 9 are also approved for use in males for the prevention of HPV-caused anal cancer, precancerous anal lesions, and genital warts. Gardasil is approved for use in males ages 9 through 26, and Gardasil 9 is approved for use in males ages 9 through 15. Cervarix is approved for use in females ages 9 through 25 for the prevention of HPV-caused cervical cancer.

50 American Cancer Society s Recommendations: Girls and boys should begin HPV Vaccine series at age 11 or 12, vaccine can be given starting as early as age 9 For the full recommendation visit auses/othercarcinogens/infectiousagen ts/hpv/acs-recommendations-for-hpvvaccine-use Women who have been vaccinated should continue to follow cervical cancer screening recommendations

51 ACIP HPV Vaccination Recommendation initiation of routine HPV vaccination at age 11 or 12 years (the vaccination series can be started beginning at age 9 years) vaccination of females aged 13 through 26 years and of males aged 13 through 21 years who have not been vaccinated previously or who have not completed the 3-dose vaccination series. Males aged 22 through 26 years may be vaccinated. vaccination through age 26 years of men who have sex with men and for immunocompromised persons if not vaccinated previously when the HPV vaccine product previously administered is not known or unavailable or the provider is switching to use of Gardasil 9, any available HPV vaccine product can be used to continue or complete the series for females; Gardasil 9 or Gardasil may be used to continue or complete the series for males HPV FREE

52 HPV Vaccine is Best at Ages 11 or 12 Years While there is very little risk of exposure to HPV before age 13, the risk of exposure increase thereafter.

53 These vaccines are effective! Proportion of Australian born females and males diagnosed as having genital warts at first visit, by age group, Females Males Ali, et al. BMJ 2013

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55 Why Is It Important for More People to be Vaccinated? Vaccination is the approved public health intervention for reducing the risk of developing HPV-associated cancers at sites other than the cervix. The combination of HPV vaccination and cervical screening can provide the greatest protection against cervical cancer. It is important that as many people as possible get vaccinated. Not only does vaccination protect vaccinated individuals against infection by the HPV types targeted by the respective vaccine, but also vaccination of a significant proportion of the population can reduce the prevalence of the vaccine-targeted HPV types in the population, thereby providing some protection for individuals who are not vaccinated (a phenomenon called herd immunity). For example, in Australia, where a high proportion of girls are vaccinated with Gardasil, the incidence of genital warts went down during the first 4 years of the vaccination program among young males who were not being vaccinated at the time as well as among young females (29).

56 Teaching point Certain HPV types can cause cancer of the cervix, vagina, and vulva in females, cancer of the penis in men, and in both females and males, cancers of the anus and the throat. We can help prevent infection with the HPV types that cause these cancers by starting the HPV vaccine series today.

57 People already know about the HPV vaccine. They will ask for it if they want it.

58 It is the providers job to educate about health promoting practices. Parents didn t know their smoking was bad for their kids till we told them. Parents didn t know breastfeeding was good for their kids till we told them. Parents didn t know bike helmets or seat belts were good until we told them. Parents did not know to ask for meningococcal vaccine until recently. Not everyone knows BPA containing plastics cause cancer. It is our job to educate all our patients that there is a cancer prevention vaccine available In fact, it will soon be a quality measure for which we are paid! PS: A patient s MD from Google University does NOT count. HPV FREE IDAHO

59 KNOWLEDGE DOES NOT MEAN ACTION Patients don t generally ask for colonoscopy even when they know it is recommended Patients don t stop smoking even when they know obesity is unhealthy. It is our job to implement recommendations once we have educated. HPV FREE IDAHO

60 Parental awareness of HPV 60% of parents are aware of HPV vaccine. Factors associated with this knowledge: Well baby check in the past 12 months. SO loss of insurance may affect this. Caucasian (tho, this also correlates with refusal of vaccine) Female offspring Past h/o abnormal pap in mom Parental income and education Urban location Areas of opportunity: Non insured Noncaucasion Parents of male kids Women born outside of the US Cutlural sensitivity---radionovelas for Hispanics

61 Reasons parents won t initiate HPV vaccination for children Not sexually active Not recommended Safety concern/side effects Not needed or necessary Lack of knowledge MMWR 2014; 63(29); ; Percent

62 Median Values Value Parents Place on the Vaccines Meningitis Hepatitis Pertussis Influenza HPV Adolescent vaccines Adapted from Healy et al. Vaccine. 2014;32: Parent HPV FREE

63 Median Values Clinicians underestimate the value parents place on HPV vaccine Parent Meningitis Hepatitis Pertussis Influenza HPV Adolescent vaccines Adapted from Healy et al. Vaccine. 2014;32: Provider's estimate 7.8

64 The perceived and real concerns of parents influence how the provider recommends and administers HPV vaccine.

65 Same Way Same Day

66 Make an Effective Recommendation Same way: Effective recommendations group all of the adolescent vaccines Recommend HPV vaccination the same way you recommend Tdap & meningococcal vaccines. Same day: Recommend HPV vaccine today Recommend HPV vaccination the same day you recommend Tdap & meningococcal vaccines.

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68 Your preteen needs three vaccines today to protect against meningitis, HPV cancers, and pertussis. HPV FREE IDAHO

69 HPV vaccination is important because it prevents cancer. That s why I m recommending that your child start the HPV vaccine series today. HPV FREE ID

70 HPV vaccination works best at the recommended ages of 11 or 12 years. That s why I d like for your son to start the HPV vaccine series today.

71 Now that Sophia is 11, she is due for three vaccines. These will help protect her from meningitis, HPV cancers, and pertussis. We ll give those shots at the end of the visit.

72 HPV vaccination is important because it prevents cancer. That s why I m recommending that your child start the HPV vaccine series today. HPV FREE ID

73 Is my child really at risk for HPV?

74 HPV is a very common and widespread virus that infects both females and males. We can help protect your child from the cancers and diseases caused by the virus by starting HPV vaccination today.

75 Why so young? You want to act before exposure. The immune response is better when younger.

76 When should the bike helmet go on? A B C

77 HPV Vaccine Recommendation Girls & Boys can start HPV vaccination at age 9 Preteens should finish HPV vaccine series by 13 th birthday Plus girls years old who haven t started or finished HPV vaccine series Plus boys years old who haven t started or finished HPV vaccine series

78 Most clinicians wait too long to make strong recommendations for HPV vaccine Allison et al.

79 HPV vaccination works best at the recommended ages of 11 or 12 years. That s why I d like for your son to start the HPV vaccine series today.

80 If a parent declines Declination is not final. The conversation can be revisited. End the conversation with at least 1 action you both agree on. Because waiting to vaccinate is the risky choice, many pediatricians ask the parent to sign a Declination Form. HPV FREE IDAHO

81 HPV FREE HPV VACCINE IS CANCER PREVENTION for boys and girls. And YOU are the key!

82 HPV FREE IDAHO Myth: Vaccine does NOT prevent cancer William Atkinson, MD, MPH

83 HPV Infection Most common sexually transmitted disease in the United States Approximately 79 million Americans infected 14 million new infections per year in the U.S. About half occur among persons aged 15 to 24 years Almost all sexually active men and women will be infected at some point in their lives Centers for Disease Control and Prevention. MMWR Morb Mortal Wkly Rep. 2014;63:1-30; Centers for Disease Control and Prevention. Accessed April 29, 2016; National Cancer Institute. Accessed April 29, 2016; National Cancer Institute. Accessed April 29, 2016; Satterwhite CL, et al. Sex Transm Dis. 2013;40: ; Ho GYF, et al. N Engl J Med. 1998;338: HPV FREE

84 HPV Infection 90% of HPV infections cleared by the immune system within 2 years Persistent infection can cause precancer or cancer years later Immunocompromised persons have higher rates of HPV acquisition and progression to disease Centers for Disease Control and Prevention. MMWR Morb Mortal Wkly Rep. 2014;63:1-30; Centers for Disease Control and Prevention. Accessed April 29, 2016; National Cancer Institute. Accessed April 29, 2016; National Cancer Institute. Accessed April 29, 2016; Satterwhite CL, et al. Sex Transm Dis. 2013;40: ; Ho GYF, et al. N Engl J Med. 1998;338: HPV FREE

85 How Vaccines Are Made Step 1: Understand The Disease What organism causes it? Can the organism be grown in a lab? Does infection result in immunity to subsequent infection? What part of the organism produces protective immunity? Can the part that produces immunity be isolated and purified? Step 1 takes years to complete HPV FREE

86 How Vaccines Are Made Step 2: Develop an Experimental Vaccine Usually done by a private company What kind of vaccine should it be? Live or killed? Develop a method to grow the live organism, kill it, or purify the important part Test the new vaccine in animals Step 2 takes months to years to complete HPV FREE

87 How Vaccines Are Made Step 3: Consult with the Food and Drug Administration (FDA) about human trials of the new vaccine Trials are conducted by private companies All vaccine trials are approved and monitored by the FDA HPV FREE

88 How Vaccines Are Made Step 4: Test the vaccine in human volunteers HPV FREE

89 RCT HPV FREE

90 How Do We Know Vaccines Work? The Gold Standard is a randomized, double blind, placebo controlled trial Half the volunteers receive vaccine Half receive an inactive placebo Neither the investigator nor the volunteer knows which product they receive All participants are followed over time and monitored for the development of the condition the vaccine is intended to prevent HPV FREE

91 How Do We Know Vaccines Work? Vaccine Efficacy is the percent reduction in disease in the vaccinated group compared to the placebo group If the vaccine is 100% effective all the disease occurs in the placebo group If the vaccine is 0% effective there is an equal number of cases in both the vaccine and placebo group HPV FREE

92 Vaccine Efficacy Example Protection from Measles after Measles Vaccine Vaccine Recipients 1,000 children 25 (2.5%) develop measles Placebo Recipients 1,000 children 500 (50%) develop measles 50% - 2.5%/50% = 95% reduction in vaccine recipients relative to placebo recipients HPV FREE

93 The HPV vaccine clinical trials were not based on cancer as an outcome How do you know the vaccine will actually prevent cancer?

94 Pagliusi SR. Vaccine 2004;23:569-78

95 What Outcome To Use in HPV Vaccine Efficacy Trials? Consultation on HPV vaccine trials convened by the World Health Organization in 2003 Experts in public health, oncology, epidemiology, national regulatory authorities, industry, and government officials from both developed and developing countries Convened to discuss appropriate endpoint measurements for HPV vaccine efficacy trials Pagliusi SR. Vaccine 2004;23:569-78

96 Possible Endpoints for Clinical Trials Virologic Incident HPV infection Persistent infection good predictor for moderate or high-grade dysplasia and cancer Clinical Cytology - Pap test Histology cervical intraepithelial neoplasia (CIN) CIN1 (mild) - ~60% resolve without treatment CIN2 (moderate) ~25% progress to more severe CIN3 (high-grade) substantial risk for invasive cancer Cancer trials would take many years to complete and not ethical Pagliusi SR. Vaccine 2004;23:569-78

97 WHO Consultation on HPV Vaccine Trial Outcomes Recommendations CIN 2/3 and cancer should be the globally defined endpoint for population-based studies Once the efficacy of a given product using high-grade histology endpoints is demonstrated other surrogate endpoints such as persistent infection may be suitable Recognizing that it will be years before reduction in cervical cancer is detectable at population level it is important to maintain existing cervical screening programs Pagliusi SR. Vaccine 2004;23:569-78

98 USA Today, June 8, 2006

99 Vaccine Efficacy Example Gardasil HPV Vaccine Efficacy Against Precancer Cervical Lesions in Women Years of Age Vaccine Recipients 5,305 women 1 (0.02%) developed CIN 2/3 lesion Placebo Recipients 5,260 women 58 (1.1%) developed CIN 2/3 lesion 1.1% %/1.1% = 98% reduction in vaccine recipients relative to placebo recipients FUTURE II Study. N Engl J Med 2007;356(19): HPV FREE

100 HPV Vaccine Efficacy: Females a End Point CIN 2/3 or AIS Efficacy 4vHPV (95% CI) N = 20,541 Efficacy 2vHPV (96.1% CI) N = 19,778 HPV types 16/18-related 98% ( ) 93% ( ) CIN or AIS HPV types 6/11/16/18 96% ( ) Genital warts HPV types 6/11 99% ( ) a Among 15- to 26-year-old females. AIS = adenocarcinoma in situ; CIN = cervical intraepithelial neoplasia. Cervarix [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; 2011; Gardasil [prescribing information]. Whitehouse Station, NJ: Merck & Co, Inc; HPV FREE

101 9vHPV Vaccine Efficacy in Females Including 5 New HPV Types 31/33/45/52/58 End Point Efficacy 9vHPV a (95% CI) High-grade cervical, vulvar, and vaginal disease b 97% ( ) CIN 2/3 or AIS 96% ( ) CIN1 (mild dysplasia/hpv infection) 99% ( ) Persistent infection 12 months 96% ( ) Reduced incidence of ASC-US HPVrelated Papanicolaou test abnormality Reduced incidence of cervical and external genital biopsy 93% ( ) 97% ( ) a Among 16- to 26-year-old females; b High grade refers to moderate or severe dysplasia. ASC-US = atypical squamous cells of undetermined significance. N Engl J Med. 2015;372: ; HPV FREE

102 4vHPV Vaccine Efficacy: Males a End Point Efficacy 4vHPV (95% CI) N = 4065 Genital warts HPV types 6/11/16/18 89% ( ) AIN 1/2/3 HPV types 6/11/16/18 78% ( ) 9vHPV vaccine has been studied in males aged 9 through 26 years. Immunogenicity was found to be noninferior to that in females and was the basis of current licensure for males 9 through 26 years. a Among 16- to 26-year-old males. AIN = anal intraepithelial neoplasia. N Engl J Med. 2015;372: ; MMWR 2015;64: HPV FREE

103 HPV FREE

104 Cervical Cancer Screening Following HPV Vaccination Continue screening Some cervical cancers caused by HPV types are not prevented by HPV vaccines Sexually active females could have been infected prior to vaccination Educate women about the importance of cervical cancer screening Centers for Disease Control and Prevention. Accessed May 3, HPV FREE

105 HPV Vaccine Efficacy High efficacy among females and males without evidence of infection with vaccine HPV types No evidence of efficacy against disease caused by vaccine types or which participants were infected at the time of vaccination Prior infection with one HPV type did not diminish efficacy of the vaccine against other vaccine HPV types HPV FREE

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