The HPV Vaccine: A Sheep in Wolf's Clothing

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1 The HPV Vaccine: A sheep in wolf s clothing Jessica Francis, MD Medical College of Wisconsin

2 Nothing to disclose Disclosures

3 Objectives To review the effects of HPV To review recommendations regarding vaccination To review and debunk myths regarding the HPV vaccine To establish useful talking points for counseling patients

4 What is HPV? The most sexually transmitted infection in the US 6.2 million infected every year There are many types, divided into the cutaneous and mucosal types Mucosal types are found in the anogenital and aerodigestive tracts Over 100 types have been identified, and at least 30 of those can infect the genital tract Emans, 2012

5 What is HPV? Subtypes are divided into low risk and high risk Low risk correlates with a risk of genital condyloma acuminata Subtypes 6 and 11 are responsible for approximately 90% of genital warts Warts are not precancerous, but can negatively affect a patients quality of life Itching, bleeding, distortion of anatomy, psychosocial stress Morbidity can be quite significant in immunocompromised patients

6 What is HPV? High risk subtypes are responsible for the majority of lower genital tract cancers Cervical, vaginal, and vulvar Subtypes 16 ad 18 are responsible for approximately 70% of cervical cancers

7 What is HPV? Both types can regress spontaneously, but persistence is associated with development of genital warts as well as cervical dysplasia and possibly cervical cancer HPV is found in approximatley 99.7% of cervical cancer tissue specimens Also found in other anogenital, oropharyngeal, tongue, and esophageal cancers

8 What is HPV? Vertical transmission is possible HPV identified on the skin of 50 70% of healthy infants from 1 4 mo of age Can result in respiratory papillomas and vulvar/anal condyloma Development of condyloma after the age of 3 is rarely due to vertical transmission and should raise a red flag Antonsson A, 2003; Hammerschlag, 1998

9 The HPV Vaccine In June 2006, the quadrivalent HPV vaccince was licensed for use among females aged 9 26 years In october 2009, the bivalent HPV vaccine was licensed for use in females aged years Studies have shown high efficacy for prevention of vaccine associated HPV type infections, CIN, and external genital lesions. MCKee, 2015

10 The 9 valent HPV vaccine Feb 2015 the ACIP (Advisory Committee on Immunization Practices) recommended this as one of three HPV vaccines that can be used for routine vaccination Approved by FDA in Dec 2014 Ages in females and in males Age 26 in men who have sex with men Age 26 in immunocompromised

11 The HPV Vaccine There is no evidence to suggest clearance of infection in patients positive for a specific vaccine HPV type prior to vaccination Duration of protection unknown There is no known minimal titer determined to be protective May be determined in the future after ongoing follow up

12 Routine vaccination and catch up vaccination Routine vaccination recommended at age 11 or 12 with three doses Can start as early as 9 years Recommended for ages in females who have not already been vaccinated or have not completed the series If a female reaches age 26 prior to completion, remaining doses should be given

13 Routine and catch up vaccination Ideally administered prior to exposure Minimum interval between first and second dose is 4 weeks Minimum interval between second and third dose is 12 weeks Minimum interval between first and third is 24 weeks Doses received after shorter interval should be repeated

14 Routine and catch up vaccination If series is interrupted, do not need to restart Can be coadministered with other vaccines, as this is not a live vaccine Ideally the same vaccine should be used for the entire series If not possible or known, complete with what you have access to

15 Special considerations Not recommended for use in pregnant women No pregnancy test needed prior to administration No intervention needed if found to be pregnant Can be administered in immunocompromised Response may not be as great Contraindicated if history of hypersensitivity to components Baker s yeast latex

16 What s going on in the media

17 What s going on in the media

18 What s going on in the media

19 Addressing concerns in the clinic Are children dying from this vaccine? 7 clinical trials including 11,778 in vaccine group; 9,686 in placebo group 10 persons who received HPV vaccine and 7 persons in control group died during these trials 2 in HPV group and 1 in placebo group died within 15 days of vaccine administration 7 MVA (4/3) 3 intentional overdose (1/2) 2 PE/DVT (1/1) 2 Sepsis (2/0) 1 Asphyxia (0/1)

20 Addressing concerns in the clinic Does this vaccine trigger autoimmune disease? Emergence of autoimmune diseases is not uncommon in the age group undergoing vaccination While a temporal association could be made, no causal association has been identified Registry based cohort study of 997,585 girls aged in Denmark and Sweden compared AEs in 296,826 girls receiving the quadrivalent HPV vaccine to AEs in unvaccinated girls and did not find evidence to support an association between the vaccine and autoimmune, neurologic, or VTE AEs. In US study, 9/3 had new autoimmune condition dx within 4 years of administration follow up Goncalves, 2014; Arnheim, 2013

21 Addressing concerns in the clinic Don t vaccines give kids autism? More specifically the MMR vaccine Extensively evaluated by the NIH and no causal relationship identified 22 independent studies reviewed to make this determination Thought to be related to thimerosal, which is not present in the HPV vaccines Taylor, 2014

22 Addressing concerns in the clinic I don t want my child to think it is ok to start having sex The disinhibition effect FRC and FOF very vocal but ultimately the message is: The HPV vaccine does not, in any circumstance, negate or substitute God s plan for sexuality, which is sexual abstinence until marriage an sexual faithfulness within marriage

23 Addressing concerns in the clinic Well then, what are the side effects? Injection site reaction (pain, swelling, redness Fever, nausea, vomiting, dizziness, myalgia, diarrhea Headache, hypertension, gastroenteritis, and bronchospasm reported in less than 0.5% of cases There are NO absolute contraindications so far to the use of these vaccines

24 References Antonsson A, et al, J Clin Microbiol 2003;41(6): Arnheim Dahlstrom L, et al. Autoimmune, neurological. Ad venous thromboembolic adverse events afer immunisation of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: cohort study. BMJ 2013; 347: f5906. Goncalves AK, et al. Safety, tolerability, and side effects of human papillomavirus (HPV) vaccines: a systematic quantitative review. Braz J Infect Dis. Epub April 27, Hammerschlag MR. Sex Transm Infect 1998; 74(3): McKee, SJ, Bergot A, Leggatt, GR. Recent progressin vaccination against human papillomavirus mediated cervical cancer. Rev. Med.Virol. 2015;25: Taylor LE, Swerdfeger AL, Eslick GD. Vaccines are not associated with autism: an evidence based metaanalysis of case control and cohor studies. Vaccine June 17;32(29):3623 9