1. HPV Vaccine Recommendations & Current
Issues
Gregory Zimet, PhD
Professor, Department of Pediatrics
Section of Adolescent Medicine
Indiana University School of Medicine

2. Disclosures
 Investigator on HPV-related research grants funded by
Merck’s Investigator-Initiated Science Program

3. Outline
 Current status of HPV vaccine
recommendations
 HPV vaccine safety
 HPV vaccination rates
 Summary & recommendations

4. CURRENT STATUS OF HPV
VACCINE RECOMMENDATIONS

5. HPV Vaccine Licensure: FDA
 Quadrivalent Vaccine
 Females 9-26 years old (licensed in 2006)
 Males 9-26 years old (licensed in 2009)
 Bivalent Vaccine
 Females 9-26 years old (licensed in 2009)

6. ACIP HPV Vaccine
Recommendations for
FEMALES
 Quadrivalent (licensed 2006):
 For prevention of vaginal, vulvar, and cervical precancers and
cancers, genital warts, and anal precancers (AIN 2/3)
 Bivalent (licensed 2009):
 For prevention of vaginal, vulvar, and cervical precancers and
cancers
 Both vaccines:
 Routine administration for 11-12 year old girls
 Administration for 9-10 year old girls at provider’s/parental
discretion
 Administration for 13-26 year old females not previously
vaccinated

7. ACIP HPV Vaccine
Recommendations for
MALES
 Quadrivalent vaccine only:
 2009 – permissive recommendation; 2011 – routine
recommendation
 For prevention of genital warts & anal precancers (AIN 2/3)
 Routine administration for 11-12 year old boys
 Administration for 9-10 year old boys at provider’s/parental
discretion
 Administration for 13-21 year old males not previously
vaccinated
 Males 22-26 may get vaccinated by not strongly recommended
 Men who have sex with men (MSM) should be immunized up to

8. Other Recommendations
 Previous sexual activity not a contraindication
 No testing for prior HPV exposure necessary
 HIV-infected males and females 9-26 should get
3-dose quadrivalent vaccine series
 HPV vaccines can be co-administered during
same visit with other recommended vaccines
(e.g., MCV4; Tdap)

9. Other Recommendations
 Though no known danger exists, HPV vaccine is
not recommended for pregnant women
 Cervical cancer screening recommendations
should be followed regardless of vaccination
status
 No evidence for prevention of penile
cancers, oropharyngeal cancers, or RRP

10. HOT TOPIC #1: SAFETY

11. HPV Vaccines are Safe
 Safety continues to be closely monitored by
several different systems*
 VAERS data to date show no concerns about
safety**
 Study based on over 600,000 doses of vaccine
found no increased risk for***:
 Stroke
 Seizures * Markowitz et al. Vaccine 2010.
** Slade et al. JAMA 2009.
 Allergic reactions *** Gee et al. Vaccine 2011.
 Many other conditions

12. HPV Vaccines are Safe
 Examination of multiple studies that compared
vaccine recipients to placebo recipients*:
 About 22,000 persons in each of the 2 groups
 Severe adverse events examined included: adverse
pregnancy outcomes, immune system
problems, heart problems, and nervous system
problems
 Severe adverse events occurred rarely in both
groups
 NO DIFFERENCE FOUND *Lu et al. BMC Infect Dis 2011.
BETWEEN THE
VACCINE GROUP AND THE CONTROL GROUP

13. HPV Vaccines are Safe
 All of the evidence to date indicates that HPV
vaccination is much safer for children &
adolescents than:
 Playing soccer
 Taking Tylenol (acetaminophen)
 Riding in or driving a car
 Mowing the lawn

14. HOT TOPIC #2: HPV VACCINATION
RATES

15. Indiana: Cervical cancer
summary
 Hispanic women have higher incidence of
invasive cervical cancer compared to other
women
 Black women have higher cervical cancer
incidence and mortality than white women
 Indiana and national rates of cervical cancer
incidence and mortality are roughly equivalent
 Lake county has a cervical cancer death rate
that is nearly twice the national rate
From: Swanson, Weathers, Rakowski. “Cancer Disparities in Indiana:
An Epidemiologic Profile”. IUSCC, IU Public Health, ACS.

16. From: Swanson, Weathers, Rakowski. “Cancer
Disparities in Indiana: An Epidemiologic Profile”.
IUSCC, IU Public Health, ACS.

17. From: Swanson, Weathers, Rakowski. “Cancer
Disparities in Indiana: An Epidemiologic Profile”.
IUSCC, IU Public Health, ACS.

18. 2010 HPV Vaccination Rates for 13-17
year old girls*
80%
70%
60%
73%
50%
58%
40% 49% 1st Dose
3 Doses
30%
34% 37%
20% 29%
10%
0%
U.S. Indiana Rhode Is.
*CDC MMWR 2011.

19. 2009 Indiana HPV Vaccination Rates
for 13-17 year old girls*
60% 1st Dose
50%
40%
52%
30% 37%
31%
20%
10%
0%
Indiana Marion Cty Lake Cty
*CDC MMWR 2010.

20. 2010 Vaccination Rates: Other
findings*
 Indiana is 4th from the bottom in HPV
vaccination
 Male vaccination: Nationally,1%-2% received 1
or more doses
 Meningococcal vaccine
 63% nationally
 71% Indiana
 2007-09 U. Mich. Health Systems
 18% of 19-26 yr old women vaccinated*
*CDC MMWR 2011
 2008 North Carolina Survey Dempsey et al. Vaccine 2011
Reiter et al. Sex Trans Dis 2010
 19% of 10-12 yr old girls vaccinated*

21. Contrasts: Race & Hispanic Ethnicity*
80%
70%
75%
60%
65%
50%
56% White, non-
56%
40% Hisp
46% 49% Black, non-
30% His.
20%
10%
0%
1st Dose Series Completion
*CDC MMWR 2011.

22. Contrasts: Poverty Status*
80%
70%
60% 73%
50% Poverty Level:
57%
At or Above
40% 52%
48%
Below
30%
20%
10%
0%
1st Dose Series Completion
*CDC MMWR 2011.

23. SUMMARY

24. Summary: The good, the bad, and the
ugly
 The good
 HPV vaccines are very effective
 HPV vaccines are very safe
 All 11-12 year olds should be receiving HPV vaccine
 The bad
 The U.S. in general has not done well with HPV
vaccination, particularly with targeted age group
 Indiana is 4th from the bottom of all states in HPV vaccination
rates for 13-17 year old girls
 The ugly
 Completion rates for non-Hispanic Blacks, Hispanics, and those
who fall below the poverty line are unacceptably low

25. Recommendations
 Develop and test new and creative strategies to
increase acceptance of vaccine and reduce
disparities in series completion
 Focus on Lake County
 Look to Rhode
Island, Massachusetts, Washington State, and
South Dakota as examples of fairly successful
HPV vaccination programs