HPV Vaccine Recommendations & Current
Issues




             Gregory Zimet, PhD

         Professor, Department of Pediatrics
           Section of Adolescent Medicine
        Indiana University School of Medicine
Disclosures


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

 Current status of HPV vaccine
  recommendations
 HPV vaccine safety
 HPV vaccination rates
 Summary & recommendations
CURRENT STATUS OF HPV
VACCINE RECOMMENDATIONS
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)
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
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
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)
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
HOT TOPIC #1: SAFETY
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
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
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
HOT TOPIC #2: HPV VACCINATION
RATES
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.
From: Swanson, Weathers, Rakowski. “Cancer
Disparities in Indiana: An Epidemiologic Profile”.
IUSCC, IU Public Health, ACS.
From: Swanson, Weathers, Rakowski. “Cancer
Disparities in Indiana: An Epidemiologic Profile”.
IUSCC, IU Public Health, ACS.
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.
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.
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*
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.
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.
SUMMARY
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
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

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HPV Vaccination Recommendation

  • 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.
  • 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