HPV Vaccine Recommendations & Current Issues

Gregory Zimet, PhD

Professor, Department of Pediatrics

Section of Adolescent Medicine

Indiana University School of Medicine

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

Disclosures

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)

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 forFEMALES

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 26 years

ACIP HPV Vaccine Recommendations forMALES

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 Allergic reactions Many other conditions

* Markowitz et al. Vaccine 2010.** Slade et al. JAMA 2009.*** Gee et al. Vaccine 2011.

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 BETWEEN THE VACCINE GROUP AND THE CONTROL GROUP

*Lu et al. BMC Infect Dis 2011.

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*

U.S. Indiana Rhode Is.0%

10%

20%

30%

40%

50%

60%

70%

80%

1st Dose3 Doses

49%

*CDC MMWR 2011.

34% 37%

29%

73%

58%

2009 Indiana HPV Vaccination Rates for 13-17 year old girls*

Indiana Marion Cty Lake Cty0%

10%

20%

30%

40%

50%

60%1st Dose

37%

*CDC MMWR 2010.

52%

31%

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*

2008 North Carolina Survey 19% of 10-12 yr old girls vaccinated*

*CDC MMWR 2011 Dempsey et al. Vaccine 2011 Reiter et al. Sex Trans Dis 2010

Contrasts: Race & Hispanic Ethnicity*

1st Dose Series Completion0%

10%

20%

30%

40%

50%

60%

70%

80%

White, non-Hisp46%

*CDC MMWR 2011.

49%

56%

75%

65%

56%

Contrasts: Poverty Status*

1st Dose Series Completion0%

10%

20%

30%

40%

50%

60%

70%

80%

At or Above

Below48%

Poverty Level:

*CDC MMWR 2011.

52%

73%

57%

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