HPV Vaccination Recommendation Update: 2 doses or 3?

Debbie Saslow, PhD │ Senior Director, HPV-related and Women’s Cancers

American Cancer Society

Learning Objectives

New schedule and intervals: 2- vs 3-dose

Why age 11-12

Strong recommendation

Change to 2 Doses

Data from all 3 HPV vaccines

Immunogenicity only

Approved by FDA (October)

Recommended by ACIP (October)

Approved by CDC (October)

Publication in MMWR (December)

The Studies

Vaccine Duration of Data # of Studies

2-valent 5 years 4

4-valent 3 years 2

9-valent 1 year 1

*Antibody response is NOT as strong if the 2 doses are given less than 5 months apart!

The Evidence: 9-valent

# Subjects Participants Schedule of Doses Findings

300 Male & Female 0, 12 months Antibody response 2-3 times higher for each HPV type300 Male 0, 6 months

300 Female 0, 6 months

300 Female 0, 1-2, 6 months Control

*Antibody response is NOT as strong if the 2 doses are given less than 5 months apart!

Recommendation

1st dose at 11-12 years old.

2nd dose 6-12 months after 1st dose.

If 1st dose given ≥15, need 3 doses.

If 2nd dose already given before 15th

birthday and <5 months after 1st dose, need 3rd dose.

For people with weakened immune systems at any age, need 3 doses.

Message to Providers & Parents

Studies have shown that 2 doses of HPV vaccine work very well in younger adolescents and we expect the same long-lasting protection with 2 doses that we expect with 3 doses. (CDC)

The HPV vaccine works even better than we expected! (Dr. Noel Brewer)

Extra incentive to vaccinate on time.

Case Example

A 15 year old is starting the HPV vaccine series. How many doses does he need?

2 doses

3 doses

A 15 year old is starting the HPV vaccine series. How many doses does he need?

This adolescent needs 3 doses (0, 1-2, 6 months schedule) because he is starting the series on or after the 15th birthday.

Case Example

A 13 year old has a history of 2 doses of HPV vaccine: 4vHPV given at age 12 and 9vHPV given 6 months later. How many doses are needed to complete the vaccine series?

No additional doses needed

1 more dose

Because the 2 doses were given more than 5 months apart, no additional doses are needed.

Case Example

A 12 year old has a history of 2 doses of HPV vaccine: 9vHPV given at age 11 and 9vHPV given 2 months later. How many more doses does she need to complete the series?

No additional doses needed

1 more dose

Although she initiated the series before her 15th birthday, she needs a third dose because the 2 HPV vaccine doses were administered less than 5 months apart.

Case Example

A 12 year old received 1 dose of HPV vaccine at age 10 years. Does he need one or two more doses to complete the series?

1 more dose

2 more doses

This adolescent needs one more dose to complete the series because he initiated the series before his 15th birthday. Since he received the first dose over a year ago; the second dose can be given as soon as possible.

VACCINATING AT AGE 11-12

SHOW ME THE EVIDENCE

Many providers believe HPV

vaccination can wait

But what if we can prove that age 11-12 is best …and without talking about sex?

Why was age 11-12

recommended in the first place?

Clinical trial inclusion

Efficacy

Exposure

Duration of protection

Adolescent platform

Programmatic reasons

Immune Response???

Effectiveness

WE ARE THE

Types of

Evidence

Clinical Trial

Observational/Ecological

Linked

Efficacy vs Effectiveness

Efficacythe percent reduction in disease incidence in a vaccinated group compared with an unvaccinated control group under experimental conditions

Age at vaccination Efficacy against CIN2 caused by HPV16/18

≤ 6

par

tner

s 15-17 79.1%

18-20 65.0%

21-25 26.4% (not significant)

≤ 4

par

tner

s <17 69.0%

18-20 61.9%

21-26 31.1%

24

Population-based Effectiveness% Reduction in cervical dysplasia 5 years

after vaccination, by age in 2007

Gertig et al 2013: population-based data linkage, Victoria, Australia

Effectivenessreduction in disease outcomes in a “real world” setting

Age at vaccination Vaccine effectiveness against CIN2+

<17 75%

17-19 46%

≥20 22%

Herweijer et al 2016: register-based data, entire population of Sweden ages 13-29

Effectivenessreduction in disease outcomes in a “real world” setting

Age at vaccination Odds of testing HPV16/18+ at first screen (age 20-21)

15-16 7.7%

17 12.5%

18 16.6%

19-21 30.3% (odds ratio 5.31)

Cameron et al 2016: linkage data, Scotland

HEDIS

Preteens have 3 times as many preventive visits as adolescents

Only 38% of adolescents (ages 12-17) had a preventive visit in

the last year

Temporary delays often become permanent

Because

I said so

ACS HPV VACCINATION GUIDELINES

Boys and girls

At age 11 or 12 = ON TIME

Can start at age 9

Can vaccinate LATE at ages 13 to 26

Individuals ages 22 to 26 who were not previously vaccinated should be informed that vaccination at older ages is less effective in lowering cancer risk

Use any HPV vaccine

Adolescent Vaccination CoverageUnited States, 2006-2015

0

10

20

30

40

50

60

70

80

90

100

2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Pe

rce

nt

Vac

cin

ate

d

Revised APD* definition

≥1 Tdap

≥1 MenACWY

≥1 HPV (F)

≥1 HPV (M)

≥3 HPV (F)

≥2MenACWY†

≥3 HPV (M)

Survey Year

Reagan-Steiner, et al. MMWR; August 26, 2016 / 65(33);850–858* APD = Adequate provider data †≥2 doses MenACWY among adolescents aged 17 years

Value Parents Place on the Vaccines

9.4 9.5 9.5 9.3 9.3 9.2

0

2

4

6

8

10

Me

dia

n V

alu

es

Par…

Adapted from Healy et al. Vaccine. 2014;32:579-584.

Provider estimations

9.4 9.5 9.5 9.3 9.3 9.29.2 9.2 9.3

0

2

4

6

8

10

Me

dia

n V

alu

es

Parent Provider's estimate

Adapted from Healy et al. Vaccine. 2014;32:579-584.

Clinicians underestimate the valueparents place on HPV vaccine

9.4 9.5 9.5 9.3 9.3 9.29.2 9.2 9.3

7.0

5.27.8

0

2

4

6

8

10

Me

dia

n V

alu

es

Parent Provider's estimate

Adapted from Healy et al. Vaccine. 2014;32:579-584.

Give an Effective Recommendation to Receive HPV Vaccine at Ages 11 or 12

An effective recommendation from you is the main reason parents decide to vaccinate

Many moms in focus groups stated that they trust their child’s doctor and would get the vaccine for their child as long as they received a recommendation from the doctor

Unpublished CDC data, 2013.

EFFECTIVErecommendation

for HPV vaccination?

What is an

Same WaySame Day

Make an Effective Recommendation

Same way: Effective recommendations group all of the adolescent vaccinesRecommend HPV vaccination the same way you recommend Tdap & meningococcal vaccines.

Same day: Recommend HPV vaccine todayRecommend HPV vaccination the same day you recommend Tdap & meningococcal vaccines.

Unpublished CDC data, 2013.

Your preteen needs three vaccines today

to protect against meningitis,

HPV cancers, and pertussis.

Some Parents Need Reassurance

Many parents simply accept of this bundled recommendation

Some parents may be interested in vaccinating, yet still have questions. Interpret a question asthey need additional reassurance from YOU, the clinician they trust with their child’s health care

Ask parents about their main concern (be sure you are addressing their real concern)

Unpublished CDC data, 2013.

Most clinicians wait too long to make strong recommendations for HPV vaccine

Allison et al. https://cdc.confex.com/cdc/nic2011/webprogram/Paper25181.html

HPV vaccination works best at the recommended ages

f 11 or 12 years. That’s why I’d like for your son to start the

HPV vaccine series today.

o

2sentences“Molly needs three

vaccines today to protect against whooping cough, HPV cancers and meningitis. She will get those at the end of the visit.”

If a parent doesn’t say yes…Ask Clarify & restate their concerns to make sure you

understand.

Acknow-ledge

•Emphasize it is the parents’ decision.•Acknowledge risks & conflicting info sources.•Applaud them for wanting what is best for their child.•Be clear that you are concerned for the health of their child, not just public health safety.

Advise •Clarify their concerns: make sure you understand & are answering the question they actually care about. •Allow time to discuss the pros & cons of vaccines. •Be willing to discuss parents’ ideas. •Offer written resources for parents.•Tailor your advice using this presentation.

TOOLS:

Just the FactsProvider Audience

http://bit.ly/VACsJustTheFacts

TOOLS:

Addressing

Parent’s Top

Questions about

HPV VACCINEProvider Audience

http://www.cdc.gov/vaccines/who/teens/for-hcp-tipsheet-hpv.pdf

TOOLS:

You Are The Key

Presentation Slide

DeckProvider Audience

http://www.cdc.gov/hpv/hcp/speaking-colleagues.html

Steps for Increasing HPV Vaccination in Practice: An Action Guide to Implement Evidence-based Strategies for Clinicians

http://bit.ly/HPVStepsActionGuide

• Toolkit+• Road map

• Portal to resources

• Launched June 2015

• Tested and improved by 30 FQHC Pilots

Monitor and report system-wide vaccination rates

Make sure providers know their vaccination rates.

Provide evidence-based tools to help providers and practices make systematic changes.

ToolsSteps Action Guide,

bit.ly/HPVStepsActionGuide

AAP HPV Champion Toolkit

bit.ly/AAPHPVChampionToolkit

VACs Report Card

VACs Report Card

1. Review2. Set a Goal3. Recommend

All HPV Roundtable resources are available at: http://bit.ly/HPVvaxSP

©2015 American Cancer Society, Inc. No.

031009

54

Thank You

Thanks to our partners:

University of Nevada School of Medicine

Project ECHO, Chris Marchand, MPH

High Sierra AHEC, Andrea Gregg

Executive Director.

June.Hunter@cancer.org

ACS.HPV.VACs@cancer.org