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HPV Vaccination Recommendation Update: 2 doses or 3?
Debbie Saslow, PhD │ Senior Director, HPV-related and Women’s Cancers
American Cancer Society
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Learning Objectives
New schedule and intervals: 2- vs 3-dose
Why age 11-12
Strong recommendation
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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)
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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!
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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!
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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.
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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.
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Case Example
A 15 year old is starting the HPV vaccine series. How many doses does he need?
2 doses
3 doses
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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.
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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
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Because the 2 doses were given more than 5 months apart, no additional doses are needed.
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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
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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.
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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
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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.
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VACCINATING AT AGE 11-12
SHOW ME THE EVIDENCE
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Many providers believe HPV
vaccination can wait
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But what if we can prove that age 11-12 is best …and without talking about sex?
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Why was age 11-12
recommended in the first place?
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Clinical trial inclusion
Efficacy
Exposure
Duration of protection
Adolescent platform
Programmatic reasons
Immune Response???
Effectiveness
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WE ARE THE
Types of
Evidence
Clinical Trial
Observational/Ecological
Linked
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Efficacy vs Effectiveness
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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%
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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
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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
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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
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HEDIS
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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
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Temporary delays often become permanent
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Because
I said so
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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
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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
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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.
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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.
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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.
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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.
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EFFECTIVErecommendation
for HPV vaccination?
What is an
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Same WaySame Day
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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.
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Your preteen needs three vaccines today
to protect against meningitis,
HPV cancers, and pertussis.
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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.
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Most clinicians wait too long to make strong recommendations for HPV vaccine
Allison et al. https://cdc.confex.com/cdc/nic2011/webprogram/Paper25181.html
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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
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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.”
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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.
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TOOLS:
Just the FactsProvider Audience
http://bit.ly/VACsJustTheFacts
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TOOLS:
Addressing
Parent’s Top
Questions about
HPV VACCINEProvider Audience
http://www.cdc.gov/vaccines/who/teens/for-hcp-tipsheet-hpv.pdf
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TOOLS:
You Are The Key
Presentation Slide
DeckProvider Audience
http://www.cdc.gov/hpv/hcp/speaking-colleagues.html
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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
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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.
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ToolsSteps Action Guide,
bit.ly/HPVStepsActionGuide
AAP HPV Champion Toolkit
bit.ly/AAPHPVChampionToolkit
VACs Report Card
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VACs Report Card
1. Review2. Set a Goal3. Recommend
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All HPV Roundtable resources are available at: http://bit.ly/HPVvaxSP
©2015 American Cancer Society, Inc. No.
031009
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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.