Addressing the counseling challenges in HPV vaccination Dr Aruna Saxena MD (Obs & Gynae)

1. Addressing the
counseling
challenges in HPV
vaccination
Dr Aruna Saxena
MD (Obs & Gynae)

2. Cervical cancer disease burden in India
India has a population of 469 million
women aged 15 years and older1 who are
at risk of developing cervical cancer.
India accounts for ~ 1/6th of
Cervical cases and ~ 1/5th
deaths worldwide1
96922 New Cases Annually1
2nd Common cause of female
cancer1
2nd most common female
cancer in women aged 15-44
years1
1. Bruni L, Barrionuevo-Rosas L, Albero G, Serrano B, Mena M, Gómez D, Muñoz J, Bosch FX, de Sanjosé S. ICO Information Centre on HPV and Cancer (HPV Information Centre). Human Papillomavirus and Related
Diseases in India. Summary Report 10 Dec 2018. [Accessed on 25 Jan 2019]

3. Cervical cancer mortality in India
2nd Cause in female cancer deaths and 2nd leading
cause of cancer deaths in women aged 15-44 years1
1. Bruni L, Barrionuevo-Rosas L, Albero G, Serrano B, Mena M, Gómez D, Muñoz J, Bosch FX, de Sanjosé S. ICO Information Centre on HPV and Cancer (HPV Information Centre). Human Papillomavirus and Related
Diseases in India. Summary Report 10 Dec 2018. [Accessed on 25 Jan 2019]
60,078
Deaths
Annually1
A Woman Dies
Every 9 Minutes1
And we are still debating on “Need For HPV Vaccination”

4. HPV Vaccination
Some common barriers/questions
I. Vaccination is pediatricians domain. Why
should I (OBGYN) vaccinate ?
II. Screening is enough for preventing
Cervical Cancer.
III. Counseling patients for HPV vaccination is
difficult
IV. Do I need to vaccinate if my patient is
already +ve for any HPV serotype?
Barriers Amongst HCPs
I. My daughter is not yet sexually active so
doesn’t need the vaccine
II. I’m too old for the vaccine
III. I’m worried about the safety
IV. I am a breastfeeding mother, is this
vaccine safe for me and my baby?
V. Will the protection from vaccines last
long?
VI. I think HPV vaccines are COSTLY
Barriers Amongst Patients
Let us see how we can effectively address these barriers

5. I. Vaccination is a Pediatricians’ domain. Why
should I (OBGYN) vaccinate for HPV?

6. Adult vaccination catching up
FOGSI Recommendation
1. FOGSI 2014 immunization guidelines
2. Census 2011 (https://www.census2011.co.in...as accessed on 25/05/2018)
3. IMS, 10 years HPV market data
3 reasons
Why OBGYNs should vaccinate?
India has a huge female population aged 9-45 years
(367 MN) who are eligible for HPV vaccination 2
But most of them are not vaccinated3
OBGYNs have an opportunity for catch up vaccination
OBGYNs see, treat and
hence know the damage
caused to the woman
and ultimately to the
family.

7. Girls/Women visit OBGYNs with various complaints throughout their life. Every
visit can be an opportunity to counsel/protect them from cervical cancer.
1. Cervical screening visit
2. Contraception counselling
3. STI* screening
4. Marriage counseling
5. Pregnancy planning
6. Tdap and Flu vaccination counselling during pregnancy visit
7. Post-partum visits
 Include counseling for immunization as part of routine history taking
 Documenting the HPV vaccine recommendation in the patient case file can
reinforce the counseling
7
Various opportunities for an OBGYN to
discuss about HPV Vaccination
*STI: Sexually Transmitted Infection

8. II. Screening is enough for preventing
Cervical Cancer.
Some OBGYNs may feel that

9. True that screening is very
important for Cervical cancer
prevention,
But,
The cervical cancer screening
coverage is a mere 3.1% in the
general female population in
India1!!
1. Bruni L, Barrionuevo-Rosas L, Albero G, Serrano B, Mena M, Gómez D, Muñoz J, Bosch FX, de Sanjosé S.
ICO Information Centre on HPV and Cancer (HPV Information Centre). Human Papillomavirus and Related Diseases in India.
Summary Report 10 Dec 2018. [Accessed on 25 Jan 2019]
2. Diaz M, Kim JJ, Albero G et al. Health and economic impact of HPV 16 and 18 vaccination and cervical cancer screening in India. British Journal of Cancer (2008) 99, 230 – 238
Combining Screening and Vaccination has
maximum impact on Cervical Cancer reduction1
Impact on cancer reduction*
Vaccination only
Screening only (VIA – 1x, 2x, 3x)
Vaccination followed by screening (VIA – 1x, 2x, 3x)
*Base case assumes 70% vaccination and screening coverage
Health impact of HPV vaccination followed by cervical cancer screening in India

10. III. Counseling patients for HPV vaccination is
difficult and time consuming

11. Addressing the HPV vaccine hesitancy questions should be like
elevator speeches, short and succinct 15 second responses
6/7/2019 11
Maximum, 15 seconds
(2-4 short sentences).
Make your message
personal and emotional.
Short, meaningful words. No science.
6/7/2019 11

12. Choosing emotional words for maximum effect
Words and phrases to use
• Today
• Prevent cancer
• Keep healthy
• Protect
• We/I/our
• Together
• Benefit
• Love
Words and phrases to avoid
• Percent
• Immunity
• Sexually-transmitted
• Promiscuous
6/7/2019 12

13. IV. Do I need to vaccinate if my patient is already
+ve for any HPV serotype?

14. Efficacy Trial Database for GARDASIL: HPV 6/11/16/18 Status Among
Female Subjects at Day 1a
Parameter
16–26
Years of
Age1
N=20,541
24–45
Years of Age2
N=3,819
Negative to all 4 types (%) 73 67
Positive to exactly 1 type (%) 20 23
Positive to exactly 2 types (%) 6 7
Positive to exactly 3 types (%) 1.2 2
Positive to all 4 types (%) 0.1 0.4
aBy polymerase chain reaction (PCR) or
serology.
1. Data on file, MSD India. 2. Velicer C et al. Sex Transm Dis. 2009;36:696–703.
FACT
The chance of a women being infected with all 4 types of HPV
included in QHPV vaccine is very low
Majority of the sexually active women can get benefit from HPV vaccination

15. When Physicians propose HPV vaccination for
adolescent girls, the usual reaction would be….
I. My daughter is too young/not yet sexually active
so doesn’t need the vaccine!

16. Five reasons why vaccinating the younger better!

17. Vaccines are for prevention, not for treatment
• Like any other vaccine, HPV vaccine is designed for preventing HPV infection before it
actually happens1.
• Just the way a seatbelt is worn before starting the car and not after the accident,
vaccination is advisable at an earlier age before the actual infection occurs.
• International organizations like WHO recommend HPV vaccine to be administered before
first exposure to HPV infection2.
1. Gardasil PI
2. https://www.who.int/cancer/prevention/diagnosis-screening/cervical-cancer/en/ as accessed on 1/3/2019

18. 1. Giuliano AR et al. Impact of baseline covariates on the immunogenecity of a quadivalent (types 6, 11, 16 and 18) human papillomavirus like particle vaccine. J Infect Dis. 2007;196:1153–1162
9 10 11 12 13 14 15 16 17 18 19 20 21 22 23
Age at Enrollment (Years)
500
700
900
1100
1300
1500
1600
SerumcLIAGMTWith
95%CI,mMU/mL
Adolescent Females Young Adult Females
Serum anti-HPV 6 responses 1 month after completion of
vaccination regimen
Per-protocol immunogenicity population (ages 9–26)a
aInclusive of protocols 007, 013, 015, 016 and 018; all GMTs measured using competitive Luminex® immunoassay;
women 24–26 years of age were omitted in the figure because of small numbers. Similar results were observed for HPV 11, 16, and 18.
GMT = geometric mean titer.6/7/2019
18
Higher immune response in Adolescents vs Young adults1

19. Immunizing before exposure can give highest possible
(per protocol) efficacy
QHPV vaccine has shown,
• 98% efficacy in preventing cervical pre cancers caused by HPV 16/18 in HPV naïve females 15-26 yr
old1
• 100% efficacy in preventing Vulvar & Vaginal pre cancers and genital warts caused by HPV 6/11/16/18
in HPV naïve females 16-24 yr old2
1Quadrivalent Vaccine against Human Papillomavirus to Prevent High-Grade Cervical Lesions n engl j med 356;19 www.nejm.org may 10, 2007
2. Garland et al; Quadrivalent Vaccine against Human Papillomavirus to Prevent Anogenital Diseases N Engl J Med 2007;356:1928-43.

20. High risk of acquiring HPV even with First Male Partner1
• The study included 244 female university students aged 18-22, between 2000 - 2006
• Enrolled within first 3 months of first intercourse with their first male partner
• Excluded from trial if they acquired a second partner
Results: Cumulative incidence of first HPV infection
 30% were positive for HPV after 1 year
 50% were positive for HPV after 3 years
1. Winer et al. J Infect Dis Jan 2008

21. 1. Gardasil PI
21
Cost of immunization is less in most of the adolescents who
just need 2 doses
9-14 year old girls require only two doses of HPV
vaccine given 6 months apart1

22. II. Women >25 years of age may say,
I am too old for the vaccine

23. 23
HPV Does Not Discriminate By Age!CumulativeRiskof
HPVInfection(%)
1. Muñoz N, et al. J Infect Dis 2004; 190:2077-87.
Cohort of Colombian Women (n = 1,610)
Years
0
10
20
30
40
50
0 1 2 3 4 5
Age at Baseline (years)
15–19
20–24
25–29
30–44
45+
12.4%
21.9%
30.0%
36.9%
42.5%
Women Remain at Risk for Acquiring HPV Infection Throughout Their Lifetime 1

24. Risk of Progression From CIN 1 to CIN 3 and Cancer
Increases With Age1
• 2,490 women with CIN 1 or less were monitored using annual cytology and high-risk HPV tests.
• At a median follow-up of 26.3 months, 47 women (1.9%) had subsequently developed
CIN 3, AIS, or cervical cancer.
• Risk of progression to CIN 3 or cancer was associated with high-risk HPV and older age (≥30 years; P=0.045).
0
0.5
1
1.5
2
2.5
3
<20 20–29 ≥30
RiskofCIN3orCancer
(Percentage)
Age (years)
Subsequent Risk of CIN 3 or Cancer After Colposcopic Diagnosis of CIN 1 or Less
0.4%
1.7%
2.7%
Retrospective review of Southern California Permanente Medical Group (SCPMG)-Fontana cancer prevention file, a computer-based record of the evaluation and follow-up of women who attended colposcopy and
dysplasia clinics at the SCPMG-Fontana Medical Center between August 1, 1998, and January 1, 2005.
AIS=adenocarcinoma in situ.
1. Pretorius RG et al. Am J Obstet Gynecol. 2006;195:1260–1265.
Risk of progression from
CIN 1 to CIN 3 is
7x higher
for women ≥30 years than
for women <20 years of
age

25. Future III – Mid-adult Women:Females United to Unilaterally Reduce Endo/Ectocervical Disease
Efficacy and Effectiveness of the 4vHPV Vaccine in Females 24–45 Years of Age Through 10 Years
89%Efficacy against
Persistent Infection,
CIN, or condyloma
Long-Term Extension Trial
(N=685)
(Years 4-10 Follow-Up)2
Effectiveness against
HPV 6-,11-,16-,18-related
CIN any grade or
condyloma
Efficacy against
ASC-US
High Risk-HPV Positivea
100%
Efficacy against
LSIL or Worsea
92%
Randomized, Controlled Trial
(N=3692)
(Years 1-4 Follow-Up)1
100%
aRelated to HPV types 6/11/16/18.
ASCUS = atypical squamous cells of undetermined significance; CIN = cervical intraepithelial neoplasia; EGL = extragenital lesion;
LSIL = low-grade squamous intraepithelial lesion; VIN = vulvar intraepithelia neoplasia; VAIN = vaginal intraepithelial neoplasia.
1. Castellsagué X, et al. Br J Cancer. 2011;105:28-37; 2. Das et al, LONG-TERM EFFECTIVENESS OF GARDASIL™ AMONG ADULT
WOMEN IN COLOMBIA.
25
4vHPV Vaccine is efficacious even in mid adult women!

26. III. I’m worried about the safety of the
HPV vaccine

27. QHPV vaccine is the result of over 10 years of
research and development
• The safety and efficacy of
GARDASIL was established
in a clinical program with 7
phase III clinical trials
involving more than 29,000
females and males.
• Safety has continued to be
evaluated in several large
post-licensure surveillance
studies - over 15 studies in
more than 1 million
preadolescents,
adolescents and adults
from various countries.
Michelle Vichnin etal - An Overview of Quadrivalent Human Papillomavirus Vaccine Safety - 2006 to 2015; Pediatr Infect Dis J 2015;34:983–991)
7 phase III studies
- ~29,000 subjects
>15 post-licensure studies
~1 mil subjects

28. 1. http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/HPV_vaccines_20/European_Commission_final_decision/WC500196773.pdf
2. WHO position statement 2017
3. http://www.cdc.gov/vaccines/hcp/vis/vis-statements/hpv-gardasil.pdf
POTS: postural orthostatic tachycardia syndrome; CRPS- chronic regional pain syndrome
Post licensure: Health authorities reaffirm the
positive safety profile of QHPV vaccine
US CDC & other leading health organizations closely monitor the safety of GARDASIL,
as they do with other vaccines

29. Major agencies endorsing HPV vaccine safety1,2
> 300 million doses dispensed
worldwide (2006-2018)1
World Health
Organization (WHO)
Public Health
Agency of Canada
(PHAC)
Centers for Disease
Control and
Prevention (CDC)
Food and Drug
Administration(FDA)
European Medicines
Agency(EMA)
Medicines &
Healthcare Products
Regulatory Agency of
the UK(MHRA)
Therapeutic Goods
Administration of
Australia(TGA)
International
Federation of
Gynecology and
Obstetrics(FIGO)
International
Papillomavirus
Society(IPVS)
1. MSD data on file
2. Papillomavirus Research 2016 (2):9-10.

30. Common question from mother of newborn
IV. I am a breastfeeding mother, is this vaccine safe
for me and my baby?

31. QHPV vaccine in breastfeeding women
31
1. Gardasil PI
• QHPV vaccines is not a live vaccine.
• It is a sterile liquid suspension prepared from the highly purified virus-like particles (VLPs) of the
recombinant major capsid (L1) protein of HPV types 6, 11, 16, and 18
Clinical data in breastfeeding women:
• QHPV vaccine or placebo were given to a total of 1,133 women who were breast feeding at any
time during the relevant Phase III clinical studies. In these studies, the rates of adverse experiences
in the mother and the nursing infant were comparable between vaccination groups
• In addition, vaccine immunogenicity was comparable among nursing mothers and women who did
not nurse during the vaccine administration.

32. 32
1. Human papillomavirus vaccination. Committee opinion no. 704. American college of obstetricians and gynecologists. Obstet Gynecol 2017;129:e173-8
2. https://www.cdc.gov/hpv/hcp/need-to-know.pdf
3. Human papillomavirus vaccines: WHO position paper, May 2017
The American College of Obstetricians and Gynecologists (ACOG)
• The HPV vaccine can be given to postpartum and breastfeeding women.1
Centers for Disease Control and Prevention (US CDC)
• HPV vaccines can safely be given to women who are breastfeeding.2
World Health Organization (WHO)
• Breastfeeding is not a contraindication for HPV vaccination. Available evidence does not indicate an increased
risk of adverse events linked to the vaccine in either the mothers or their babies after administration of HPV
vaccine to lactating females.3
Guidelines of International Organizations on
HPV Vaccination During Lactation

33. Patients worried about long term effectiveness can
say,
V. The advice is to get vaccinated early, but cervical
cancer usually occurs late in the life. Will the
protection last long?

34. 100%
effectiveness
even after 14
years of
vaccination
(15-26 yr
females)
Data on File, MSD India. Presented at EUROGIN 2018

35. VI. I think HPV vaccines are COSTLY

36. GPs (n=337), OB/GYNs (n=101)
The National Survey Of Canadian Physicians On HPV
Durand N, Blake J, Guichon J, McFaul S, Ogilvie G, Steben M; A National Survey of Canadian Physicians on HPV: exploring knowledge, barriers and clinical preventive practices; presented at IPV 2017, STI and HIV
World Congress 2017 and Eurogin 2017, . J Ob Gynaecol Can Jan 2019 - https://www.jogc.com/article/S1701-2163(18)30758-8/pdf
HCP’s perspective
92-95% of the physicians think that cost
is a No. 1 barrier for HPV vaccination

37. Vaccinated (VW) (n=337) and Unvaccinated 18–45 year old women (UW) (n=802), and 18–26 year old men (M) (n=200)
The National Survey Of Canadian Adults On HPV
37
Durand N, Blake J, Guichon J, McFaul S, Ogilvie G, Steben M; A National Survey of Canadian Physicians on HPV: exploring knowledge, barriers and clinical preventive practices; presented at IPV 2017, STI and HIV
World Congress 2017 and Eurogin 2017, . J Ob Gynaecol https://sti.bmj.com/content/93/Suppl_2/A17.3
Patient’s perspective
Majority of the consumers don't see cost as a barrier,
only 18-20% considered cost as a barrier for HPV
vaccination
Many un-vaccinated women (55-38% ) and un-
vaccinated men (57-49%) felt that physicians'
recommendation/discussion would motivate them to be
vaccinated
Cost barrier is more of a Physicians’ perception than
a patient’s barrier

38. Effective HPV vaccination counseling and
strong recommendation is all it takes to
save WOMEN from CERVICAL CANCER
THANK YOU