Cervical cancer prevention Dr Sharda Jain

1. CERVICAL CANCER
PREVENTION
the role of QHPV
vaccine
Lets
Talk
about
Dr. Sharda Jain …Caring hearts, healing hands

2. Over 370 ppts are available on
slideshare.net ***for use of public/Doctors
www.slideshare.net / Lifecarecentre

3. INDIAN EXPRESS
DELHI EDITION SEP 13,2018
• Cervical cancer cases down but increase in
Breast cancer cases in india.
• LANCET STUDY by former DG,ICMR & CURRENT
DDG of WHO---tracing the incidence of various
cancers across indian states suggests that India
has managed to bring down cases of cervical &
oesophageal cancers ,
• However Breast,liver & lungs have increased
drastically- contributing to steep rise in cancer
cases in INDIA between 1990 & 2016.
EARLY DETECTION IS THE KEY

4. CERVICAL CANCER PREVENTION
World Health Organization, United Nations Population Fund. Preparing for the Introduction of HPV
Vaccines: Policy and Programme Guidance for Countries. Geneva, Switzerland: World Health
Organization; 2006.
Palliative
care
Cancer treatment
Secondary prevention:
Screening and treatment
of PRECANCEROUS LESION
Primary prevention:
Vaccination

5. THIS PPT Deals with
The role of QHPV vaccine in
CERVICAL Cancer Prevention

6. Flow of the presentation
• Cervical cancer disease burden
• Cervical cancer and HPV
• Cervical cancer prevention
• The QHPV vaccine
• Who should be vaccinated?
• The importance of postpartum vaccination

7. 7
Cervical cancer – Disease Burden

8. 8
Cervical Cancer Worldwide disease
burden
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 27 July 2017. [Accessed on 16th April 2018]
5,27,624
New cases annually
(estimations for 2012)
4th
Common cause of female
cancer
2nd
Most common female
cancer in women aged 15-
44 years

9. 9
Cervical Cancer mortality Worldwide
9
2,65,672
Deaths
Annually
Approx. 728 women die every day
A women is dies every 2 minutes
Approx. 30 women die every hour
4th Cause in female cancer deaths and 2nd most common
cancer deaths in women aged 15-44 years
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 27 July 2017. [Accessed on 16th April 2018]

10. 10
Cervical Cancer disease burden in India
1,22,844 New cases annually
2nd Common cause of
female cancer
2nd
Most common female cancer
in women aged 15-44 years
• India has a population of 436.76 million women aged 15
years and older who are at risk of developing cervical cancer.
• India accounts for ~ 1/4th of Cervical cases and deaths
worldwide
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 27 July 2017. [Accessed on 16th April 2018]

11. 11
Cervical Cancer mortality in India
11
67,477
Deaths
Annually
Approx. 185 women die every day
A women is dies every 8 minutes
Approx. 8 women die every hour
2nd Cause in female cancer deaths and 2nd leading cause of
cancer deaths in women aged 15-44 years
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 27 July 2017. [Accessed on 16th April 2018]

12. 12
Mortality Rate compared to other cancers
in Indian women
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 27 July 2017. [Accessed on 16th April 2018]

13. 13
Cervical cancer affects Women in their PRIME when
they are needed most by the family
Rates per 100,000 women per year
Annual number of cases and age-specific incidence rates of
cervical cancer in India
The Incidence of
Cervical cancer in
India is highest
amongst 40-64 yrs
women
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 27 July 2017. [Accessed on 16th April 2018]

14. 14
Women Remains at Risk for Acquiring
HPV Infection Throughout Their
Lifetimes

15. 15
Adult Women at Risk of HPV
related Genital warts
15
1. Insinga RP. Clin Inf Dis. 2003;36:1397-1403.
High Risk Zone for Cervical
Cancer

16. 16
Cervical Cancer and HPV

17. HPV 16
HPV 18
HPV 6
HPV 11
Cancer causing Types1,2,4 Non-cancer causing types1,2
• >75% of Cervical Cancer5,6
• >50% of Vaginal & Vulvar Cancer5
90% of Anogenital warts5
HPV is a necessary cause of cervical cancer – 99.7%4
HPV
1.Schiffman M, Castle PE. Arch Pathol Lab Med. 2003;127:930–934. 2. Wiley DJ, Douglas J, Beutner K, et al. Clin Infect Dis. 2002;35(suppl 2):S210–S224. 3. Muñoz N, Bosch FX, Castellsagué X, et al. Int J Cancer.
2004;111:278–285. Reprinted from J Virol. 1994;68:4503–4505 with permission from the American Society for Microbiology Journals Department. 4. Walboomers JM, Jacobs MV, Manos MM, et al. J
Pathol. 1999;189:12–19. 5. X. Castellsagué, S. de Sanjose, T. Aguado, K. S. Louie, L. Bruni, J.Muñoz, M. Diaz, K. Irwin, M. Gacic, O. Beauvais, G. Albero, E. Ferrer, S. Byrne,F. X. Bosch. HPV and Cervical
Cancer in the World. 2007 Report. WHO/ICO Information Centre on HPV and Cervical Cancer (HPV Information Centre). Available at: www.who.int/hpvcentre6. Bhatla N et al.Vaccine (2008;26; 2811-17
What causes Cervical Cancer?

18. 18
Cervical cancer and HPV infection
• Human papillomavirus (HPV) infection is now a well-
established cause of cervical cancer. HPV causes virtually
100% of cervical cancer cases. It spreadsthrough skin to
skin contact,body fluids sexua intercourse.
• There is growing evidence of HPV being a relevant factor in
other anogenital cancers (anus, vulva, vagina and penis)
and head and neck cancers.
• HPV is also responsible for other diseases such as
recurrent juvenile respiratory papillomatosis and genital
warts
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 27 July 2017. [Accessed on 16th April 2018]

19. 19
Cervical cancer and HPV types
• HPV types 16 and 18 are responsible for about 70% of all
cervical cancer cases worldwide. After HPV16/18, the six
most common cervical cancer causing HPV types are 31,
33, 35, 45, 52 and 58
• In India 82.7% of invasive cervical cancers are attributed
to HPVs 16 or 18.
• In India about 5.0% of women in the general population
are estimated to harbor cervical HPV-16/18 infection at a
given time
• HPV types 6 and 11 are responsible for over 90% of all
anogenital warts
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 27 July 2017. [Accessed on 16th April 2018]

20. 20
Cervical Cancer - Prevention

21. 21
Prevention strategies
SCREENING:
• Well-organised cervical screening programmes or widespread good
quality cytology can reduce cervical cancer incidence and mortality.1
• However, competing health care priorities, insufficient financial
resources, weak health systems, and limited numbers of trained
providers have made high coverage for cervical cancer screening in
most low- and middle-income countries difficult to achieve. 2
VACCINATION:
• The introduction of HPV vaccination has considerably reduced the
burden of Cervical cancer.
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 27 July 2017. [Accessed on 16th April 2018] 2. WHO guidance note: comprehensive cervical cancer prevention and control: a healthier future for girls and women. Accessed online
on 20-4-2016 from http://apps.who.int/iris/bitstream/10665/78128/3/9789241505147_eng.pdf?ua=1

22. 22
The coverage of cervical cancer screening
is very low in India
The cervical cancer screening coverage is a
mere 2.6% in the general female population
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 27 July 2017. [Accessed on 16th April 2018]

23. 23
Health impact of HPV vaccination and cervical cancer
screening in India
Impact on cancer reduction*
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
*Base case assumes 70% vaccination and screening coverage
Vaccination only
Screening only (VIA – 1x, 2x, 3x)

24. 24
Combining Screening and Vaccination has maximum impact
on Cervical Cancer reduction
Impact on cancer reduction*
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
*Base case assumes 70% vaccination and screening coverage
Vaccination only
Screening only (VIA – 1x, 2x, 3x)
Vaccination followed by screening (VIA – 1x, 2x, 3x)
Health impact of HPV vaccination followed by cervical cancer screening in India

25. 25
Vaccination and Screening
• Women who have been vaccinated should continue with the
Cervical cancer screening
• Screening is not recommended before vaccination.
• Sexually active women and women with previous abnormal
cervical cytology can receive the HPV vaccine.
• Women who have been infected with vaccine HPV-type but
have cleared the cervical infection will have similar protective
effects as those who are naïve to the same vaccine HPV-type.
Recommendations for Vaccination against Human Papilloma Virus (HPV) Infection For the prevention of Cervical Cancer, The Journal of Obstetrics and
Gynecology of India May / June 2011

26. 26
Rationale for Vaccination
Natural Infection – Weak AB response
Vaccination - High AB Response
Higher AB level at
cervical epithelium
prevents HPV infection

27. 27
The Quadrivalent Human Papillomavirus
Vaccine (QHPV)

28. GARDASIL®
The Only Quadrivalent HPV Vaccine1
• The vaccine is composed of Virus like
particles (VLP) for HPV types 6, 11, 16, 18
• Manufactured in Saccharomyces cerevisiae
• Amorphous aluminum hydroxyphosphate
sulfate (AAHS) adjuvant – 225 μg per dose
• 3 dose (0, 2 & 6) or 2 dose (0 & 6) month
dosing regimen
• Does not contain viral DNA and
therefore doesn’t cause infectious
Gardasil PI India MSDIN 10/16

29. 29
Gardasil
Quadrivalent
HPV Types
Indicated age and
gender
Female 9-45 years old
Indicated for
preventing…
Cervical cancer,
Vulvar cancer,
Vaginal cancer,
Genital warts
Gardasil PI India MSDIN 10/16
6 11 16 18

30. DOSAGE FOR ALL
GARDASIL®
should be administered intra muscular in the deltoid region
of the upper arm or in the higher anterolateral area of the thigh as 3
separate 0.5-mL doses according to the following schedule:
• First dose: at elected date
• Second dose: 2 months after the first dose
• Third dose: 6 months after the first dose
Individuals are encouraged to adhere to the 0, 2, and 6 months
vaccination schedule.
(The second dose should be administered at least one month after the first
dose and the third dose should be administered at least 3 months after the
second dose. All three doses should be given within a 1-year period.)
Vaccination
0 1 2 3 4 5 6 7 8Months
Gardasil PI India MSDIN 10/16

31. Gardasil is now approved for use in an
alternative 2 dose schedule in India for 9 – 14
yr old girls
Females 9 to 14 years of age:
• Gardasil can be administered according to a 2-dose
schedule at 0, 6 months.
(If the second vaccine dose is administered earlier than 6 months after the first dose,
a third dose should always be administered.)
• Alternatively, Gardasil can be administered according to a 3-dose
schedule as described previously
Vaccination
0 1 2 3 4 5 6 7 8Months
Gardasil PI India MSDIN 10/16

32. Gardasil
Efficacy, Safety, long term and real world
effectiveness

33. PPE Population; subjects were free of HPV 6, 11, 16, 18 infection through 1
month Postdose 3
*Subjects are counted once per row but may be counted in more than 1 row.
†Confidence level is 95 percent for all intervals except for the first bolded row, where the confidence level is 95.89 percent, reflecting a multiplicity adjustment for the
primary efficacy analysis.
FUTURE II
The FUTURE II Study Group. New Engl J Med. 2007;356:1915–1927.
CIN = cervical intraepithelial neoplasia; AIS = adenocarcinoma in situ. Exceptional Efficacy
FUTURE II study Efficacy: 98% Efficacious
Against HPV 16/18-Related CIN 2/3 and AIS
End Point by Lesion Type
QHPV Vaccine *
(n=5,305)
Placebo*
(n=5,260)
Vaccine
Efficacy CI† P Value
HPV 16/18-related CIN 2/3 or AIS 1 42
CIN 2 0 28
CIN 3 1 29
AIS 0 1
98%
100%
97%
100%
86–100
81–100
80–100
<0–100
<0.001
Gardasil has shown 98% efficacy in
preventing cervical pre cancers caused by
HPV 16/18

34. FUTURE I study Efficacy: 100% Efficacious Against HPV
6/11/16/18-Related VIN/VaIN and Genital Warts
End Point by Lesion Type
QHPV Vaccine*
(n=2,261)
Placebo*
(n=2,279)
Vaccine
Efficacy CI
HPV 6/11/16/18 VIN/VaIN, genital
warts
0 60
Genital warts 0 48
VIN 1 or VaIN 1 0 9
VIN 2/3 or VaIN 2/3 0 9
*Subjects are counted once per row but may be counted in more than 1 row.
PPE population; subjects were free of HPV 6, 11, 16, 18 infection through 1 month
Postdose 3
1. Garland SM et al. New Engl J Med. 2007;356:1928–1943.
VIN = vulvar intraepithelial neoplasia.
VaIN = vaginal intraepithelial neoplasia.
100%
100%
100%
100%
94–100
92–100
49–100
49–100
FUTURE I
Gardasil has shown 100% efficacy in
preventing Vulvar & Vaginal pre cancers and
genital warts caused by HPV 6/11/16/18

35. Genital Warts2
Vulvar/ Vaginal Precancers
(Grade 1- 3)2
Cervical Cancer &
Precancers (Grade 2/ 3)1
99%
98%
100%
HPV induced lesions Protection
1. The Future II Study Group. Lancet 2007; 369:
1861–68 2.Garland SM et al. New Engl J Med.
2007;356:1928–1943.
Efficacy of Quadrivalent/ Bivalant HPV Vaccine:
BIVALANT
cervarix
√
X
√

36. Safety of Gardasil

37. GARDASIL 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

38. 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 Gardasil®
US CDC & other leading health organizations closely monitor the safety of GARDASIL,
as they do with other vaccines

39. Human papillomavirus vaccines:
WHO position paper, May 2017
• The WHO Global Advisory Committee for Vaccine Safety
(GACVS) regularly reviews the evidence on the safety of HPV
vaccines.
• The Committee reviews the available post-licensure
surveillance data from countries such as the United States,
Australia, Japan, as well as other countries as any concerns
arise and from the manufacturers.
• Data from all sources continue to be reassuring regarding
the safety profile of all 3 vaccinesThe WHO position statement from May 2017 concluded that
QHPV vaccine has excellent safety profile
Human papillomavirus vaccines: WHO position paper, May 2017

40. Long term effectiveness

41. A 12-Year Follow-up on the Long-Term
Effectiveness of
the Quadrivalent Human Papillomavirus
Vaccine in 4 Nordic Countries
Kjaer, Nygård, Dillner et al

42. Effectiveness By Lesion Type
(12-Years Follow up data)
NORDIC STUDY
Kjaer, Nygård, Dillner et al, A 12-Year Follow-up on the Long-Term Effectiveness of the Quadrivalent Human Papillomavirus Vaccine in 4 Nordic Countries Clinical
Infectious Diseases® 2017;XX(00):1–7

43. Impact &Effectiveness of the QHPV Vaccine:
A Systematic Review of 10 Years of RWE
Garland et al; Impact and Effectiveness of the Quadrivalent Human Papillomavirus Vaccine: A Systematic Review of 10 Years of
Real-world Experience: CID, 2016

44. Impact of 4vHPV Vaccine in Public Vaccination
Programs: Select Reportsa
Fairley
Sex Transm
Infect7
Ali
BMC Infect Dis16
Ali
BMJ17
Baandrup
Sex Transm Dis13
*Baldur-Felskov
Cancer Causes
Control30
*Baldur-Felskov
JNCI4
Bauer
Am J
Public
Health12
2006 2007 2008 2009 2011 2012 2013 2014
*Blomberg
Clin Infect
Dis14
Brotherton
Lancet27
Chow
BMJ21
*Crowe
BMJ31
Deleré
BMC Infect
Dis39
Donovan
Lancet
Infect Dis9 Flagg
Am J Public
Health18
*Gertig
BMC Med29
Harrison
PLoS One22
Leval
J Infect
Dis11
*Leval
JNCI3
*Mahmud
J Clin Oncol32
Markowitz
J Infect Dis37
Mikolajczyk
Sex Transm
Dis15
Oliphant
NZMJ10
*Powell
Vaccine28
Read
Sex Transm
Infect8
*Tabrizi
J Infect
Dis36
*Tabrizi
Lancet
Infect Dis38
Liu
Sex Transm
Infect23
2015
Smith
J Infect Dis24
Wilson
Sex Transm
Infect20
Nsouli-Maktabi
MSMR19
*Smith
Pediatrics33
*Droletc
Lancet Infect
Dis25
*Petráš
Vaccine26
*Dominiak-Felden
PLoS One6
Introduction of 4vHPV vaccine1–6
*Herweijer
Int J
Cancer35
2016
HPV Prevalence
Cervical
Abnormalities
Genital Warts
*Dunne
J Infect
Dis40
*Hariri
Vaccine34
New
Zealand
Denmarkb
Sweden
United
States
Germany
Australia
Canada
Czech Republic
Belgium
*Markowitz
Pediatrics41
*Study links effectiveness data to vaccination statusaIncludes reports published in the peer-reviewed scientific literature, and does not encompass reports at scientific conferences. bBeginning on February 1,
2016 the childhood vaccination program includes the 2vHPV vaccine.42 cMeta-analysis of data from 20 studies in 9 countries (United States, Australia, England, Scotland, New Zealand, Sweden, Denmark,
Canada, and Germany), including both 4vHPV vaccine and 2vHPV vaccine.25
Please see corresponding slide note for references.

45. Summary of Publications Reporting the Effectiveness &
Impact & QHPV Vaccination Programs in 9 Countries
S.N
o
Country NIP start Catch up Genital Warts HPV Infection
Cervical
Cytological
Abnormalities
Cervical
Histological
Abnormalities
1 Australia 2007
12-17 &
18-26 10 3 5 5
2 Belgium 2007 15-18 1 1 0 0
3 Canada 2007 4-8 Grade 1 0 2 1
4 Denmark 2008
13-15 &
<27 5 0 2 3
5 France 2012 15-19 1 0 0 0
6 Germany 2007 13-17 1 1 0 0
7
New
Zealand 2009 <20 2 0 0 0
8 Sweden 2012 13-18 3 1 0 1
9 USA 2006 >11 4 9 0 4
28 15 9 14
Garland et al; Impact and Effectiveness of the Quadrivalent Human Papillomavirus Vaccine: A Systematic Review of 10 Years of
Real-world Experience: CID, 2016

46. Key messages from real world
effectiveness publication
46
• Irrespective of study design, declines were detected within 4 years after
vaccine availability, even in settings with comparatively low vaccine
coverage.
• In Australia and the United States, decreases in the prevalence of HPV
6/11/16/ 18 infection and genital warts became evident <4 years after
vaccine availability.
• In Australia and Denmark where programs had achieved high and
timely coverage with catch-up vaccination, respective reductions as high
as 57% in CIN2+ and 80% in CIN3+ lesions were reported in the youngest
cohorts vaccinated shortly after program implementation
• Australia: Within 6 years of 4vHPV vaccination availability, prevalent HPV
6/11/16/18 infections in women 18–24 years of age decreased by 86% after
3 doses and by 76% after ≥1 dose.
• USA: Reductions in 6/11/16/18 infections in women (89%) within 6
years were reported in nationally representative samples of sexually
active females aged 14–24 years who received ≥1 dose.
Garland et al; Impact and Effectiveness of the Quadrivalent Human Papillomavirus Vaccine: A Systematic Review of 10 Years of
Real-world Experience: CID, 2016

47. 47
Who should be
vaccinated ?

48. 48
Who should be vaccinated?
• HPV vaccination offers maximum benefit in sexually
naïve girls/women, hence the ideal target group is 9-14
year old girls.(1) In some countries school vaccination
programs have been established as a strategy to
vaccinate girls against HPV. [2]
Two Vaccine are only needed
0 & 6 if given
Between 9- 14 years
1. VM Vashishta etal - Indian Academy of Pediatrics (IAP) Recommended Immunization Schedule for Children Aged 0 through 18 years – India, 2014 and Updates
on Immunization; INDIAN PEDIATRICS VOLUME 51__OCTOBER 15, 2014.
2. Wright, Govindappagari, Pawar et al, Acceptance and Compliance With Postpartum Human Papillomavirus Vaccination, Obstet Gynecol 2012;120:771–82
In spite of this intervention, the vaccination rates for the
target group are very low. [2]

49. 49
In order to improve coverage among the at-
risk young female population, the
opportunities for catch-up
vaccination
are valuable. [1]
1. VM Vashishta etal - Indian Academy of Pediatrics (IAP) Recommended Immunization Schedule
for Children Aged 0 through 18 years – India, 2014 and Updates on Immunization; INDIAN
PEDIATRICS VOLUME 51__OCTOBER 15, 2014.
CATCH UP VACCINATION

50. 50
Postpartum – the ideal period for
catch up vaccination
• One potential opportunity for HPV catch-up
vaccination is offered by healthcare provided
at first delivery. [1]
• Furthermore, early age at first delivery has
been identified as a risk factor for cervical
cancer development. [1]
1. Rama, Villa, Pagliusi et al, Opportunity for catch-up HPV vaccination in young women after first delivery, J Epidemiol Community Health 2010;64:610e615

51. 51
What’s the Evidence for Postpartum HPV
vaccination
• Rama and colleagues conducted a study to determine cervical type-
specific HPV DNA prevalence and risk factors associated with
HPV infection after the delivery of the first child. [1 Brazil ]
• In another study, wright and colleagues tested the
acceptance and compliance of women with a postpartum
HPV vaccination program. [2 USA]
• Castellsague etal – studied the efficacy and safety of qHPV in
24-45 yr old women (3)
• R. Das - Long-term effectiveness (10 years) of Gardasil
among adult women in Colombia. [4]
• Data in lactating women with Gardasil [5]
• Recommendations [6]
1. Rama, Villa, Pagliusi et al, Opportunity for catch-up HPV vaccination in young women after first delivery, J Epidemiol Community Health 2010;64:610e615
2. Wright, Govindappagari, Pawar et al, Acceptance and Compliance With Postpartum Human Papillomavirus Vaccination, Obstet Gynecol 2012;120:771–82
3. X Castellsague, N Mun˜oz, P Pitisuttithum et al, End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24–45 years of age, British
Journal of Cancer (2011), 1 –10
4. Oct 8-11 2017 - EUROGIN 2017 European Research Organization on Genital Infection and Neoplasia 2017 International Multidisciplinary Congress, Amsterdam, The Netherlands. Abstract SS 06-04
5. Gardasil PI

52. 52
Opportunity for catch-up HPV
vaccination in young women
after first delivery
Rama et al

53. 53
Acceptance and Compliance
With Postpartum Human
Papillomavirus Vaccination
Wright et al

54. 54
End-of-study safety, immunogenicity,
and efficacy of quadrivalent HPV
(types 6, 11, 16, 18) recombinant
vaccine in adult women 24–45 years
of age
X Castellsague etal
X Castellsague, N Mun˜oz, P Pitisuttithum et al, End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24–45 years of age,
British Journal of Cancer (2011), 1 –10

55. Long-term effectiveness (10 years) of
Gardasil™ among adult women in
Colombia - R. Das.

56. Clinical data in lactating
women

57. Clinical data in Lactating women
• GARDASIL 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.
• GARDASIL may be administered to lactating women.
Gardasil PI India MSDIN 10/16

58. Position of international organizations on
HPV vaccination during lactation
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.
Centers for Disease control and prevention (US CDC)
• HPV vaccines can safely be given to Women who are breastfeeding
The American College of Obstetricians and Gynecologists (ACOG).
*In US Gardasil is approved till 26 years and in India it is approved for use in females up to
45 years of age.
1. Human papillomavirus vaccines: WHO position paper, May 2017
2. https://www.cdc.gov/hpv/hcp/need-to-know.pdf
3. Human papillomavirus vaccination. Committee opinion no. 704. American college of obstetricians and gynecologists. Obstet Gynecol 2017;129:e173-8

59. 59
SUMMARY
• Cervical cancer is associated with huge morbidity and
mortality in India
• HPV causes virtually 100% of cervical cancers and
90% of ano-genital warts
• Combining Screening and Vaccination has maximum
impact on Cervical Cancer reduction
• Gardasil, the QHPV vaccine is indicated for preventing
cervical, vulvar & vaginal cancers and genital warts
• Gardasil has established efficacy, safety, long term data and
real world effectiveness data

60. 60
Summary contd.
Post partum HPV vaccination
• Post partum period is one potential opportunity for
catch-up HPV vaccination1
• There is high HPV prevalence in postpartum women
and only few women were positive for one or both
oncogenic HPV types, so majority of this group can
still benefit from HPV vaccination. 1
• Postpartum administration of the HPV vaccine is
feasible and is associated with a high degree of
satisfaction among women. 2
References in the slide notes. CIN: Carcinoma in situ; EGL: external genital lesions

61. 61
Summary contd.
Post partum HPV vaccination
• Vaccine efficacy against the combined incidence of
persistent infection, CIN/EGL in the per protocol
population of 24-45 year old women was close to
90%3
• The 10 year follow-up data in adult women showed
that Gardasil is generally safe and induces durable
immune response.
• Various international organizations like WHO, CDC
and ACOG endorses the safety of HPV vaccination
during lactation
References in the slide notes. CIN: Carcinoma in situ; EGL: external genital lesions

62. 62
Gardasil has got the evidence which matters
most
Efficacy
98% efficacy in preventing cervical cancer.
100% efficacy in preventing vulvar cancer, vaginal cancer and genital warts
Effectiveness
The ONLY HPV vaccine with ZERO breakthrough cases even after 12 years of
follow-up
10 years of effectiveness in adolescent/preadolescents and adult women
Evidence
The ONLY HPV vaccine with 10 years of real world evidence
Experience
Gardasil is the ONLY HPV vaccine approved >135 countries. It is recommended
by the National Expert Advisory Bodies on Immunization in >60 countries.
>235 million doses dispersed till date with >90% market share across the
world
Exclusive 2 dose study
The ONLY HPV vaccine with large 2 dose study in adolescents in India
References in the slide notes.

63. 63
Thank You
Say “NO”
to
Cervical
Cancer

64. 64
ADDRESS
11 Gagan Vihar, Near Karkari
Morh Flyover, Delhi - 51
CONTACT US
9650588339
9599044257
011-22414049
WEBSITE :
www.lifecareivf.in
www.lifecarecentre.in
www.lifecareabs.in
ISO 14001:2004 (EMS)
…..Caring hearts, healing hands
ISO 9001:2008
Helpline : 9599044257
Web.www.lifecareivf.in
Helpline : 9910081484
27
Year
In
your
servic
e