1. The document discusses the burden of HPV infection and related diseases worldwide and in India. HPV is responsible for cervical cancer as well as other cancers and diseases. 2. Data shows that HPV prevalence is high among males as well, with around 6.5 out of 10 males estimated to be infected. Additional HPV types included in Gardasil 9 contribute to a significant percentage of HPV-related cancers in India. 3. Gardasil 9 provides protection against 9 HPV types and has a broader indication for use in both males and females from age 9 to 26 years. This makes it potentially more effective at reducing the HPV disease burden compared to other vaccines.

1. GARDASIL 9*
FREQUENTLY ASKED
QUESTIONS
Dr Sharda Jain
Secretary General DGF

2. A new leap in India’s Journey towards
Protecting lives from HPV related
Cancers & Diseases
9 Valent
HPV Vaccine

3. HPV is responsible for huge Cervical Cancer
burden, but that’s not it!
Anal cancer: 50865
cases4
(Men & Women)
Vulvar/vaginal
Cancer: 63148
cases1,2 (Women)
HPV Infection: 660
million cases6 (Men &
Women)
Genital Wart: 30
million cases5 (Men &
Women)
Low-grade
dysplasia:
30 million
cases5(Women)
Annual Incidence of HPV
BurdenEstimated Worldwide
Attribu
table
to
Low-
risk
HPV
types
Cervical Cancer:
604127 cases3
(Women)
High-grade
dysplasia:
10 million cases5
(Women)
660
Millio
n
Cases
Worldwide6
1. Vulva Globacon 2020. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/21-Vulva-fact-sheet.pdf, accessed on 22 apr 2021; 2. Vagina
Globacon 2020. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/22-Vagina-fact-sheet.pdf, accessed on 22 apr 2021; 3. Cervix uteri Globacon
2020. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/23-Cervix-uteri-fact-sheet.pdf, accessed on 22 apr 2021; 4. Anus Globacon 2020.
Available at: https://gco.iarc.fr/today/data/factsheets/cancers/10-Anus-fact-sheet.pdf. accessed on 22 apr 2021; 5. Data on File: HPV and HPV related
diseases. MSD REF-128791; 6. Report of the consultation on human papillomavirus vaccines : World Health Organization, Geneva, April 2005. Available at:
https://apps.who.int/iris/bitstream/handle/10665/69150/WHO_IVB_05.16.pdf?sequence=1&isAllowed=y. Accessed on 22 Apr 2021

4. Why 'Protecting
Boys’* Against
HPV is Important?
* 9-15 years of age as per approved India PI
IN-GSL-00033 20/10/2021 13/10/2022
WHY WE NEED GENDER NUTRAL
HPV VACCINE

5. HPV Infections are More Prevalent in Males than Females
across Age Groups1,2,a
Most HPV infections clear on their own,
but persistent infection can lead to
certain cancers or other diseases3
1. Shi, R., Devarakonda, S., Liu, L. et al. Factors associated with genital human papillomavirus infection among adult females in the United
States, NHANES 2007–2010. BMC Res Notes 7, 544 (2014).;
2. Giuliano A et al. The Human Papillomavirus Infection in Men Study: Human Papillomavirus Prevalence and Type Distribution among Men
Residing in Brazil, Mexico, and the United States. Cancer Epidemiol Biomarkers Prev. 2008;17:2036–2043;
3. Alizon S et al. Why Human Papillomavirus Acute Infections Matter Viruses. 2017;9:293.
aPrevalence of at least 1 of 37 HPV types.
25–
29
years
old
35–
39
years
old
45–
49
years
old
20–
24
years
old
30–
34
years
old
40–
44
years
old
70
%
60
%
50
%
40
%
30
%
20
%
10
%
IN-GSL-00033 20/10/2021 13/10/2022

6. HPV prevalence in Male in India1:
A. Gupta et al. / Journal of Clinical Virology 37 (2006) 190–194
HPV prevalence among men
in India: 26.7%
In the cohort where their spouses are suffering
from Cervical Cancer
HPV Prevalence among the Males:
66.7%
IN-GSL-00033 20/10/2021 13/10/2022

7. HPV Transmission from Females to Males is Higher than from
Males to Females1
aInfections per 1,000 person-months.
1. Nyitray AG et al. The role of monogamy and duration of heterosexual relationships in human papillomavirus transmission. J Infect Dis. 2014;209:1007–1015.
12.3a
7.3a
IN-GSL-00033 20/10/2021 13/

8. GNV = gender-neutral vaccination.
1. Giuliano A et al. Cancer Epidemiol Biomarkers Prev. 2008;17:2036–2043. 2. de Martel C et al. Int J Cancer. 2017;141:664–670. 3. Giuliano AR et al. J Infect Dis. 2019;219:703–710. 4. Giuliano AR et al. Papillomavirus Res.
2015;1:109—115; 5. Srivastava AN, et al. Indian J Med Res. 2018; 148(6):687-696; 6. Pamnani SJ et al. Cancer Res. 2016;76:6066–6075. 7. Pamnani SJ et al. J Infect Dis. 2018;218:1219–1227.; 8. Brisson M et al. Lancet Public
Health. 2016;1:e8–e17.; 9. Elfström KM et al. J Infect Dis. 2016;213:199–205; 10. Simoens S, et al. Front. Pharmacol. 2021;12:628434. doi: 10.3389/fphar.2021.628434
2. * 9-15 years of age as per approved India PI
Gender Neutral HPV Vaccination may enhance routine adoption of
HPV immunization in office practice10
Why Male HPV Vaccination is important
High prevalence
rates of infection
across age groups1
At risk for
certain diseases
and cancer2,3
Low rates of
seroconversion4
Susceptible to new
and recurrent
infection6,7
Gender* neutral
vaccination
programs increase
protection8,9
Males remain susceptible to HPV infection
throughout their life1
Absence of routine
screening increases
the risk5
IN-GSL-00033 20/10/2021 13/10/2022

9. To make significant impact on HPV Disease Burden,
Broadest Serotype Coverage is required.
6 11
3
1
3
3
4
5
5
2
5
8
18
16
IN-GSL-00033 20/10/2021 13/10/2022

10. HPV Vaccination - Indian Perspective
HPV vaccine type Females Males Recommended
dose
Vaccine
sequence
Bivalent
(Cerverix)
9-45 years Not approved 9-14 years: 2
doses Beyond
14 years: 3
doses
0 (baseline)
6-12 M
1, 1-2M, 6M
Quadrivalent
Gardasil
CERAVAC qHPV
9-45 years Not approved 9-14 years: 2
doses Beyond
14 years: 3
doses
0 (baseline)
6-12 M
1, 1-2M, 6M
Nonavalent 9-26 years 9-15 years 3-dose 0, 1-2 M, 6M

11. GARDASIL 9*
FREQUENTLY ASKED
QUESTIONS

12. What is the route of HPV infection
(transmission) for males?
Nearly everyone gets infected with HPV within months to a
few years of becoming sexually active. HPV transmission
from females to males is higher than from males to females
• The transmission of genital HPV occurs predominantly via
sexual contact.
• Other types of genital contact (less common) include
oral-genital, manual-
• Genital, and genitalgenital contact.

13. What is the route of HPV infection
(transmission) for males?
• HPV transmission may occur via inanimate objects
(fomites) such as environmental surfaces and
clothing (uncommon)
• Rarely, mother-to-newborn transmission may occur.
This can at times lead to recurrent respiratory
papillomatosis.

14. Kindly highlight the data which
mentions that 6.5 out of 10 males
have HPV infection?
As per the HIM (Human papilloma virus in men)
study done across many countries, genital HPV
infection is very common with an estimated
prevalence of 65.2% in asymptomatic males
aged 18–70 years. This translates to 6.5 out of
10 males.

15. Which are the common serotypes
responsible for HPV disease in
Indian males?
There have been handful studies that document the HPV
disease burden in Indian males
Kindly note that anal cancer is similar to cervical cancer with HPV
being responsible for nearly 100% of anal cancer cases.

16. As per Alka Suresh's study from Kerala, the
prevalence of HPV serotype 33 was (40%).
How should this information be
put forward impactfully?
Suresh A et al studied the prevalence of high-risk
HPV in women from Vypeen Island, Kerala, India from
2017–2019. Cervical samples of 2443 women were
screened. Prevalence noted was HPV16 (52%), HPV33
(40%), HPV18 (4%), HPV31 (2%), and HPV66 (2%).

17. In Basu P et al study, only
278 subjects were enrolled.
How should the salient points
be discussed?
• In this multicenter study, women (n=278) with histology-confirmed cervical
cancer were enrolled from cancer institutes in four cities (Kolkata, Delhi,
Nagpur, and Bangalore)
• The study period was around 9 months (1 April 2007 and 31 January 2008).
• Overall HPV detection rate was 91.7% in these cervical cancer patients

18. In Basu P et al study, only
278 subjects were enrolled.
How should the salient
points be discussed?
• HPV serotypes 16, 18, 31, 33, 45, 52 and 58 were detected in 87.9% of
the cases (n= 278)
• Additional serotypes included in Gardasil 9 (31, 33, 45, 52 and 58)
contributed to approximately 13.5% cases
• This remains a very good country data that stresses on the importance of
additional serotypes that are included in 9vHPV vaccine.

19. From an Indian perspective, why is a
3-dose Gardasil 9
schedule recommended in boys/girls
9 to 15 years age? AND why is the age limit for
boys’ up to 15 years only?
The approval for the three-dose regimen for Gardasil 9 is based on a
noninferiority immunogenicity study conducted to bridge the findings in
young women to girls and boys aged 9 to 15 years9. India was one of the 17
countries in which enrolment happened. Apart from demonstrating safety,
at 4 weeks after dose 3, strong immunogenicity was demonstrated. Basis
this data, the Drug Controller General of India
recommended the 3-dose schedule in the country for
boys/girls 9 to 15 years of age.

20. Do the Indian Academy of Pediatrics (IAP)
guidelines recommend
HPV vaccines for males?
Till sometime back, only 2 HPV vaccines (bivalent and
quadrivalent) have been available and included in IAP
guidelines.
Both these vaccines have labelled indications
only for females.
9vHPV vaccine has now been launched and is additionally
indicated for boys. We are hopeful, once the IAP guidelines get
revised, the male indication will be included.

21. Let us look at the composition for common serotypes included
in the two HPV vaccines.
Do the Indian Academy of Pediatrics (IAP)
guidelines recommend HPV vaccines for males?
There is a difference between the common 4 serotype
concentrations in qHPV and 9vHPV vaccines. Both these are
recombinant vaccines, available in 0.5-mL single-dose. To
make immunogenic and safe vaccines (that fits in 0.5 mL) a
titration of the concentration of serotypes has to be done so as
to make an immunogenic, safe and effective vaccine..

22. What are the additional benefits of using
Gardasil 9 over quadrivalent
(qHPV) vaccine?
Let us look at the salient point of
differences between the
2 HPV vaccines

24. Key Points
• Gardasil 9 has a wider indication base compared to qHPV
vaccine
• Gardasil 9 the only HPV vaccine that can be offered to boys
(gender-neutral)
• Gardasil 9 will offer comprehensive protection against HPV-
related diseases based on the Indian epidemiological data
wherein 9-HPV serotypes contribute to

25. • ~95% of vulvar pre-cancer cases will be covered by GARDASIL 9
• ~77% vaginal pre-cancer
• and ~73% anal cancer cases.
• Thus Gardasil 9 may prevent 55 million cases of HPV cancers and
HPV related diseases in India
Key Points