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HPV VACCINATION : Do we need it
for Prevention of cervical cancer &
other HPV related diseases
HPV
DR. SHARDA JAIN
CHAIRMA...
Presentation Outlines
 Cervical cancer disease burden
 Prevention with HPV vaccination
 Vaccination of sexually active ...
India ~1,22,844
Total world ~ 5,27,624
India ~23% of new
Cervical Cancer cases in world
India ~ 67,477
Total world ~ 2,65,...
Years of Life Lost (YLL)
An Airbus-320 full of WOMEN crashing every day in India
Deaths Due to CaCx - Just Think !
HPV 16
HPV 18
HPV 6
HPV 11
Cancer causing Types
High risk group-16,18,
31,33,45,52,58
Non-cancer causing types
Low risk gr...
1. Forman D et al. Vaccine 30S (2012) F12– F23; 2. Lacey CJ et al (2006). Vaccine, 24 (Suppl 3), S35–S41.
THE CAUSE
HPV in...
HPV Vaccination: The Basis of Cancer Control
World Health Organization, United Nations Population Fund. Preparing for the ...
Cervical Cancer Screening Practices in India
Estimated coverage of cervical cancer screening in India, by age & study
(1) ...
WHY VACCINATION ?
• HPV vaccines are highly effective at preventing the infection
of susceptible women with the HPV types ...
Rationale for Vaccination
Natural Infection – Weak AB response
Vaccination - High AB Response
Higher AB level at
cervical ...
GARDASIL®: The Only Quadrivalent
HPV Vaccine1
• HPV types 6, 11, 16, 18
• Manufactured in Saccharomyces
cerevisiae
• Amorp...
Genital Warts2
Vulvar/ Vaginal Precancers
(Grade 1- 3)2
Cervical Cancer &
Precancers (Grade 2/ 3)1
99%
98%
100%
HPV induce...
GARDASIL® : Nordic Cancer Registry Extension Evaluation of Long-
Term Efficacy of Vaccination
• Nordic European countries ...
Data on File
a FUTURE= Females United to Unilaterally Reduce Endo/Ectocervical Disease
Registry-Based Follow-Up
Vaccinatio...
0 0 0
100 % 100 % 100 %
0
20
40
60
80
100
Zero number
of cases
Vaccine
Effectiveness
Vaccine
Effectiveness
Vaccine
Effecti...
0 0 0 0 0
0
20
40
60
80
100 Vaccineeffectiveness
(N=1,080)
Vaccineeffectiveness
Vaccineeffectiveness
Vaccineeffectiveness
...
Is it worth vaccinating sexually
active women
Estimated Benefit of Vaccination With GARDASIL in Sexually
Active Women
99.9% of
women will
benefit2
99.6% of
women will
b...
aEfficacy after 3 doses in women 24–45 years of age naïve to
the relevant type at baseline.
Per-Protocol Efficacy Populati...
GARDASIL®: FUTURE III: Adult Women Study (LTFU)
Combined Incidence of HPV 6/11/16/18-Related CIN2 or worse in Women
24–45 ...
Opportunity of HPV vaccination
during postpartum period
23
– Primiparous women aged between 15 and 24 years, living
in the metropolitan area of São Paulo for at least 6
months, a...
24
• After the first dose of vaccine,
– 97.2% of women felt it was worthwhile to receive the vaccine,
– whereas 98.6% said...
How importance is prevention of
other HPV diseases e.g.
Genital Wart (GW)
PREVALENCE AND PATIENT EXPERIENCE WITH
CONDYLOMATA ACUMINATA (GENITAL WARTS) IN INDIA
Khopkar U et al. Poster presented at...
Genital Warts and Risk of Cancer: A Danish Study of Nearly
50000 Patients With Genital Warts
Blomberg M et al. J Infect Di...
Genital Warts and Risk of Cancer: A Danish Study of
Nearly 50000 Patients With Genital Warts
Blomberg M et al. J Infect Di...
Real world effectiveness of
QHPV vaccine
Impact of HPV Vaccine in Public Vaccination Programs: Selected
Reports as of April 20131–21
qHPV=quadrivalent human papill...
The incidence of high grade cervical abnormalities has decreased
following the qHPV programme
1. Reprinted from The Lancet...
The prevalence of vaccine-preventable HPV types has decreased
following the qHPV vaccination programme
1. Tabrizi S et al....
1. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2009/11/news_detail_000389.jsp&mid=WC0b01ac05800...
Global Vaccine Safety
Human papillomavirus vaccines safety (HPV)
Extract from report of GACVS meeting of 11-12 December 20...
IN INDIA, BOTH IAP AND FOGSI RECOMMEND THE
HPV VACCINE AND SCREENING
► Both are equally efficacious against cervical cance...
Summary
• HPV infection is more than cervical cancer!
• There is an increasing evidence strongly
linking HPV DNA with canc...
38
NOW !!!
ADDRESS
11 Gagan Vihar, Near Karkari Morh Flyover,
Delhi - 51
CONTACT US
9650588339 (Helpline)
011-22414049,22058865
WEBSI...
HPV Vaccination , Dr. Sharda Jain
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HPV Vaccination , Dr. Sharda Jain

HPV Vaccination, Cerviocal Cancer : Do we need it
for Prevention of cervical cancer &
other HPV related diseasesm,

Presentation Outlines
Cervical cancer disease burden
Prevention with HPV vaccination
Vaccination of sexually active women
Opportunity of Postpartum HPV vaccination
Importance of genital warts prevention
Real world effectiveness data
Safety of HPV vaccine

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HPV Vaccination , Dr. Sharda Jain

  1. 1. HPV VACCINATION : Do we need it for Prevention of cervical cancer & other HPV related diseases HPV DR. SHARDA JAIN CHAIRMAN & FOUNDER ISO 9001:2008 ISO 14001:2004 (EMS) …..Caring hearts, healing hands ISO 9001:2008 25/08/2015
  2. 2. Presentation Outlines  Cervical cancer disease burden  Prevention with HPV vaccination  Vaccination of sexually active women  Opportunity of Postpartum HPV vaccination  Importance of genital warts prevention  Real world effectiveness data  Safety of HPV vaccine
  3. 3. India ~1,22,844 Total world ~ 5,27,624 India ~23% of new Cervical Cancer cases in world India ~ 67,477 Total world ~ 2,65,653 India ~23% Rest of World - 77% India ~25% of deaths due to Cervical Cancer in world Rest of World - 73% India - 27% Cervical cancer: Disease Burden Incidence Mortality India ~25% Rest of World - 75% 2. Bruni L, Barrionuevo-Rosas L, Serrano B, Brotons M, Cosano R, Muñoz J, Bosch FX, de Sanjosé S, Castellsagué X. ICO Information Centre on HPV and Cancer (HPV Information Centre). Human Papillomavirus and Related Diseases in India. Summary Report 2014-01-31. [Accessed on 11th Feb 14]
  4. 4. Years of Life Lost (YLL)
  5. 5. An Airbus-320 full of WOMEN crashing every day in India Deaths Due to CaCx - Just Think !
  6. 6. HPV 16 HPV 18 HPV 6 HPV 11 Cancer causing Types High risk group-16,18, 31,33,45,52,58 Non-cancer causing types Low risk group- 6,11. • >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 Human Papillomavirus (HPV) Need for multivalent HPV vaccine for broader HPV protection
  7. 7. 1. Forman D et al. Vaccine 30S (2012) F12– F23; 2. Lacey CJ et al (2006). Vaccine, 24 (Suppl 3), S35–S41. THE CAUSE HPV infection is a necessary cause of cervical cancer and is linked to several other anogenital diseases Genital Warts ~100% 70% ~100% 43% 88% Cervical Cancer Vaginal Cancer Vulvar Cancer Anal Cancer 13-56% Orophar yngeal Cancer 50% Penile Cancer HPV Percent of cases attributable to HPV infection 1,2 HPV Causes More Than Cervical Cancer
  8. 8. HPV Vaccination: The Basis of Cancer Control 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 precancers Primary prevention: Vaccination
  9. 9. Cervical Cancer Screening Practices in India Estimated coverage of cervical cancer screening in India, by age & study (1) WHO Household Surveys with geographical information system (GIS) multistage cluster sampling. Screening coverage among women aged 18-69. 2. Bruni L, Barrionuevo-Rosas L, Serrano B, Brotons M, Cosano R, Muñoz J, Bosch FX, de Sanjosé S, Castellsagué X. ICO Information Centre on HPV and Cancer (HPV Information Centre). Human Papillomavirus and Related Diseases in India. Summary Report 2014-01-31. [Accessed on 11th Feb 14]
  10. 10. WHY VACCINATION ? • HPV vaccines are highly effective at preventing the infection of susceptible women with the HPV types covered by the vaccine. • HPV vaccine should be given to females before they reach an age when the risk of HPV infection increases and they are at subsequent risk of cervical cancer. • HPV vaccine can be given to all female between 9 to 45 years of age group. • HPV vaccine is given as 3 doses over a period of 6 months. The ‘Green Book’ chapter on Human papillomavirus (HPV) Gardasil : Quadrivalent Cervix : Bivalent Nonovalent (2016)
  11. 11. Rationale for Vaccination Natural Infection – Weak AB response Vaccination - High AB Response Higher AB level at cervical epithelium prevents HPV infection
  12. 12. GARDASIL®: The Only Quadrivalent HPV Vaccine1 • HPV types 6, 11, 16, 18 • Manufactured in Saccharomyces cerevisiae • Amorphous aluminum hydroxyphosphate sulfate (AAHS) adjuvant – 225 μg per dose • 0-, 2-, 6-month dosing regimen • Does not contain viral DNA and therefore not infectious 1. Worldwide Product Circular. GARDASIL® [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine]; WPC-GRD-I-122008.
  13. 13. 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 √
  14. 14. GARDASIL® : Nordic Cancer Registry Extension Evaluation of Long- Term Efficacy of Vaccination • Nordic European countries have organized mass screening programs. – Compulsory reporting of Paps, biopsies, CIN/cancer • By enrolling phase III studies in the region, we can evaluate: – Duration of effectiveness – Data for use in assessing interaction of vaccination with cervical screening programs – Long-term safety Denmark Norway Iceland Sweden CIN = cervical intraepithelial neoplasia.
  15. 15. Data on File a FUTURE= Females United to Unilaterally Reduce Endo/Ectocervical Disease Registry-Based Follow-Up Vaccination Reports 6 years 8 years 10 years US FDA Approval 5 years 7 years3 years 2003 2004 2005 2006 2007 2008 20132010 2011 20122009 3.5 years FUTUREa II Study Total Duration Time since approval Report of 6-yr F/U Follow-Up Through Nordic Registries Provides a Sentinel Cohort (vaccinated at the start of study)
  16. 16. 0 0 0 100 % 100 % 100 % 0 20 40 60 80 100 Zero number of cases Vaccine Effectiveness Vaccine Effectiveness Vaccine Effectiveness (N=1,080) (N=921) (N=1.032) HPV 16/18-Related CIN 2 or Worse HPV 16-Related CIN 2 or Worse HPV 18-Related CIN 2 or Worse Zero number of cases Zero number of cases Vaccine effectiveness measures the relative reduction of the disease incidence in vaccine recipients compared to the baseline incidence rate of 0.0287 per 100 person-years established from the incidence rate in an unvaccinated cohort and under the assumption vaccine efficacy is 90%. Per Protocol Efficacy Population Percentage Data on File Effectiveness Against HPV 16/18-Related CIN 2 or Worse (8 years registries based f/u data from Nordic countries) Nygard, M., Long-term immunogenicity, safety and effectiveness of Gardasil in the Nordic countries Obstetrics & Gynaecology Forum;Aug2013, Vol. 23 Issue 3, p36
  17. 17. 0 0 0 0 0 0 20 40 60 80 100 Vaccineeffectiveness (N=1,080) Vaccineeffectiveness Vaccineeffectiveness Vaccineeffectiveness Vaccineeffectiveness Zero number of cases Zero number of cases Zero number of cases Zero number of cases Zero number of cases (N=1,080) (N=1,080) (N=1,080) (N=1,080) CIN 2 CIN 3 CIN 3 + AIS CC Vaccine effectiveness measures the relative reduction of the disease incidence in vaccine recipients compared to the baseline incidence rate of 0.0287 per 100 person-years established from the incidence rate in an unvaccinated cohort and under the assumption vaccine efficacy is 90%. Percentage Per Protocol Efficacy Population 100 % 100 % 100 % 100 % 100 % Data on File Effectiveness by Lesion Type (8 years registries based f/u data from Nordic countries) Nygard, M., Long-term immunogenicity, safety and effectiveness of Gardasil in the Nordic countries Obstetrics & Gynaecology Forum;Aug2013, Vol. 23 Issue 3, p36
  18. 18. Is it worth vaccinating sexually active women
  19. 19. Estimated Benefit of Vaccination With GARDASIL in Sexually Active Women 99.9% of women will benefit2 99.6% of women will benefit2 ► Women who have been exposed to at least 1 but not all vaccine-targeted HPV types will derive some benefit from vaccination.1 1. Wright TC Jr et al. Gynecol Oncol. 2008;109(2 suppl):S40-S47. 2. Data on file, MSD. Infected with all 4 types Infected with 3 types Infected with 2 types Infected with 1 typeWomen unexposed to any vaccine-targeted type
  20. 20. aEfficacy after 3 doses in women 24–45 years of age naïve to the relevant type at baseline. Per-Protocol Efficacy Populationa – Primary Endpoint Related Cases 5510 86 56 30 0 20 40 60 80 24- to 45-Year-Olds 24- to 34-Year-Olds 35- to 45-Year-Olds n=1910 n=1907 88.7% Reduction (78, 95) 91.3% Reduction (78.4, 97.3) 83.8% Reduction (57.9, 95.1) GARDASIL® PlaceboTotal Mean Follow-Up: 3.8 Years GARDASIL®: Adult Women Efficacy Study Combined Incidence of HPV 6/11/16/18-Related Persistent Infection or Cervical/Vulvar/Vaginal Disease in Women 24–45 Years of Age1 1. Castellsagué X et al. Br J Cancer. 2011.
  21. 21. GARDASIL®: FUTURE III: Adult Women Study (LTFU) Combined Incidence of HPV 6/11/16/18-Related CIN2 or worse in Women 24–45 Years of Agea a Effectiveness in the early vaccination group after 3 doses in women 24–45 years of age naïve to the relevant type at baseline in an extension study of FUTURE III trial in Columbia. Per-Protocol Efficacy Population a – Primary Endpoint Related Cases 1511 29 21 7 0 30 CIN & EGL or worse CIN or worse CIN 2 or worse GARDASIL® Expected cases Total Mean Follow-Up: 6.3 Years 1 20 10 una J, et al. Long-term follow-up observation of the safety, immunogenicity, and effectiveness of Gardasil™ in adult women PLoS One. 2013 Dec 31;8(12):e83431 High efficacy seen in adult women
  22. 22. Opportunity of HPV vaccination during postpartum period
  23. 23. 23 – Primiparous women aged between 15 and 24 years, living in the metropolitan area of São Paulo for at least 6 months, and gave birth at this hospital after more than 32 weeks of gestation, were enrolled at their postnatal visit, from June 2006 to February 2007. – Exclusion criteria: non-Brazilian, inability or refusal to give informed consent, or immunodeficiency (including AIDS/HIV infection checked in medical records). – Women were recruited to take part in the study during the postdelivery follow-up period in the hospital. J Epidemiol Community Health 2010;64:610-615
  24. 24. 24 • After the first dose of vaccine, – 97.2% of women felt it was worthwhile to receive the vaccine, – whereas 98.6% said that administration was convenient. • When asked, 50.4% of participants said they would not have asked to be vaccinated if they were not part of the study. • Among those vaccinated, – 99.3% were happy they participated in the study and – 97.9% would have recommended the vaccine to a friend • Despite the acceptability of this strategy, only 30.7% of enrolled patients completed the three-vaccine series Wright, Govindappagari, Pawar et al, Acceptance and Compliance With Postpartum Human Papillomavirus Vaccination, Obstet Gynecol 2012;120:771–82
  25. 25. How importance is prevention of other HPV diseases e.g. Genital Wart (GW)
  26. 26. PREVALENCE AND PATIENT EXPERIENCE WITH CONDYLOMATA ACUMINATA (GENITAL WARTS) IN INDIA Khopkar U et al. Poster presented at AOGIN Hong Kong 2012 PercentofGW Estimates are adjusted for by specialty type Females (95% CI) Males (95% CI) 18-24 years 0.69 (0.49; 0.89) 1.25 (0.95; 1.55) 25-29 years 1.36 (1.07; 1.65) 1.60 (1.38; 1.82) 30-34 years 1.16 (0.82; 1.50) 1.76 (1.23; 2.28) 35-39 years 1.04 (0.67; 1.41) 1.63 (1.09; 2.17) 40-44 years 1.04 (0.70; 1.38) 0.90 (0.70; 1.10) 45-49 years 0.88 (0.52; 1.24) 0.55 (0.27; 0.83) 50-54 years 0.93 (0.52; 1.34) 0.46 (0.31; 0.61) > 54 years 0.31 (0.16; 0.46) 0.84 (0.32; 1.36) Overall 0.99 (0.88; 1.10) 1.22 (1.12; 1.33) Both males and females have shown significantly higher psychosocial impact than those without GW diseases
  27. 27. Genital Warts and Risk of Cancer: A Danish Study of Nearly 50000 Patients With Genital Warts Blomberg M et al. J Infect Dis. 2012 May 15;205(10):1544-53. Standardized Incidence Ratios (SIRs) of Cancer among women (n = 33,422) diagnosed of GW in Denmark during 1978–2009 2.8 1.5 5.9 7.8 14.8 4.7 4.8 0 2 4 6 8 10 12 14 16 All HPV related cancers Cervix uteri Vagina Anus Vulva Tonsils HPV Associated HNC StandardizedIncidenceRatios(SIRs) CI: 2.4- 3.1 CI: 5.5- 9.2 CI: 2.2-12.9 CI: 5.4- 11.0 CI: 11.7-18.6 CI: 2.3-8.4 CI: 2.7-8.0 Diagnosis of GW was strongly related to anal, vulvar, vaginal, cervical & sub sites of HN cancer with confirmed HPV association.
  28. 28. Genital Warts and Risk of Cancer: A Danish Study of Nearly 50000 Patients With Genital Warts Blomberg M et al. J Infect Dis. 2012 May 15;205(10):1544-53. Standardized Incidence Ratios (SIRs) of Cancer among women (n = 33,422) diagnosed of GW in Denmark during 1978–2009, The risks in anal cancer remained elevated for >10 years following GW diagnosis. 9.7 14.5 9.8 6.2 0 2 4 6 8 10 12 14 16 < 1 Yr 1-4 Yr 5-9 Yr ≥10 yr StandardizedIncidenceRatios(SIRs) Follow up time CI: .1-54.0 CI: 5.8-29.8 CI: 3.9-20.1 CI: 3.6-9.7 According to Follow-up time by cancer site-Anus
  29. 29. Real world effectiveness of QHPV vaccine
  30. 30. Impact of HPV Vaccine in Public Vaccination Programs: Selected Reports as of April 20131–21 qHPV=quadrivalent human papillomavirus. Please see corresponding slide note for references. Markowitz. IPV 2012. 2006–2007 Dec ‘09 Jul ‘11Jan ‘11 Dec ‘11 May ‘12Jun ‘11 Jul ‘12 Jan ‘13Dec ‘12Oct ‘12 Introduction of qHPV vaccine Oliphant et al. NZ Med J. 2011. Bauer et al. Am J Pub Health. 2012. Wikström et al. EUROGIN 2012. Mikolajczyk et al. Sex Transm Dis. 2013. Baandrup et al. Sex Transm Dis. 2013. Fairley et al. Sex Transm Infect. 2009; Donovan et al. Lancet Infect Dis. 2011. Kliewer et al. IPV 2012. Kjaer et al. IPV 2012. Brotherton et al. Lancet. 2011. Van Tielen; Weyers et al. EUROGIN 2012. Leval et al. J Infect Dis. 2012. Ali et al. IUSTI 2012. Read et al. Sex Transm Infect. 2011. Powell et al. Vaccine. 2012. Tabrizi et al. J Infect Dis. 2012. 2012 Sep ‘12 Feb ‘13 Leval et al. J Natl Cancer Inst. 2013. Mar ‘13 Ali et al. BMJ 2013 Apr ‘13 Ali et al. BMC Infect Dis 2013.
  31. 31. The incidence of high grade cervical abnormalities has decreased following the qHPV programme 1. Reprinted from The Lancet, 377, Brotherton JM et al, Early effect of HPV vaccination programme on cervical abnormalities in Victoria, Australia: an ecological study, 2085–2092, Copyright (2011), with permission from Elsevier. Vaccination program begins IMPACT1 “With data from a state-based cervical screening register, we have shown a decrease in high-grade cervical abnormalities in young women after the implementation of the vaccination programme”. Using data from the Victorian Cervical Cytology Registry between 2003 and 2009, the incidence of histopathologically defined high-grade cervical abnormalities (HGAs, lesions coded as cervical intraepithelial neoplasia of grade 2 or worse or adenocarcinoma in situ; primary outcome) and low-grade cytological abnormalities (LGAs) was compared in five age groups before (Jan 1, 2003, to March 31, 2007) and after (April 1, 2007, to Dec 31, 2009) the vaccination programme began. Green dots represent the number of new diagnoses within a 3-month period per 100 women tested. HGA = high-grade cervical abnormalities; qHPV = quadrivalent human papillomavirus. Incidence of high grade abnormalities among girls < 18 yrs 1 Australian experience: Real World Effectiveness of QHPV Vaccine
  32. 32. The prevalence of vaccine-preventable HPV types has decreased following the qHPV vaccination programme 1. Tabrizi S et al. The Journal of Infectious Diseases 2012;206:1645–51 Differences in HPV genoprevalence between pre-vaccine and post-vaccine populations 1, * IMPACT1 “……we have shown that a substantial and statistically significant decrease in the prevalence of vaccine-preventable HPV genotype infections has occurred following implementation of Australia’s national HPV vaccination program”. * P < 0.05 for differences in percentages between groups This study used a repeat cross-sectional design to compare HPV prevalence in 2 samples of women recruited from sentinel clinical sites. The first or “pre–vaccine implementation” sample was made up of women aged 18–24 years (at the time of recruitment) who were recruited from participating family planning clinics (FPCs) for Papanicolaou screening during the recruitment period of 2005–2007 and had participated in the Women, Human papillomavirus prevalence, Indigenous, Non-Indigenous, Urban, Rural Study (WHINURS) study. The second or “post–vaccine implementation” sample comprised women aged 18–24 years who had attended FPCs in the same cities during the recruitment period 2010–2011 for Papanicolaou screening; qHPV = quadrivalent human papillomavirus. 28.7% 6.7% Australian experience: Real World Effectiveness of QHPV Vaccine
  33. 33. 1. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2009/11/news_detail_000389.jsp&mid=WC0b01ac058004d5c1 2. Centers for Disease control website. Available at: http://www.cdc.gov/vaccinesafety/vaers/gardasil.htm- last accessed on 16.04.10. 3. RELEVE EPIDEMIOLOGIQUE HEBDOMADAIRE, No. 15, 2009, 84, http://www.who.int/wer 4. Press release Spain MINISTERIO DE SANIDAD Y POLÍTICA SOCIAL 23.04.2009 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
  34. 34. Global Vaccine Safety Human papillomavirus vaccines safety (HPV) Extract from report of GACVS meeting of 11-12 December 2013, published in the WHO Weekly Epidemiological Record on 14 February 2014
  35. 35. IN INDIA, BOTH IAP AND FOGSI RECOMMEND THE HPV VACCINE AND SCREENING ► Both are equally efficacious against cervical cancer and precancerous lesions. The quadrivalent vaccine additionally protects against anogenital warts ► The recommended age for initiation of vaccination is 11-12 years. Catch up vaccination is permitted up to the age of 45 years ► Experience with the HPV vaccines used in the post-licensure observational study confirms the good safety profile reported in clinical trials Indian Academy of Pediatrics (IAP) 1,2 Efficacy Cohort Safety 1. Yewale V, Choudhury P, Thacker N. IAP Immunization Committee - IAP Guidebook on Immunization 2009-2011; 2. VIPIN M VASHISHTHA, AJAY KALRA, ANURADHA BOSE, PANNA CHOUDHURY, VIJAY N YEWALE, CP BANSAL, SAILESH G GUPTA Indian Academy of Pediatrics, Advisory Committee on Vaccines and Immunization Practices (ACVIP) , 2013; 3. Purandare CN and Saraiya UB. Recommendations for vaccination against Human Papilloma Virus (HPV) infection forthe prevention of cervical cancer. FOGSI ICOG Good Clinical Practice Recommendations ► Both protect against HPV genotypes 16 and 18. The quadrivalent vaccine also protects against types 6 and 11 that are responsible for about 90% of genital warts ► Routine HPV vaccination is recommended for females aged 10 to 12 years. HPV vaccination may be offered to all upto 45 years, but offers less benefit if already sexually active Federation of Obstetric & Gynecology Societies of India (FOGSI)3 Efficacy Cohort
  36. 36. Summary • HPV infection is more than cervical cancer! • There is an increasing evidence strongly linking HPV DNA with cancers of anus, vulva, vagina, penis & sub sites of HEAD & NECK CANCER • Genital Warts has confirmed HPV association.
  37. 37. 38 NOW !!!
  38. 38. ADDRESS 11 Gagan Vihar, Near Karkari Morh Flyover, Delhi - 51 CONTACT US 9650588339 (Helpline) 011-22414049,22058865 WEBSITE : www.drshardajain.in www.lifecarecenreivf.com E-MAIL ID Lifecarecentre21@gmail.com info@lifecareivf.com ISO 14001:2004 (EMS) …..Caring hearts, healing hands ISO 9001:2008 ISO 9001:2008 www.globalstemgenn.com , Helpline: 9599044357 www.lifecarecentre.in Helpline:9599044257
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HPV Vaccination, Cerviocal Cancer : Do we need it for Prevention of cervical cancer & other HPV related diseasesm, Presentation Outlines Cervical cancer disease burden Prevention with HPV vaccination Vaccination of sexually active women Opportunity of Postpartum HPV vaccination Importance of genital warts prevention Real world effectiveness data Safety of HPV vaccine

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