Why HPV Vaccination for Preventing Cervical Cancer in India Should Become a Part of Immunization Programme

1. Why HPVVaccination for Preventing
Cervical Cancer in India Should Become
a Part of Immunization Programme
Dr Anil Gupta
Senior Resident
Department of Radiation Oncology
AIIMS, New Delhi
Presenter
Dr D N Sharma
Prof and Head
Department of Radiation Oncology
AIIMS, New Delhi and NCI, Jhajjar
Moderator

2. Incidence of Cancer in Females in India
Cervical cancer is a public health problem in India.
Only cancer which can be prevented, detected and treatable

3. Estimated number of new cases from
2020 to 2040
GLOBOCAN 2020
One-fifth of the global burden of this
cancer
about 73 000 women die of
the disease annually in India

4. How HPVVaccine works?
 CIN of grade 2 (CIN2), CIN3 and adenocarcinoma in situ (AIS) are considered as high-risk
HPV (hrHPV) infection
 Cervical cancer is etiologically linked with persistent high-risk HPV infection.
 Approx. 85% are caused by HPV, 70% are caused by HPV strain 16 and 18.
 Prophylactic HPV vaccines contain virus-like-particles (VLPs) consisting of the major L1
protein of the capsid.
 Administration by i.m injection triggers production of antibodies that are believed to
prevent new type-specific infections and subsequent development of CIN

5. What HPV vaccines are available?
All three vaccines areWHO prequalified, which means thatWHO has
determined that they meet global standards of quality, safety and efficacy

7. Safety
Some concerns of AEFI
• Syncope, Dizziness, and Nausea
• Neurological events
• VenousThromboembolic Events
• Premature ovarian failure/infertility
• Deaths
No causal association is established
Lot of negative publicity without any scientific grounds

8. Cochrane metanalysis
26 trials (73,428 participants)
Most trials were at low risk of bias
Certainty of evidence for protection against cervical precancer CIN 2, CIN 3 and
adenocarcinoma‐in‐situ [AIS]
Adverse events and Pregnancy outcomes analysed
Cochrane Database of Systematic Reviews 09 May 2018

9. Adverse events
Relative risk (Vaccinated vs non
vaccinated)
CI (95%)
Short-term local adverse
events
1.18 to 1.73
Overall systemic events 1.02 0.98–1.07
Serious adverse events 0.98 0.92 to 1.05
Mortality ratio 1.29 0.85–1.98
Young women 0.98 0.59-
Mid-adult women 2.36 1.10–5.03
Miscarriage 0.88 0.68–1.14
Termination of pregnancy 0.9 0.80–1.02
Stillbirths 1.12 0.68–1.83
Congenital abnormalities 1.22 0.88–1.69

10. JAMA, August 19, 2009—Vol 302, No. 7

12. WHO RegionalOffice for Europe

13. Efficacy
main outcomes:
CIN2+, CIN3+, and AIS related to the HPV types/irrespective of HPV types

14. Cochrane metanalysis
Relative risk to develop CIN2+ associated with HPV16/18 infection in women

15. Key points
Bivalent and quadrivalent HPV vaccines induce excellent protection against persistent
HPV16/18 infection and associated precursor lesions in young who are not infected with
high-risk HPV.
Vaccine efficacy decreases by age. No protection against any CIN2+/AIS was found in the
group of older women (aged 24 or older) unselected by HPV DNA status at enrolment.
Similar rates of serious adverse events were observed in the experimental and control
arms of randomized trials.
INFERENCE
Young females (less than 25 year old) should be the primary target of vaccination
campaign.

16. HPV vaccine reduces incidence of cervical
cancer?
N Engl J Med 2020;383:1340-8.
DOI: 10.1056/NEJMoa1917338
1,672,983 girls
and women 10
to 30 years of
age included in
the study

17. History of HPV
Vaccination in
India demonstration
project
suspended

18. Present Status in India
FOGSI and the IndianAcademy of Paediatrics,Association ofGynaecologicOncologists of
India (AGOI) recommend its use
Presently not a part of Universal Immunization Programme but NationalTechnical
Advisory Group on Immunisation advised its inclusion.
2 dose vs 3 dose trial suspended in between follow up continuedimmunogenicity
following two doses of HPV vaccination was non-inferior to that following three doses, and
one-dose recipients showed a robust and sustained immune response

19. Cost-effectiveness analysis
 Cost of vaccinating 11-year-old girls in Punjab is around 135 million INR
 lifetime cost of treating cervical cancer cases in vaccinated is INR 52 million
 In Unvaccinated is INR 149 million
 The net cancer treatment costs is around 38 million INR
 incremental cost per cervical case prevented and death averted found to be INR 51,808 and INR
52,330
o If the cost per vaccinated girl is less than $10, vaccination is likely to be extremely cost-effective in
India
o Assuming 70% coverage, mean reduction in lifetime cancer risk was 44% (range, 28–57%) with
vaccination alone, and 21–33% with screening 3 times per lifetime
o
Prinja S et al Cancer 2017
Diaz M, et al Br J Cancer 2008

20. Prevention
Prevention Detection
Vaccination vs screening

21. Punjab Model of HPVVaccination
• Phase I
Bathinda and Mansa districts-high annual incidences
Training targeting officials, teachers, district immunisation officers, medical officers, cold
chain handlers, auxiliary nurse midwives, and accredited social health activist workers was
provided by Department of Health and FamilyWelfare Punjab in collaboration withWHO.
Education of the parents of class 6 girls was done through the Punjab Edusat Society
Administration of the vaccine initiated in 2016, through community health centres, and
sub-district and district hospitals.
98% targeted girls completing the prescribed two doses, less than 1% ofvaccine being
wasted. Minor adverse events were documented in 28 girls
• Phase II
Started in 2017
99% targeted girls completed treatment

22. What about other countries
Denmark
Initially vaccine uptake was 80-90% (started in 2009)
From 2014, the uptake dropped to below 40% due to negative publicity
No link between adverse effects found
“Stop HPV, Stop Cervical Cancer” campaign started
Vaccination picked up from 27% in 2016 to 76% in 2018
• Similar case with Ireland

23. Can it Prevent other HPV related diseases?
Gardasil 9 is licensed for
prevention of HPV-related
cervical, vaginal and vulvar
cancers in females and HPV-
related anogenital lesions and
anal cancers in males and females

24. Conclusion
• Vaccination is the most practical solution.
• Although Misinformation and confusion surround the safety, duration of immunity, validity,
effectiveness, and cost-effectiveness exists even after so much evidence.
• Worldwide and nation studies have refuted the doubts over safety and efficacy again and again.
• State-wise introduction of HPV vaccination in Sikkim, Punjab and opportunistic vaccination in
Delhi are encouraging signs of government engagement
• Leading international (UICC/GACVS/FDA) and national health organisations continue to
recommend their use.
• It’s apt time to put all doubts to rest and introduce vaccination in Universal Immunization
Programme.

26. Thank you