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Fogsi Guidelines
1. FOGSI RECOMMENDATIONS
FOR CERVICAL CANCER VACCINATION
11 th OCTOBER 2008
DR. JYOTI BHASKAR
Director Lifecare IVF
Consultant
Pushpanjali Crosslay Hospital
2. VACCINATION TARGET GROUP
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APPROVED
Bivalent 10-45 YRS Quadrivalent 9-45 yrs
Most convenient and optimal age (12-16 years old) –
before first sexual exposure
Offered to all upto 45 years, regardless of sexual
activity but less effective if sexually active.
Informed discussion between the woman and her
health care provider
Not recommended in males
3. COUNSELLING
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Full explanation of the role, action and
usefulness of the vaccine
the role of HPV in cervical carcinogenesis (in
particular HPV-16 and HPV-18); It is NOT
therapeutic
trial results and expectations;
immunological responses;
safety and efficacy;
as well as answer queries on issues
4. DOSAGE SCHEDULE
BIVALENT
• 0, 1, 6 months
QUADRIVALENT
• 0, 2, 6 months
Minimum Intervals between doses
• 4 weeks between 1st & 2nd dose
• 12 weeks between 2nd and 3rd dose
ADMINISTRATION:
1. Intramuscularly in deltoid Muscle
2. In lying down position and observe for 15 mts
5. HPV TESTING
• Before Vaccination not recommended
• Vaccinated women should be screened as per
the standard guideline
• Screen positive women may be vaccinated
after counseling
6. Sexually Active Women
• Sexually active women and women with
previous abnormal cervical cytology can
receive the HPV vaccine
• Benefits may be limited to the protection
against infection of HPV genotypes with which
they have not been infected
7. SPECIAL SITUATION
PREVIOUS CIN
• Should be Vaccinated
• Counselled - the benefits may be limited to the
protection against infection of HPV genotypes (and
related CIN) with which they have not been infected.
• Cervical screening and corresponding management
must continue.
9. PREGNANCY AND LACTATION
• The use of the vaccine in pregnancy is not
recommended, although no teratogenic effect
caused by the vaccine has been reported.
• There is no evidence to show that the HPV vaccine
adversely affects fertility, pregnancy or infant
outcome.
• Women who are planning to conceive are advised to
defer vaccination until after delivery.
10. PREGNANCY AND LACTATION
• Women who become pregnant before completion of
vaccination are advised to postpone the remaining
dose until after the pregnancy.
• Termination of pregnancy is not indicated for women
who become inadvertently pregnant during the
course of vaccination.
• Lactating women can receive the HPV vaccine and still
continue breastfeeding because it is a vaccine
without live viral DNA.
11. Clinical Efficacy
Use of CIN grade 2 or 3 (CIN2–3) and AIS
as clinical end-points in vaccine efficacy trials
instead of invasive cervical cancer
12. Contraindications and Precautions
• History of hypersensitivity to any vaccine
component.
• Women with moderate or severe acute
illnesses should be deferred until after the
illness improves.
• If administered concomitantly with any other
vaccine, it should be at a separate site, with a
separate syringe
13. "There are challenges for countries in
terms of cost and so on, but this vaccine
is unique and offers tremendous
possibilities."
Dr Teresa Aguado, WHO’s coordinator for the
Initiative for Vaccine Research, Product Research and
Development team.