FOGSI RECOMMENDATIONS FOR CERVICAL CANCER VACCINATION

11 th OCTOBER 2008

DR. JYOTI BHASKARDirector Lifecare IVF

Consultant Pushpanjali Crosslay Hospital

VACCINATION TARGET GROUP

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

COUNSELLING

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

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

HPV TESTING

• Before Vaccination not recommended

• Vaccinated women should be screened as per the standard guideline

• Screen positive women may be vaccinated after counseling

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

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.

IMMUNOCOMPROMISED PATIENTS

• Not a contraindication to vaccination.

• Immune response to the HPV vaccine may be less competent.

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.

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.

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

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

"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.