Human Papillomavirus Vaccine (Bivalent)

What it is and how it works

Contains purified L1 capsid protein virus-like particles of HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58, produced by recombinant DNA technology and adsorbed on an aluminium adjuvant. It induces neutralising antibodies that protect against infection with the vaccine HPV types.

Indications

Active immunisation from 9 years of age against premalignant lesions and cancers of the cervix, vulva, vagina and anus, and against genital warts (condyloma acuminata), caused by the vaccine HPV types.

Dosage and administration (summary)

0.5 mL by intramuscular injection: individuals aged 9–14 years may receive a 2-dose schedule (0 and 5–13 months); from 15 years a 3-dose schedule (0, 2 and 6 months) is used, or according to national immunisation programmes.

Contraindications

Hypersensitivity to the active substances or excipients, including yeast, or after a previous dose of HPV vaccine; postpone in acute severe febrile illness.

Warnings and precautions

Syncope may follow injection, particularly in adolescents, so recipients should be observed for about 15 minutes. It does not protect against HPV types not in the vaccine or treat existing infection, and cervical screening must continue. Use with caution in thrombocytopenia or coagulation disorders.

Pregnancy

Vaccination should be postponed until after pregnancy; inadvertent vaccination during pregnancy has not shown harm.

Storage and supply

Store at 2–8 °C in a refrigerator; do not freeze; protect from light.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.