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Human papillomavirus type 6, 11, 16, 18 vaccine

Updated 2 Feb 2023 | Human papilloma virus vaccine


Suspension for injection containing Human Papilloma virus L1 protein in a 0.5ml pre-filled syringe.

Drugs List

  • human papillomavirus (type 6 11 16 18) vaccine
  • Therapeutic Indications


    Genital warts: Active immunisation
    Human papilloma virus related cancer: Active immunisation

    Human papilloma virus (HPV) vaccine type 6, 11, 16, 18 is indicated for active immunisation of individuals from the age of 9 years against the following HPV diseases:
    Premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic human papilloma virus (HPV) types. Genital warts (Condyloma acuminata) causally related to specific HPV types.


    The use of the vaccine should follow official recommendations.

    For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed:


    Three doses of 0.5ml at 0, 2 and 6 months. The second dose must be given at least one month after the initial dose and the third dose must be administered at least 3 months after the second dose. All doses are to be given within a 1 year period.


    Children aged 14 years and over at the time of first dose
    Three doses of 0.5ml at 0, 2 and 6 months. The second dose must be given at least one month after the initial dose and the third dose must be administered at least 3 months after the second dose. All doses are to be given within a 1 year period.

    Children aged 9 to 13 years at the time of first dose
    Two doses of 0.5ml doses at 0 and 6 months. If the second vaccine is administered earlier than 6 months after the initial dose, a third dose should always be administered.

    Alternatively, three doses of 0.5ml at 0, 2 and 6 months may be given. The second dose should be administered at least one month after the initial dose and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1 year period.

    The Green Book suggests:
    Children aged 15 years and above at the time of first dose
    An initial dose of 0.5ml is given, followed by 0.5ml at least one month after the initial dose. A third dose of 0.5ml is then given at least 3 months after the second dose.
    Children aged between 11 years and below 15 years at the time of first dose
    Initially a dose of 0.5ml is given, and a second dose of 0.5ml is given at least 6 to 24 months after the first dose.

    If the course is interrupted, it should be resumed (with the same vaccine) but not repeated, even if more than 24 months has lapsed since the initial dose.


    The vaccine should be administered by intramuscular injection.

    The preferred site is the deltoid area of the upper arm. Human papilloma virus (HPV) vaccine type 6, 11, 16, 18 can also be administered into the higher anterolateral area of the thigh.


    Children under 9 years
    Severe febrile conditions

    Precautions and Warnings

    Immunodeficiency syndromes

    Postpone immunisation if there is active or suspected infection
    Advise ability to drive/operate machinery may be affected by side effects
    Impaired response possible in immunocompromised patients
    Vaccine may not be effective in 100% of patients
    Different brands may not be interchangeable
    Do not mix with other vaccines in the same syringe
    Do not use if any signs of precipitate or particulate matter apparent
    Inject other vaccines at different sites
    Resuscitation facilities must be immediately available
    Risk of syncope. Monitor patients for 15 min after vaccination
    Advise women to participate in breast/cervical cancer screening programmes
    Treatment does not protect against risk of sexually transmitted disease

    The decision to vaccinate an individual should take into account the risk of previous HPV exposure and the potential benefit from vaccination.

    Vaccination may not result in protection in all vaccine recipients. Appropriate precautions against transmitted diseases should continue to be used.

    Human papillomavirus vaccine is for prophylactic use only. It has not been shown to have a therapeutic effect. The vaccine is therefore not indicated for the treatment of cervical cancer, high-grade cervical, vulvar and vaginal dysplastic lesions or genital warts. It is also not intended to prevent progression of other established HPV-related lesions. Human papillomavirus vaccine does not prevent lesions due to a vaccine HPV type in patients already infected with that HPV type at the time of vaccination.

    The use of human papillomavirus in adults should take into consideration the variability of HPV type prevalence in different geographical areas. Since no vaccination is 100% effective and human papilloma virus vaccine will not provide protection against non-vaccine HPV types, or against existing HPV infections, routine cervical screening in women remains critically important and should follow local recommendations. Vaccination is not a substitute for routine cervical screening in women.

    There are no data on the use of human papilloma virus vaccine in subjects with impaired immune responsiveness. Individuals with impaired immune responsiveness, whether due to the use of potent immunosuppressive therapy, a genetic defect, HIV infection, or other causes, may not respond to the vaccine.

    The duration of protection is currently unknown. Timing and need of booster dose(s) has not been established.

    Pregnancy and Lactation


    Human papilloma virus vaccine type 6, 11, 16, 18 is contraindicated in pregnancy.

    Limited data on pregnant women indicated no malformative nor foetal toxicity when using this HPV vaccine during pregnancy. However this data is insufficient and thus vaccination should be postponed until the completion of the pregnancy.

    Schaefer (2015) suggests that HPV vaccine should not be routinely administered during pregnancy but an accidental vaccination should carry no consequences. Booster injections should be carried out after completion of the pregnancy.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Human papilloma virus vaccine type 6, 11, 16, 18 may be used during breastfeeding.

    The manufacturer suggests that there have been no reports of adverse reactions in nursing infants whose mothers were receiving the vaccination.

    Schaefer (2015) also agrees that the use of this vaccine during breastfeeding is safe.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Acute disseminated encephalomyelitis
    Anaphylactic reaction
    Anaphylactoid reaction
    Bruising at injection site
    Cellulitis (injection site)
    Erythema at injection site
    Extremity pain
    Guillain-Barre syndrome
    Hypersensitivity reactions
    Idiopathic thrombocytopenic purpura (ITP)
    Local pain (injection site)
    Swelling (injection site)
    Syncope accompanied by tonic-clonic movements


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111.

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: October 2016

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    NICE Evidence Services Available at: Last accessed: 15 January 2020

    Summary of Product Characteristics: Gardasil. Sanofi Pasteur MSD Limited. Revised March 2019.

    Immunisation against infectious diseases: 'The Green Book', Department of Health.
    Available at:
    Last accessed: 14 January 2020

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Human papillomavirus vaccines. Last revised: 02 June 2016
    Last accessed: 21 October 2016

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