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Papillomavirus (Types 16, 18) Vaccine (Human, Recombinant)

Medically reviewed by Drugs.com. Last updated on Jun 11, 2020.

Pronunciation

(pap ih LO ma VYE rus typs SIX teen AYE teen vak SEEN YU man ree KOM be nant)

Index Terms

  • 2-Valent HPV
  • 2vHPV
  • Bivalent Human Papillomavirus Vaccine
  • GSK-580299
  • HPV 16/18 L1 VLP/AS04 VAC
  • HPV Vaccine (Bivalent)
  • HPV2
  • Human Papillomavirus Vaccine (Bivalent)

Pharmacologic Category

  • Vaccine
  • Vaccine, Inactivated (Viral)

Pharmacology

Contains inactive human papillomavirus (HPV) proteins HPV 16 L1, and HPV 18 L1 which produce neutralizing antibodies to prevent cervical cancer, cervical adenocarcinoma, and cervical neoplasia cause by HPV.

Efficacy: HPV2 has shown to be 95% to 99% effective against HPV types 16 and 18-related cervical disease in females 15 to 25 years of age. In addition, vaccination against HPV types 16 and 18 may prevent ~70% of anogenital cancers and 60% of high-risk precancerous cervical lesions (NACI 2017).

Onset of Action

Seroconversion was observed at month 7

Duration of Action

Unknown. Clinical studies followed HPV2 vaccinated participants for 10 years and found no evidence of waning protection (NACI 2017).

Use: Labeled Indications

Prevention of human papillomavirus infection: Prevention in females 9 to 45 years of age of the following diseases caused by oncogenic HPV types 16 and 18: Cervical cancer, cervical intraepithelial neoplasia (CIN) grades 1 to 3 and cervical adenocarcinoma in situ

The Canadian National Advisory Committee on Immunization (NACI) recommends routine vaccination for females between 9 and 26 years of age. It should not be administered in females <9 years but may be administered to females >26 years who are at ongoing risk of exposure (NACI 2017).

Contraindications

Hypersensitivity to any component of the formulation

Dosing: Adult

Note: Immunization during coronavirus disease 2019 (COVID-19) pandemic: Routine vaccination should not be delayed because of the COVID-19 pandemic (CDC 2020; WHO 2020). In general, simultaneous administration of all vaccines for which a patient is eligible (according to current immunization schedules/guidelines) is recommended (ACIP [Ezeanolue 2020]). However, vaccination of patients with suspected or confirmed COVID-19 infection (regardless of symptoms) should be postponed to avoid exposure to health care personnel and other patients (CDC 2020). Additional information is available from the CDC, the American Academy of Pediatrics, and the Immunization Action Coalition.

Prevention of human papillomavirus infection: IM: Females ≤45 years: 0.5 mL at 0, 1, and 6 months. Administer the second dose 1 to 2.5 months after the first dose; administer the third dose 5 to 12 months after the first dose.

NACI recommendations: Recommended for females ≤26 years; may be given to those ≥27 years who are at ongoing risk (NACI 2017).

Dosing: Pediatric

Note: Immunization during coronavirus disease 2019 (COVID-19) pandemic: Routine vaccination should not be delayed because of the COVID-19 pandemic (CDC 2020; WHO 2020). In general, simultaneous administration of all vaccines for which a patient is eligible (according to current immunization schedules/guidelines) is recommended (ACIP [Ezeanolue 2020]). However, vaccination of patients with suspected or confirmed COVID-19 infection (regardless of symptoms) should be postponed to avoid exposure to health care personnel and other patients (CDC 2020). Additional information is available from the CDC, the American Academy of Pediatrics, and the Immunization Action Coalition.

Note: Bivalent HPV vaccine has been discontinued from the US market; other HPV vaccines should be used for immunization. According to ACIP, doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (ACIP [Ezeanolue 2020]).

Primary immunization:

CDC (ACIP) recommendations: In a 2-dose series, the minimum interval between the first and second dose is 5 months. In a 3-dose schedule, minimum interval between first and second doses is 4 weeks; the minimum interval between the second and third dose is 12 weeks; the minimum interval between first and third doses is 5 months (CDC/ACIP [Meites 2016])

Non-immunocompromised patients and certain specified medical conditions: Asplenia, asthma, chronic granulomatous disease, chronic liver disease, chronic lung disease, chronic renal disease, central nervous system anatomic barrier defects (eg, cochlear implant), complement deficiency, diabetes, heart disease, or sickle cell disease:

Children ≥9 years and Adolescents <15 years: Females: 2-dose series: IM: 0.5 mL at 0, and 6 to 12 months. Administer first dose at age 11 to 12 years; for patients with any history of sexual abuse or assault, vaccination should be started at 9 years of age

Adolescents ≥15 years: Females: 3-dose series: IM: 0.5 mL at 0, 1 to 2, and 6 months

Immunocompromised patients including those with immunocompromising conditions that might reduce cell-mediated or humoral immunity, such as B lymphocyte antibody deficiencies, T lymphocyte complete or partial defects, HIV infection, malignant neoplasms, transplantation, autoimmune disease, or immunosuppressive therapy): Children ≥9 years and Adolescents: Females: 3-dose series: IM: 0.5 mL at 0, 1 to 2, and 6 months

Manufacturer's labeling: Females: Children ≥9 years and Adolescents: IM: 0.5 mL per dose for a total of 3 doses. Administer the second and third doses at 1 and 6 months after initial dose.

Catch-up immunization: CDC (ACIP) recommendations (Meites 2016): Note: Do not restart the series. If doses have been given, begin the below schedule at the applicable dose number. Children ≥9 years and Adolescents: IM: 0.5 mL per dose for a total of 2 to 3 doses (See CDC/ACIP recommendations above for 2-dose vs 3-dose schedule criteria):

First dose given on the elected date

Second dose given at least 4 weeks after the first dose (for 3-dose schedule) or 5 months after the first dose (for a 2-dose schedule)

Third dose (for a 3-dose schedule) given at least 12 weeks after the second dose and at least 5 months after the first dose

Administration

IM: Shake well prior to use. Do not use if discolored or if containing particulate matter, or if syringe is cracked. Inject IM into the deltoid region of the upper arm. Do not administer IV, SubQ, or intradermally. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope related injuries, patients should be vaccinated while seated or lying down. When given with other age appropriate vaccines, human papillomavirus vaccine should be given after other vaccines because it may cause more pain with injection (NACI 2017).

For patients at risk of hemorrhage following intramuscular injection, the vaccine should be administered intramuscularly if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered (ACIP [Ezeanolue 2020]). A fine needle (23 gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for 5 to 10 minutes (NACI 2017). The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (ACIP [Ezeanolue 2020]; NACI 2017).

Storage

Store under refrigeration at 2°C to 8°C (36°F to 46°F); do not freeze. Store in original package to protect from light. Administer as soon as possible after removing from refrigeration. Stable for up to 3 days when stored between 8°C and 25°C (46°F to 77°F) or for up to 1 day when stored at 25°C to 37°C (77°F to 99°F). Discard if exposed to >37°C (99°F). May develop a fine, white deposit with a clear, colorless supernatant during storage (not a sign of deterioration).

Drug Interactions

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Consider therapy modification

Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Consider therapy modification

Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy

Adverse Reactions

>10%:

Central nervous system: Fatigue (55%)

Local: Pain at injection site (92%), erythema at injection site (48%), swelling at injection site (44%)

Neuromuscular & skeletal: Myalgia (49%), arthralgia (21%)

1% to 10%:

Dermatologic: Urticaria (7%), injection site pruritus (1%)

Genitourinary: Vaginal infection (1%)

Infection: Influenza (3%), infection (chlamydia: 2%)

Respiratory: Nasopharyngitis (4%), pharyngolaryngeal pain (3%), pharyngitis (2%)

<1%, postmarketing, and/or case reports: Anaphylactoid reaction, anaphylaxis, angioedema, erythema multiforme, hypersensitivity reaction, induration at injection site, lymphadenopathy, paresthesia (local), syncope (may be associated with tonic-clonic movements), vasodepressor syncope

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (NACI 2017).

• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis, tendinitis) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).

• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Ezeanolue 2020]; NACI 2017).

Disease-related concerns:

• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Defer administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (NACI 2017).

• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Ezeanolue 2020]; NACI 2017).

• Human papillomavirus (HPV) infection: There is no evidence that individuals already exposed to or infected with HPV will be protected; those already infected with 1 or more HPV types were protected from disease in the remaining HPV types. Will not provide therapeutic benefit for active HPV disease or abnormal Pap test; will not protect against diseases not caused by HPV vaccine types 16 and 18.

Concurrent drug therapy issues:

• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Ezeanolue 2020]).

• Vaccines: In order to maximize vaccination rates, simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) is recommended of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist. The NACI prefers each dose in a HPV vaccine series be the same vaccine when possible; however, if the previous vaccine is not known then any of the HPV vaccines licensed for use in Canada may be used (NACI 2017).

Special populations:

• Altered immunocompetence: Consider deferring immunization during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]); may have a reduced response to vaccination (NACI 2017). In general, household and close contacts of persons with altered immunocompetence may receive all age appropriate vaccines. Inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; inactivated vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Ezeanolue 2020]; IDSA [Rubin 2014]; NACI 2017).

• Males: Not approved for use in males.

Other warnings/precautions:

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (NACI 2017).

Monitoring Parameters

Gynecologic screening exam, papillomavirus test as per current guidelines; screening for HPV is not required prior to vaccination and screening for cervical cancer should continue as recommended following vaccination. Monitor for anaphylaxis and syncope for 15 minutes following administration (NACI 2017). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Reproductive Considerations

The manufacturer recommends pregnancy be avoided for 2 months following vaccination.

Pregnancy Considerations

Administration of the human papillomavirus vaccine during pregnancy is not recommended. Although exposure to human papillomavirus vaccine has not been causally associated with adverse pregnancy outcomes, until additional information is available the vaccine series (or completion of the series) should be delayed until pregnancy is completed (NACI 2017).

Exposures to bivalent human papillomavirus vaccine during pregnancy should be reported to the manufacturer (800-387-7374).

Patient Education

What is this drug used for?

• It is used to prevent these health problems caused by HPV: Cervical cancer or cervical growths that may lead to cancer.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Loss of strength and energy

• Headache

• Muscle pain

• Joint pain

• Nausea

• Vomiting

• Diarrhea

• Abdominal pain

• Injection site pain or irritation

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Severe dizziness

• Passing out

• Abnormal movements

• Seizures

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

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