Gardasil 9

Pronunciation: Unresolved from the sources reviewed.

Generic name
Human Papillomavirus 9-valent Vaccine, Recombinant
Brand names
Gardasil 9
Drug class
Human papillomavirus 9-valent recombinant vaccine
Form
Vaccine injection administered by a healthcare professional
Route
Intramuscular injection
Legal status
Unresolved from the sources reviewed

Availability and supply rules vary by country

Trade names by country:

Australia: · Full directory

What Human Papillomavirus 9-valent Vaccine, Recombinant is and how it works

Gardasil 9 is an intramuscular vaccine that helps protect against diseases caused by 9 types of human papillomavirus (HPV). (2)

It is indicated for individuals aged 9 to 45 years. It helps protect against specified HPV-related cancers and genital warts; it is administered by a healthcare professional.

Mechanism of action: how Human Papillomavirus 9-valent Vaccine, Recombinant works

Gardasil 9 is a recombinant human papillomavirus 9-valent vaccine that helps protect against diseases caused by 9 types of HPV. (2)

What Human Papillomavirus 9-valent Vaccine, Recombinant is used for

HPV-related cancers

Gardasil 9 is indicated to help protect individuals aged 9 to 45 years against HPV-related cervical, vaginal, and vulvar cancers in females; anal cancer; and certain head and neck cancers, such as throat and back-of-mouth cancers, in both males and females.

Genital warts

Gardasil 9 is indicated to help protect individuals aged 9 to 45 years against genital warts caused by HPV types covered by the vaccine, in both males and females.

Before taking Human Papillomavirus 9-valent Vaccine, Recombinant

Do not take / not appropriate for

  • Individuals with demonstrated hypersensitivity to yeast should not receive Gardasil 9. The vaccine is manufactured using yeast fermentation. (Gardasil 9) (2)
  • A complete contraindications list was not extractable from the reviewed FDA label text. Contraindications beyond yeast hypersensitivity remain unresolved and should be confirmed by the vaccinating clinician using current product information. (Gardasil 9) (2)

Tell your clinician about

  • Any demonstrated hypersensitivity to yeast.
  • Pregnancy or plans for pregnancy, because safety in pregnant women has not been established and clinical use during pregnancy is not recommended in the source reviewed.
  • Breastfeeding, because limited data exist regarding vaccine excretion in breast milk and healthcare providers should weigh benefits against potential risks for nursing individuals.
  • Any previous fainting with injections or vaccination, because syncope can occur after Gardasil 9 administration.
  • Any history of severe allergic reaction, so the vaccinating clinician can assess suitability using current product information.
(2)

How to take Human Papillomavirus 9-valent Vaccine, Recombinant

  • Gardasil 9 is administered by a healthcare professional as a 0.5 mL intramuscular injection.
  • The injection is given in the deltoid or the anterolateral area of the thigh.
  • For people aged 9 to 14 years, Gardasil 9 is FDA-approved as a 2-dose series. The detailed interval for this series was not established from the sources reviewed.
  • For people aged 15 to 45 years, Gardasil 9 is FDA-approved as a 3-dose series at 0, 1 to 2, and 6 months.
  • If a second dose in a 3-dose series is given earlier than 5 months after the first dose, a third dose should be given at least 4 months after the second dose; the vaccinating clinician should determine the schedule.
(2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)

Missed dose

If a dose in the multi-dose series is missed or delayed, contact the vaccinating clinician for scheduling advice. Catch-up schedule details were not reviewed in the sources used for this draft.

Overdose

Overdose information was not established from the sources reviewed. If there is concern that an incorrect vaccine dose was administered, contact the vaccinating service promptly for assessment. (2)

Side effects

Reported side effects include injection-site reactions, headache, fever, nausea, and dizziness. Specific numeric incidence data for fever, nausea, and dizziness were not established from the sources reviewed.

Injection-site reactions

What to notice: Pain, swelling, redness, itching, bruising, bleeding, or a lump at the injection site.

What to do: Tell the vaccinating clinician about reactions that are concerning or persistent.

Headache

What to notice: Headache was reported following vaccination. In clinical trials in women aged 16 to 26 years, headache was reported in 14.6%.

What to do: Discuss symptoms that are concerning or persistent with a clinician.

Fever, nausea, or dizziness

What to notice: These effects have been reported after Gardasil 9 vaccination.

What to do: Discuss symptoms that are concerning or persistent with a clinician.

Fainting or injury after fainting

What to notice: Syncope (fainting) can occur after receiving Gardasil 9. A person who faints may fall and be injured.

What to do: Tell the vaccinating team promptly if fainting occurs or if an injury is suspected. (2)

Serious warnings

Anaphylaxis — emergency

Symptoms: A severe allergic reaction is possible. Specific patient-facing symptom details were not extracted from the sources reviewed.

Action: Medical personnel and appropriate emergency equipment must be available during vaccination. Seek emergency medical assessment for a suspected severe allergic reaction. (2)

Syncope (fainting) — urgent

Symptoms: Fainting can occur after vaccination and can lead to injury from falling.

Action: Remain seated or lying down for observation after vaccination as directed by the vaccinating team; observation for 15 minutes is recommended in the reviewed sources. (2)

Interactions

Medicine or testEffectAction
Medicines, other vaccines, and vaccine co-administrationDrug-drug interaction and vaccine co-administration information was not established from the sources reviewed.Give the vaccinating clinician a complete list of medicines and vaccines so current product information can be checked. (2)

Pregnancy, breastfeeding, kidney/liver function, age

Children and adolescents

Gardasil 9 is indicated for individuals from age 9 years. For ages 9 to 14 years, it is FDA-approved as a 2-dose series; the detailed interval was not established from the sources reviewed.

Adults aged 15 to 45 years

Gardasil 9 is indicated through age 45 years. For ages 15 to 45 years, it is FDA-approved as a 3-dose series at 0, 1 to 2, and 6 months.

Pregnancy

Safety in pregnant women has not been established. Clinical use during pregnancy is not recommended based on the source reviewed; discuss timing with the vaccinating clinician. (2)

Breastfeeding

Limited data exist regarding vaccine excretion in breast milk. Healthcare providers should weigh benefits against potential risks for nursing individuals. (2)

Monitoring

Before starting

  • Confirm the person's age and the appropriate FDA-approved series.
  • Review demonstrated yeast hypersensitivity and any contraindications using current product information, because a complete contraindications list was not extracted in this review.
  • Discuss pregnancy or breastfeeding status with the vaccinating clinician.
  • Confirm the dose, route, and injection site: 0.5 mL intramuscularly in the deltoid or anterolateral thigh.

During treatment

  • Observe vaccine recipients for 15 minutes after administration because syncope can occur.
  • Keep the recipient seated or lying down during observation to reduce injury risk from fainting.
  • Ensure medical personnel and appropriate emergency equipment are available during vaccination because anaphylaxis is possible.
  • For multi-dose series scheduling, have the vaccinating clinician assess any missed or delayed dose.
(2)

Storage

Not applicable to patient-facing self-storage: Gardasil 9 is administered by a healthcare professional. Product storage requirements were not established from the sources reviewed.

Professional information

Clinician-facing context only. Use the current FDA-approved prescribing information and applicable local immunization guidance.

United States

Indication: Gardasil 9 vaccination in individuals aged 9 to 45 years

Dose summary: Each dose is 0.5 mL intramuscularly in the deltoid or anterolateral thigh. Ages 9 to 14 years: FDA-approved 2-dose series; the detailed interval was not established from the sources reviewed. Ages 15 to 45 years: 3-dose series at 0, 1 to 2, and 6 months. If the second dose is administered earlier than 5 months after the first, administer a third dose at least 4 months after the second dose.

Renal context: Renal and hepatic impairment dosing information was not established from the sources reviewed. (2)

Mechanism of action

Hepatic guidance

Hepatic impairment information was not established from the sources reviewed.

Overdose note

Overdose information was not established from the sources reviewed. (2)

Frequently asked questions

What does Gardasil 9 help protect against?

It helps protect individuals aged 9 to 45 years against diseases caused by 9 HPV types, including specified cervical, vaginal, vulvar, anal, and certain head and neck cancers, as well as genital warts.

How many Gardasil 9 doses are needed?

The FDA-approved schedule is a 2-dose series for ages 9 to 14 years and a 3-dose series for ages 15 to 45 years. The reviewed sources did not establish the detailed interval for the 2-dose series. For the 3-dose series, doses are given at 0, 1 to 2, and 6 months.

Why do I need to wait after the injection?

Fainting can occur after Gardasil 9 vaccination and may cause injury from falling. The reviewed sources recommend observation for 15 minutes, with the recipient seated or lying down. (2)

What is the mechanism of action of Human Papillomavirus 9-valent Vaccine, Recombinant?

Gardasil 9 is a recombinant human papillomavirus 9-valent vaccine that helps protect against diseases caused by 9 types of HPV. (2)

What is the generic name of Gardasil 9?

The generic name is Human Papillomavirus 9-valent Vaccine, Recombinant. It is sold under brand names including Gardasil 9. (2)

What class of drug is Human Papillomavirus 9-valent Vaccine, Recombinant?

Gardasil 9 is classed as: Human papillomavirus 9-valent recombinant vaccine. (2)

References

  1. Package Insert — Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) and Gardasil9.com Dosing ScheduleU.S. Food and Drug Administration and Merck (gardasil9.com) · United States · accessed 2026-08-05 · source 1
  2. Package Insert — Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) — direct PDF fetchU.S. Food and Drug Administration · United States · accessed 2026-08-05 · source 2

Brand names by country

Single-ingredient Human Papillomavirus 9-valent Vaccine, Recombinant names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

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