rxevidence.com

HPV vaccines: Gardasil 9, Gardasil and Cervarix

Vaccine Academy › Vaccine School › Childhood and adolescent

Vaccine School · Childhood and adolescent

A pharmacist-focused lesson on human papillomavirus vaccination: the cancers and warts it prevents, the three FDA-licensed products (only 9-valent Gardasil 9 is distributed in the United States), who should be vaccinated (age 11 to 12, catch-up through 26, shared decision-making 27 to 45), 2-dose and 3-dose schedules, administration, storage, contraindications, safety, pregnancy and counseling, with the 2026 CDC schedule dispute shown side by side. Unreviewed draft.

Content current as of October 11, 2026. AI-assisted draft; not yet reviewed by a licensed pharmacist. Current CDC schedules: immunization schedules.

The disease and why it matters

HPV is the most common sexually transmitted infection in the United States; most infections are asymptomatic and resolve spontaneously, but persistent infection can develop into anogenital warts, precancers, and cervical, anogenital or oropharyngeal cancers in women and men. [1]

HPV is spread through intimate skin-to-skin or sexual contact; nearly all people will get at least one type of HPV at some time in their lives, and most infections go away on their own within 2 years. [2]

CDC estimates that 36,500 people in the United States are diagnosed each year with a cancer caused by HPV infection, and that HPV vaccination could prevent more than 90% of these cancers (an estimated 33,700 cases a year). [1]

Estimated yearly U.S. cancers caused by HPV, as listed by CDC
CancerEstimated cases per year
Oropharyngeal cancer14,000 people [1]
Cervical cancer11,000 cases (about 4,000 women die of cervical cancer each year) [1]
Anal cancer6,500 people [1]
Vulvar and vaginal cancer3,500 people [1]
Penile cancer900 people [1]

Cervical cancer is the only HPV-caused cancer with a recommended screening test for early detection; the other cancers may not be detected until they cause health problems. [1]

Declines reported by CDC since HPV vaccines were first used in the United States in 2006 [3]
GroupReported change
Teen girls: infections with HPV types that cause most HPV cancers and genital wartsDropped 88% [3]
Young adult women: infections with those HPV typesDropped 81% [3]
Vaccinated women: percentage of cervical pre-cancers caused by the HPV types most often linked to cervical cancerDropped 40% [3]

Video and figures

Video

The video loads from YouTube when played.

Human papillomavirus or HPV
Channel: Osmosis from Elsevier · Uploaded February 13, 2019 · Confirmed available October 12, 2026 · Open on YouTubeThis video is more than three years old; recommendations in it may be out of date.RxEvidence has not checked every statement in this video.

Get CE credit

RxEvidence is not an accredited continuing education provider and does not award CE credit. These are links to activities offered by others.

Products available

FDA has licensed three HPV vaccines (Gardasil 9, 9-valent; Gardasil, quadrivalent; and Cervarix, bivalent), but CDC states that Gardasil 9 is the HPV vaccine distributed in the United States and that the quadrivalent and bivalent vaccines were licensed in the past. [3]

HPV vaccines on FDA's licensed-vaccine list, from FDA product pages and prescribing information
VaccineManufacturer (FDA page)HPV typesFDA-approved ages and populationsInitial U.S. approval
Gardasil 9Merck Sharp & Dohme LLC [4]6, 11, 16, 18, 31, 33, 45, 52 and 58 [5]Girls and women, and boys and men, 9 through 45 years of age [5]2014 [5]
GardasilMerck Sharp & Dohme LLC [6]6, 11, 16 and 18 [7]Girls and women, and boys and men, 9 through 26 years of age [7]2006 [7]
CervarixGlaxoSmithKline Biologicals [8]16 and 18 [9]Females 9 through 25 years of age [9]2009 [9]

Gardasil 9 contains virus-like particles (VLPs) of the L1 protein of HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58, produced in Saccharomyces cerevisiae (baker's yeast) and adsorbed on an aluminum-containing adjuvant; it is non-infectious. [5]

The Gardasil 9 product page is marked content current as of 03/26/2025 and its label is revised 03/2025. The Gardasil and Cervarix labels posted on FDA's pages carry placeholder revision dates ("XX/XXXX"), and the Cervarix page is marked content current as of 10/25/2019, so those two labels may not be the current versions; they are shown for completeness only. [4] [5] [7] [8] [9]

Who should get it

CDC / ACIP (HPV vaccine recommendations for health care providers, July 9, 2024)

As of July 9, 2024

CDC recommends routine HPV vaccination at 11 or 12 years of age (series can be started at age 9), catch-up vaccination through age 26 for anyone not adequately vaccinated, and shared clinical decision-making for some adults 27 through 45 years; vaccination is not recommended for everyone older than 26 and does not need to be discussed with most adults over 26. [10]

FDA labels (Gardasil 9; Gardasil)

As of March 26, 2025

The Gardasil 9 label is indicated for girls and women and for boys and men 9 through 45 years of age, which is a wider age range than CDC's routine and catch-up recommendation (through age 26); the Gardasil label is indicated for 9 through 26 years of age. CDC's age 27 through 45 range is shared clinical decision-making. [5] [7] [10]

CDC's adult-schedule notes (July 2, 2025) say all persons through age 26 years should complete a 2- or 3-dose series depending on age at initial vaccination or condition, and that adults age 27 through 45 may complete the series based on shared clinical decision-making. [11]

CDC's child and adolescent schedule notes (July 2, 2025) say HPV vaccination is routinely recommended at age 11 to 12 years (can start at age 9) and that catch-up vaccination is recommended for all persons through age 18 years if not adequately vaccinated; for a history of sexual abuse or assault, vaccination starts at age 9. [12]

For adults 27 through 45 years, clinicians can consider discussing HPV vaccination with people most likely to benefit; CDC notes that vaccination in this age range provides less benefit for several reasons, including that more people in this age range have already been exposed to HPV, and that having a new sex partner is a risk factor for a new HPV infection at any age. [10]

CDC: January 2026 schedule revision and its legal status (HPV)

As of June 11, 2026

On January 5, 2026 the CDC Acting Director approved a revised childhood and adolescent schedule that changed HPV vaccine dosing from a two- or three-dose regimen to a one-dose regimen; the schedule's first category (recommended for all children) lists measles, mumps, rubella, polio, pertussis, tetanus, diphtheria, Hib, pneumococcal disease, HPV and varicella. A federal district court stayed that schedule on March 16, 2026 and reverted it to the version as of May 2025, and CDC's schedule page continues to show the July 2, 2025 addendum edition. [13] [14] [15]

American Academy of Pediatrics 2026 schedule (endorsed by AAFP, ACOG, AMA, IDSA, APhA and others)

As of January 26, 2026

The AAP published its own 2026 schedule on January 26, 2026, which continues to recommend routine immunization for protection against 18 diseases, including RSV, hepatitis A, hepatitis B, rotavirus, influenza and meningococcal disease, and differs from the schedule recently issued by CDC; the AAP schedule is formally endorsed by 12 organizations, including AAFP, ACOG, AMA, IDSA and the American Pharmacists Association. [16]

Dosing and schedule, including catch-up

CDC dosing schedule by age at first dose
Age at initial vaccinationSeriesSchedule and minimum intervals
9 through 14 years2 doses [12]0 and 6 to 12 months; minimum interval 5 months, repeat the dose if given too soon [12]
15 years or older3 doses [12]0, 1 to 2 months and 6 months; minimum intervals dose 1 to 2 = 4 weeks, dose 2 to 3 = 12 weeks, dose 1 to 3 = 5 months [12]
Immunocompromising conditions, including HIV infection (age 9 through 26)3 doses, even if started at 9 through 14 years [11]0, 1 to 2 months and 6 months [10]

If a teen aged 9 through 14 years receives 2 doses less than 5 months apart, a third dose is needed; if two doses were given at least 5 months apart, the series is complete and no additional dose is needed. [11]

CDC notes that no additional dose is recommended when any HPV vaccine series of any valency has been completed using the recommended dosing intervals, and that any licensed HPV vaccine can be used to complete a series started with another HPV vaccine, using the schedule that matches age at the first dose; interrupted series do not need to be restarted or repeated. [11] [1]

Someone who received a first dose before their 15th birthday and is now 15 or older needs only one more dose; the second dose can be given right away because there is no upper time limit for the second dose of a 2-dose series. [1]

CDC / ACIP and the Gardasil 9 label compared

As of March 26, 2025

CDC says the recommended 2-dose schedule for ages 9 through 14 is 0 and 6 to 12 months with a 5-month minimum interval, and CDC's adult-schedule notes use minimum intervals for 3-dose series of 4 weeks (dose 1 to 2) and 12 weeks (dose 2 to 3). [12] [11]

Gardasil 9 prescribing information (revised 03/2025)

As of March 26, 2025

The Gardasil 9 label lists a 2-dose regimen (0 and 6 to 12 months) or a 3-dose regimen (0, 2 and 6 months) for ages 9 through 14, and a 3-dose regimen (0, 2 and 6 months) for ages 15 through 45; if the second dose of the 2-dose regimen is given earlier than 5 months after the first dose, a third dose is given at least 4 months after the second dose. Each dose is 0.5 mL. [5]

The Gardasil 9 label states that studies using a mixed regimen of HPV vaccines to assess interchangeability were not performed for Gardasil 9. [5]

Administration

  • Gardasil 9 is given intramuscularly in the deltoid or anterolateral area of the thigh; do not dilute or mix it with other vaccines. [5]
  • Shake well immediately before use to maintain suspension; inspect for particulate matter and discoloration, and do not use if particulates are present or it appears discolored. After thorough agitation it is a white cloudy liquid. [5]
  • The single-dose vial dose is withdrawn with a sterile needle and syringe and used promptly (discard the vial after use); the prefilled-syringe package does not contain a needle, so attach one by twisting clockwise until it fits securely. [5]
  • Observe patients for 15 minutes after administration; CDC advises that adolescents be seated or lying down during vaccination and remain in that position for 15 minutes. [5] [10]
  • HPV vaccine may be given at the same time as other vaccines. [2]

Storage and handling

  • Store Gardasil 9 refrigerated at 2 to 8 °C (36 to 46 °F); do not freeze; protect from light. [5]
  • Administer Gardasil 9 as soon as possible after it is removed from refrigeration; it can be administered if total cumulative time out of refrigeration (between 8 and 25 °C) does not exceed 72 hours, and cumulative time between 0 and 2 °C does not exceed 72 hours. The label states these are not recommendations for storage. [5]
  • Gardasil 9 is supplied as cartons of ten 0.5-mL single-dose vials (NDC 0006-4119-03) or ten 0.5-mL single-dose prefilled Luer Lock syringes with tip caps (NDC 0006-4121-02). [5]

Contraindications and precautions

Contraindications and precautions
ItemStatementSource
Contraindication: severe allergyA severe allergic reaction (e.g., anaphylaxis) to a vaccine component or following a prior dose of HPV vaccine is a contraindication. [10]CDC
Contraindication: yeast9-valent HPV vaccine is contraindicated for persons with a history of immediate hypersensitivity to yeast. [10]CDC
Gardasil 9 labelHypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of Gardasil 9 or Gardasil. [5]FDA label
Precaution: moderate or severe acute illnessVaccination should be deferred until symptoms of the acute illness improve. [10]CDC
Not a reason to deferA minor acute illness (e.g., diarrhea or mild upper respiratory tract infection, with or without fever) is not a reason to defer vaccination. [10]CDC

Safety and adverse events

CDC states that HPV vaccines are very safe and that no serious adverse events have been associated with any HPV vaccine; the most common reactions in prelicensure trials were local reactions (pain, redness, swelling), reported by 20% to 90% of recipients. [10]

A temperature of 100 °F during the 15 days after vaccination was reported in 10% to 13% of HPV vaccine recipients, and a similar proportion of placebo recipients reported an elevated temperature. [10]

Most common (10% or more) local and systemic adverse reactions reported in Gardasil 9 trials, from the prescribing information [5]
GroupInjection-site painInjection-site swellingInjection-site erythemaHeadache
Girls and women 16 through 26 years89.9% [5]40.0% [5]34.0% [5]14.6% [5]
Girls 9 through 15 years89.3% [5]47.8% [5]34.1% [5]11.4% [5]
Women 27 through 45 years82.8% [5]23.3% [5]16.9% [5]13.6% [5]
Boys and men 16 through 26 years63.4% [5]20.2% [5]20.7% [5]Not listed at 10% or more
Boys 9 through 15 years71.5% [5]26.9% [5]24.9% [5]Not listed at 10% or more

Syncope: because vaccinees may develop syncope, sometimes resulting in falling with injury, the label recommends 15 minutes of observation after administration; syncope sometimes associated with tonic-clonic movements has been reported following HPV vaccination, is usually transient, and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position. [5]

Appropriate medical treatment and supervision must be readily available in case of anaphylactic reactions after Gardasil 9; report suspected adverse reactions to Merck at 1-877-888-4231 or to VAERS at 1-800-822-7967. [5]

The Gardasil 9 safety evaluation included seven clinical studies with 15,703 individuals who received at least one dose of Gardasil 9; CDC states that Gardasil 9 was studied in more than 15,000 males and females before licensure. [5] [10]

Special populations

Pregnancy: HPV vaccine is not recommended during pregnancy; pregnancy testing before vaccination is not needed. Women known to be pregnant should delay starting the series until after pregnancy, and if a woman is found to be pregnant after starting, the remaining doses should be delayed until she is no longer pregnant. [10]

If a woman is vaccinated inadvertently while pregnant no intervention is needed; HPV vaccines have not been linked to adverse pregnancy outcomes or fetal side effects in inadvertently vaccinated pregnant women, but they have not been studied in pregnant women in clinical trials. Suspected adverse events during pregnancy should be reported to VAERS. [11] [10]

The Gardasil 9 label states that there are no adequate and well-controlled studies of Gardasil 9 in pregnant women and that available data (including pregnancy registry data) do not suggest an increased risk of major birth defects and miscarriage. [5]

Lactation: available data are not sufficient to assess the effects of Gardasil 9 on the breastfed infant or on milk production or excretion, and the benefits of breastfeeding should be considered with the mother's clinical need for the vaccine. [5]

Immunocompromised people: the immune response to Gardasil 9 may be diminished (for example with irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids at greater than physiologic doses), and CDC recommends a 3-dose series for people aged 9 through 26 with immunocompromising conditions, including HIV infection; children with asthma, diabetes and similar conditions that do not suppress the immune response are not in this group. [5] [1]

Pediatric and geriatric use: safety and effectiveness have not been established in children younger than 9 years, and have not been evaluated in people aged 65 and over. [5]

Counseling pearls for the pharmacy counter

  • HPV vaccination prevents new HPV infections but does not treat existing infections or diseases, and it works best when given before any exposure to HPV. [10]
  • Vaccination does not remove the need for recommended cervical cancer screening; recipients should not stop anal cancer screening if a health care provider has recommended it. [5]
  • Gardasil 9 has not been shown to protect against disease from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity. [5]
  • Tell the vaccination provider about an allergic reaction after a previous dose or any severe, life-threatening allergy, and about pregnancy; people with minor illnesses may be vaccinated, while moderately or severely ill people should usually wait. [2]
  • Soreness, redness or swelling where the shot is given, fever, headache and fainting can happen; call 9-1-1 for signs of a severe allergic reaction (hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness or weakness). [2]
  • A vaccine information statement is required to be given with each vaccination to the patient, parent or guardian, and the full series should be completed unless contraindicated. [5]

Common patient questions

Why is a 2-dose schedule recommended only for ages 9 through 14?

CDC says immunogenicity studies show two doses given at least 6 months apart to 9 through 14-year-olds provided as good or better antibody responses as three doses given to older adolescents or young adults; the immune response in older people has not been studied the same way, so older teens and adults should get three doses. [1]

A 12-year-old got two doses 3 months apart. Is the series complete?

No. If the second dose is given earlier than the 5-month minimum interval, a third dose should be given. [1]

A patient started with Gardasil (4-valent) years ago. Do they restart with Gardasil 9?

No. CDC says any licensed HPV vaccine can be used to complete the series with the same schedule and intervals, and the patient will not need to restart. [1]

Should every adult aged 27 through 45 be vaccinated?

No. CDC does not recommend vaccination for everyone older than 26; some adults 27 through 45 who are not already vaccinated may decide to get it after speaking with their clinician about their risk for new HPV infections and the possible benefits. [10] [3]

Is a pregnancy test needed before HPV vaccination?

No. CDC says pregnancy testing before vaccination is not needed, but HPV vaccination is not recommended until after pregnancy. [11]

What if a child has a cold?

A minor acute illness, with or without fever, is not a reason to defer; CDC says HPV vaccines are safe for children who are mildly ill, including a low-grade fever of less than 101 degrees, a cold, runny nose or cough. [10] [3]

References

  1. Centers for Disease Control and Prevention. Clinical overview of HPV. Page dated July 9, 2024. Accessed October 11, 2026. https://www.cdc.gov/hpv/hcp/clinical-overview/index.html. Accessed October 11, 2026.
  2. Centers for Disease Control and Prevention. HPV (human papillomavirus) vaccine: what you need to know. Vaccine Information Statement, August 6, 2021. Accessed October 11, 2026. https://www.cdc.gov/vaccines/hcp/current-vis/hpv.html. Accessed October 11, 2026.
  3. Centers for Disease Control and Prevention. HPV vaccination. Page dated August 20, 2024. Accessed October 11, 2026. https://www.cdc.gov/hpv/vaccines/index.html. Accessed October 11, 2026.
  4. U.S. Food and Drug Administration. GARDASIL 9 product page (content current as of 03/26/2025). Accessed October 11, 2026. https://www.fda.gov/vaccines-blood-biologics/vaccines/gardasil-9. Accessed October 11, 2026.
  5. GARDASIL 9 (human papillomavirus 9-valent vaccine, recombinant), suspension for intramuscular injection: prescribing information, revised 03/2025. Merck Sharp & Dohme LLC. U.S. Food and Drug Administration. Accessed October 11, 2026. https://www.fda.gov/media/90064/download?attachment. Accessed October 11, 2026.
  6. U.S. Food and Drug Administration. GARDASIL product page (content current as of 05/14/2025). Accessed October 11, 2026. https://www.fda.gov/vaccines-blood-biologics/vaccines/gardasil. Accessed October 11, 2026.
  7. GARDASIL (human papillomavirus quadrivalent [types 6, 11, 16, and 18] vaccine, recombinant), suspension for intramuscular injection: prescribing information as posted on FDA's product page (revision date shown as a placeholder, "XX/XXXX"). Merck Sharp & Dohme LLC. U.S. Food and Drug Administration. Accessed October 11, 2026. https://www.fda.gov/media/186364/download?attachment. Accessed October 11, 2026.
  8. U.S. Food and Drug Administration. Cervarix product page (content current as of 10/25/2019). Accessed October 11, 2026. https://www.fda.gov/vaccines-blood-biologics/vaccines/cervarix. Accessed October 11, 2026.
  9. CERVARIX (human papillomavirus bivalent [types 16 and 18] vaccine, recombinant): prescribing information as posted on FDA's product page (revision date shown as a placeholder, "xx/xxxx"). GlaxoSmithKline Biologicals. U.S. Food and Drug Administration. Accessed October 11, 2026. https://www.fda.gov/media/78013/download?attachment. Accessed October 11, 2026.
  10. Centers for Disease Control and Prevention. HPV vaccine recommendations (for health care providers). Page dated July 9, 2024. Accessed October 11, 2026. https://www.cdc.gov/hpv/hcp/vaccination-considerations/index.html. Accessed October 11, 2026.
  11. Centers for Disease Control and Prevention. Adult immunization schedule notes: recommendations for ages 19 years or older, United States, 2025. July 2, 2025. Accessed October 11, 2026. https://www.cdc.gov/vaccines/hcp/imz-schedules/adult-notes.html. Accessed October 11, 2026.
  12. Centers for Disease Control and Prevention. Child and adolescent immunization schedule notes: recommendations for ages 18 years or younger, United States, 2025. July 2, 2025. Accessed October 11, 2026. https://www.cdc.gov/vaccines/hcp/imz-schedules/child-adolescent-notes.html. Accessed October 11, 2026.
  13. Congressional Research Service. The 2026 Childhood Immunization Schedule (R48982). June 11, 2026. Accessed October 11, 2026. https://www.congress.gov/crs_external_products/R/PDF/R48982/R48982.1.pdf. Accessed October 11, 2026.
  14. Centers for Disease Control and Prevention. CDC acts on Presidential Memorandum to update childhood immunization schedule. News release, January 5, 2026. Accessed October 11, 2026. https://www.cdc.gov/media/releases/2026/2026-cdc-acts-on-presidential-memorandum-to-update-childhood-immunization-schedule.html. Accessed October 11, 2026.
  15. Centers for Disease Control and Prevention. Healthcare professionals: immunization schedules. Accessed October 11, 2026. https://www.cdc.gov/vaccines/hcp/imz-schedules/index.html. Accessed October 11, 2026.
  16. American Academy of Pediatrics. AAP releases recommended childhood and adolescent immunization schedule for 2026. HealthyChildren.org news. Accessed October 11, 2026. https://healthychildren.org/English/news/Pages/AAPs-recommended-childhood-and-adolescent-immunization-schedule-for-2026.aspx. Accessed October 11, 2026.

For professional education. Check current labeling and guidance before acting. Not medical advice.

Scroll to Top