Gardasil 9 (Human Papillomavirus 9-Valent Vaccine) is a recombinant vaccine against Human Papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. It is indicated for men and women aged 9 to 45 years for the prevention of genital, anal, and oropharyngeal carcinomas caused by HPV.

Gardasil 9 (Human Papillomavirus 9-Valent Vaccine) Uses:

• Prevention of human papillomavirus infection:
  • Females 9 to 45 years of age:
    • For the prevention of the following diseases:
      • Cervical, vulvar, vaginal, and anal cancer caused by human papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58
      • Genital warts (condyloma acuminata) caused by HPV types 6 and 11
      • Prevention of precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
      • Cervical intraepithelial neoplasia (CIN) grades 1, 2, and 3
      • Cervical adenocarcinoma in situ (AIS)
      • Vulvar intraepithelial neoplasia (VIN) grades 2 and 3
      • Vaginal intraepithelial neoplasia (VaIN) grades 2 and 3
      • Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3
    • Males 9 through 45 years of age:
      • For the prevention of the following diseases:
        • Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58
        • Genital warts (condyloma acuminata) caused by HPV types 6 and 11
        • For the prevention of the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
        • Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3
    • The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination for:
      • Females and males 11 to 12 years.
      • Vaccination should begin at age 9 for patients who have a history of sexual abuse.
      • Catch-up vaccination is recommended for females and transgender persons 13 to 26 years and males 13 to 21 years.
      • Vaccination for males 22 through 26 years is recommended if immunocompromised (including HIV) and for men who have sex with men and may be considered for any other male in this age group.

Read Details about other human papillomavirus vaccines:

• Cervarix (Human Papillomavirus Bivalent Vaccine) - Dose, Schedule
• Gardasil (Human Papillomavirus Quadrivalent Vaccine) - Dose, Schedule

Gardasil 9 (Human Papillomavirus 9-Valent Vaccine) Dose in Adults

Gardasil 9 (Human Papillomavirus 9-Valent Vaccine) Dose: IM:

• Manufacturer's labeling:
  • Adults ≤45 years of age:
    • 3-dose series: 0.5 mL at 0, 2, and 6 months

Gardasil 9 (Human Papillomavirus 9-Valent Vaccine) CDC/ACIP recommended immunization schedule:

• Adults ≤26 years of age:
  • Vaccination recommended in females and transgender persons ≤26 years of age or males ≤21 years of age if not previously vaccinated or completed the 3-dose series (typically administer the first dose at age 11 to 12 years).
  • Vaccination for males 22 through 26 years is recommended if immunocompromised (including HIV) and for men who have sex with men and may be considered for any other male in this age group.
  • Second and third doses may be given after age 26 years to complete a previously initiated series.
  • Have not received any doses:
    • 3-dose series: IM: 0.5 mL at 0, 1 to 2, and 6 months.
    • There should be at least a 4-week interval between the first and second dose; a minimum12-week interval between the second and third dose; a minimum 5-month interval between the first and third dose.
  • Partially vaccinated, the first dose before 15 years of age:
    • If 2 doses administered at least 5 months apart:
      • no more doses needed
    • If only a single dose or if doses <5 months apart: IM:
      • Administer one additional 0.5 mL dose
  • Partially vaccinated, the first dose at 15 years of age or later:
    • Complete 3-dose series: IM:
      • There should be a 4-week minimum interval between the first and second dose; a 12-week minimum interval between the second and third dose; a 5-month minimum interval between the first and third dose.

Gardasil 9 (Human Papillomavirus 9-Valent Vaccine) Dose Children

Note:

• Consult CDC/ACIP annual immunization schedules for additional information including specific detailed recommendations for catch-up scenarios and/or care of patients with high-risk conditions.
• According to ACIP, doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe.

Note:

• If the HPV product previously administered is not known or not available, any available HPV vaccine product may be used to continue or complete the series for females for protection against HPV 16 and 18;
• the 9-valent HPV or 4-valent HPV may be used to continue or complete the series for males.

Gardasil 9 (Human Papillomavirus 9-Valent Vaccine) dose in primary immunization:

• Manufacturer's labeling:
  • Children ≥9 years and Adolescents <15 years:
    • 2-dose series: IM:
      • 0.5 mL per dose;
      • administer the second dose at 6 to 12 months after the initial dose.
      • If the second dose is inadvertently administered earlier than 5 months after the first dose, then the patient should be converted to a 3-dose series.
    • 3-dose series: IM:
      • 0.5 mL per dose;
      • administer the second and third doses at 2 and 6 months after the initial dose
  • Adolescents ≥15 years:
    • IM: 0.5 mL per dose for a total of 3 doses;
    • administer the second and third doses at 2 and 6 months after the initial dose
• CDC/ACIP recommended immunization schedule:
  • Routine vaccination at 11 to 12 years of age; may start as early as 9 years of age.
  • In a 2-dose schedule, the minimum interval between the first and second doses is 5 months.
  • In a 3-dose schedule, the minimum interval between first and second doses is 4 weeks; the minimum interval between the second and third doses is 12 weeks; the minimum interval between first and third doses is 5 months.
• 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:
      • 2-dose series: IM:
        • 0.5 mL at 0, and 6 to 12 months.
        • Administer the 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.
    • Adolescents ≥15 years:
      • 3-dose series: IM:
        • 0.5 mL at 0, 1 to 2, and 6 months
• Immunocompromised patients:
  • Immunocompromised patients, including those with 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:
      • 3-dose series: IM:
        • 0.5 mL at 0, 1 to 2, and 6 months.

Gardasil 9 (Human Papillomavirus 9-Valent Vaccine) dose for Catch-up immunization: CDC/ACIP recommendations:

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 selected date.
    • The second dose is given at least 4 weeks after the first dose (for a 3-dose schedule) or 5 months following 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 following the first dose.

Gardasil 9 (Human Papillomavirus 9-Valent Vaccine) Pregnancy Risk Category: B

• In animal reproduction studies, adverse events were not seen.
• Clinical trials showed that women who were pregnant after the 3-dose regimen was completed were told to keep the remaining dose until the pregnancy ends.
• No congenital abnormalities were found in pregnancies that were detected within 30 days after vaccination.
• Pregnancies that began after 30 days had been vaccinated showed a similar rate of congenital anomalies to the general population.
• It is not recommended to administer the vaccine while pregnant.
• The administration of the vaccine is done without any pregnancies testing (CDC/ACIP [Petrosky (2015)]).

Use of the 9-valent human papillomavirus vaccine during breastfeeding

• The vaccine is safe for both mother and baby while breastfeeding, though it is unknown if it is absorbed into breast milk.

Dose in Kidney Disease:

The manufacturer's labeling does not mention dosage adjustments.

Dose in Liver disease:

The manufacturer's labeling does not mention dosage adjustments.

To report suspected adverse reactions, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at (877) 888-4231 or VAERS at (800) 822-7967 or http://www.vaers.hhs.gov. Frequency not always defined. Reported incidences are for individuals (females 9 to 26 years of age and males 9 to 15 years of age) who the vaccine is approved for use unless otherwise specified by a specific population.

Common Side Effects of Gardasil 9 (Human Papillomavirus 9-Valent Vaccine):

• Central nervous system:
  • Headache
• Local:
  • Pain at Injection Site
  • Swelling at Injection Site
  • Erythema at Injection Site

Less Common Side Effects of Gardasil 9 (Human Papillomavirus 9-Valent Vaccine):

• Cardiovascular:
  • Syncope
• Central Nervous System:
  • Dizziness
  • Fatigue
• Gastrointestinal:
  • Diarrhea
  • Upper Abdominal Pain
  • Nausea
• Immunologic:
  • Autoimmune Disease
• Local:
  • Itching At Injection Site
  • Hematoma At Injection Site
  • Bruising At Injection Site
  • Induration At Injection Site
  • Bleeding At Injection Site
  • Injection Site Nodule
  • Injection Site Reaction
• Neuromuscular & Skeletal:
  • Myalgia
• Respiratory:
  • Oropharyngeal Pain
• Miscellaneous:
  • Fever

Contraindications to Gardasil 9 (Human Papillomavirus 9-Valent Vaccine):

• Hypersensitivity to yeast, which can include severe allergic reactions (a vaccine component) or following a previous dose (recombinant) of this vaccine or the human papillomavirus vaccination (recombinant), for types 6, 11, 16, 18,

Warnings and precautions

• Anaphylactoid reactions and hypersensitivity reactions
  • Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use.
• Syncope
  • Syncope can be caused by injectable vaccines. It is most common in young adults and adolescents. Usually, it occurs within 15 minutes after vaccination.
  • It is important to have procedures in place to prevent injuries from falls, and to restore cerebral perfusion in the event of syncope.
• Acute illness:
  • The severity of the symptoms and the etiology are key factors in deciding whether to give or defer vaccinations due to current or recent febrile disease.
  • Patients with severe or moderate acute illness (with fever) should be avoided.
  • Patients with mild acute illnesses (with or without fever) should be vaccinated immediately.
• Bleeding disorders:
  • Use cautiously in patients with a history of bleeding disorders (including thrombocytopenia).Bleeding/hematoma may occur from IM administration.
  • If the patient has received antihemophilic therapy or another similar therapy, IM injections can be scheduled within a few hours.
• Infection with human papillomavirus, HPV
  • There is no evidence that HPV-infected individuals will be protected.
  • However, those infected by 1 or more HPV types have been protected against the disease caused by the remaining HPV type.
  • It is not for active disease treatment; it will protect against diseases caused primarily by HPV vaccine types.
  • This does not negate the need for anal or cervical cancer screenings.

Monitoring parameters:

• Screening for HPV is not required before vaccination.
• Monitor for anaphylaxis and syncope for 15 minutes following administration.
• If seizure-like activity associated with syncope occurs, keep the patient in supine or Trendelenburg position to maintain adequate cerebral perfusion.
• Continue recommended anal cancer screening.
• Females:
  • Gynecologic screening exam,
  • papillomavirus test;
  • screening for cervical cancer should continue according to current guidelines even after vaccination

How to administer Gardasil 9 (Human Papillomavirus 9-Valent Vaccine)?

IM:

• Shake the suspension well before use.
• Do not use if discolored or contains particulate matter, or if the syringe is cracked.
• Inject the entire dose IM into the deltoid region of the upper arm or higher anterolateral thigh area.
• Do not mix with other vaccines or injections; use separate needles and syringes for each injection.
• For patients at risk of hemorrhage following IM injection, the vaccine should be administered IM only at treating clinicians' discretion.
• If the patient receives antihemophilic or other similar therapy, schedule intramuscular vaccination shortly after such therapy.
• Use fine needle (23 gauge or smaller), apply firm pressure (without rubbing) for at least 2 minutes.
• The patient should be counseled regarding the risk of hematoma at the injection site.
• Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders.

Mechanism of action of Gardasil 9 (Human Papillomavirus 9-Valent Vaccine):

• It contains inactive human papillomavirus proteins (types 6L1,11 L1, 16L1, 18 L1, 33L1, 33L1, 45 L1, 53 L1, and 58L1) that produce neutralizing antibodies to prevent cervical and vulvar, vaginal and anal cancers.
• Although the exact mechanism for protection of the HPV 9-valent vaccine against anogenital disease related to vaccine HPV types is not known, it is believed that the vaccine induces humoral immune responses.

International Brands of Human Papillomavirus 9-Valent Vaccine:

• Gardasil 9

Human papillomavirus 9-valent vaccine Brand Names in Pakistan:

No Brands Available in Pakistan.