Human papillomavirus 9-valent vaccine (Gardasil 9) is a recombinant vaccine indicated for the prevention of human papillomavirus (HPV) infections and their associated diseases. It is only effective against the following 9 HPV types contained within the vaccine: 6, 11, 16, 18, 31, 33, 45, 52, and 58. HPV infections are sexually transmitted diseases that infect an estimated 14 million people (age 15 to 59 years) each year in the US; an estimated 79 million Americans are currently infected. There are over 150 HPV strains. Types 16 and 18 are considered high-risk as they have been associated with the development of anal cancer, vulvar cancer, vaginal cancer, and over 70% of all cervical cancers. Vaccination with HPV 9-valent vaccine protects against these oncogenic HPV types. However, routine Pap smears are still recommended because HPV strains other than 16 and 18 may cause cervical cancer and because not all vaccine recipients achieve immunity. Routine screening and early intervention are paramount for prevention as these strategies are proven to reduce cervical cancer rates and deaths. HPV types 6 and 11 are also pathogenic, causing more than 90% of condyloma acuminata (genital warts); HPV 9-valent vaccine provides immunity against these HPV types. The vaccine is only prophylactic and will not treat an active HPV infection. To offer the greatest protection, it is recommended to administer the vaccine prior to exposure (i.e., before onset of sexual activity). Patients with previous HPV exposure may still benefit from vaccination, although there is no evidence of protection from disease caused by the HPV types they are PCR positive or seropositive for at baseline. The duration of protection has not been clearly defined; data indicate no loss of protection 8 to 10 years after vaccination. The HPV 9-valent vaccine is FDA-approved for use in both females and males age 9 to 45 years. Children ages 9 to 12 years may receive routine vaccination, catch-up vaccination is recommended for adults and adolescents age 13 to 18 who have not initiated or completed the series, and routine vaccination is recommended for adults 19 to 26 years not previously vaccinated. The decision to vaccinate adults 27 to 45 years of age should be based on shared clinical decision-making.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
NOTE: According to U.S. federal laws, the health care provider must record in the patient's permanent record the manufacturer, lot number, administration date, and the name and address of the person administering the vaccine.
-Inform the patient, parent, guardian, or responsible adult of the benefits and risks of the vaccine. Provide the Vaccine Information Statements from the manufacturer to the recipient or guardian before each immunization. The action is required by the National Childhood Vaccine Injury Act of 1986.
-If a human papillomavirus (HPV) vaccine has been previously given, question the patient, parent, or guardian about any symptoms or signs of an adverse reaction.
-Complete a Vaccine Adverse Event Reporting System (VAERS) report form if adverse events have been identified. The reporting of events is required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS is 1-800-822-7967. Also, report an adverse event to the manufacturer. Depending on the adverse reaction, a subsequent dose may be contraindicated
-Health care professionals administering vaccines should take appropriate precautions to prevent allergic reactions in vaccine recipients. The health care professional should have immediate availability of epinephrine (1:1000) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction.
Route-Specific Administration
Injectable Administration
-Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. Following vigorous shaking, the vaccine is a cloudy white suspension. If discoloration or visible particulate matter are present, discard the vaccine dose.
-Do not mix with any other vaccine or product in the same syringe.
Intramuscular Administration
-Use the vaccine as supplied; no dilution or reconstitution is necessary.
-Both the prefilled syringe and single-dose vial require vigorous shaking prior to administration to ensure a homogenous white suspension; DO NOT administer if the vaccine cannot be re-suspended.
-Single-dose vial: Using a sterile needle and syringe, withdraw the 0.5 mL dose and administer immediately.
-Prefilled syringe: Attach a sterile needle by twisting in a clockwise direction. Administer entire dose contained within the syringe.
-Prior to administration, clean skin over the injection site with a suitable cleansing agent.
-The preferred injection site is the deltoid muscle of the upper arm or the higher anterolateral area of the thigh. Do NOT inject into the gluteal area or other areas where there may be a major nerve trunk.
-Aspirate before injecting the dose to avoid injecting the vaccine into a blood vessel. If blood appears in the syringe, remove the needle and discard the vaccine. Use a new dose to try again.
-Carefully observe patients for approximately 15 minutes after administration of the vaccine; syncope may occur.
-Storage of unopened vials/syringes: Store refrigerated at 2-8 degrees C (36 to 46 degrees F); do not freeze. Administer as soon as possible after being removed from refrigeration. Total time (cumulative multiple excursions) outside of refrigeration [temperatures 8-25 degrees C (46 to 77 degrees F)] must not exceed 72 hours. Cumulative multiple excursions between 0-2 degrees C (32 to 36 degrees F) are also permitted if total time does not exceed 72 hours.
During the human papillomavirus 9-valent vaccine clinical trials, up to 90.3% of vaccine recipients experienced an injection site reaction. The most frequently reported localized reactions were pain at the injection site (90.3% or less), edema or swelling (49% or less), and erythema or redness (42.3% or less). Other injection site reactions included bruising (1.9%), hematoma (0.9% to 4.8%), hemorrhage or bleeding (1%), induration (0.8% to 2%), local mass (1.2% to 1.3%), pruritus (1% to 7.7%), and warmth (0.7% to 0.8%).
Systemic adverse events reported by recipients of the human papillomavirus 9-valent vaccine during clinical trials include abdominal pain (0.7% to 1.7%), diarrhea (0.3% to 1.2%), dizziness (0.7% to 3%), fatigue (1.4% to 3.4%), fever or pyrexia (1% to 10.4%), headache (7.3% to 19.6%), influenza-like symptoms (1.2%), myalgia (0.7% to 1%), nausea (1% to 4.4%), oropharyngeal pain (1% to 2.7%), and upper respiratory tract infection (0.1% to 0.3%). No deaths were attributed to the vaccine; however, at least 1 serious adverse event was experienced by 5 subjects during the clinical trials, and by 2 subjects during the post-trial period. These serious adverse events were determined to be associated to the vaccine, and included allergic reaction, asthmatic crisis, headache, hypersomnia, orthostatic tachycardia syndrome, pyrexia, and tonsillitis.
Adverse reactions reported during post-marketing use of human papillomavirus quadrivalent vaccine (Gardasil quadrivalent) are considered relevant to human papillomavirus 9-valent vaccine (Gardasil 9), and include the following: autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, lymphadenopathy, pulmonary embolism, pancreatitis, vomiting, asthenia, chills, fatigue, malaise, autoimmune disease, anaphylactic and anaphylactoid reactions, bronchospasm, urticaria, arthralgia, acute disseminated encephalomyelitis, Guillain-Barre syndrome, motor neuron disease, muscle paralysis, seizures, syncope, transverse myelitis, cellulitis, deep venous thrombosis. Due the the voluntary nature of post-marketing reports, neither a frequency nor a definitive causal relationship can be established.
Human papillomavirus (HPV) 9-valent vaccine is contraindicated for use in patients with a severe allergic reaction to yeast (yeast hypersensitivity), as the vaccine components are recombinantly produced in brewers yeast, Saccharomyces cerevisiae. In addition, administration must be avoided in patients who have experienced a hypersensitivity reaction to a previous dose of the vaccine or to Gardasil quadrivalent. With any biologic product, the prescriber or health care professional should take precautions to prevent allergic reactions. The health care professional should have immediate availability of epinephrine 1 mg/mL injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction. Prior to administration, inform the parent, guardian, or responsible adult of the benefits and risks of the vaccine, and provide the Vaccine Information Statement, accessible at the Centers for Disease Control and Prevention (CDC) website. These actions are required by the National Childhood Vaccine Injury Act of 1986. If a dose of human papillomavirus 9-valent vaccine has been previously given, question the parent or guardian about previous adverse reactions that may preclude further administration. Report all adverse reactions to the Vaccine Adverse Event Reporting System (VAERS), as well as the manufacturer. The toll-free number for VAERS is 1-800-822-7967. Educate the responsible adult(s) to promptly report any adverse reaction after vaccine administration to a health care provider.
The human papillomavirus 9-valent vaccine is indicated for intramuscular administration. Therefore, the vaccine should be given cautiously to patients receiving anticoagulant therapy. Also, patients with thrombocytopenia, vitamin K deficiency, a coagulopathy (e.g., hemophilia), or other bleeding disorders should be monitored closely for bleeding at the IM injection site. Steps to avoid hematoma are recommended.
Injectable vaccines, including human papillomavirus 9-valent vaccine, have been associated with episodes of syncope and fainting. These events may be accompanied by transient tonic-clonic limb movements and other seizure-like activities. Prior to administration, ensure procedures are in place to prevent falls and restore cerebral perfusion. Monitor vaccine recipients for 15 minutes after administration of the dose. If syncope occurs, place the patient in a supine or Trendelenburg position to restore cerebral perfusion.
Patients with significant immunosuppression may not have an adequate antibody response to human papillomavirus 9-valent vaccine. Immunosuppressed persons may include patients with human immunodeficiency virus (HIV) infection; severe combined immunodeficiency (SCID); hypogammaglobulinemia; agammaglobulinemia; altered immune states due to generalized neoplastic disease; or an immune system compromised by radiation therapy or drug therapy (e.g., chemotherapy or corticosteroid therapy with greater than physiologic doses). Short-term (< 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive.
The decision to administer or to delay vaccination with the human papillomavirus 9-valent vaccine because of current or recent febrile illness depends on the severity of symptoms and on the etiology of the disease. The Advisory Committee on Immunization Practices recommends that vaccinations be delayed during the course of a moderate or severe acute febrile illness and administered after the acute phase of illness has resolved. All vaccines can be given to persons with minor illnesses such as diarrhea, mild upper-respiratory infection with or without low-grade fever, or other low-grade febrile illness.
Safety and efficacy of the human papillomavirus 9-valent vaccine have not been established in neonates, infants, nor children younger than 9 years of age.
No adequate and well controlled studies have been conducted in pregnant women. Human papillomavirus 9-valent vaccine is not recommended until after pregnancy. No intervention is needed if inadvertently vaccinated while pregnant. Pregnancy Exposure Registry data are available from 69 and 1,640 enrolled patients with known pregnancy outcomes who were vaccinated with human papillomavirus 9-valent vaccine and human papillomavirus quadrivalent vaccine, respectively. The data do not suggest an increased risk of major birth defects and miscarriage in patients who receive human papillomavirus 9-valent vaccine or human papillomavirus quadrivalent vaccine. A six-year pregnancy registry for human papillomavirus 9-valent vaccine enrolled 185 women who were exposed to the human papillomavirus 9-valent vaccine within one month prior to the last menstrual period (LMP) or any time during pregnancy. There were 69 pregnancies with known outcomes. Five women had exposure twice during their pregnancy; therefore, a total of 74 exposures to human papillomavirus 9-valent vaccine occurred. Three occurred during the 30 days prior to LMP, 34 during the first trimester, 13 during the second trimester, 19 during the third trimester, and 5 were unknown trimester. There were 3 miscarriages (all during the first trimester) and 3 major birth defects (one with exposure during the 30 days prior to LMP, first trimester, and second trimester). Women who were exposed twice during the pregnancy had 0 miscarriages and 0 major birth defects. The data do not suggest an increased risk of major birth defects and miscarriages in women who receive human papillomavirus 9-valent vaccine. During a five-year pregnancy registry with human papillomavirus quadrivalent vaccine there were 1,640 pregnancies with known outcomes. Rates of miscarriage (6.8%; 111/1,640) and major birth defects (2.4%; 37/1,527) were consistent with pregnancy outcomes observed in the general population. Two postmarketing studies included 1,740 pregnancies and found no suggestion of increased risk in the rate of assessed outcomes with human papillomavirus quadrivalent vaccine administration during pregnancy.
Data are limited regarding use of the human papillomavirus 9-valent vaccine during breast-feeding and its excretion in human milk is unknown. The manufacturer recommends caution when administering to nursing women; however, according the Advisory Committee on Immunization Practices (ACIP), vaccines administered to a lactating woman do not affect the safety of breast-feeding. In addition, breast-feeding does not adversely affect immunization and is not a contraindication for any inactivated recombinant vaccine. In fact, limited data suggest breast-feeding may enhance the immune response to certain antigens. Also, no serious adverse events in a breast-fed infant have been associated with the use of an inactivated recombinant vaccine. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.
General information on immunization against human papillomavirus (HPV)
-Ideally, vaccinate before sexual activity onset.
-Children 9 to 12 years: Routine vaccination with 2 doses of HPV vaccine if series is initiated before age 15. Administer vaccine series beginning at age 9 for children and youth with any history of sexual abuse or assault; vaccination may be administered starting at age 9, even in the absence of a high risk condition.
-Adults and Adolescents 13 to 18 years: Catch-up vaccination is recommended for adults and adolescents age 13 to 18 who have not initiated or completed the 2- or 3-dose series. A 3 dose series is recommended for adults and adolescents who receive the first dose on or after their 15th birthday.
-Adults 19 to 26 years: Routine vaccination recommended if not previously vaccinated.
-Adults 27 to 45 years: Catch-up HPV vaccination is not recommended for all patients over 27 years. ACIP recommends shared clinical decision-making regarding the decision to vaccinate this population. Patients at highest risk are those having a new sex partner.
-If the vaccination schedule is interrupted, the series does not need to be restarted. No additional dose is recommended after completing the series with recommended dosing intervals using any HPV vaccine.
-For immunocompromising conditions, including HIV infection, administer the 3-dose series regardless of age at initial vaccination. The guidelines for opportunistic infections in adults and adolescents with HIV recommend vaccinating persons with HIV through age 26 years, with a target vaccination age of 11 to 12 years. However, in some situations, there may be benefit to vaccinating persons who are older than 26 years. In these situations, shared clinical decision-making between the patient and health care provider is recommended.
Gardasil 9 (9vHPV)
-FDA-approved for girls and women age 9 to 45 years for the prevention of the following diseases:-cervical, vulvar, vaginal, anal, and oropharyngeal and other head and neck cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58
-condyloma acuminata (genital warts) caused by HPV types 6 and 11
-cervical adenocarcinoma in situ, cervical intraepithelial neoplasia (CIN) grade 1 and 2/3, vulvar intraepithelial neoplasia grade 2 and 3, vaginal intraepithelial neoplasia grade 2 and 3, and anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
-FDA-approved for boys and men age 9 to 45 years for the prevention of the following diseases:-anal and oropharyngeal and other head and neck cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58
-condyloma acuminata (genital warts) caused by HPV types 6 and 11
-anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Limitations of Use
-Vaccination does not protect against diseases caused by any HPV type not contained within the vaccine. Therefore, recipients of the HPV vaccine should continue to undergo cervical and anal cancer screening as per standard of care.
-The vaccine may not provide protection in all recipients. Vaccine efficacy has not been demonstrated in those previously exposed to HPV through sexual activity.
-The vaccine is HPV infection prophylaxis. It is not approved for the treatment of cervical, vulvar, vaginal, anal, oropharyngeal or other head and neck cancers, neoplasias, or precancerous lesions, including genital warts.
For human papillomavirus (HPV) infection prophylaxis:
Intramuscular dosage:
Adults 18 to 45 years: 0.5 mL IM for 3 doses. Administer the second dose 1 to 2 months after the first and the third dose 6 months (minimum 5 months) after the first. Repeat doses if administered too soon. Vaccination is recommended for adults through 26 years of age who have not already been vaccinated or who have not completed the 3-dose series. If any recipient reaches age 27 years before the 3-dose series is complete, the second and/or third doses may be administered after 26 years of age to complete the series. For adults 27 to 45 years of age, ACIP recommends shared clinical decision making regarding the decision to vaccinate patients who are not adequately vaccinated.
Adolescents 15 to 17 years: 0.5 mL IM for 3 doses. Administer the second dose 1 to 2 months after the first and the third dose 6 months (minimum 5 months) after the first. Repeat doses if administered too soon. For routine vaccination, ACIP recommends administering the first dose at age 11 or 12 years, or any time between 13 and 26 years if not previously vaccinated.
Children and Adolescents 9 to 14 years: 0.5 mL IM for 2 or 3 doses. For the 2 dose regimen, give the second dose 6 to 12 months (minimum 5 months) after the first. For the 3 dose regimen, give the second dose 1 to 2 months after the first and the third dose 6 months (minimum 5 months) after the first. Repeat doses if administered too soon. ACIP recommends routine vaccination with 2 doses if series is initiated before age 15. Administer at age 9 for children with any history of sexual abuse or assault; vaccination may be administered starting at age 9, even in the absence of a high risk condition. For routine vaccination, administer the first dose at age 11 or 12, or any time between age 13 and 26 if not previously vaccinated. Patients who are HIV positive or immunosuppressed for other reasons should receive 3 doses.
Maximum Dosage Limits:
-Adults
46 years and older: Safety and efficacy not established.
18 to 45 years: 0.5 mL IM.
-Geriatric
Safety and efficacy not established.
-Adolescents
13 to 17 years: 0.5 mL IM.
-Children
9 years and older: 0.5 mL IM.
8 years and younger: Safety and efficacy not established.
-Infants
Safety and efficacy not established.
-Neonates
Safety and efficacy not established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
Albuterol; Budesonide: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Betamethasone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Bimekizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to vaccines. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Budesonide: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Budesonide; Formoterol: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Budesonide; Glycopyrrolate; Formoterol: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Corticosteroids (systemic): (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Corticotropin, ACTH: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Cortisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Deflazacort: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Deucravacitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished vaccine response. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Dexamethasone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Elivaldogene Autotemcel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least six weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Hydrocortisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Methylprednisolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Ocrelizumab: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Ofatumumab: (Major) Administer all needed non-live vaccines according to immunization guidelines at least 2 weeks before initiation of ofatumumab. Ofatumumab may interfere with the effectiveness of inactivated vaccines due to its actions, which cause B-cell depletion.
Prednisolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Prednisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Satralizumab: (Major) Administer all non-live vaccines according to immunization guidelines at least 2 weeks before initiation of satralizumab.
Siponimod: (Moderate) Administer all non-live vaccines at least 2 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment. Patients should be considered unimmunized if vaccinated within a 14-day period before starting immunosuppresive therapy or during immunosuppressive therapy, and should they be revaccinated at least 3 months after therapy is discontinued if immune competence is restored.
Triamcinolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Ublituximab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Vamorolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
The human papillomavirus (HPV) only infects humans. An infection from this virus can cause squamous cell cervical cancer and cervical adenocarcinoma and their precursor lesions, which are cervical intraepithelial neoplasia (CIN) 1, 2, and 3 and adenocarcinoma in situ (AIS), respectively. HPV also causes anal cancer, vulvar cancer, vaginal cancer, and genital warts (condyloma acuminata), which are growths of the cervicovaginal, vulvar, and the external genitalia that rarely progress to cancer. The HPV 6, 11, 16, and 18 types cause 35% to 50% of all CIN 1, VIN 1, and VaIN 1 cases and 90% of genital wart cases. Further, the HPV 16 and 18 types cause approximately 70% of cervical cancer, AIS, CIN 3, VIN 2/3, and VaIN 2/3 cases and 50% of CIN 2 cases.
The exact mechanism by which the HPV 9-valent vaccine protects against type-specific HPV infection and sequela is unknown. Receipt of the HPV 9-valent vaccine is thought to result in a humoral immune response directed against HPV-L1 capsid proteins. The vaccine contains recombinant L1 protein, which is the major antigenic protein of the capsid of HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. These L1 proteins are produced in brewers yeast (i.e., Saccharomyces cerevisiae), purified, and adsorbed on an aluminum-containing adjuvant (amorphous aluminum hydroxyphosphate sulfate or AAHS).
The HPV 9-valent vaccine series elicited detectable antibody concentrations against those HPV types contained within the vaccine; however, the minimum anti-HPV titer needed to confer protective efficacy has not been determined. To evaluate efficacy against HPV types 31, 33, 45, 52, and 58, the vaccine was administered to 7,099 girls and women age 16 to 26 years. In this study primary efficacy was determined based on a composite clinical endpoint of cervical, vulvar, vaginal cancers and neoplasia. An analysis of the data starting 7 months post-dose found the vaccine to be effective in preventing HPV type 31-, 33-, 45-, 52-, and 58-related persistent infections and diseases, as observed through a reduction in the incidence of Pap test abnormalities, cervical and external genital biopsy, and definitive therapy. For HPV 6, 11, 16, and 18, immunogenicity was determined by comparing the vaccine induced geometric mean titers (GMTs) with those induced by the HPV quadrivalent vaccine (Gardasil quadrivalent). At 7 months post-dose, Gardasil 9 was found to be non-inferior to Gardasil quadrivalent, with 99.7% of girls and women (age 9 to 26 years) becoming seropositive for each of the 4 HPV types. Results from these two studies were subsequently used to infer vaccine efficacy in boys and girls age 9 to 15 years. This was accomplished through a non-inferiority comparison of the GMTs in boys and girls age 9 to 15 years with those observed in females age 16 to 26 years.
One study evaluated the immune response to Gardasil 9 in 921 girls and women (ages 12 to 26 years) who had recently received (within a 1 year period) 3 Gardasil quadrivalent injections. Data from this study found the anti-HPV 31, 33, 45, 52, and 58 GMTs induced by Gardasil 9 to be 25% to 63% of those that were observed in Gardasil 9 recipients who had not previously received Gardasil quadrivalent. The clinical relevance if these results are unknown. Efficacy of Gardasil 9 in preventing infections/diseases from HPV types 31, 33, 45, 52, and 58 in individuals previously vaccinated with Gardasil quadrivalent has not been evaluated.
The duration of immunity after vaccination with the Gardasil 9 series has not been established. Peak anti-HPV GMTs are observed at month 7; however, despite the decline after month 7, a similar proportion of vaccine recipients remain seropositive to each vaccine HPV type at month 24.
The human papillomavirus 9-valent vaccine is administered intramuscularly. Vaccination does not ensure immunity. Distrubution, metabolism, and excretion of the vaccine have not been defined.
Pooled data from clinical trials found >= 99.5% of vaccine recipients became seropositive for each of the 9 human papillomavirus (HPV) types contained within the vaccine by month 7. Peak anti-HPV geometric mean titers (GMTs) are observed at month 7; however despite the decline after month 7, a similar proportion of vaccine recipients remain seropositive to each vaccine HPV type at month 24. The duration of immunity has not been established.
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Seven months after administration of the human papillomavirus (HPV) 9-valent vaccine series, the anti-HPV geometric mean titers (GMTs) observed in girls and boys age 9 to 15 years were comparable to those observed in females age 16 to 26 years.