Hepatitis A Vaccine
(hep a TYE tis aye vak SEEN)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, suspension [adult, preservative free]:
Havrix: Hepatitis A virus antigen 1440 ELISA units/mL (1 mL) [contains aluminum, neomycin (may have trace amounts); may contain natural rubber/natural latex in prefilled syringe]
VAQTA: Hepatitis A virus antigen 50 units/mL (1 mL) [contains aluminum, natural rubber/natural latex in packaging]
Injection, suspension [pediatric, preservative free]:
Havrix: Hepatitis A virus antigen 720 ELISA units/0.5 mL (0.5 mL) [contains aluminum, neomycin (may have trace amounts); may contain natural rubber/natural latex in prefilled syringe]
Injection, suspension [pediatric/adolescent, preservative free]:
VAQTA: Hepatitis A virus antigen 25 units/0.5 mL (0.5 mL) [contains aluminum, natural rubber/natural latex in packaging]
Brand Names: U.S.
- Vaccine, Inactivated (Viral)
As an inactivated virus vaccine, hepatitis A vaccine induces active immunity against hepatitis A virus infection
Onset of Action
Protective antibodies develop in 95% of adults after the first dose and in 100% of adults after the second dose of the vaccine; ≥97% of children and adolescents will be seropositive within 1 month of the first dose and 100% will develop protective antibodies after receiving two doses. The efficacy of preventing hepatitis A disease in children living in highly infected areas is 94% to 100% (CDC 2015).
Duration of Action
Protective antibodies induced by the vaccine may persist for ≥17 years (CDC 2015).
Use: Labeled Indications
Hepatitis A virus disease prevention:
For active immunization of persons 12 months and older against disease caused by hepatitis A virus (HAV).
The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination for:
- All children ≥12 months of age (CDC/ACIP [Fiore 2006])
- All unvaccinated adults requesting protection from HAV infection (CDC/ACIP [Fiore 2006])
- Unvaccinated persons with any of the following conditions: Men who have sex with men; injection and non-injection illicit drug users; persons who work with HAV-infected primates or with HAV in a research laboratory setting; persons with chronic liver disease; patients who receive clotting-factor concentrates; persons traveling to or working in countries with high or intermediate levels of endemic HAV infection (CDC/ACIP [Fiore 2006])
- Unvaccinated persons who anticipate close personal contact with international adoptee from a country of intermediate to high endemicity of HAV, during their first 60 days of arrival into the United States (eg, household contacts, babysitters) (CDC/ACIP 58 2009)
- Vaccination can be a component of hepatitis A outbreak response or as postexposure prophylaxis, as determined by local public health authorities (CDC/ACIP 56 2007; CDC/ACIP [Fiore 2006])
The Canadian National Advisory Committee on Immunization (NACI) also recommends vaccination for the following (NACI 2016):
- Persons ≥6 months at risk for hepatitis A infection (eg, traveling to or from endemic countries) or severe hepatitis A (eg, underlying hepatic disease of idiopathic, metabolic, infectious or cholestatic etiology)
- Infants ≥6 months living with an individual at risk for hepatitis A infection or severe hepatitis A
- Post-exposure prophylaxis:
- Healthy patients ≥6 months (vaccine is preferred over immune globulin [Ig])
- Within 14 days of exposure of susceptible adults ≥60 years of age who are household or close contacts of a case (Ig may also be given)
- Susceptible individuals with chronic liver disease (Ig should also be administered within 14 days of exposure)
- May be considered in patients who receive repeat administration of plasma-derived clotting factors
Immediate and/or severe allergic or hypersensitivity reaction to hepatitis A containing vaccines or any component of the formulation, including neomycin.
Immunization: Note: Although it is preferred to use the vaccines according to their approved labeling, Havrix and VAQTA are considered to be interchangeable for booster doses (CDC/ACIP [Fiore 2006]).
Primary immunization: Note: When used for primary immunization, the vaccine should be given at least 2 weeks prior to expected HAV exposure. When used prior to an international adoption, the vaccination series should begin when adoption is being planned, but ideally ≥2 weeks prior to expected arrival of adoptee (CDC 58 2009).
Avaxim [Canadian product]: IM: 160 units (0.5 mL) with a booster dose of 160 units (0.5 mL) to be given 6 to 36 months following primary immunization
Havrix: IM: 1440 ELISA units (1 mL) with a booster dose of 1440 ELISA units (1 mL) to be given 6 to 12 months following primary immunization.
VAQTA: IM: 50 units (1 mL) with a booster dose of 50 units (1 mL) to be given 6-18 months after primary immunization (6 to 12 months if initial dose was with Havrix).
Postexposure prophylaxis (off-label use): Adults without immunity: IM: Administer a single dose as soon as possible following recent exposure to hepatitis A virus (during last 2 weeks) (CDC 56 2007).
Refer to adult dosing.
Immunization: Note: Although it is preferred to use the vaccines according to their approved labeling, Havrix and VAQTA are considered to be interchangeable for booster doses (CDC/ACIP [Fiore 2006]).
Primary immunization: Advisory Committee on Immunization Practices (ACIP): Children ≥12 months: All children should receive primary immunization with a two-dose series. The series should be initiated at 12 to 23 months; the two doses should be separated by 6 to 18 months (CDC/ACIP [Fiore 2006]). Note: When used for primary immunization, the vaccine should be given at least 2 weeks prior to expected HAV exposure. When used prior to an international adoption, the vaccination series should begin when adoption is being planned, but ideally ≥2 weeks prior to expected arrival of adoptee (CDC 58 2009).
Avaxim [Canadian product]: Children ≥12 years and Adolescents: Refer to adult dosing.
Avaxim-Pediatric [Canadian product]: Children ≥12 months and Adolescents ≤15 years: IM: 80 units (0.5 mL) with a booster dose of 80 units (0.5 mL) to be given 6 to 36 months following primary immunization
Havrix: Children ≥12 months and Adolescents: IM: 720 ELISA units (0.5 mL) with a booster dose of 720 ELISA units (0.5 mL) to be given 6 to 12 months following primary immunization
VAQTA: Children ≥12 months and Adolescents: IM: 25 units (0.5 mL) with a booster dose of 25 units (0.5 mL) to be given 6 to 18 months after primary immunization (6 to 12 months if initial dose was with HAVRIX)
Postexposure prophylaxis (off-label use): Children and Adolescents without immunity: IM: 0.5 mL once as soon as possible following recent exposure to hepatitis A virus (during last 2 weeks) (CDC 56 2007).
Dosing: Renal Impairment
There are no dosage adjustments provided in the manufacturer's labeling.
Dosing: Hepatic Impairment
There are no specific recommendations provided in manufacturer’s labeling. However, data suggest patients with chronic liver disease have a lower antibody response to HAVRIX than healthy subjects.
For IM administration. The deltoid muscle is the preferred site for injection for older children and adults; administer to the anterolateral aspect of the thigh in infants and young children. Do not administer to the gluteal region; may decrease efficacy. Do not administer intravenously, intradermally, or subcutaneously. Shake well prior to use; discard if the suspension is discolored or does not appear homogenous after shaking, or if there are cracks in the vial or syringe. Do not dilute. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection (ACIP [Kroger 2017]). To prevent syncope related injuries, adolescents and adults should be vaccinated while seated or lying down (ACIP [Kroger 2017]). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record.
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. A fine needle (23 gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. 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 [Kroger 2017]).
Store refrigerated between 2°C and 8°C (36°F and 46°F). Do not freeze; discard if the product has been frozen.
The following stability information has also been reported for Havrix: May be stored at room temperature for up to 72 hours (Cohen 2007).
VAQTA: Canadian labeling suggests that the vaccine may be used if cumulative exposure to temperatures of 0°C to 2˚C (32°F to 36°F) or 8°C to 25˚C (46°F to 77°F) is ≤72 hours.
Belimumab: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Patients should receive inactivated vaccines prior to initiation of belimumab therapy whenever possible, due to the risk for an impaired response to the vaccine during belimumab therapy. Consider therapy modification
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. Exceptions: Cytarabine (Liposomal). Consider therapy modification
Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy
All serious adverse reactions must be reported to the U.S. Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or online at https://vaers.hhs.gov/esub/index. In Canada, adverse reactions may be reported to local provincial/territorial health agencies or to the Vaccine Safety Section at Public Health Agency of Canada (1-866-844-0018).
Frequency dependent upon age, product used, and concomitant vaccine administration. In general, headache and injection site reactions were less common in younger children.
Central nervous system: Drowsiness, headache, irritability
Gastrointestinal: Decreased appetite
Local: Erythema at injection site, injection site reaction (soreness, warmth), pain at injection site, swelling at injection site, tenderness at injection site
Neuromuscular & skeletal: Weakness
Miscellaneous: Fever (≥100.4°F [1-5 days postvaccination], >98.6°F [1-14 days postvaccination])
1% to 10%:
Central nervous system: Chills, fatigue, insomnia, malaise
Dermatologic: Skin rash
Endocrine & metabolic: Menstrual disease
Gastrointestinal: Abdominal pain, anorexia, constipation, diarrhea, gastroenteritis, nausea, vomiting
Local: Bruising at injection site, induration at injection site
Neuromuscular & skeletal: Arm pain, back pain, myalgia, stiffness
Otic: Otitis media
Respiratory: Asthma, cough, nasal congestion, nasopharyngitis, pharyngitis, rhinitis, rhinorrhea, upper respiratory tract infection
Miscellaneous: Excessive crying, fever ≥102°F (1-5 days postvaccination)
<1%, postmarketing, and/or case reports: Anaphylaxis, angioedema, arthralgia, ataxia (cerebellar), bronchiolitis, bronchoconstriction, croup, dehydration, dermatitis, dizziness, dysgeusia, dyspnea, encephalitis, erythema multiforme, eye irritation, flu-like symptoms, Guillain-Barre syndrome, hematoma at injection site, hepatitis, hyperhidrosis, hypersensitivity reaction, hypertonia, hypoesthesia, increased creatine kinase, increased serum transaminases (transient), injection site reaction (nodule), insomnia, jaundice, lymphadenopathy, multiple sclerosis, myelitis, neuropathy, otitis, paresthesia, photophobia, pneumonia, pruritus, rash at injection site, respiratory congestion, seizure, serum sickness-like reaction, syncope, thrombocytopenia, urticaria, vasculitis, vertigo, viral exanthem, wheezing
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 (ACIP [Kroger 2017]).
• 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 [Kroger 2017]).
• 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) (ACIP [Kroger 2017]).
• Bleeding disorders: Use with caution in patients with 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 [Kroger 2017]). Canadian product labeling suggests that subcutaneous administration may be considered in exceptional circumstances (eg, patients with thrombocytopenia or at risk for hemorrhage); however, this may convey a higher risk for local reactions (eg, injection site nodule). In healthy adults, seroconversion following an initial subcutaneous dose of VAQTA was slower than that historically observed following intramuscular administration (Linglöf 2001).
• Hepatic impairment: Recommended for patients with chronic liver disease; however, these patients may have decreased antibody response.
• 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. 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 [Kroger 2017]; IDSA [Rubin 2014]).
Concurrent drug therapy issues:
• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2017]).
• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist. The use of combination vaccines is generally preferred over separate injections, taking into consideration provider assessment, patient preference, and adverse events. When using combination vaccines, the minimum age for administration is the oldest minimum age for any individual component; the minimum interval between dosing is the greatest minimum interval between any individual components. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible (ACIP [Kroger 2017]).
Dosage form specific issues:
• Latex: Packaging may contain natural latex rubber.
• Neomycin: Some products may contain neomycin.
• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Kroger 2017]). One study reported that routine prophylactic administration of acetaminophen prior to vaccination to prevent fever decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).
• Appropriate use: Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the ACIP Recommended Immunization Schedules (ACIP [Kim 2017]; CDC/ACIP [Robinson 2017]). Specific recommendations for vaccination in immunocompromised patients with asplenia, cancer, HIV infection, cerebrospinal fluid leaks, cochlear implants, hematopoietic stem cell transplant (prior to or after), sickle cell disease, solid organ transplant (prior to or after), or those receiving immunosuppressive therapy for chronic conditions as well as contacts of immunocompromised patients are available from the IDSA (Rubin 2014).
• 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 is 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 (ACIP [Kroger 2017]). Due to the long incubation period for hepatitis A (15 to 50 days), unrecognized hepatitis A infection may be present; immunization may not prevent infection in these patients.
Liver function tests; monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Kroger 2017]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
Pregnancy Risk Factor
Animal reproduction studies have not been conducted. The safety of vaccination during pregnancy has not been determined, however, the theoretical risk to the infant is expected to be low. Inactivated vaccines have not been shown to cause increased risks to the fetus (ACIP [Kroger 2017]).
• Discuss specific use of vaccine and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience headache, loss of strength and energy, injection site pain or irritation, irritability (children), fatigue (children), lack of appetite (children), fever (children), or rhinitis (children). Have patient report immediately to prescriber burning or numbness feeling, abnormal movements, severe dizziness, passing out, or vision changes (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
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