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Hepatitis A Vaccine

Pronunciation

(hep a TYE tis aye vak SEEN)

Index Terms

  • HepA

Dosage Forms

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.

  • Havrix
  • VAQTA

Pharmacologic Category

  • Vaccine
  • Vaccine, Inactivated (Viral)

Pharmacology

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 2012).

Duration of Action

Protective antibodies induced by the vaccine may persist for ≥20 years (CDC 2012).

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[36] 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[41] 2007; CDC/ACIP [Fiore 2006])

Contraindications

Immediate and/or severe allergic or hypersensitivity reaction to hepatitis A containing vaccines or any component of the formulation, including neomycin.

Dosing: Adult

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[36] 2009).

Manufacturer’s labeling:

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). Note: Canadian labeling recommends that adults with HIV receive a booster dose 6 months after primary immunization.

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[41] 2007).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

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[36] 2009).

Manufacturer’s labeling:

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 12 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[41] 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.

Administration

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. To prevent syncope related injuries, adolescents and adults should be vaccinated while seated or lying down (NCIRD/ACIP 2011). 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 (NCIRD/ACIP 2011). Note: Canadian product labeling suggests that subcutaneous administration may be considered in exceptional circumstances (eg, patients with thrombocytopenia or at risk for hemorrhage), although 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).

Compatibility

Do not mix with other vaccines or injections. Separate needles and syringes should be used for each injection.

Storage

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.

Drug Interactions

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

Adverse Reactions

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.

>10%:

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°C [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

Ophthalmic: Conjunctivitis

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% (Limited to important or life threatening): Anaphylaxis, angioedema, ataxia (cerebellar), bronchiolitis, bronchoconstriction, dehydration, dermatitis, encephalitis, erythema multiforme, Guillain-Barre syndrome, hematoma at injection site, hepatitis, hypersensitivity reaction, hypoesthesia, increased creatine kinase, increased serum transaminases (transient), injection site reaction (nodule), jaundice, lymphadenopathy, multiple sclerosis, myelitis, neuropathy, paresthesia, photophobia, pruritus, rash at injection site, seizure, serum sickness-like reaction, syncope, thrombocytopenia, vasculitis, wheezing

Warnings/Precautions

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 (NCIRD/ACIP 2011).

• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (e.g. 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 (NCIRD/ACIP 2011).

Disease-related concerns:

• 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. Consider deferring 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) (NCIRD/ACIP 2011).

• Bleeding disorders: Use with caution in patients with bleeding disorders (including thrombocytopenia) and patients on anticoagulant therapy; 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 (NCIRD/ACIP 2011). 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.

Special populations:

• Altered immunocompetence: Use with caution in severely immunocompromised patients (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 (IDSA [Rubin 2014]; NCIRD/ACIP 2011); inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible (IDSA [Rubin 2014]).

Concurrent drug therapy issues:

• 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 (NCIRD/ACIP 2011).

Dosage form specific issues:

• Latex: Packaging may contain natural latex rubber.

• Neomycin: Some products may contain neomycin.

Other warnings/precautions:

• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (NCIRD/ACIP 2011). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination 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 Adult Recommended Immunization Schedule (ACIP [Kim 2016]). 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 (NCIRD/ACIP 2011). 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.

Monitoring Parameters

Liver function tests; monitor for syncope for 15 minutes following administration (NCIRD/ACIP 2011). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Pregnancy Risk Factor

C

Pregnancy Considerations

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 (NCIRD/ACIP 2011).

Patient Education

• 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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