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Hepatitis A Vaccine

Medically reviewed by Drugs.com. Last updated on Aug 30, 2020.

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, formaldehyde, 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, formaldehyde, 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 2015).

Duration of Action

Protective antibodies induced by the vaccine have been observed to persist for ≥20 years (Plumb 2017; Theeten 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 vaccination for:

- All children 12 to 23 months of age (CDC/ACIP [Fiore 2006], ACIP [Robinson 2020]).

- All unvaccinated children and adolescents 2 through 18 years of age (ACIP [Robinson 2020]).

- All unvaccinated adults requesting protection from HAV infection (CDC/ACIP [Fiore 2006]).

- Unvaccinated adults with any of the following: Men who have sex with men; injection and non-injection drug users; persons who work with HAV-infected primates or with HAV in a research laboratory setting; persons with HIV; persons with chronic liver disease (eg, persons with hepatitis B or C infection, cirrhosis, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, ALT or AST > twice the upper limit of normal); patients experiencing homelessness; pregnant patients at risk for infection or severe outcome from infection during pregnancy; workers in health care settings targeting services to injection or noninjection drug users or group homes and nonresidential day care facilities for developmentally disabled persons (ACIP [Freedman 2020]; ACIP [Robinson 2020]; CDC/ACIP [Doshani 2019]; CDC/ACIP [Fiore 2006]).

- Unvaccinated persons ≥6 months traveling to or working in countries with high or intermediate levels of endemic HAV infection (CDC/ACIP [Nelson 2018]).

- 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).

- A component of hepatitis A outbreak response, or as postexposure prophylaxis to patients ≥12 months of age within 14 days of exposure, as determined by local public health authorities (CDC/ACIP [Fiore 2006]; CDC/ACIP [Nelson 2018]).

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.

- Postexposure 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.

Contraindications

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

Dosing: Adult

Note: Immunization during coronavirus disease 2019 (COVID-19) pandemic: Routine vaccination should NOT be delayed because of the COVID-19 pandemic (CDC 2020; WHO 2020). In general, simultaneous administration of all vaccines for which a patient is eligible (according to current immunization schedules/guidelines) is recommended (ACIP [Ezeanolue 2020]). However, outpatient visits solely for vaccination should be delayed in persons in quarantine due to close contact with COVID-19 or persons who have suspected or confirmed COVID-19 infection (regardless of symptoms); refer to the CDC's "Interim Guidance for Immunization Services During the COVID-19 Pandemic" for current recommendations (https://www.cdc.gov/vaccines/pandemic-guidance/index.html). Additional information is available from the American Academy of Pediatrics and the Immunization Action Coalition.

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 hepatitis A virus (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: 1,440 ELISA units (1 mL) with a booster dose of 1,440 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 to 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 HAV (within 14 days); for long-term protection, complete vaccine series with a second dose ≥6 months after initial dose (CDC/ACIP [Nelson 2018]).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Immunization during coronavirus disease 2019 (COVID-19) pandemic: Routine vaccination should NOT be delayed because of the COVID-19 pandemic (CDC 2020; WHO 2020). In general, simultaneous administration of all vaccines for which a patient is eligible (according to current immunization schedules/guidelines) is recommended (ACIP [Ezeanolue 2020]). However, outpatient visits solely for vaccination should be delayed in persons in quarantine due to close contact with COVID-19 or persons who have suspected or confirmed COVID-19 infection (regardless of symptoms); refer to the CDC's "Interim Guidance for Immunization Services During the COVID-19 Pandemic" for current recommendations (https://www.cdc.gov/vaccines/pandemic-guidance/index.html). Additional information is available from the American Academy of Pediatrics and the Immunization Action Coalition.

Note: Consult CDC/ACIP annual immunization schedules or National Advisory Committee on Immunization (NACI) guidelines (Canada) 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 (ACIP [Ezeanolue 2020]).

Primary immunization: Note: When used for primary immunization, the vaccine should be given at least 2 weeks prior to expected hepatitis A virus (HAV) exposure. When used prior to an international adoption, the vaccination series should begin when adoption is being planned, but at least ≥2 weeks prior to expected arrival of adoptee (CDC 58[36] 2009).

ACIP recommendations (CDC/ACIP [Fiore 2006]): Havrix, VAQTA: 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]).

Children 12 to 23 months: IM: 0.5 mL per dose for a total of 2 doses. The series should be initiated at 12 to 23 months of age; the 2 doses should be separated by 6 to 18 months.

Note: Havrix doses should be separated by 6 to 12 months; VAQTA doses should be separated by 6 to 18 months. If VAQTA is used as booster dose following primary Havrix, the VAQTA dose should be administered at 6 to 12 months postdose immunization.

Canadian labeling: Note: Review product labeling carefully; although dose volume is the same, products differ by concentration and appropriate ages; use extra precaution to ensure accuracy.

Avaxim-Pediatric [Canadian product]: Children and Adolescents ≤15 years: IM: 0.5 mL with a booster dose of 0.5 mL to be administered ideally 6 to 36 months following primary immunization but can be administered up to 7 years following primary vaccination series. Note: The need for an additional booster dose has not been determined; anti-HAV antibodies have been observed up to 14 to 15 years following primary series with Avaxim-Pediatric in healthy subjects.

Avaxim [Canadian product]: Children ≥12 years and Adolescents: IM: 0.5 mL with a booster dose of 0.5 mL to be administered 6 to 36 months following primary immunization.

Catch-up immunization: CDC (ACIP) recommendations (ACIP [Robinson 2020]; CDC/ACIP [Fiore 2006]): Note: Do not restart the series. If doses have been given, begin the following schedule at the applicable dose number. Children ≥2 years and Adolescents: IM: 0.5 mL per dose for a total of 2 doses separated by at least 6 months.

Preexposure prophylaxis: Infants 6 to 11 months of age: IM: 0.5 mL once, administer as soon as travel is considered. Note: Dose does not count toward primary immunization series; at 12 months of age, the full 2-dose primary immunization hepatitis A schedule should be initiated (see Primary Immunization) (CDC/ACIP [Nelson 2018]).

Postexposure prophylaxis: Children and Adolescents without immunity: IM: 0.5 mL as soon as possible following recent exposure to HAV (during last 2 weeks); immunocompromised individuals or those with chronic liver disease should also receive immune globulin. A second vaccine dose is not necessary for postexposure prophylaxis but should be considered in 6 months following initial dose to complete the hepatitis A vaccine series to ensure long-term immunity (CDC/ACIP [Nelson 2018]).

Administration

For IM administration. The deltoid muscle is the preferred site for injection. 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 [Ezeanolue 2020]). To prevent syncope related injuries, patients should be vaccinated while seated or lying down (ACIP [Ezeanolue 2020]). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.

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 [Ezeanolue 2020]).

Storage

Store refrigerated between 2°C and 8°C (36°F and 46°F). Do not freeze; discard if the product has been frozen. Extended storage information at room temperature may be available; contact product manufacturer to obtain current recommendations.

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

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: Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated less than 2 weeks before starting or during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Consider therapy modification

Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

All serious adverse reactions must be reported to the US 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°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

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%, 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

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 (ACIP [Ezeanolue 2020]).

• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis or tendinopathy) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).

• 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 [Ezeanolue 2020]).

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. 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 [Ezeanolue 2020]).

• 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 [Ezeanolue 2020]). 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: 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. An exception when administration should not be delayed may include use of the hepatitis A vaccine for preexposure prophylaxis prior to international travel to certain areas (CDC/ACIP [Nelson 2018]). 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 [Ezeanolue 2020]; IDSA [Rubin 2014]).

Concurrent drug therapy issues:

• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration; ideally vaccinations should be administered prior to initiation of anticoagulation therapy if possible (ACIP [Ezeanolue 2020]).

• 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 [Ezeanolue 2020]).

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 (ACIP [Ezeanolue 2020]). 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 annual ACIP Recommended Immunization Schedules (refer to CDC schedule for detailed information). 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 [Ezeanolue 2020]). 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

Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Ezeanolue 2020]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Pregnancy Considerations

In general, maternal use of inactivated vaccines are not associated with increased risks to the fetus (ACIP [Ezeanolue 2020]). In addition, an increased risk of most adverse maternal or fetal events, including miscarriage or major birth defects, has not been observed following maternal use of the hepatitis A vaccine (Groom 2019; Nasser 2019).

The Centers for Disease Control and Prevention recommends immunization for pregnant patients at risk for hepatitis A infection or patients who are at risk for severe outcomes from infection during pregnancy (ACIP [Freedman 2020]). Refer to current immunization schedule for vaccinating pregnant females.

Patient Education

What is this drug used for?

• It is used to prevent hepatitis A infection.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache

• Loss of strength and energy

• Nausea

• Injection site pain, redness, swelling, or irritation

• Irritability (children)

• Fatigue (children)

• Lack of appetite

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Burning or numbness feeling

• Abnormal movements

• Severe dizziness

• Passing out

• High fever

• Vision changes

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.