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Hepatitis A vaccine (HepA): Pediatric drug information

Hepatitis A vaccine (HepA): Pediatric drug information
(For additional information see "Hepatitis A vaccine (HepA): Drug information" and see "Hepatitis A vaccine (HepA): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Havrix;
  • Vaqta
Brand Names: Canada
  • Avaxim;
  • Avaxim Pediatric [DSC];
  • Havrix 1440;
  • Havrix 720 Junior;
  • Vaqta
Therapeutic Category
  • Vaccine;
  • Vaccine, Inactivated Virus
Dosing: Pediatric

Note: The Advisory Committee on Immunization Practices prefers that doses in the series come from the same manufacturer; however, if this is not possible or the previous vaccine is unknown, then may administer whichever hepatitis A vaccine is available (CDC/ACIP [Nelson 2020]). 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 [Kroger 2023]).

Primary immunization

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 (eg, travel to intermediate or high HAV endemicity area). 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/ACIP [Nelson 2020]).

ACIP recommendations: Havrix, VAQTA:

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 timing of the second dose is dependent on vaccine product:

Havrix: The second dose should be given 6 to 12 months after the first dose.

VAQTA: The second dose should be given 6 to 18 months after the first dose; if initial dose was Havrix, give second dose 6 to 12 months after first.

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

Avaxim-Pediatric [Canadian product]: Children and Adolescents ≤15 years: IM: 0.5 mL per dose for 2 doses; second dose should ideally be administered 6 to 36 months after first dose but can be administered up to 7 years after first dose.

Avaxim [Canadian product]: Children ≥12 years and Adolescents: IM: 0.5 mL per dose for 2 doses; administer second dose 6 to 36 months after first dose.

Catch-up immunization

Catch-up immunization: CDC (ACIP) recommendations (CDC/ACIP [Nelson 2020]): 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 ≤18 years: IM: 0.5 mL per dose for a total of 2 doses separated by ≥6 months.

Revaccination

Revaccination (CDC/ACIP [Nelson 2020]): Note: Revaccination is not recommended for healthy persons who received a complete HAV vaccine series. May consider revaccination in persons with HIV or those who received vaccination during a period of immunosuppression who had inadequate response, as determined by postvaccination serologic testing; limited data are available, refer to "Primary Immunization" for dosing details.

Preexposure prophylaxis, international travel

Preexposure prophylaxis, international travel (CDC/ACIP [Nelson 2020]):

Infants 6 to <12 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").

Children and Adolescents ≤18 years, previously unvaccinated: IM: 0.5 mL per dose; administer first dose as soon as travel is considered; complete series according to routine schedule.

Postexposure prophylaxis in individuals who are unvaccinated or incompletely vaccinated

Postexposure prophylaxis in individuals who are unvaccinated or incompletely vaccinated: Children and Adolescents ≤18 years: IM: 0.5 mL as soon as possible following recent exposure to HAV (within 14 days); immunocompromised individuals or those with chronic liver disease should also receive immune globulin. For long-term protection in those previously unvaccinated, complete vaccine series with a second dose ≥6 months after initial dose (CDC/ACIP [Nelson 2020]).

Outbreak control in individuals unvaccinated or incompletely vaccinated

Outbreak control in individuals unvaccinated or incompletely vaccinated: Children and Adolescents ≤18 years: IM: 0.5 mL per dose; administer a single dose in all unvaccinated persons who are at risk for HAV infection or severe disease from HAV (CDC/ACIP [Nelson 2020]).

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, data suggest patients with chronic liver disease have a lower antibody response to Havrix product than healthy subjects.

Dosing: Adult

(For additional information see "Hepatitis A vaccine (HepA): Drug information")

Note: The Advisory Committee on Immunization Practices (ACIP) prefers that doses in the series come from the same manufacturer; however, if this is not possible or the previous vaccine is unknown, then may administer whichever hepatitis A vaccine is available (CDC/ACIP [Nelson 2020]).

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 [Kroger 2023]).

Primary immunization

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 (eg, travel to intermediate to high HAV endemicity area). 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/ACIP [Nelson 2020]).

Avaxim [Canadian product]: IM: 0.5 mL (160 units) as a 2-dose series at 0 and 6 to 36 months.

Havrix: Note: If the second dose is administered <6 months after the first dose, then a third dose administered ≥6 months after the first dose is required (CDC/ACIP [Nelson 2020]).

18 to <19 years of age: IM: 0.5 mL (720 ELISA units) as a 2-dose series at 0 and 6 to 12 months.

≥19 years of age: IM: 1 mL (1,440 ELISA units) as a 2-dose series at 0 and 6 to 12 months.

VAQTA: Note: If the second dose is administered <6 months after the first dose, then a third dose administered ≥6 months after the first dose is required (CDC/ACIP [Nelson 2020]).

US labeling:

18 to <19 years of age: IM: 0.5 mL (25 units) as a 2-dose series at 0 and 6 to 18 months (6 to 12 months if initial dose was with Havrix).

≥19 years of age: IM: 1 mL (50 units) as a 2-dose series at 0 and 6 to 18 months (6 to 12 months if initial dose was with Havrix).

Canadian labeling: ≥18 years of age: IM: 1 mL (50 units) as a 2-dose series at 0 and 6 to 18 months (6 to 12 months if initial dose was with Havrix).

Revaccination (CDC/ACIP [Nelson 2020]): Note: Revaccination is not recommended for healthy persons who received a complete HAV vaccine series. May consider revaccination in persons with HIV or those who received vaccination during a period of immunosuppression who had inadequate response, as determined by postvaccination serologic testing; limited data are available.

Postexposure prophylaxis

Postexposure prophylaxis (off-label use): Unvaccinated or incomplete vaccination: IM: Administer a single dose as soon as possible following recent exposure to HAV (within 14 days); for long-term protection in those previously unvaccinated, complete vaccine series with a second dose ≥6 months after initial dose. Immune globulin may be indicated in select patients (eg, patients with risk factors for HAV infection or severe disease) based on provider assessment (CDC/ACIP [Nelson 2020]).

Outbreak control

Outbreak control (off-label use): IM: Administer a single dose in all unvaccinated persons who are at risk for HAV infection or severe disease from HAV (CDC/ACIP [Nelson 2020]).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

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.

Adverse Reactions

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).

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

Contraindications

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

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 [Kroger 2023]).

• 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 [Kroger 2023]).

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. Postpone 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 2023]).

• 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 2023]). 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: Postpone vaccination during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]) if appropriate; 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 and as postexposure prophylaxis; in addition, immune globulin should be considered (CDC/ACIP [Nelson 2020]). In general, household and close contacts of persons with altered immunocompetence may receive all age-appropriate vaccines. Nonlive vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; nonlive vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2023]; 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 [Kroger 2023]).

• 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 nonlive) for which a person is eligible at a single visit, unless contraindications exist. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible (ACIP [Kroger 2023]).

Dosage form specific issues:

• Latex: Vaqta: 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 [Kroger 2023]). 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 (ACIP [Kroger 2023]). 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.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Intramuscular:

Havrix: Hepatitis A virus antigen 720 ELISA units/0.5 mL (0.5 mL) [contains formaldehyde solution, neomycin sulfate]

Vaqta: Hepatitis A virus antigen 50 units/mL (1 mL); Hepatitis A virus antigen 25 units/0.5 mL (0.5 mL) [contains formaldehyde solution]

Suspension, Intramuscular [preservative free]:

Havrix: Hepatitis A virus antigen 1440 ELISA units/mL (1 mL) [contains neomycin sulfate]

Vaqta: Hepatitis A virus antigen 50 units/mL (1 mL); Hepatitis A virus antigen 25 units/0.5 mL (0.5 mL) [contains formaldehyde solution]

Generic Equivalent Available: US

No

Pricing: US

Suspension (Havrix Intramuscular)

720 Elisa units/0.5 mL (per 0.5 mL): $45.46

1440 Elisa units/mL (per mL): $99.29

Suspension (Vaqta Intramuscular)

25 units/0.5 mL (per 0.5 mL): $45.13

50 units/mL (per mL): $94.61

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Suspension, Intramuscular:

Avaxim Pediatric: Hepatitis A virus antigen 80 units per 0.5 mL ([DSC])

Havrix 1440: Hepatitis A virus antigen 1440 ELISA units/mL (1 mL) [contains neomycin sulfate]

Havrix 720 Junior: Hepatitis A virus antigen 720 ELISA units/0.5 mL (0.5 mL) [contains neomycin sulfate]

Vaqta: Hepatitis A virus antigen 50 units/mL (0.5 mL, 1 mL)

Suspension Prefilled Syringe, Intramuscular:

Avaxim: 160 units/0.5 mL (0.5 mL) [contains alcohol, usp, formaldehyde solution, neomycin, polysorbate 80]

Additional Information

The ACIP recommends that healthy adults >40 years, immunocompromised persons, or persons with underlying medical conditions (including chronic liver disease) who are traveling to an area with high or intermediate hepatitis A virus (HAV) endemicity be evaluated for possible immune globulin in addition to hepatitis A vaccination (CDC/ACIP [Nelson 2020]).

For postexposure prophylaxis, immune globulin may be indicated in select patients based on provider assessment. Hepatitis A vaccine and immune globulin should be administered simultaneously at different anatomic sites. See CDC/ACIP guidelines for more details (CDC/ACIP [Nelson 2020]).

Administration: Pediatric

Parenteral: IM: 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. Administer IM into midlateral aspect of the thigh in infants and small children; administer in the deltoid area to older children and adolescents. Use proper injection technique 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). Do not administer to the gluteal region; may decrease efficacy. Not for IV, intradermal, or SubQ administration. If administered subcutaneously (either inadvertently or for a clinical reason), the dose is considered valid and does not need to be repeated. In children and adolescents requiring a postexposure prophylaxis dose, administer at a separate anatomic site (different limb) than intramuscular immune globulin dose (CDC/ACIP [Nelson 2020]). Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope-related injuries, adolescents should be vaccinated while seated or lying down (ACIP [Kroger 2023]). 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 IM injection, the vaccine should be administered IM 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, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) should be used for the vaccination and firm pressure on 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 2023]).

Administration: Adult

IM: Shake well prior to use; discard if the suspension is discolored or does not appear homogenous after shaking. Do not dilute. For IM administration. The deltoid muscle is the preferred site for injection. Use proper injection technique 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). Do not administer to the gluteal region; may decrease efficacy. Do not administer IV, intradermally, or SubQ. If administered SubQ (either inadvertently or for a clinical reason), the dose is considered valid and does not need to be repeated. If immune globulin is required, do not administer in the same anatomical site as hepatitis A vaccine (CDC/ACIP [Nelson 2020]). Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope related injuries, patients should be vaccinated while seated or lying down (ACIP [Kroger 2023]). 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 [Kroger 2023]).

Storage/Stability

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.

Medication Guide and/or Vaccine Information Statement (VIS)

In the US, the appropriate CDC-approved Vaccine Information Statement (VIS) must be provided to the patient/caregiver before administering each dose of this vaccine; the VIS edition date and date it was provided to the patient/caregiver should be recorded as required by US law; VIS is available at http://www.cdc.gov/vaccines/hcp/vis/vis-statements/hep-a.html.

Use

Active immunization against disease caused by hepatitis A virus (HAV) (FDA approved in ages ≥12 months and adults).

The Advisory Committee on Immunization Practices (ACIP) recommends vaccination for the following (CDC/ACIP [Nelson 2020]):

• All children 12 to 23 months of age

• All unvaccinated children and adolescents 2 through 18 years of age

• All unvaccinated adults requesting vaccination

• Persons ≥6 months of age traveling to or working in countries with high or intermediate levels of endemic HAV infection

• Men who have sex with men

• Persons who use injection or non-injection illicit drugs

• Persons with occupational risk for exposure due to work with HAV-infected nonhuman primates or HAV-containing material in a laboratory setting

• Persons who anticipate close personal contact (eg, household contacts, babysitters) with an international adoptee from a country of intermediate to high endemicity of HAV during their first 60 days of arrival of the adoptee into the United States

• Persons ≥1 year of age experiencing homelessness

• Persons with chronic liver disease (eg, hepatitis B or C infection, cirrhosis, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, ALT or AST persistently greater than twice the ULN)

• Persons ≥1 year of age with HIV infection

• Pregnant persons at risk for HAV infection or severe outcome from infection during pregnancy

• Unvaccinated adults in settings that provide services to adults in which a high proportion have risk factors for HAV infection (eg, homeless shelters, group homes and day care facilities for persons with developmental disabilities)

• Unvaccinated persons ≥12 months of age in outbreak settings, or as postexposure prophylaxis within 14 days of exposure, as determined by local public health authorities

The Canadian National Advisory Committee on Immunization (NACI) also recommends vaccination for the following (NACI 2016):

• Persons ≥6 months of age 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 of age (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.

Medication Safety Issues
Sound-alike/look-alike issues:

HepA (hepatitis A vaccine) may be confused with HepB (hepatitis B vaccine)

HepA (hepatitis A vaccine) may be confused with HPV4 (human papillomavirus vaccine [quadrivalent]; 4vHPV is the correct abbreviation)

International issues:

Avaxim [Canada and multiple international markets] may be confused with Avastin brand name for bevacizumab [US, Canada, and multiple international markets]

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification

Anti-CD20 B-Cell Depleting Therapies: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation or 6 months after anti-CD20 B-cell depleting therapies. If vaccinated prior to B cell recovery, consider assessing immune response to vaccination. Risk D: Consider therapy modification

Cladribine: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of cladribine when possible. Patients vaccinated less than 14 days before initiating or during cladribine should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification

Corticosteroids (Systemic): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to immunosuppressive corticosteroids if possible. If patients are vaccinated less than 14 days prior to or during such therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification

Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). 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. Risk D: Consider therapy modification

Immunosuppressants (Cytotoxic Chemotherapy): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification

Immunosuppressants (Miscellaneous Oncologic Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification

Immunosuppressants (Therapeutic Immunosuppressant Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification

Methotrexate: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to methotrexate initiation, if possible. If patients are vaccinated less than 14 days prior to or during methotrexate therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification

Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification

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

Teplizumab: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccination with inactivated or non-replicating vaccines is not recommended in the 2 weeks prior to teplizumab therapy, during treatment, or for 6 weeks following completion of therapy. Risk D: Consider therapy modification

Pregnancy Considerations

Nonlive bacterial vaccines have not been shown to cause increased risks to the fetus (ACIP [Kroger 2023]). 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 indications for hepatitis A vaccine in pregnant patients are the same as those for nonpregnant adults and adolescents. 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 (CDC/ACIP [Nelson 2020]). Refer to current immunization schedule for vaccinating pregnant patients.

Monitoring Parameters

Observe for anaphylaxis and syncope for 15 minutes following administration (ACIP [Kroger 2023]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Pre- and postvaccination serologic testing are not recommended routinely but may be considered in certain settings. Postvaccination serologic testing may be warranted in patients with HIV or those persons who received hepatitis A vaccination while immunosuppressed from chemotherapy (CDC/ACIP [Nelson 2020]).

Reference Range

Seroconversion is defined as postvaccination IgG anti-hepatitis A virus (HAV) level of ≥10 milliunits/mL (CDC/ACIP [Nelson 2020]).

Mechanism of Action

As an inactivated virus vaccine, hepatitis A vaccine induces active immunity against hepatitis A virus infection

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Protective antibodies develop in 91% to 99.7% of adults after the first dose and in 95.3% to 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/ACIP [Nelson 2020]).

Duration: Protective antibodies induced by the vaccine have been observed to persist for ≥20 years in the majority of adults and for ≥15 years in patients whose vaccination series began at 6 to 21 months of age (CDC/ACIP [Nelson 2020]; Plumb 2017; Theeten 2015). Duration of seroprotection may be decreased in patients vaccinated at 12 or 15 months whose mothers were positive for HAV antibodies (Spradling 2016).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Avaxim | Epaxal | Vaqta;
  • (AR) Argentina: Avaxim | Havrix | Vaqta | Virohep A | Virohep A Junior | Virohep-a berna;
  • (AT) Austria: Avaxim | Epaxal | Havrix | Vaqta | Vaqta-k;
  • (AU) Australia: Avaxim | Havrix | Vaqta;
  • (BD) Bangladesh: Havrix | Prevahav;
  • (BE) Belgium: Epaxal | Havrix | Vaqta;
  • (BF) Burkina Faso: Avaxim | Havrix junior;
  • (BG) Bulgaria: Avaxim | Havrix;
  • (BR) Brazil: Avaxim | Havrix | Vacina adsorvida hepatite a (inativada) | Vaqta;
  • (CH) Switzerland: Epaxal | Havrix;
  • (CL) Chile: Avaxim | Havrix | Vaqta;
  • (CN) China: Epaxal | Havrix | Vaqta;
  • (CO) Colombia: Avaxim | Havrix | Havrix 720 junior | Vaqta;
  • (CU) Cuba: Healive;
  • (CZ) Czech Republic: Avaxim | Havrix | Vaqta;
  • (DE) Germany: Avaxim | Epaxal | Havrix | Vaqta;
  • (DO) Dominican Republic: Havrix;
  • (EC) Ecuador: Avaxim | Epaxal | Havrix | Havrix 720 junior;
  • (EE) Estonia: Havrix | Havrix junior | Vaqta;
  • (EG) Egypt: Havrix;
  • (ES) Spain: Avaxim | Havrix;
  • (ET) Ethiopia: Avaxim;
  • (FI) Finland: Avaxim | Epaxal | Havrix;
  • (FR) France: Avaxim | Havrix | Vaqta;
  • (GB) United Kingdom: Avaxim | Epaxal | Havrix | Vaqta;
  • (GR) Greece: Avaxim | Havrix | Vaqta;
  • (HK) Hong Kong: Avaxim | Epaxal berna | Havrix | Vaqta;
  • (HU) Hungary: Avaxim | Havrix | Vaqta;
  • (ID) Indonesia: Avaxim | Havrix | Vaqta;
  • (IE) Ireland: Avaxim | Havrix | Vaqta;
  • (IL) Israel: Avaxim | Havrix;
  • (IN) India: Avaxim | Hapibev | Havrix | Havshield;
  • (IT) Italy: Avaxim | Epaxal | Havrix | Havrix adulti | Havrix bambini | Vaqta;
  • (JO) Jordan: Havrix;
  • (KE) Kenya: Avaxim | Avaxim pediatric | Havrix | Havrix junior;
  • (KR) Korea, Republic of: Avaxim | Boryung hepatitis a | Havrix | Vaqta;
  • (KW) Kuwait: Avaxim | Vaqta;
  • (LB) Lebanon: Avaxim | Havrix;
  • (LT) Lithuania: Avaxim | Havrix;
  • (LU) Luxembourg: Avaxim | Epaxal | Havrix | Vaqta;
  • (LV) Latvia: Avaxim | Havrix;
  • (MA) Morocco: Avaxim | Havrix;
  • (MX) Mexico: Avaxim | Havrix | Vaqta;
  • (MY) Malaysia: Avaxim | Havrix | Vaqta;
  • (NL) Netherlands: Avaxim | Epaxal | Havrix | Havrix junior | Vaqta;
  • (NO) Norway: Avaxim | Epaxal | Havrix | Vaqta;
  • (NZ) New Zealand: Avaxim | Epaxal berna | Havrix | Vaqta;
  • (PA) Panama: Havrix | Havrix junior;
  • (PE) Peru: Avaxim | Havrix;
  • (PH) Philippines: Avaxim | Havrix | Vaqta;
  • (PK) Pakistan: Avaxim | Havrix | Healive;
  • (PL) Poland: Avaxim | Havrix | Vaqta;
  • (PR) Puerto Rico: Havrix | Vaqta;
  • (PT) Portugal: Avaxim | Epaxal | Havrix | Vaqta;
  • (PY) Paraguay: Avaxim | Avaxim pediatrico | Havrix;
  • (QA) Qatar: Avaxim | Havrix | Havrix Junior | Vaqta Adult | Vaqta Paediatric and Adolescent;
  • (RO) Romania: Avaxim | Havrix;
  • (RU) Russian Federation: Algavac | Avaxim | Havrix | Hep a in vac | Vaqta;
  • (SA) Saudi Arabia: Avaxim | Havrix | Vaqta;
  • (SE) Sweden: Avaxim | Vaqta;
  • (SG) Singapore: Avaxim | Havrix | Vaqta;
  • (SI) Slovenia: Havrix;
  • (SK) Slovakia: Avaxim | Havrix;
  • (SV) El Salvador: Havrix | Havrix junior;
  • (TH) Thailand: Avaxim | Epaxal | Havrix | Vaqta;
  • (TN) Tunisia: Avaxim | Epaxal | Havrix | Healive;
  • (TR) Turkey: Avaxim | Havrix | Havtec | Vaqta;
  • (TW) Taiwan: Avaxim | Havrix A | Vaqta;
  • (UA) Ukraine: Avaxim;
  • (UG) Uganda: Avaxim | Avaxim paediatric;
  • (UY) Uruguay: Avaxim | Havrix;
  • (VE) Venezuela, Bolivarian Republic of: Epaxal | Havrix 1440 adult | Havrix 720 junior;
  • (ZA) South Africa: Avaxim | Havrix | Havrix junior;
  • (ZW) Zimbabwe: Avaxim
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