Dosing & Uses
Dosage Forms & Strengths
injection
- 50 units/mL (Vaqta adult dose)
- 1440 ELISA units/mL (Havrix adult dose)
Hepatitis A Immunization
Indicated as active immunization for any person seeking protection and for persons at risk for HAV infection
At risk populations
- Chronic liver disease (eg, hepatitis B infection, hepatitis C infection, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, ALT or AST >2x ULN)
- HIV infection
- Men who have sex with men
- Injection or noninjection drug use
- Persons who are homeless
- Work with hepatitis A virus (eg, research laboratory, work with nonhuman primates with HAV infection)
- Travel in countries with high or intermediate endemic HAV infection
- Close, personal contact with international adoptee (eg, household or regular babysitting) in first 60 days after arrival from country with high or intermediate endemic HAV infection (administer dose 1 as soon as adoption planned, at least 2 weeks before adoptee’s arrival)
- Pregnancy if at risk for infection or severe outcome from infection during pregnancy
- Setting for exposure, including healthcare settings targeting services to injection or noninjection drugs users or group homes; nonresidential day care facilities for developmentally disabled persons
2-dose vaccination series
- ≥19 years: 1 mL IM (primary dose)
- Administer primary dose at least 2 weeks before expected exposure to HAV
- Havrix: Administer booster dose 6-12 mo after primary dose
- Vaqta, ACIP guidelines: Administer booster dose 6-18 mo after primary dose
Preexposure protection against HAV for travelers (ACIP guidelines)
- 1 mL IM given at least 2 weeks before expected exposure to HAV
- For persons not previously vaccinated with hepatitis A vaccine, administer dose as soon as travel is considered, and complete 2-dose series according to routine schedule
- Also consider giving immune globulin for patients who are immunocompromised or have chronic liver disease, or those 40 yr or older who are otherwise healthy
Postexposure prophylaxis (PEP) for HAV
- 1 mL IM
- A second dose is not required for PEP; however, for long-term immunity, ACIP recommends completing the 2-dose series
- Age ≥40 years: Consider the need to also give immunoglobulin
- Immunocompromised or chronic liver disease: Vaccine and immune globulin should be administered simultaneously at different anatomic sites
Additional Information
Up-to-date vaccination schedules available at http://www.cdc.gov/vaccines/default.htm
Dosage Forms & Strengths
injection
- 25 units/0.5 mL (Vaqta pediatric dose)
- 720 ELISA units/0.5mL (Havrix pediatric dose)
Hepatitis A Immunization
Indicated as routine vaccination for children at least 12 months of age (ACIP guidelines)
<12 months: Not indicated; if administered, not counted toward the routine 2-dose series
≥12 months through 18 years (2-dose series)
- Primary dose: 0.5 mL IM
- Havrix: Administer booster dose 6-12 mo after primary dose
- Vaqta, ACIP guidelines: Administer booster dose 6-18 mo after primary dose
- Children who have received 1 dose before age 24 months, should receive a second dose 6-18 months after the first dose
Catch up schedule
- For any person ≥2 yr who has not already received hepatitis A vaccine series, give 2 doses separated by 6-18 months if immunity against hepatitis A virus infection is desired
- Minimum interval between the 2-dose series is 6 months
Preexposure protection against HAV for travelers (ACIP guidelines)
- <6 months: Do not administer hepatitis A vaccine, but do administer immune globulin
- 6-11 months: 0.5 mL IM; this dose does not count toward routine 2-dose vaccination series
- 12 months through 18 years: 0.5 mL IM; if not previously vaccinated with hepatitis A vaccine, complete 2-dose series according to routine schedule
- Immunocompromised or chronic liver disease: 0.5 mL IM; also consider giving immune globulin
Postexposure prophylaxis (PEP) for HAV
- 12 months through 18 years: 0.5 mL IM; if not previously vaccinated with hepatitis A vaccine, complete 2-dose series according to routine schedule
- Immunocompromised or chronic liver disease: Vaccine and immune globulin should be administered simultaneously at different anatomic sites
International travel
-
Persons traveling to or working in countries with high or intermediate endemic hepatitis A
- Infants age 6-11 months: 1 dose before departure; revaccinate with 2 doses, separated by at least 6 months, between 12 and 23 months of age
- Unvaccinated >12 months: Administer dose 1 as soon as travel is considered; give dose 2 after 6 months
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967
>10%
Injection site tenderness (3-56%), erythema (1-22%), warmth (1-17%), swelling (9-11%)
Irritability (11-36%)
Anorexia (1-19%)
Drowsiness (15-17%)
Headache (1-16%)
Fever > 100.4 F (9-11%)
1-10%
URI (1-10%)
Otitis media (8%)
Rhinorrhea (6%)
Diarrhea (1-6%)
Cough (1-5%)
Rash (1-5%)
Weakness/fatigue (4%)
Vomiting (1-4%)
Fever > 102 F (3%)
Crying (2%)
<1%
Hematoma
Incr. CPK
Photophobia
Vertigo
Warnings
Contraindications
Documented hypersensitivity
Cautions
First dose at least 2 wk before exposure to HAV
Current exposure to HAV: may co-administer IG
The tip caps of prefilled syringes contain natural rubber latex which may cause allergic reactions
Syncope (fainting) can occur in association with administration of injectable vaccines; syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements; procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of vaccine
Immunocompromised persons may have diminished immune response to drug, including individuals receiving immunosuppressant therapy
Hepatitis A virus has a relatively long incubation period (15 to 50 days); therapy may not prevent hepatitis A infection in individuals who have an unrecognized hepatitis A infection at time of vaccination; additionally, vaccination may not protect all individuals
Pregnancy & Lactation
Pregnancy Category: C
Lactation: not established
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Attenuated strain of hepatitis A virus (HAV) which stimulates active immunity
Pharmacokinetics
Onset: 4 wk
Duration: unknown
These products convey active immunity via stimulation of production of endogenously produced antibodies
The onset of protection from disease is relatively slow, but duration is long lasting (years)
Administration
IM Preparation
Do not dilute
Shake vial or syringe well to obtain a slightly opaque, white suspension before administering
Discard if suspension does not appear homogenous or if extraneous particulate matter remains or discoloration observed
IM Administration
Adults, adolescents, and children aged ≥2 years: Administer in deltoid region
Children aged 12-23 months: Administer in anterolateral area of the thigh
Storage
Refrigerate at 2-8°C (36-46°F)
Do not freeze; discard if vaccine has been frozen (freezing destroys potency)
Images
Patient Handout
Formulary
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