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hepatitis a vaccine inactivated (Havrix, Vaqta)

 

Classes: Vaccines, Inactivated, Viral; Vaccines, Travel

Dosing and uses of Vaqta, Havrix (hepatitis a vaccine inactivated)

 

Adult dosage forms and strengths

injection

  • 50 units/mL (Vaqta adult dose)
  • 1440 ELISA units/mL (Havrix adult dose)

 

Hepatitis A Immunization

Indicated as active immunization against hepatitis A virus (HAV) for any person seeking protection, and persons with the following risks: men who have sex with men, IV or non-IV illicit drug abusers, chronic liver disease, international travelers, close contact with an international adoptee, persons working with HAV-infected primates or HAV in lab setting

2-dose vaccination series: 1 mL IM; separate the 2 doses by 6-18 months (ACIP guidelines); Havrix labeling states separating the dose by 6-12 months

 

Additional Information

Up-to-date vaccination schedules available at https://www.cdc.gov/vaccines/default.htm

 

Pediatric dosage forms and 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

Routine vaccination (2-dose series): 0.5 mL IM initiated at aged 12 through 23 months; separate the 2 doses by 6-18 months (ACIP guidelines); Havrix labeling states separating the dose by 6-12 months

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

 

Vaqta, Havrix (hepatitis a vaccine inactivated) adverse (side) 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

 

Pregnancy and 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 of Vaqta, Havrix (hepatitis a vaccine inactivated)

Mechanism of action

Attenuated strain of hepatitis A virus (HAV) which stimulates active immunity

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)