Frequently asked questions about VAQTA
What is the indication and usage for VAQTA® (Hepatitis A Vaccine, Inactivated)?
VAQTA is indicated for the prevention of disease caused by hepatitis A virus in persons 12 months of age and older. The primary dose should be given at least 2 weeks prior to expected exposure to HAV.
What is the recommended dosing for VAQTA® (Hepatitis A Vaccine, Inactivated)?
For children and adolescents 12 months through 18 years of age, vaccination with VAQTA consists of a 0.5-mL primary dose administered intramuscularly and a 0.5-mL booster dose administered intramuscularly 6 to 18 months later.
For adults 19 years of age and older, vaccination with VAQTA consists of a 1-mL primary dose administered intramuscularly and a 1-mL booster dose administered intramuscularly 6 to 18 months later.
What is the Select Safety Information for VAQTA® (Hepatitis A Vaccine, Inactivated)?
Do not administer VAQTA to individuals with a history of immediate and/or severe allergic or hypersensitivity reactions (eg, anaphylaxis) after a previous dose of any hepatitis A vaccine, or to individuals who have had an anaphylactic reaction to any component of VAQTA, including neomycin.
The vial stopper and the syringe plunger stopper and tip cap contain dry natural latex rubber that may cause allergic reactions in latex-sensitive individuals
The most common local adverse reactions and systemic adverse events (≥15%) reported in different clinical trials across different age groups when VAQTA was administered alone or concomitantly were:
Children 12 through 23 months of age: injection-site pain/tenderness (37.0%), injection-site erythema (21.2%), and fever (16.4% when administered alone, and 27.0% when administered concomitantly).
Children/Adolescents 2 through 18 years of age: injection-site pain (18.7%).
Safety and effectiveness in infants below 12 months of age have not been established.
Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to VAQTA and may not be protected against HAV infection after vaccination.
Hepatitis A virus has a relatively long incubation period (approximately 20 to 50 days). VAQTA may not prevent hepatitis A infection in individuals who have an unrecognized hepatitis A infection at the time of vaccination.
In clinical trials in children, VAQTA was concomitantly administered with one or more of the following US-licensed vaccines: Measles, Mumps, and Rubella Virus Vaccine, Live; Varicella Vaccine, Live; Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine, Adsorbed; Measles, Mumps, Rubella, and Varicella Vaccine, Live; Pneumococcal 7-valent Conjugate Vaccine; and Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate). Safety and immunogenicity were similar for concomitantly administered vaccines compared to separately administered vaccines.
There are no adequate and well-controlled studies designed to evaluate VAQTA in pregnant women, including those 19 years of age or younger. Available post-approval data do not suggest an increased risk of miscarriage or major birth defects in women who received VAQTA during pregnancy.
It is not known whether VAQTA is excreted in human milk. Data are not available to assess the effects of VAQTA on the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VAQTA and any potential adverse effects on the breastfed child from VAQTA or from the underlying maternal condition.
In clinical trials in adults, VAQTA was concomitantly administered with typhoid Vi polysaccharide and yellow fever vaccines. Safety and immunogenicity were similar for concomitantly administered vaccines compared to separately administered vaccines.
The total duration of the protective effect of VAQTA in healthy vaccinees is unknown at present.
Vaccination with VAQTA may not result in a protective response in all susceptible vaccinees.
Before administering VAQTA, please read the accompanying Prescribing Information. The Patient Information also is available.
How is VAQTA® (Hepatitis A Vaccine, Inactivated) administered?
VAQTA is administered intramuscularly. The deltoid muscle is the preferred site of intramuscular administration in adults, adolescents, and children older than 2 years of age. The anterolateral area of the thigh is the preferred site for children 12 through 23 months of age.
Can VAQTA® (Hepatitis A Vaccine, Inactivated) be given following a first dose of Havrix*?
Yes, a booster dose of VAQTA may be given at 6 to 12 months following a primary dose of Havrix*.
*Havrix is a registered trademark of GlaxoSmithKline.
What was the immune response of VAQTA® (Hepatitis A Vaccine, Inactivated) in adults when VAQTA is given as the second dose following a first dose with another brand?
A clinical study was conducted in adult patients 18 years of age and older to evaluate the immune response of VAQTA as a second dose after a first dose of Havrix* compared to Havrix for the 2-dose regimen.
*Havrix is a registered trademark of GlaxoSmithKline.
What are the ACIP recommendations for hepatitis A vaccination?
The ACIP guidance for hepatitis A vaccination:
All unvaccinated persons aged 1–18 years should receive 2 doses of hepatitis A vaccine (minimum interval: 6 months). Patients who previously received 1 dose at age 12 months or older should receive dose 2 at least 6 months after dose 1.1
All appropriate adults 19 years or older should receive a 2-dose hepatitis A vaccination series (minimum interval: 6 months).2
How is VAQTA® (Hepatitis A Vaccine, Inactivated) supplied?
For children and adolescents 12 months through 18 years of age, VAQTA is available in 0.5-mL prefilled Luer-Lok® syringes. For adults, VAQTA is available in 1-mL prefilled Luer-Lok® syringes.
Can VAQTA® (Hepatitis A Vaccine, Inactivated) be given at the same time with other vaccinations?
VAQTA can be given concomitantly with certain other vaccines to appropriate patients. For children and adolescents 12 months through 18 years of age, these include Measles, Mumps, and Rubella Virus Vaccine, Live; Varicella Vaccine, Live; Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine, Adsorbed; Measles, Mumps, Rubella, and Varicella Vaccine, Live; Pneumococcal 7-valent Conjugate Vaccine; and Haemophilus B Conjugate Vaccine.
For adults 19 years of age and older, vaccines that can be administered concomitantly include typhoid Vi polysaccharide vaccine and yellow fever vaccine.
Are there contraindications for VAQTA® (Hepatitis A Vaccine, Inactivated)?
VAQTA should not be given to individuals with a history of immediate and/or severe allergic or hypersensitivity reactions, such as anaphylaxis, following a previous dose of any hepatitis A vaccine or with an anaphylactic reaction to any component of VAQTA, including neomycin.
What is the dosing schedule for VAQTA® (Hepatitis A Vaccine, Inactivated)?
For children and adolescents 12 months of age through 18 years of age, the vaccination schedule consists of a primary 0.5-mL dose of VAQTA administered intramuscularly, followed by a 0.5-mL booster dose of VAQTA administered intramuscularly 6 to 18 months later. There is a 12-month window of opportunity to administer the second dose of VAQTA after the first dose of VAQTA.
The vaccination schedule for adults consists of a primary 1-mL dose of VAQTA that is administered intramuscularly, followed by a 1-mL booster dose of VAQTA administered intramuscularly 6 to 18 months later. There is a 12-month window of opportunity to administer the second dose of VAQTA after the first dose of VAQTA.
At what age can VAQTA® (Hepatitis A Vaccine, Inactivated) be given?
VAQTA can be given to appropriate patients starting at 12 months of age.
What is the efficacy of VAQTA® (Hepatitis A Vaccine, Inactivated)?
A landmark study was done to evaluate the efficacy of VAQTA in children 2 to 16 years of age.
View data from the Monroe Clinical Study
A clinical study in children 12 through 23 months of age was conducted to evaluate the efficacy of VAQTA against hepatitis A after each of the first and second doses.
In combined clinical studies of children and adolescents, the efficacy of VAQTA against hepatitis A was evaluated after each of the first and second doses.
In a clinical study of adults 19 years of age and older who received VAQTA, the efficacy of VAQTA against hepatitis A was evaluated after the second dose.
Does VAQTA® (Hepatitis A Vaccine, Inactivated) provide long-term protection? How long does it last?
The landmark, community-based Monroe Clinical Study was conducted to evaluate the efficacy of VAQTA against hepatitis A in children aged 2 through 16, along with a 9-year follow-up study.
View data from the Monroe Clinical Study
A clinical study of adult patients 19 years of age and older who received VAQTA was conducted to measure the antibody response against hepatitis A virus at 6 years.
The total duration of the protective effect of VAQTA in healthy vaccinees is unknown at present.
Is VAQTA® (Hepatitis A Vaccine, Inactivated) available for children and adolescents through the Vaccines For Children (VFC) Program?
Yes, VAQTA 0.5 mL in prefilled syringes is available through the Vaccines For Children (VFC) Program for children who qualify.3
Does VAQTA® (Hepatitis A Vaccine, Inactivated) require a booster?
Following a primary dose (0.5 mL in children and 1mL in adults), a second dose (0.5 mL in children and 1 mL in adults), sometimes referred to as a booster dose, should be administered 6 to 18 months following the first dose. The full regimen of vaccination is a 2-dose series and there is no official recommendation for any booster doses in addition to the 2-dose series. At present, the duration of protection is unknown.
References
- Centers for Disease Control and Prevention (CDC). Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger, United States, 2024. Published November 16, 2023. Accessed June 25, 2024. https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf
- Centers for Disease Control and Prevention (CDC). Recommended Adult immunization Schedule by ages 19 years or older, United States, 2024. Updated November 15, 2023. Accessed June 25, 2024. https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf
- Centers for Disease Control and Prevention. Vaccines for Children Program. Current CDC Vaccine Price List, United States, 2024. Updated July 1, 2024. Accessed July 29,2024. https://www.cdc.gov/vaccines-for-children/php/awardees/current-cdc-vaccine-price-list.html