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Adult storage and handling for VAQTA® (Hepatitis A Vaccine, Inactivated)

Condition on arrival

Should not be frozen. Refrigerate on arrival.1

Storage

Store vaccine at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE since freezing destroys potency.

Not shown actual size

NDC 0006-4096-02

How supplied

VAQTA is available in prefilled Luer-Lok® syringes.

Adult formulations

Prefilled Luer-Lok® syringes

  • Carton of ten 1-mL prefilled single-dose Luer-Lok® syringes with tip caps, NDC 0006-4096-02

Brands mentioned are the trademarks of their respective owners.

General tips

  • If you have questions about the condition of the vaccine at the time of delivery, you should immediately place vaccine in recommended storage and call the Merck Vaccine Customer Center at 877.VAX.MERCK (877.829.6372).
  • Rotate stock so that doses with the earliest expiration dates are used first.1
  • Ensure that the refrigerator is plugged into an outlet in a protected area where it cannot be disconnected accidentally.1
  • A separate needle and syringe should be used for each injection. Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated.2,3
  • For general questions concerning the proper storage and handling of Merck vaccines, please contact the Merck Vaccine Customer Helpline at 800.MERCK.90 (800.637.2590), Monday through Friday, 8:00 AM to 7:00 PM ET.

References

  1. Centers for Disease Control and Prevention (CDC). Vaccine Storage and Handling Toolkit. Last reviewed March 29, 2024. Accessed January 15, 2026. https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf
  2. Centers for Disease Control and Prevention (CDC). Vaccine Administration. United States, Last updated June 18, 2024. Accessed January, 2026. https://www.cdc.gov/vaccines/hcp/imz-best-practices/vaccine-administration.html
  3. Centers for Disease Control and Prevention. Vaccination programs. CDC Vaccines & Immunizations. Updated July 17, 2024. Accessed January 15, 2026. https://www.cdc.gov/vaccines/hcp/imz-best-practices/vaccination-programs.html#

Indications and Usage

VAQTA® (Hepatitis A Vaccine, Inactivated) is indicated for the prevention of disease caused by hepatitis A virus (HAV) in persons 12 months of age and older. The primary dose should be given at least 2 weeks prior to expected exposure to HAV.

Select Safety Information

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 contains 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:

  • Adults 19 years of age and older: injection-site pain, tenderness, or soreness (67.0%), injection site warmth (18.2%), and headache (16.1%).

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.

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.

Vaccination with VAQTA may not result in a protective response in all susceptible vaccinees.

VAQTA may be administered concomitantly with Immune Globulin, human, using separate sites and syringes.

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.

The total duration of the protective effect of VAQTA in healthy vaccinees is unknown at present.

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.

 

Dosage and Administration 

Adults (19 years of age and older): The vaccination schedule consists of a primary 1 mL dose administered intramuscularly and a 1 mL booster dose administered intramuscularly 6 to 18 months later.

Booster Immunization Following Another Manufacturer’s Hepatitis A Vaccine: 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 GSK.

Before administering VAQTA, please read the accompanying Prescribing Information. The Patient Information also is available.

Indications and Usage
Select Safety Information

VAQTA® (Hepatitis A Vaccine, Inactivated) is indicated for the prevention of disease caused by hepatitis A virus (HAV) in persons 12 months of age and older. The primary dose should be given at least 2 weeks prior to expected exposure to HAV.

Select Safety Information

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 contains 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:

  • Adults 19 years of age and older: injection-site pain, tenderness, or soreness (67.0%), injection site warmth (18.2%), and headache (16.1%).

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.

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.

Vaccination with VAQTA may not result in a protective response in all susceptible vaccinees.

VAQTA may be administered concomitantly with Immune Globulin, human, using separate sites and syringes.

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.

The total duration of the protective effect of VAQTA in healthy vaccinees is unknown at present.

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.

 

Dosage and Administration 

Adults (19 years of age and older): The vaccination schedule consists of a primary 1 mL dose administered intramuscularly and a 1 mL booster dose administered intramuscularly 6 to 18 months later.

Booster Immunization Following Another Manufacturer’s Hepatitis A Vaccine: 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 GSK.

Before administering VAQTA, please read the accompanying Prescribing Information. The Patient Information also is available.