Storage and Handling for VAQTA® (Hepatitis A Vaccine, Inactivated)
Condition on Arrival
- Should not be frozen; refrigerate on arrival.
- Store vaccine at 2°C to 8°C (36°F to 46°F); DO NOT FREEZE since freezing destroys potency.
VAQTA is available in single-dose vials and prefilled Luer-Lok® syringes.
25 U/0.5 mL in single-dose vials and prefilled Luer-Lok® syringes
- Box of ten 0.5-mL single-dose vials, NDC 0006-4831-41
- Carton of ten 0.5-mL prefilled single-dose Luer- Lok® syringes with tip caps, NDC 0006-4095-02
50 U/1.0 mL in single-dose vials and prefilled Luer-Lok® syringes
- 1-mL single-dose vial, NDC 0006-4841-00
- Box of ten 1-mL single-dose vials, NDC 0006-4841-41
- 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.
- 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
- VFC providers should separate and identify VFC and other vaccines purchased with public funds within the storage unit. In addition, clearly label the space where the vaccine is placed to help staff choose the appropriate vaccine.1
- It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of infectious agents from one person to another.
- 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.
VFC=Vaccines for Children.
Indication for VAQTA
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.
Dosage and Administration for VAQTA
Children/Adolescents (12 months through 18 years of age): The vaccination schedule consists of a primary 0.5 mL dose administered intramuscularly and a 0.5 mL booster dose administered intramuscularly 6 to 18 months later.
Adults (19 years of age and older): The vaccination schedule consists of a primary 1.0 mL dose administered intramuscularly and a 1.0 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 GlaxoSmithKline.
Do not administer VAQTA® (Hepatitis A Vaccine, Inactivated) 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%).
- Adults 19 years of age and older: injection-site pain, tenderness, or soreness (67.0%), injection site warmth (18.2%), and headache (16.1%).
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.
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.
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.
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.
Before administering VAQTA, please read the Prescribing Information.