Indication

VAQTA 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 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%).
  • 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® (Hepatitis A Vaccine, Inactivated) and may not be protected against HAV infection after vaccination.

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.

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.

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.

Before administering VAQTA® (Hepatitis A Vaccine, Inactivated), please read the Prescribing Information.

Merck Vaccine Pharmacy Savings Plan

VAQTA has been added to the MERCK VACCINE PHARMACY SAVINGS PLAN (the "Plan")

To help meet the needs of your growing vaccination business, retail pharmacies in the United States can now enroll in the Merck Vaccine Pharmacy Savings Plan. Once enrolled, your pharmacy can earn on-invoice discounts for VAQTA and other products.

In order to be eligible, send a request to Pharmacysavings@merck.com to receive the enrollment materials. Your enrollment in the Plan will begin on or before the first day of the last month in the calendar quarter in which your enrollment form was submitted and approved by Merck.

If you have any questions about the Merck Vaccine Pharmacy Savings Plan or would like to obtain an updated authorized wholesalers and physician distributors list, please contact the Merck Vaccine Customer Center at 877-VAX-MERCK (877.829.6372).

Indication

VAQTA 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 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%).
  • 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® (Hepatitis A Vaccine, Inactivated) and may not be protected against HAV infection after vaccination.

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.

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.

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.

Before administering VAQTA® (Hepatitis A Vaccine, Inactivated), please read the Prescribing Information.

VACC-1159573-0005 02/17