Pharmaceutical Name

Trade (marketing or proprietary) name: VAQTA®, HAVRIX

Generic (nonproprietary or active ingredient) name: Hepatitis A Vaccine, Inactivated

Indication and Usage

Reason the product has been approved for sale on the market.

The FDA approved this vaccine for the prevention of disease caused by hepatitis A virus (HAV) in persons 12 months of age and older.

Manufacturer Insert

Ingredients

Also known as “excipients” for vaccines.

VAQTA is an inactivated whole virus vaccine derived from hepatitis A virus grown in cell culture in human MRC-5 diploid fibroblasts. Each 0.5-mL pediatric dose contains 25U of hepatitis A virus antigen and adsorbed onto approximately 0.225 mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate, and 35 mcg of sodium borate as a pH stabilizer, in 0.9% sodium chloride. Each 1-mL adult dose contains 50U of hepatitis A virus antigen and adsorbed onto approximately 0.45 mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate, and 70 mcg of sodium borate as a pH stabilizer, in 0.9% sodium chloride.

HAVRIX is a sterile suspension of inactivated virus for intramuscular administration. The virus (strain HM175) is propagated in MRC-5 human diploid cells. After removal of the cell culture medium, the cells are lysed to form a suspension. Each 1-mL adult dose of vaccine contains 1440 EL.U. of viral antigen, adsorbed on 0.5 mg of aluminum as aluminum hydroxide. Each 0.5-mL pediatric dose of vaccine contains 720 EL.U. of viral antigen, adsorbed onto 0.25 mg of aluminum as aluminum hydroxide. HAVRIX contains the following excipients: Amino acid supplement (0.3% w/v) in a phosphate-buffered saline solution and polysorbate 20 (0.05 mg/mL). From the manufacturing process, HAVRIX also contains residual MRC-5 cellular proteins (not more than 5 mcg/mL), formalin (not more than 0.1 mg/mL), and neomycin sulfate (not more than 40 ng/mL), an aminoglycoside antibiotic included in the cell growth media.

Contraindications

Per the FDA, contraindications are conditions in a recipient that increases the risk for a serious adverse reaction. Product should not be administered when a patient has a listed contraindication.

VAQTA®: Do not administer VAQTA to individuals with a history of immediate and/or severe allergic or hypersensitivity reactions (e.g., 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.

HAVRIX: Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis A-containing vaccine, or to any component of HAVRIX, including neomycin, is a contraindication to administration of HAVRIX.

Warnings and Precautions

Per the FDA, warnings are clinically significant adverse reactions or risks. According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.

VAQTA®

Prevention and Management of Allergic Vaccine Reactions: Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

Hypersensitivity to Latex: 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.

Altered Immunocompetence: 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.

Limitations of Vaccine Effectiveness: 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. Vaccination with VAQTA may not result in a protective response in all susceptible vaccinees.

Immunosuppressive Therapy: If VAQTA is administered to a person receiving immunosuppressive therapy, an adequate immunologic response may not be obtained.

HAVRIX

Syncope: Syncope (fainting) can occur in association with administration of injectable vaccines, including HAVRIX. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

Preventing and Managing Allergic Vaccine Reactions: Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

Altered Immunocompetence: Immunocompromised persons may have a diminished immune response to HAVRIX, including individuals receiving immunosuppressant therapy.

Limitations of Vaccine Effectiveness: Hepatitis A virus has a relatively long incubation period (15 to 50 days). HAVRIX may not prevent hepatitis A infection in individuals who have an unrecognized hepatitis A infection at the time of vaccination. Additionally, vaccination with HAVRIX may not protect all individuals.

Immunosuppressive Therapies: Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater-than-physiologic doses), may reduce the immune response to HAVRIX.

Manufacturer-Listed Adverse Reactions

Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.

VAQTA® can cause: Thrombocytopenia, Guillain-Barré syndrome, Cerebellar ataxia, Encephalitis, Diarrhea, and Gastroenteritis

HAVRIX can cause: Rhinitis, Thrombocytopenia, Anaphylactic reaction, Anaphylactoid reaction, Serum sickness–like syndrome, Convulsion, Dizziness, Encephalopathy, Guillain-Barré syndrome, Hypoesthesia, Multiple sclerosis, Myelitis, Paresthesia, Somnolence, Syncope, Vasculitis, Dyspnea, Hepatitis, Jaundice, Angioedema, Erythema multiforme, Hyperhidrosis, Congenital anomaly, Musculoskeletal stiffness, Chills, Influenza-like symptoms, Neuropathy, Injection site reaction, and Local swelling.

Specific Populations

Pregnancy

There are no adequate and well-controlled studies designed to evaluate VAQTA/HAVRIX in pregnant women.

Breastfeeding

It is not known whether VAQTA/HAVRIX is excreted in human milk. Data are not available to assess the effects of VAQTA/HAVRIX on the breastfed infant or on milk production/excretion.

Fertility

VAQTA/HAVRIX has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.

Pediatric

Safety and effectiveness in infants below 12 months of age have not been established.

Mechanism of Action

This is the specific biochemical interaction through which a drug or vaccine substance produces its pharmacological effect. This section also includes the minimum protective level designated for a certain disease.

VAQTA®

VAQTA has been shown to elicit antibodies to hepatitis A as measured by ELISA. Protection from hepatitis A disease has been shown to be related to the presence of antibody. However, the lowest titer needed to confer protection has not been determined.

HAVRIX

The hepatitis A virus belongs to the picornavirus family. It is 1 of several hepatitis viruses that cause systemic disease with pathology in the liver. The incubation period for hepatitis A averages 28 days (range: 15 to 50 days).1 The course of hepatitis A infection is extremely variable, ranging from asymptomatic infection to icteric hepatitis and death. The presence of antibodies to HAV confers protection against hepatitis A infection. However, the lowest titer needed to confer protection has not been determined.

Analytical Deep Dive

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