Vaqta 0.5ml Im Vial (pediatric)
It is used to prevent hepatitis A infection.
Drug Class
Vaccine
Pharmacologic Class
Inactivated viral vaccine
Pregnancy Category
Not assigned by FDA, refer to specific guidance
FDA Approved
Feb 1995
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vaqta is a vaccine that helps protect children from hepatitis A, a serious liver infection caused by a virus. It works by teaching your child's body to make its own protection (antibodies) against the virus, so if they are exposed to it later, their body can fight it off. It's given as a shot in the muscle, usually in the arm or thigh.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all provided guidelines. This drug is administered via intramuscular injection.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
In the event that you miss a dose, contact your doctor to receive guidance on the appropriate course of action.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
In the event that you miss a dose, contact your doctor to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Maintain good hygiene, especially handwashing, to prevent the spread of hepatitis A, even after vaccination.
- Ensure proper food and water safety practices, particularly when traveling to areas with high hepatitis A prevalence.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not applicable for Vaqta 0.5ml (pediatric formulation). Adult dose is Vaqta 1.0ml.
Pediatric Dosing
Neonatal:
Not established (typically not administered to neonates).
Infant:
0.5 mL intramuscularly (IM) for infants 12 through 23 months of age, as a 2-dose series given 6 to 18 months apart.
Child:
0.5 mL intramuscularly (IM) for children 2 through 17 years of age, as a 2-dose series given 6 to 18 months apart.
Adolescent:
0.5 mL intramuscularly (IM) for adolescents 2 through 17 years of age, as a 2-dose series given 6 to 18 months apart.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Dialysis:
No specific dose adjustment recommended; however, immune response may be suboptimal in immunocompromised individuals, including those on dialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Pharmacology
Mechanism of Action
Vaqta is an inactivated vaccine that induces active immunity to the hepatitis A virus (HAV) by stimulating the production of anti-HAV antibodies. The vaccine contains inactivated HAV particles which, when administered, are recognized by the immune system, leading to the development of humoral and cellular immune responses without causing disease.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (vaccine, not a drug absorbed systemically for therapeutic effect).
Tmax:
Not applicable (immune response develops over weeks).
FoodEffect:
Not applicable.
Distribution:
Vd:
Not applicable.
ProteinBinding:
Not applicable.
CnssPenetration:
Not applicable.
Elimination:
HalfLife:
Not applicable (immune response duration, not drug half-life).
Clearance:
Not applicable.
ExcretionRoute:
Not applicable.
Unchanged:
Not applicable.
Pharmacodynamics
OnsetOfAction:
Protective antibody levels typically achieved within 2-4 weeks after the first dose.
PeakEffect:
Peak antibody titers usually observed 1 month after the second dose.
DurationOfAction:
Long-term immunity (likely lifelong) after completion of the 2-dose series.
Confidence:
High
Safety & Warnings
Side Effects
WHAT ARE SOME SIDE EFFECTS THAT I NEED TO CALL MY DOCTOR ABOUT RIGHT AWAY? WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.A burning, numbness, or tingling feeling that is not normal.Trouble controlling body movements.Change in eyesight.High fever.Severe dizziness or passing out can happen after or sometimes before getting a vaccine. Tell your doctor right away if you feel dizzy. WHAT ARE SOME OTHER SIDE EFFECTS OF THIS DRUG? All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:For all patients taking this drug:Headache.Feeling tired or weak.Upset stomach. Decreased appetite.Mild fever.Diarrhea.Pain, redness, swelling, or warmth where the shot was given.Young children:Feeling fussy.Feeling sleepy. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.Report side effects to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS) at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967.
Seek Immediate Medical Attention If You Experience:
- Signs of a severe allergic reaction (anaphylaxis): difficulty breathing, wheezing, hives, swelling of the face or throat, dizziness, weakness, fast heartbeat. Seek immediate medical attention (call 911 or go to the nearest emergency room).
- High fever (above 102°F or 39°C) that doesn't respond to fever reducers.
- Severe or persistent pain, redness, or swelling at the injection site.
- Unusual bruising or bleeding.
- Any other concerning or severe symptoms.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a latex allergy, consult your doctor, as some products may contain latex.
As with all vaccines, this vaccine may not provide complete protection for everyone who receives it. If you have any questions or concerns, discuss them with your doctor. Note that this vaccine will only protect against a specific type of hepatitis and will not prevent other types of hepatitis.
This vaccine contains a non-active virus, which means it cannot cause the disease itself. However, if you have a weakened immune system or are taking medications that suppress the immune system, consult your doctor, as the vaccine may not be as effective.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of the vaccine to both you and your baby.
As with all vaccines, this vaccine may not provide complete protection for everyone who receives it. If you have any questions or concerns, discuss them with your doctor. Note that this vaccine will only protect against a specific type of hepatitis and will not prevent other types of hepatitis.
This vaccine contains a non-active virus, which means it cannot cause the disease itself. However, if you have a weakened immune system or are taking medications that suppress the immune system, consult your doctor, as the vaccine may not be as effective.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of the vaccine to both you and your baby.
Overdose Information
Overdose Symptoms:
- Overdose with Vaqta is unlikely to cause specific toxic effects beyond exaggerated local or systemic reactions. No specific symptoms of overdose are known.
What to Do:
In case of suspected overdose, monitor the patient for adverse reactions and provide symptomatic and supportive care as needed. For medical emergencies, call 911 or your local emergency number. For poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Known severe allergic reaction (e.g., anaphylaxis) to a previous dose of hepatitis A vaccine or to any component of the vaccine, including neomycin.
Major Interactions
- Immunosuppressive therapies (e.g., high-dose corticosteroids, chemotherapy, radiation therapy): May reduce the immune response to the vaccine, leading to suboptimal protection. Vaccination should be deferred until immune function recovers, if possible.
Moderate Interactions
- Blood products or immunoglobulins: Administration of immunoglobulins or other blood products containing antibodies may interfere with the immune response to the vaccine. Vaccination should generally be delayed for at least 3 months after receipt of such products.
Monitoring
Baseline Monitoring
Allergy history (especially to vaccine components like neomycin)
Rationale: To identify contraindications and potential for severe allergic reactions.
Timing: Prior to vaccine administration.
Current health status (acute moderate or severe illness with or without fever)
Rationale: Vaccination should be deferred in such cases to avoid confounding adverse reactions or reduced immune response.
Timing: Prior to vaccine administration.
Routine Monitoring
Observation for immediate adverse reactions (e.g., anaphylaxis)
Frequency: For at least 15 minutes post-vaccination.
Target: Absence of severe allergic symptoms.
Action Threshold: Any signs of anaphylaxis (e.g., rash, swelling, difficulty breathing, hypotension) require immediate medical intervention.
Local injection site reactions (pain, redness, swelling)
Frequency: Patient/caregiver self-monitoring for 24-48 hours post-vaccination.
Target: Mild to moderate, self-limiting reactions.
Action Threshold: Severe or persistent reactions, or signs of infection, warrant medical evaluation.
Systemic reactions (fever, headache, malaise, fatigue)
Frequency: Patient/caregiver self-monitoring for 24-48 hours post-vaccination.
Target: Mild to moderate, self-limiting symptoms.
Action Threshold: High fever, severe or persistent symptoms, or unusual reactions warrant medical evaluation.
Symptom Monitoring
- Injection site pain, redness, swelling
- Fever
- Headache
- Malaise
- Fatigue
- Nausea
- Loss of appetite
- Irritability (in infants/young children)
- Signs of severe allergic reaction: hives, swelling of the face/throat, difficulty breathing, dizziness, weakness, fast heartbeat.
Special Patient Groups
Pregnancy
Hepatitis A vaccine is generally considered safe for use during pregnancy when indicated. The Advisory Committee on Immunization Practices (ACIP) recommends vaccination for pregnant women at increased risk for HAV infection or severe outcomes from HAV infection. As an inactivated vaccine, it poses no theoretical risk to the fetus.
Trimester-Specific Risks:
First Trimester:
No evidence of increased risk of adverse fetal outcomes.
Second Trimester:
No evidence of increased risk of adverse fetal outcomes.
Third Trimester:
No evidence of increased risk of adverse fetal outcomes.
Lactation
Hepatitis A vaccine is considered compatible with breastfeeding. It is an inactivated vaccine and is not excreted in breast milk. Vaccination of a breastfeeding mother poses no risk to the infant.
Infant Risk:
Low to none.
Pediatric Use
Vaqta 0.5ml is specifically formulated and dosed for pediatric patients aged 12 months through 17 years. It is a routine childhood immunization recommended by ACIP for all children at 1 year of age. Safety and efficacy have been well-established in this population.
Geriatric Use
While the 0.5ml formulation is pediatric, the 1.0ml adult formulation of Vaqta is used in adults, including geriatric patients, when indicated (e.g., for travel, chronic liver disease). No specific dose adjustment is needed for age alone, but immune response may be less robust in older adults.
Clinical Information
Clinical Pearls
- Vaqta 0.5ml is for pediatric use (12 months to 17 years of age). Ensure the correct formulation (0.5ml vs 1.0ml) is used based on age.
- Administer intramuscularly (IM) in the deltoid muscle for children 12 months and older. For infants 12-23 months, the anterolateral thigh may also be used.
- The vaccine should be stored refrigerated (2°C to 8°C or 36°F to 46°F) and not frozen. Freezing destroys the potency.
- A 2-dose series is required for full protection, with the second dose given 6 to 18 months after the first.
- Can be co-administered with other routine childhood vaccines, but administer at different injection sites.
- Patients with a history of severe allergic reaction to neomycin should not receive this vaccine, as neomycin is used in the manufacturing process and trace amounts may be present.
Alternative Therapies
- Havrix (Hepatitis A Vaccine, Inactivated) - another brand of inactivated hepatitis A vaccine available in the US.
Cost & Coverage
Average Cost:
$70 - $100 per 0.5ml vial
Insurance Coverage:
Typically covered under preventative care benefits (Tier 1 or 2) by most health insurance plans, often without cost-sharing, as recommended by ACIP.
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, never share your prescription medications with others, and do not take medications that have been prescribed to someone else.
All medications should be stored in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. Instead, consult with your pharmacist to determine the best disposal method, as some communities have designated drug take-back programs.
Additionally, some medications may have a separate patient information leaflet; check with your pharmacist for more information. If you have any questions or concerns about your medication, it is crucial to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the medication, including the amount taken, the time it was taken, and any other relevant details.
All medications should be stored in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. Instead, consult with your pharmacist to determine the best disposal method, as some communities have designated drug take-back programs.
Additionally, some medications may have a separate patient information leaflet; check with your pharmacist for more information. If you have any questions or concerns about your medication, it is crucial to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the medication, including the amount taken, the time it was taken, and any other relevant details.