Vaqta 0.5ml Im Pfs (pediatric)
It is used to prevent hepatitis A infection.
Drug Class
Vaccine
Pharmacologic Class
Viral vaccine; Inactivated vaccine
Pregnancy Category
Not applicable (inactivated vaccine, generally considered safe when indicated)
FDA Approved
Feb 1995
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vaqta is a vaccine that helps protect children from a serious liver infection called Hepatitis A. It works by teaching your child's body to make its own protection (antibodies) against the Hepatitis A virus, so if they ever come into contact with it, their body can fight it off. It's given as a shot, usually in the arm.
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 guidelines provided. This medication is administered via intramuscular injection.
For proper storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store this medication at home.
If you miss a dose, contact your doctor promptly to receive guidance on the next steps to take.
For proper storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store this medication at home.
If you miss a dose, contact your doctor promptly to receive guidance on the next steps to take.
Lifestyle & Tips
- Maintain good hygiene practices, especially handwashing, to prevent the spread of Hepatitis A, even after vaccination.
- Ensure proper food and water safety, particularly when traveling to areas where Hepatitis A is common.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not indicated for 0.5ml formulation; adult dose is 1.0ml
Pediatric Dosing
Neonatal:
Not established (typically not given before 12 months)
Infant:
Not established (typically not given before 12 months)
Child:
0.5 mL IM (deltoid muscle) for individuals 12 months through 18 years of age. Administer as a 2-dose series: first dose at elected date, second dose 6 to 18 months after the first dose.
Adolescent:
0.5 mL IM (deltoid muscle) for individuals 12 months through 18 years of age. Administer as a 2-dose series: first dose at elected date, second dose 6 to 18 months after the first dose.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific adjustment needed; however, immune response may be blunted in immunocompromised individuals.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Vaqta is an inactivated vaccine that induces active immunity against Hepatitis A virus (HAV). It contains purified, inactivated HAV antigen, which, upon administration, stimulates the recipient's immune system to produce anti-HAV antibodies. These antibodies provide protection against subsequent HAV infection.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (vaccine, not a drug absorbed into systemic circulation in the traditional sense)
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 (refers to antigen clearance, not drug elimination)
Clearance:
Not applicable
ExcretionRoute:
Not applicable
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Antibody seroconversion typically occurs within 2-4 weeks after the first dose.
PeakEffect:
Peak antibody titers are generally observed 1 month after the second dose.
DurationOfAction:
Long-term protection (likely lifelong) after completion of the 2-dose series.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek medical attention:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Abnormal sensations, such as burning, numbness, or tingling
Difficulty controlling body movements
Changes in eyesight
High fever
Severe dizziness or fainting, which can occur before or after receiving a vaccine; if you feel dizzy, inform your doctor promptly
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor:
Common side effects for all patients taking this medication:
+ Headache
+ Fatigue or weakness
+ Upset stomach
+ Decreased appetite
+ Mild fever
+ Diarrhea
+ Pain, redness, swelling, or warmth at the injection site
Additional side effects in young children:
+ Irritability
+ Drowsiness
This is not an exhaustive list of potential side effects. If you have questions or concerns, consult your doctor. For medical advice about side effects, contact your doctor. You can also 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.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek medical attention:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Abnormal sensations, such as burning, numbness, or tingling
Difficulty controlling body movements
Changes in eyesight
High fever
Severe dizziness or fainting, which can occur before or after receiving a vaccine; if you feel dizzy, inform your doctor promptly
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor:
Common side effects for all patients taking this medication:
+ Headache
+ Fatigue or weakness
+ Upset stomach
+ Decreased appetite
+ Mild fever
+ Diarrhea
+ Pain, redness, swelling, or warmth at the injection site
Additional side effects in young children:
+ Irritability
+ Drowsiness
This is not an exhaustive list of potential side effects. If you have questions or concerns, consult your doctor. For medical advice about side effects, contact your doctor. You can also 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) such as hives, swelling of the face or throat, difficulty breathing, wheezing, dizziness, or a fast heartbeat. Seek immediate medical attention if these occur.
- High fever, persistent vomiting, or unusual weakness that lasts more than a day or two after the shot.
- Severe pain, redness, or swelling at the injection site that worsens or does not improve.
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to:
Discuss all your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Avoid starting, stopping, or changing the dosage of any medication without first consulting your doctor. This precaution will help prevent potential interactions and adverse effects.
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to:
Discuss all your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Avoid starting, stopping, or changing the dosage of any medication without first consulting your doctor. This precaution will help prevent potential interactions and adverse effects.
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 not protect you against 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 breastfeeding, inform your doctor. You 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 not protect you against 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 breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of the vaccine to both you and your baby.
Overdose Information
Overdose Symptoms:
- Overdose with a vaccine is not typically associated with specific toxic symptoms beyond exaggerated local or systemic reactions. However, administering more than the recommended dose is not advised.
What to Do:
Contact a healthcare provider or poison control center (1-800-222-1222) for advice. Management would be supportive care for any adverse reactions.
Drug Interactions
Contraindicated Interactions
- Known severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or to a previous dose of any Hepatitis A vaccine.
Major Interactions
- Immunosuppressive therapies (e.g., corticosteroids, chemotherapy, radiation therapy): May diminish the immune response to the vaccine, leading to suboptimal protection. Vaccination should be deferred if possible, or antibody response should be assessed.
Moderate Interactions
- Other inactivated vaccines: Can generally be co-administered at separate injection sites.
- Live vaccines: Can generally be co-administered at separate injection sites or at any interval.
Monitoring
Baseline Monitoring
Allergy history (especially to vaccine components like neomycin, aluminum)
Rationale: To identify contraindications or precautions.
Timing: Prior to vaccination
Current health status (acute febrile illness)
Rationale: Vaccination should be deferred in individuals with moderate or severe acute illness.
Timing: Prior to vaccination
Routine Monitoring
Observation for immediate adverse reactions (e.g., anaphylaxis)
Frequency: For at least 15 minutes post-vaccination
Target: Absence of severe reactions
Action Threshold: Any signs of anaphylaxis (e.g., rash, swelling, difficulty breathing) require immediate medical intervention.
Local injection site reactions (pain, redness, swelling)
Frequency: Daily for a few days post-vaccination (patient self-monitoring)
Target: Mild to moderate, self-limiting
Action Threshold: Severe or persistent reactions, or signs of infection, warrant medical evaluation.
Symptom Monitoring
- Injection site pain, redness, swelling, tenderness
- Fever (low-grade)
- Headache
- Fatigue
- Nausea
- Loss of appetite
- Malaise
- Rash (rare)
- Allergic reactions (hives, swelling of face/throat, difficulty breathing, dizziness, weakness)
Special Patient Groups
Pregnancy
Hepatitis A vaccine is an inactivated vaccine and is generally considered safe for use during pregnancy when indicated (e.g., for pregnant individuals at increased risk of HAV infection or severe disease). Data from post-marketing surveillance and studies have not indicated adverse fetal effects.
Trimester-Specific Risks:
First Trimester:
No specific risks identified; vaccination can be considered if indicated.
Second Trimester:
No specific risks identified; vaccination can be considered if indicated.
Third Trimester:
No specific risks identified; vaccination can be considered if indicated.
Lactation
Hepatitis A vaccine is compatible with breastfeeding. It is an inactivated vaccine and poses no known risk to the breastfed infant or to milk production.
Infant Risk:
Low (L1 - compatible)
Pediatric Use
Vaqta 0.5ml is specifically formulated and indicated for pediatric use in individuals 12 months through 18 years of age. It is a critical vaccine for preventing Hepatitis A infection in this age group, especially for those traveling to endemic areas or with underlying liver conditions.
Geriatric Use
The 0.5ml formulation is not indicated for geriatric patients. The 1.0ml formulation of Vaqta is indicated for individuals 19 years of age and older.
Clinical Information
Clinical Pearls
- Vaqta 0.5ml is specifically for pediatric patients (12 months to 18 years); ensure correct formulation is used.
- The 2-dose series is crucial for long-term protection; emphasize the importance of completing the series.
- Can be co-administered with other routine childhood vaccines at separate injection sites.
- While generally safe, always screen for severe allergies to vaccine components (e.g., neomycin, aluminum) and defer vaccination in cases of moderate to severe acute illness.
- Immunocompromised children may have a diminished immune response; consider serologic testing post-vaccination if immune status is a concern, though not routinely recommended.
Alternative Therapies
- Havrix (another inactivated Hepatitis A vaccine)
- Afluria Quadrivalent (Influenza vaccine, not a direct alternative but another common pediatric vaccine)
Cost & Coverage
Average Cost:
$50 - $100 per 0.5ml single-dose prefilled syringe
Insurance Coverage:
Most private insurance plans and public health programs (e.g., Vaccines for Children program) cover Hepatitis A vaccine as a preventative measure.
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 guidance. To ensure your safety and the safety of others, never share your medication with anyone, and do not take medication prescribed to someone else.
Store all medications 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 drug take-back programs in place.
Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance.
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 overdose, including the name of the medication, the amount taken, and the time it was taken, to ensure you receive appropriate care.
Store all medications 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 drug take-back programs in place.
Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance.
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 overdose, including the name of the medication, the amount taken, and the time it was taken, to ensure you receive appropriate care.