Havrix Vaccine is given to protect against Hepatitis A. Hepatitis A is a serious disease which is caused by the Virus. This disease can cause Cirrhosis and liver cancer.
Hepatitis A has spread the contact with the stool of a person infected with the hepatitis A virus. If you are eating food or drinking water by the infected person, there is a chance you also infected by Hepatitis A.
So this vaccine is given to the 12 months old children or more than that.
After the vaccine, it releases small amounts of viruses and making the body more resistant to the disease.
Like any other vaccines, this vaccine also not provide protection to everybody.
- 1 Havrix Vaccine Dosage
- 2 Presentation of the Vaccine
- 3 Follow The Guideline before taking the vaccine
- 4 Havrix Vaccine given process
- 5 Havrix Interactions
- 6 Side Effects Of Havrix Vaccine
- 7 Importance of Havrix Vaccine
- 8 Havrix Vaccine Clinical trial experience
- 9 Co-administration study of Havrix Vaccine Between 11 to 25 months old Children
- 10 Record The adverse Reactions after the Vaccinations
- 11 Solicited Local adverse reaction and General Adverse reaction 4 days of Vaccination
- 12 Experience of Post Marketing
- 13 Vaccine use in Specific Population
- 14 Clinical Pharmacology of Havrix Vaccine
- 15 Nonclinical Toxicology
- 16 Havrix Handling, Storage and Supplied
- 17 Counseling information on Patient
Havrix Vaccine Dosage
Like other vaccines shake well before use it. This Vaccine is a turbid, Homogenous and white suspension.
This vaccine must be given intramuscularly. Use separate sterilization needles and syringes for each person.
Do not give this vaccine subcutaneously, Intradermatly or Intravenously.
Those people age is between 12 months to 18 years old. A 0.5 ml single dose is given to them. 0.5 ml booster dose administered anytime after 6 to 12 months.
Those people age is more than 19 (adults) 1ml dose given to them. 1 ml booster dose administered anytime (6-12 months) after the first dose.
Read– Rotateq Vaccine
Presentation of the Vaccine
0.5 ml single-dose vials and prefilled Tip-lok syringes.
1 ml single-dose vials and prefilled Tip-lok syringes.
Follow The Guideline before taking the vaccine
If anyone already affects by the virus then this vaccine does not work at all.
If you have any allergic reaction then you should not receive this vaccine.
Call your healthcare provider if you have
1〉 Allergic reactions to natural rubber latex.
2〉 Weak immune system by any medicine.
If you have a minor cold you still receive this vaccine. In case you have a serious kind of fever or any type of serious infection just wait until you are well.
The vaccine is not good for unborn children or pregnant women. Not vaccinating to the mother could be more harmful for the baby. So you can consult with your doctor if you are infected by Hepatitis. Follow the doctor’s instructions.
FDA does not approve the Havrix vaccine to use younger than 12 months old children.
Read– Vaccine Definition
Havrix Vaccine given process
This vaccine is given as an injection intramuscularly. You must receive this injection in the Hospital or Doctor Clinic.
Depending on your situation to the risk you will receive 2 separate injections of Havrix over a period of 6 to 12 months.
You must take the Havrix vaccine at least 2 weeks before your trip to prevent Hepatitis while traveling.
Before receiving the Havrix Vaccine tell your doctor if you receive any drug that weakens your immune system.
Medicine that helps to prevent organ transplant rejection.
Injectable steroid medicine.
Any kind of medication to treat Rheumatoid arthritis, psoriasis, Cancer.
Twinrix(Hepatitis A and B adult vaccine).
Vaqta (Hepatitis A adult Vaccine).
If you receive any of these medicines you can not take the Havrix vaccine until the previous treatment is finished.
Side Effects Of Havrix Vaccine
After receiving Havrix you should track you or your child. After receiving the first dose if you notice any allergic reaction. You should not receive the Booster dose of Havrix.
You must consult with your doctor if you have
Swelling, Warmth, Tenderness
Loss of Appetite
Weakness or tiredness
Swollen glands in the neck
Swelling inside the nose
Some very rare side effects
Muscle pain or Joint pain.
Stomach pain or abdominal pain.
Dark color urine
Difficulty in moves legs and arm
Symptoms like Flu
Faster Heart Beat.
Swollen Lymph Glands
Vomiting of Blood
Yellow color skin or eye.
Havrix adult vaccines can cause some side effects that usually do not require any medical care.
Swelling, Redness, Pain
Warmth at the injection area.
Bleeding amount changes during periods.
Monthly Period pattern changes.
Rare Side Effects are
Difficulty in Sleeping.
Muscle Tightness or Tension.
Excessive Muscle tone.
Changes in color Vision.
Collection of Blood under the Skin.
Importance of Havrix Vaccine
Remember this you should not receive Havrix Vaccine. If you have life-threating allergies to the neomycin.
Havrix is always recommended to the adults if you are traveling around the world where Hepatitis A is a common disease.
Some other risk factors include Hepatitis are, chronic liver disease, use an intravenous drug. If you are receiving treatment for any bleeding disorders. If you are always around animals especially monkey then there is a chance to infect by Hepatitis A.
Havrix Vaccine Clinical trial experience
The vaccine safety evaluates by the 64 clinical trials. It involves approximately 37,000 individuals receiving a dose of 360 EL.U (n=21, 928 in 3 or 4 dose schedule),720 EL. u (n=12,274 in 2 or 3 dose schedule) or 1440 EL.U (n=2,782 in 2 or 3 dose schedule).
After the clinical trials most frequent reports are Injection site soreness( according to 56% adults and 21%).
14% of adults report a headache and only 9% of children report a headache.
During the clinical trials, some other solicited and unsolicited reactions are
Psychiatric Disorders– Insomnia
Nervous system Disorders– Hypertonia, Dysgeusia.
Gastrointestinal Disorders -Vomiting, Abdominal pain, Diarrhea, Nausea.
Blood & Lymphatic system Disorder– Lymphadenopathy
General Disorder– Swelling of the injection site, Fatigue, Fever, Malaise
Metabolism Disorder– Anorexia.
Skin and Subcutaneous Tissue Disorders– Rash, Urticaria, Pruritus.
Musculoskeletal and Connective Tissue disorder– Myalgia, Arthralgia.
Co-administration study of Havrix Vaccine Between 11 to 25 months old Children
For this study, almost 3,152 children (age between 11 to 25) receive a one dose of Havrix Vaccine.
In the studies, Hav 23 conducted in the U.S in 1,241 children age between 15 months were randomized to receive group 1 Havrix alone Group 2. Havrix concomitantly with mumps, measles, and rubella vaccine and Varicella vaccine. Group 3 who receive MMR and Varicella vaccines receive the first dose of Havrix 42 days later. A second dose of Havrix administrates 6 to 9 months after the first dose of Havrix vaccine.
Record The adverse Reactions after the Vaccinations
After vaccination Solicited adverse reaction recorded by the parents/Guardians on Dairy cards for 4 days. Unsolicited adverse events record the next 31 days on a dairy card after vaccination. Telephone follow-up also conducted the next 6 months after the last vaccination. 6 months followup done on a total of 1,035 children. It contains 53% are male, 69% subject is white, 16% are Hispanic. 9% were black and 6% are racial or Ethnic groups.
Solicited Local adverse reaction and General Adverse reaction 4 days of Vaccination
|Group 1(Havrix) Dose 1||Group 2
Havrix MMR TV Dose 1%
|Group 1 Havrix Dose 2%||Group 2 Havrix Dose 2 %|
|Local Injection site||298||411||272||373|
|Irritability Grade 3||0||2||2||0|
|Drowsiness Grade 3||1||2||1||0|
|Loss of Appetite||18||26||20||21|
|Loss of Appetite grades||1||1||0||0|
|Fever>100 degrees 6 degree F||3||5||3||3|
|Fever>101.5 Degree F||2||3||2||2|
|Fever> 102.4 Degree F||1||1||0||1|
Serious adverse events reported in children between 11 to 25 months of age. According to the 4 studies, only 0.9% of the subject report serious adverse events 31 days period Following vaccination of Havrix. Those are receiving Havrix concomitantly with other childhood vaccines. 0.9% reported serious adverse events.
Experience of Post Marketing
According to the clinical trials report. The global entry of this vaccine as a global voluntary report for Havrix has been listed below.
Hepatobiliary Disorders– Jaundice and Hepatitis.
Vascular Disorders– Vasculitis
Congenital, Familial and connective tissue disorder– Musculo Skeletal Stiffness.
General Disorders and administration site condition– Chills, Influenza-like symptoms, Local swelling, Injection site reaction.
Infections and infestations– Rhinitis
Immune system Disorder– Serum Sickness, Anaphylactic reaction, and Anaphylactoid reaction.
Blood and Lymphatic system disorder– Thrombocytopenia.
Nervous System Disorder– Neuropathy, Syncope, Convulsion, Dizziness, Encephalopathy, Hypoesthesia.
Vaccine use in Specific Population
This is for pregnancy-c category
Actually it is also not clear whether Havrix can cause fetal damage or affect fertility if administered to a pregnant woman. Given this vaccine, if pregnant women really need this.
Havrix Vaccine efficacy and evaluated in 20,869 subjects, age between 1 year to 18 years.
This vaccine is not less than 12 months of age.
Chronic liver disease subjects had a lower antibody response to Havrix than healthy subjects.
Havrix efficacy and safety to the 65 years of age or older is not clear. The clinical experience did not identify a difference in overall between these subject and Young adults subjects
Clinical Pharmacology of Havrix Vaccine
Normally Hepatitis A virus belongs to the picornavirus family. It is one of the several Hepatitis viruses that can cause systemic disease through the liver.
Hepatitis A incubation period is 28 days. The course of infection in Hepatitis A is highly variable ranging from Asymptomatic infection to icteric hepatitis and death.
The presence of antibodies in HAV protects against Hepatitis A infection. However, the minimum number of Titer has not been determined to provide protection.
Mutagenesis, impairment of fertility and Carcinogenesis.
This vaccine is not evaluated for mutagenic potential, Carcinogenic potential, and Potential for impairment of Fertility.
Read– Boostrix Vaccine
Havrix Handling, Storage and Supplied
This vaccine is available in a single-dose vial and prefilled Tip-lok syringes. It contains latex and Preservative free formulation.
720 EL.U/0.5 ml
NDC 58160-825-41 syringe tip cap and plunger contain latex in a package of 5:NDC 58160-825-46.
NDC 58160-825-41 syringe tip cap and plunger contain latex in a package of 10:NDC 58160-825-51
NDC 58160-825-01 Vial contains no latex in a package of 10:NDC 58160-825-11.
NDC 58160-825-43 syringe tip cap may contain latex in a package of 10:Ndc 58160-825-52.
NDC 58160-826-43 Syringe tip cap may contain latex in a package of 10:NDC 58160-826-52.
NDC 58160-826-43 syringe tip cap contain latex in a package of 5: NDC 58160-826-48.
NDC 58160-826-41 syringe tip cap and plunger contain latex in a package of 5:NDC 58160-826-46.
NDC 58160-826-31 syringe tip cap and plunger contain latex in a package of 1:NDC 58160-826-32.
NDC 58160-826-01 vial contains no latex in a package of 10:NDC 58160-826-11.
You should store this vaccine between 2 to 8-degree c. Do not store this vaccine in the freezer section.
Read– Newborn Vaccines
Counseling information on Patient
Notify Havrix vaccine recipients and parents or Guardians of Potential Benefits and risks of vaccination with Havrix.
Always educating vaccine recipients and parents or guardians about possible side effects. Tell that Havrix has a non-infectious Killed virus and can not transmit Hepatitis A.
Always instruct vaccine receptors or parents or Guardians. If they notice any kind of adverse event, they must consult with their healthcare provider.
Give vaccine information statements to the parents or Guardians or vaccine recipients. Because it required by the national childhood vaccine injury act of 1986.
Read– AFM Vaccine
Read– PPSV23 Vaccine