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Ingredients In Hepatitis B Vaccine

How Common Is Hepatitis B

Hepatitis B Vaccine for Babies – Importance and Recommended Schedule

One U.S. study following trends in hepatitis B infection over a three-year periodfound that 4.3% of the population had a past or present HBV infection.

Estimates suggest that about 240 million people around the world have chronic hepatitis B. Up to 1.89 million people in the United States have a chronic HBV infection.

Information For The Patient:

Patients, parents, or guardians should be informed of the potential benefits and risks of the vaccine, and of the importance of completing the immunization series. As with any vaccine, it is important when a subject returns for the next dose in a series that he or she be questioned concerning occurrence of any symptoms and/or signs of an adverse reaction after a previous dose of the same vaccine. Patients, parents, or guardians should be told to report severe or unusual adverse reactions to their healthcare provider.

The parent or guardian should be given the Vaccine Information Materials, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization.

What Is A Hepatitis B Vaccine

A hepatitis B vaccine prevents hepatitis B virus infection . Engerix-B, Heplisav-B, and Recombivax HB are examples of hepatitis B vaccines approved by the U.S. Food and Drug Administration . Engerix-B and Recombivax HB are both approved for use in people of all ages. Heplisav-B is approved for use in adults 18 years of age and older.HBV can be an opportunistic infection of HIV. An OI is an infection that occurs more frequently or is more severe in people with weakened immune systemssuch as people with HIVthan in people with healthy immune systems. To learn more about OIs, read the HIVinfo What is an Opportunistic Infection? fact sheet. To learn how HIV and HBV infection are connected, read the HIVinfo HIV and Hepatitis B fact sheet.

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Hepatitis B Vaccine Schedules For Infants By Maternal Hbsag Status

Hepatitis B vaccine schedules for infants

Maternal HBsAg Status
4 6 mos¶

* Mothers should have blood drawn and tested for HBsAg as soon as possible after admission for delivery if the mother is found to be HBsAg positive, the infant should receive HBIG as soon as possible but no later than age 7 days. Pediarix and Vaxelis should not be administered before age 6 weeks.§ HBIG should be administered at a separate anatomical site from vaccine.¶ The final dose in the vaccine series should not be administered before age 24 weeks .

Origin Of Antiviral Resistance

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The genetic makeup of viruses is constantly changing, which can cause a virus to become resistant to currently available treatments. Viruses can become resistant through spontaneous or intermittent mechanisms throughout the course of an antiviral treatment. Immunocompromised patients, more often than immunocompetent patients, hospitalized with are at the highest risk of developing oseltamivir resistance during treatment. Subsequent to exposure to someone else with the flu, those who received oseltamivir for “post-exposure prophylaxis” are also at higher risk of resistance.

Multiple strains of one virus can be present in the body at one time, and some of these strains may contain mutations that cause antiviral resistance. This effect, called the , results in immense variation in any given sample of virus, and gives the opportunity for natural selection to favor viral strains with the highest fitness every time the virus is spread to a new host. Also, recombination, the joining of two different viral variants, and , the swapping of viral gene segments among viruses in the same cell, play a role in resistance, especially in influenza.

Antiviral resistance has been reported in antivirals for herpes, HIV, hepatitis B and C, and influenza, but antiviral resistance is a possibility for all viruses. Mechanisms of antiviral resistance vary between virus types.

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What Is A Recombinant Vaccine

Recombinant vaccines contains non-infectious parts of the virus, rather than a live virus or an attenuated virus.

Recombivax contains synthetic Hepatitis B surface antigen produced in yeast cells. A plasmid containing the DNA of a Hepatitis B virus that codes for HBsAg is cloned into yeast cells. Recombivax HB is made from cell cultures of this recombinant yeast strain.

A Look At Each Vaccine: Hepatitis B Vaccine

View larger image The hepatitis B vaccine is given to prevent the severe liver disease that can develop when children or adults are infected with hepatitis B virus. The hepatitis B vaccine is given as a series of three shots. The first dose is given within 24 hours of birth. The second dose is given one to two months after the first dose, and the third dose is given between 6 months and 18 months of age. The vaccine is also recommended for those up to 60 years of age who have not previously received it and those 60 years and older who are at increased risk or who simply want the protection afforded by vaccination.

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How Do You Catch Hepatitis B Virus

Blood from a person infected with hepatitis B virus is heavily contaminated with the virus. As a result, contact with blood is the most likely way to catch hepatitis B. Even casual contact with the blood of someone who is infected can cause infection.

Healthcare workers are at high risk of catching the disease, as are intravenous drug users and newborns of mothers infected with the virus. Sexual contact can also expose people to infection. The virus is also present in low levels in saliva.

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According to the CDC, the hepatitis B vaccine is recognized as the first anti-cancer vaccine because it can prevent primary liver cancer.3

A clear link has been demonstrated between chronic hepatitis B infection and the occurrence of hepatocellular carcinoma. In a Taiwanese study, the institution of universal childhood immunization against hepatitis B virus has been shown to decrease the incidence of hepatocellular carcinoma among children.4 In a Korean study in adult males, vaccination against hepatitis B virus has been shown to decrease the incidence of, and risk of, developing hepatocellular carcinoma in adults.5

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Are Hepatitis B Virus Infections Easily Avoided

Large quantities of hepatitis B virus are present in the blood of people with hepatitis B in fact, as many as one billion infectious viruses can be found in a milliliter of blood from an infected individual. Therefore, hepatitis B virus is transmitted in the blood of infected individuals during activities that could result in exposure to blood, such as intravenous drug use, tattooing, or sex with people who are infected. However, it is also possible to catch hepatitis B virus through more casual contact, such as sharing washcloths, toothbrushes or razors. In each of these cases, unseen amounts of blood can contain enough viral particles to cause infection. In addition, because many people who are infected don’t know that they are infected, it is very hard to avoid the chance of getting infected with hepatitis B virus.

What Form Does This Medication Come In

Engerix®-B Each 1 mL adult dose contains 20 µg of hepatitis B surface antigen adsorbed onto 0.5 mg of aluminum hydroxide. Nonmedicinal ingredients: aluminum hydroxide. The vaccine is a slightly opaque, white, sterile suspension. A slow settling of the white aluminum hydroxide may occur during storage leaving a clear, colourless, supernatant liquid. Thimerosal-free

Engerix®-B Pediatric Dose Each 0.5 mL pediatric dose contains 10 µg of hepatitis B surface antigen adsorbed onto 0.25 mg of aluminum hydroxide. Nonmedicinal ingredients: aluminum hydroxide. The vaccine is a slightly opaque, white, sterile suspension. A slow settling of the white aluminum hydroxide may occur during storage leaving a clear, colourless, supernatant liquid. Thimerosal-free.

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What Side Effects Are Possible With This Medication

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • fever of 37.7°C or higher
  • hard lump, redness, swelling, pain, itching, purple spot, tenderness, or warmth at the place of injection

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Why Should I Vaccinate My Newborn Child If I Know That I Am Not Infected With Hepatitis B Virus

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Before the hepatitis B vaccine, every year in the United States about 18,000 children were infected with hepatitis B virus by the time they were 10 years old. This statistic is especially important because people are much more likely to develop liver cancer or cirrhosis if they are infected early in life, rather than later in life .

About 9,000 of the 18,000 children infected in the first 10 years of life caught the virus from their mother during birth. However, many young children didn’t catch the disease from their mother. They caught it from either another family member or someone else who came in contact with the child. Because hepatitis B can be transmitted by relatively casual contact with items contaminated with the blood of an infected person, and because many people who are infected with hepatitis B virus don’t know that they have it, it is virtually impossible to be “careful enough” to avoid this infection.

For these reasons, all young children are recommended to receive the hepatitis B vaccine. The best time to receive the first dose is right after birth. This will ensure that the child will be protected as early as possible from catching hepatitis B from people who dont know that they are infected with the virus.

Listen to Dr. Offit explain why newborns get the hepatitis B vaccine by watching this short video, part of the series Talking About Vaccines with Dr. Paul Offit.

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Quantities Of Aluminum In Other Substances

Breast milk

  • 0.04 milligrams per liter

Ponds, lakes, streams

Antacid

  • 104-208 mg/tablet

Given the quantities of aluminum we are exposed to on a daily basis, the quantity of aluminum in vaccines is miniscule. Aluminum-containing vaccines have been used for decades and have been given to more than 1 billion people without problem. In spring 2000, the National Vaccine Program Office reviewed aluminum exposure through vaccines and determined that no changes to vaccine recommendations were needed based on aluminum content. The Global Advisory Committee on Vaccine Safety, part of the World Health Organization , has also reviewed studies and found no evidence of health risks that would require changes to vaccine policy.

What Are Side Effects Of Inactivated Viral Vaccines

Side effects of inactivated viral vaccines may include the following:

  • Injection site reactions include:
  • Triggering of shingles in pre-exposed individuals
  • Precipitation or aggravation of autoimmune disorders such as multiple sclerosis
  • Information contained herein is not intended to cover all possible side effects, precautions, warnings, drug interactions, allergic reactions, or adverse effects. Check with your doctor or pharmacist to make sure these drugs do not cause any harm when you take them along with other medicines. Never stop taking your medication and never change your dose or frequency without consulting your doctor.

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    Concurrent Administration Of Vaccines

    HB-containing vaccines may be administered concomitantly with other vaccines or with HBIg. Different injection sites and separate needles and syringes must be used for concurrent parenteral injections.

    Refer to Timing of Vaccine Administration in Part 1 for additional information about concurrent administration of vaccines.

    General Information About Vaccination Outside The Us

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    In developing countries, the pentavalent vaccine, a combination 5-in-one vaccine that protects against five diseases, diphtheria, pertussis, tetanus, Hib and hepatitis B, may be given to babies more than 6 weeks of age, and can be given up to 1 year of age. The first dose is given at 6 weeks, and the second and third doses are given at 10 and 14 weeks of age. The pentavalent vaccine may be made available free of charge with the support of GAVI, the vaccine alliance. Check the GAVI country hub to see the resources and immunizations that may be available:

    For babies born to mothers with hepatitis B, waiting for the first dose of the pentavalent vaccine is too late and will NOT protect the baby from vertical or horizontal transmission of hepatitis B. Babies born to a mother with hepatitis B have a greater than 90% chance of developing chronic hepatitis B if they are not properly treated at birth.

    WHO recommends the hepatitis B vaccine within 24 hours of birth for ALL babies. Plan ahead and inquire about the availability and cost of the monovalent , birth dose of the vaccine, as it is not a GAVI provided immunization. This is particularly important to women who are positive for hepatitis B.

    If you are unsure of your hepatitis B status, please be sure your doctor tests you for hepatitis B!

    *WHO does not recommend a birth dose of HBIG, which may not be available in all countries. Talk to your doctor if you have questions.

    Page updated September 2022.

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    Persons With Chronic Diseases

    Refer to Immunization of Persons with Chronic Diseases in Part 3 for additional general information about vaccination of people with chronic diseases.

    Chronic renal disease and patients on dialysis

    People with chronic renal disease may respond sub-optimally to HB vaccine and experience more rapid decline of anti-HBs titres, and are therefore recommended immunization with a higher vaccine dose. Individuals undergoing chronic dialysis are also at increased risk for HB infection. In people with chronic renal disease anti-HBs titre should be evaluated annually and booster doses using a higher vaccine dose should be given as necessary.

    Neurologic disorders

    People with conditions such as autism spectrum disorders or demyelinating disorders should receive all routinely recommended immunizations, including HB-containing vaccine.

    Chronic liver disease

    HB immunization is recommended for non-immune persons with chronic liver disease, including those infected with hepatitis C, because they are at risk of more severe disease if infection occurs. Vaccination should be completed early in the course of the disease, as the immune response to vaccine is suboptimal in advanced liver disease. Post-immunization serologic testing may be used to confirm vaccine response.

    Non-malignant hematologic disorders

    Persons with bleeding disorders and other people receiving repeated infusions of blood or blood products are considered to be at higher risk of contracting HB and should be offered HB vaccine.

    Vaccine Side Effects And Risks

    The vaccine is safe, effective and generally well tolerated. The most frequent reactions are pain and redness where the vaccine was given. Common side effects include headache, fever, dizziness, nausea or feeling faint shortly after receiving the vaccine. Reactions are usually mild and lasts only a few days.

    In rare cases, serious allergic reactions such as trouble breathing, rash, swelling in the throat and face may occur. Allergic reactions can be treated and are usually temporary. Please stay at the clinic for 15 minutes after vaccination for staff to monitor for any reactions. There are no long-term side effects associated with this vaccine.

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    What Is Hepatitis B

    Hepatitis B is a contagious liver disease caused by the hepatitis B virus. When a person is first infected with the virus, he or she can develop an acute infection. Acute hepatitis B refers to the first 6 months after someone is infected with the hepatitis B virus. This infection can range from a very mild illness with few or no symptoms to a serious condition requiring hospitalization. Some people are able to fight the infection and clear the virus.

    For others, the infection remains and is chronic, or lifelong. Chronic hepatitis B refers to the infection when it remains active instead of getting better after 6 months. Over time, the infection can cause serious health problems, and even liver cancer.

    Contraindications And Precautions To Vaccination

    Active Pharmaceutical Ingredients

    As with other vaccines, a history of a severe allergic reaction to a vaccine component or following a prior dose is a contraindication to further doses. Moderate or severe acute illness in a patient is considered a precaution to vaccination, although persons with minor illness may be vaccinated.

    In 2011, the Institute of Medicine concluded that the evidence convincingly supports a causal relationship between HepB vaccine and anaphylaxis in yeast-sensitive persons. HepB vaccination is contraindicated for persons with a history of hypersensitivity to yeast or any other vaccine component. The estimated incidence of anaphylaxis among HepB vaccine recipients is 1.1 per million vaccine doses administered.

    Some presentations of HepB vaccines contain latex, which may cause allergic reactions.

    Vaccination is not contraindicated in persons with a history of multiple sclerosis, Guillain-Barré syndrome, autoimmune disease or other chronic diseases.

    Contraindications to combination vaccines that contain HepB vaccine include the contraindications to the individual component vaccines specific ingredients differ by vaccine.

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