Wednesday, September 21, 2022

Hepatitis B Vaccine Drug Information

What Are The Side Effects

Treatment of Hepatitis Part 1 – Introduction

Vaccines are very safe. It is much safer to get the vaccine than to get hepatitis B.

Many people have no side effects from the vaccine. However, for those that do, common side effects may include soreness, redness and swelling where the vaccine was given. Some may experience a mild fever.

It is important to stay in the clinic for 15 minutes after getting any vaccine because there is a very rare possibility, between one in 100,000 and one in a million, of a life-threatening allergic reaction called anaphylaxis. This may include hives, difficulty breathing, or swelling of the throat, tongue or lips. Should this reaction occur, your health care provider is prepared to treat it. Emergency treatment includes administration of epinephrine and transfer by ambulance to the nearest emergency department. If symptoms develop after you leave the clinic, call 9-1-1 or the local emergency number.

It is important to always report serious or unexpected reactions to your health care provider.

Vaccine For Hepatitis B

Hepatitis B Vaccine

It takes only a few shots to protect yourself and your loved ones against hepatitis B for a lifetime.

The hepatitis B vaccine is a safe and effective vaccine that is recommended for all infants at birth and for children up to 18 years. The hepatitis B vaccine is also recommended for adults living with diabetes and those at high risk for infection due to their jobs, lifestyle, living situations, or country of birth. Since everyone is at some risk, all adults should seriously consider getting the hepatitis B vaccine for a lifetime protection against a preventable chronic liver disease.

The hepatitis B vaccine is also known as the first anti-cancer vaccine because it prevents hepatitis B, the leading cause of liver cancer worldwide.

You cannot get hepatitis B from the vaccine. All hepatitis B vaccines that have been used since 1986 are made synthetically meaning the hepatitis B vaccines do not contain any blood products. Learn more.

If you have a current HBV infection or have recovered from a past HBV infection, the hepatitis B vaccine series will not benefit you or clear the virus. However, the vaccine can provide a lifetime of protection for loved ones who do not have hepatitis B and get the vaccine as soon as possible. Testing is the only way to know if you or your loved ones have a current infection or have recovered from a past infection.

Hepatitis B Vaccine Recommendations

Three-Dose Hepatitis B Vaccine Schedule

Selected Safety Information For Recombivax Hb

Do not administer RECOMBIVAX HB® to individuals with a history of severe allergic or hypersensitivity reactions after a previous dose of any hepatitis B-containing vaccine or to any component of RECOMBIVAX HB, including yeast.

The vial stopper and the syringe plunger stopper and tip cap contain dry natural latex rubber, which may cause allergic reactions in latex-sensitive individuals.

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including RECOMBIVAX HB, to infants born prematurely should be based on consideration of the individual infants medical status and the potential benefits and possible risks of vaccination. For RECOMBIVAX HB, this assessment should include consideration of the mothers hepatitis B antigen status and high probability of maternal transmission of hepatitis B virus to infants born to mothers who are HBsAg positive if vaccination is delayed.

Hepatitis B vaccination should be delayed until 1 month of age or hospital discharge in infants weighing < 2000 g if the mother is documented to be HBsAg negative at the time of the infants birth. Infants weighing < 2000 g born to HBsAg positive or HBsAg unknown mothers should receive vaccine and hepatitis B immune globulin in accordance with ACIP recommendations if HBsAg status cannot be determined.

Vaccination with RECOMBIVAX HB may not protect all individuals.

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Interchangeability With Other Hepatitis B Vaccines:

Recombinant DNA vaccines are produced in yeast by expression of a hepatitis B virus gene sequence that codes for the hepatitis B surface antigen. Like plasma-derived vaccine, the yeast-derived vaccines are protein particles visible by electron microscopy and have hepatitis B surface antigen epitopes as determined by monoclonal antibody analyses. Yeast-derived vaccines have been shown by in vitro analyses to induce antibodies which are immunologically comparable by epitope specificity and binding affinity to antibodies induced by plasma-derived vaccine.13 In cross-absorption studies, no differences were detected in the spectra of antibodies induced in man to plasma-derived or to yeast-derived hepatitis B vaccines.13

Additionally, patients immunized approximately 3 years previously with plasma-derived vaccine and whose antibody titers were < 100 mIU/mL were given a 20-mcg dose of ENGERIX-B. All patients, including 2 who had not responded to the plasma-derived vaccine, showed a response to ENGERIX-B . There have been no clinical studies in which a 3-dose vaccine series was initiated with a plasma-derived hepatitis B vaccine and completed with ENGERIX-B, or vice versa. However, because the in vitro and in vivo studies described above indicate the comparability of the antibody produced in response to plasma-derived vaccine and ENGERIX-B, it should be possible to interchange the use of ENGERIX-B and plasma-derived vaccines .

Treatment Options For Antiviral Resistant Pathogens

Euvax

If a virus is not fully wiped out during a regimen of antivirals, treatment creates a bottleneck in the viral population that selects for resistance, and there is a chance that a resistant strain may repopulate the host. Viral treatment mechanisms must therefore account for the selection of resistant viruses.

The most commonly used method for treating resistant viruses is combination therapy, which uses multiple antivirals in one treatment regimen. This is thought to decrease the likelihood that one mutation could cause antiviral resistance, as the antivirals in the cocktail target different stages of the viral life cycle. This is frequently used in retroviruses like HIV, but a number of studies have demonstrated its effectiveness against influenza A, as well. Viruses can also be screened for resistance to drugs before treatment is started. This minimizes exposure to unnecessary antivirals and ensures that an effective medication is being used. This may improve patient outcomes and could help detect new resistance mutations during routine scanning for known mutants. However, this has not been consistently implemented in treatment facilities at this time.

Despite their successes, in the United States there exists plenty of stigma surrounding vaccines that cause people to be incompletely vaccinated. These “gaps” in vaccination result in unnecessary infection, death, and costs. There are two major reasons for incomplete vaccination:

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Hepatitis B Vaccination In Pregnancy

Hepatitis B infection in pregnant women may result in severe disease for the mother and chronic infection for the baby. This is why the hepatitis B vaccine is recommended for pregnant women who are in a high-risk category.

There’s no evidence of any risk from vaccinating pregnant or breastfeeding women against hepatitis B. And, as it’s an inactivated vaccine, the risk to the unborn baby is likely to be negligible .

Immunizing Agents Available For Use In Canada

Hepatitis A-containing vaccines

  • AVAXIM® and AVAXIM®-Pediatric , Sanofi Pasteur SA , Sanofi Pasteur Ltd.
  • HAVRIX®1440 and HAVRIX®720 Junior , GlaxoSmithKline Inc.
  • TWINRIX® and TWINRIX®Junior , GlaxoSmithKline Inc. Refer to Hepatitis B Vaccine in Part 4 for additional information about HAHB vaccine.
  • VAQTA® , Merck Canada Inc.
  • ViVAXIM® , Sanofi Pasteur Ltd.

Human immunoglobulin

  • GamaSTAN® , Grifols Therapeutics LLC.

Standard human immunoglobulin is a sterile, concentrated solution for intramuscular injection containing 15% to 18% immunoglobulin. It is obtained from pooled human plasma from screened donors and contains mainly IgG with small amounts of IgA and IgM. For complete prescribing information, consult the product leaflet or information contained within the product monograph available through Health Canada’s Drug product database.

Refer to Contents in Immunizing Agents Available for Use in Canada in Part 1 for lists of vaccines and passive immunizing agents available for use in Canada and their contents.

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Immunogenicity Efficacy And Effectiveness

Immunogenicity

Protective concentrations of antibody against HA develop in 95% to 100% of vaccine recipients after 1 dose of HA vaccine, and nearly 100% seroconvert after receiving 2 doses of vaccine.

Pre-exposure

HA vaccines are at least 90% to 97% effective in preventing clinical HA illness.

Post-exposure

The use of HA vaccine in susceptible populations interrupts HA outbreaks. The protective efficacy of HA vaccine when used within 1 week of exposure is approximately 80%.

Approaches By Virus Life Cycle Stage

EVERYDAY LIFE: Events surrounding the fake Hepatitis B vaccine

consist of a and sometimes a few stored in a capsule made of , and sometimes covered with a layer . Viruses cannot reproduce on their own and instead propagate by subjugating a host cell to produce copies of themselves, thus producing the next generation.

Researchers working on such “” strategies for developing antivirals have tried to attack viruses at every stage of their life cycles. Some species of mushrooms have been found to contain multiple antiviral chemicals with similar synergistic effects.Compounds isolated from fruiting bodies and filtrates of various mushrooms have broad-spectrum antiviral activities, but successful production and availability of such compounds as frontline antiviral is a long way away. Viral life cycles vary in their precise details depending on the type of virus, but they all share a general pattern:

  • Attachment to a host cell.
  • Release of viral genes and possibly enzymes into the host cell.
  • Replication of viral components using host-cell machinery.
  • Assembly of viral components into complete viral particles.
  • Release of viral particles to infect new host cells.
  • Before cell entry

    This stage of viral replication can be inhibited in two ways:

  • Using agents which mimic the virus-associated protein and bind to the cellular receptors. This may include VAP , natural of the receptor and anti-receptor antibodies.
  • Uncoating inhibitor

    Inhibitors of uncoating have also been investigated.

    During Viral Synthesis

    Reverse transcription
    Transcription

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    Known Or Presumed Exposure To Hepatitis B Virus

    Persons with known or presumed exposure to the hepatitis B virus should be given hepatitis B immune globulin in addition to ENGERIX-B in accordance with Advisory Committee on Immunization Practices recommendations and with the package insert for HBIG. ENGERIX-B can be given on either dosing schedule .

    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.

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    How To Get Vaccinated Against Hepatitis B

    All babies in the UK born on or after 1 August 2017 are given 3 doses of hepatitis B-containing vaccine as part of the NHS routine vaccination schedule. These doses are given at 8, 12 and 16 weeks of age.

    Babies at high risk of developing hepatitis B infection from infected mothers are given additional doses of the hepatitis B vaccine at birth, 4 weeks and 1 year of age.

    If you think you’re at risk and need the hepatitis B vaccine, ask your GP to vaccinate you, or visit any sexual health or genitourinary medicine clinic.

    If your GP or nurse is unable to offer you the hepatitis B vaccine because of a temporary shortage in supply, you may need to wait longer for the vaccine. For more information, read What to do if you have to wait for a dose of hepatitis B vaccine .

    If your job places you at risk of hepatitis B infection, it’s your employer’s responsibility to arrange vaccination for you, rather than your GP. Contact your occupational health department.

    Precautions While Using Hepatitis B Vaccine Recombinant Adjuvanted

    Engerix

    It is important that your doctor check your progress to make sure hepatitis b vaccine recombinant, adjuvanted is working properly. Blood tests may be needed to check for unwanted effects.

    Tell any doctor or dentist who treats you that you are using hepatitis b vaccine recombinant, adjuvanted. Hepatitis b vaccine recombinant, adjuvanted may affect certain medical test results..

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription medicines and herbal or vitamin supplements.

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    What Is Hepatitis B Vaccine

    Hepatitis B is a serious disease caused by a virus. Hepatitis causes inflammation of the liver, vomiting, and jaundice . Hepatitis can lead to liver cancer, cirrhosis, or death.

    Hepatitis B is spread through blood or bodily fluids, sexual contact, and by sharing items such as a razor, toothbrush, or IV drug needle with an infected person. Hepatitis B can also be passed to a baby during childbirth when the mother is infected.

    The hepatitis B adult vaccine is used to help prevent this disease in adults. The dialysis form of this vaccine is for adults receiving dialysis.

    This vaccine helps your body develop immunity to hepatitis B, but it will not treat an active infection you already have.

    Vaccination with hepatitis B adult vaccine is recommended for all adults who are at risk of getting hepatitis B. Risk factors include: living with someone infected with hepatitis B virus having more than one sex partner men who have sex with men having sexual contact with infected people having hepatitis C, chronicliver disease, kidney disease, diabetes, HIV or AIDS being on dialysis using intravenous drugs living or working in a facility for developmentally disabled people working in healthcare or public safety and being exposed to blood or body fluids living or working in a correctional facility being a victim of sexual abuse or assault and traveling to areas where hepatitis B is common.

    How Is This Vaccine Given

    This vaccine is given as an injection into a muscle. A healthcare provider will give you this injection.

    The hepatitis B vaccine is given in a series of 2 to 4 shots. The booster shots are sometimes given 1 month and 6 months after the first shot. If you have a high risk of hepatitis B infection, you may be given an additional booster 1 to 2 months after the third shot.

    Your individual booster schedule may be different from these guidelines. Follow your doctor’s instructions or the schedule recommended by the health department of the state you live in.

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    How Should I Use This Medicine

    This vaccine is for injection into a muscle. It is given by a health care professional.

    A copy of Vaccine Information Statements will be given before each vaccination. Read this sheet carefully each time. The sheet may change frequently.

    Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as newborn for selected conditions, precautions do apply.

    Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

    NOTE: This medicine is only for you. Do not share this medicine with others.

    What Are The Risks From Hepatitis B Vaccine

    Government says vaccines pose no direct health risk

    Soreness where the shot was given or fever can happen after hepatitis B vaccination.

    People sometimes faint after medical procedures, including vaccination. Tell your provider if you feel dizzy or have vision changes or ringing in the ears.

    As with any medicine, there is a very remote chance of a vaccine causing a severe allergic reaction, other serious injury, or death.

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    What Are The Uses For Hepatitis B Vaccine

    Hepatitis B vaccine is used to prevent hepatitis B, a serious infection that affects the liver.

    Most children are given their first shot at birth, followed by a 2nd shot at 1-2 months of age, and a 3rd shot at 6-18 months of age. Also, anyone who is 18 years of age or younger and hasn’t received the vaccine should be vaccinated.

    Additionally, all unvaccinated adults at risk for hepatitis B infection should be vaccinated. This includes:

    • Partners or people infected with hepatitis B
    • Men who have sex with men
    • People who inject street drugs
    • People with more than one sex partner
    • People with chronic liver or kidney disease
    • People under the age of 60 who have type 1 or 2 diabetes
    • People with jobs that expose them to human blood or other body fluids
    • People who live with a family member infected with hepatitis B

    Precautions To Be Taken Before Hepatitis B Vaccine

    Before using this medication tell your doctor or pharmacist of all prescription and nonprescriptionherbal products you may use especially of blood thinners eg warfarin heparin high blood pressure medicinesThis document does not contain all possible interactions Therefore before using this product tell your doctor or pharmacist of all the products you use Keep a list of all your medications with you and share the list with your doctor and pharmacist

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    Who Should Receive The Hepatitis B Vaccine And When

    Hepatitis B vaccine is usually given as 2, 3, or 4 shots.

    Infants should get their first dose of hepatitis B vaccine at birth and will usually complete the series at 6-18 months of age. The birth dose of hepatitis B vaccine is an important part of preventing longterm illness in infants and the spread of hepatitis B in the United States.

    Children and adolescents younger than 19 years of age who have not yet gotten the vaccine should also be vaccinated.

    Adults who were not vaccinated previously and want to be protected against hepatitis B can also get the vaccine.

    Hepatitis B vaccine is also recommended for the following people:

    People whose sex partners have hepatitis B

  • Sexually active persons who are not in a long-term monogamous relationship

  • People seeking evaluation or treatment for a sexually transmitted disease

  • Victims of sexual assault or abuse

  • Men who have sexual contact with other men

  • People who share needles, syringes, or other drug injection equipment

  • People who have household contact with someone infected with the hepatitis B virus

  • Healthcare and public safety workers at risk for exposure to blood or body fluids

  • Residents and staff of facilities for developmentally disabled persons

  • People living in jail or prison

  • Travelers to regions with increased rates of hepatitis B

  • People with chronic liver disease, kidney disease on dialysis, HIV infection, infection with hepatitis C, or diabetes

  • Hepatitis B vaccine may be given at the same time as other vaccines.

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