How Is The Hepatitis B Vaccine Made
People are protected against hepatitis B virus infection by making an immune response to a protein that sits on the surface of the virus. When hepatitis B virus grows in the liver, an excess amount of this surface protein is made. The hepatitis B vaccine is made by taking the part of the virus that makes surface protein and putting it into yeast cells. The yeast cells then produce many copies of the protein that are subsequently used to make the vaccine. When the surface protein is given to children in the vaccine, their immune systems make an immune response that provides protection against infection with the hepatitis B virus.
The first hepatitis B vaccine was made in the 1980s by taking blood from people infected with hepatitis B virus and separating or purifying the surface protein from the infectious virus. Because blood was used, there was a risk of contaminating the vaccine with other viruses that might be found in blood, such as HIV. Although contamination with HIV was a theoretical risk of the early, blood-derived hepatitis B vaccine, no one ever got HIV from the hepatitis B vaccine. That is because the blood used to make vaccine was submitted to a series of chemical treatments that inactivated any possible contaminating viruses. Today, there is no risk of contaminating the vaccine with other viruses because the surface protein is manufactured in the laboratory.
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Interchangeability And Dosing Schedule
- 2-dose HepB vaccine series only applies when both doses consist of HepB-CpG, administered at least 4 weeks apart.
- Series consisting of a combination of 1 dose of HepB-CpG and a vaccine from a different manufacturer should do the following:
- Adhere to the 3-dose schedule minimum intervals of 4 weeks between dose 1 and 2, 8 weeks between dose 2 and 3, and 16 weeks between dose 1 and 3. However, if HepB-CpG is substituted for dose 2 of HepB-alum, a provider has the option of administering the next dose of HepB-CpG a minimum of 4 weeks from the previous dose for a complete series.
Babies And Children Can Develop Chronic Hbv
You may be wondering why the recommendations for the HBV vaccine start on the first day of life.
Adults who contract HBV will likely not experience long-term complications from hepatitis B. But the same is not the case for babies. As many as of babies who contract an HBV infection at birth from their mothers become chronically infected with HBV.
Children between the ages of 1 and 5 who get an HBV infection have a 25 percent of people who become chronically infected during childhood will develop liver cancer or cirrhosis. Thats why pediatricians want children to have immunity from HBV from the earliest possible age. Many babies and children exposed to HBV receive post-exposure prophylaxis, which decreases chance of infection.
If youre pregnant, youll most likely have a blood test to see if youre positive for hepatitis B. This allows doctors to find out if theres a chance that you could pass on the virus. These tests are highly sensitive and have a good accuracy rate, but they arent perfect. Additionally, a pregnant person may become infected between the time of the test and giving birth. The first dose of the vaccine given at birth lowers the risk of a newborn baby contracting hepatitis B.
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What Are Side Effects Of Inactivated Viral Vaccines
Side effects of inactivated viral vaccines may include the following:
- Injection site reactions include:
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.
What Hepatitis B Immunisation Involves
Full protection involves having 3 injections of the hepatitis B vaccine at the recommended intervals.
Babies born to mothers with hepatitis B infection will be given 6 doses of hepatitis B-containing vaccine to ensure long-lasting protection.
If youre a healthcare worker or you have kidney failure, youll have a follow-up appointment to see if you have responded to the vaccine.
If you have been vaccinated by your employers occupational health service, you can request a blood test to see if you have responded to the vaccine.
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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.
Many People With Hbv Dont Know They Have It
HBV infections are becoming less common in the United States. But HBV is still widespread in other parts of the world. Around 257 million people living around the world currently have HBV, and many of them dont know it. Chronic HBV is often asymptomatic, and even when it isnt, it can take months for symptoms to show up.
HBV can be transmitted through sexual contact and the use of IV drugs , and other risk factors. Although rare, there
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Hepatitis B Vaccine Schedule For Adults
Hepatitis B is a vaccine-preventable viral disease that involves inflammation of the liver.
The hepatitis B virus usually leads to a short-term infection known as acute hepatitis B. If their infection is left untreated, some people develop chronic hepatitis B. Chronic hepatitis B is a serious, permanent condition that can cause organ damage, cirrhosis , liver cancer, liver failure, and even death.
According to the Centers for Disease Control and Prevention , all people should be vaccinated against hepatitis B starting at birth. Adults who are at risk of developing hepatitis B should also receive the vaccine, which is highly effective in preventing infection.
Read on to learn more about the hepatitis B vaccine for adults, including who should receive it, the details of the dosage schedule, side effects, and more.
Prasit photo / Getty Images
What Are Severe Side Effects Of Engerix
Premature babies have developed apnea after receiving Engerix-B. Decisions about when to administer the vaccine to premature infants should be based on consideration of the infants medical status, and potential risks and benefits of the vaccine.
SIRVA is a side effect that occurs when the needle damages tendons, ligaments, or the bursa in the shoulder. It can cause chronic shoulder pain, limited range of motion, and disability. It is not caused by nerve damage.
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What Are Warnings And Precautions For Hepatitis B Vaccine
This medication contains the hepatitis b vaccine. Do not take Engerix B or Recombivax HB if you are allergic to the hepatitis b vaccine or any ingredients contained in this drug.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
- See “What Are Side Effects Associated with Using Hepatitis B Vaccine?”
- See “What Are Side Effects Associated with Using Hepatitis B Vaccine?”
- Not protective against hepatitis A, C, or E
- Gluteal muscle injection is not recommended
- Heptavax B is no longer used in the US
Pregnancy and Lactation
- Use the hepatitis B vaccine during pregnancy with caution if the benefits outweigh the risks. Animal studies show risk and human studies are not available, or neither animal nor human studies were done.
- It is not known if the hepatitis B vaccine is excreted in breast milk. Consult your doctor before breastfeeding.
For Adults And Children
This vaccine schedule involves three doses within 2 months, followed by a booster dose at 1 year.
The initial accelerated doses provide immediate protection from HBV, and the booster dose helps provide long-term protection.
Below is the accelerated vaccination schedule approved for both adults and children:
|2 months after the first dose
|1 year after the first dose
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Concomitant Administration With Vaccines And Immune Globulin
ENGERIX-B may be administered concomitantly with immune globulin.
When concomitant administration of other vaccines or immune globulin is required, they should be given with different syringes and at different injection sites. Do not mix ENGERIX-B with any other vaccine or product in the same syringe or vial.
Immunogenicity In Children And Adults
Persons Aged 6 Months through 10 Years
In clinical trials, children aged 6 months through 10 years were given ENGERIX-B at 0, 1, and 6 months. One to 2 months after the third dose, the seroprotection rate was 98% and the GMT of seroconverters was 4,023 mIU/mL.
Persons Aged 5 through 16 Years
In a separate clinical trial including both children and adolescents aged 5 through 16 years, ENGERIX-B was administered at 0, 1, and 6 months or 0, 12, and 24 months . Immediately before the third dose of vaccine, seroprotection was achieved in 92.3% of subjects vaccinated on the 0-, 1-, and 6-month schedule and 88.8% of subjects on the 0-, 12-, and 24-month schedule . One month following the third dose, seroprotection was achieved in 99.5% of children vaccinated on the 0-, 1-, and 6-month schedule compared with 98.1% of those on the 0-, 12-, and 24-month schedule. GMTs were higher for children receiving vaccine on the 0-, 1-, and 6-month schedule compared with those on the 0-, 12-, and 24-month schedule .
Persons Aged 11 through 19 Years
In clinical trials with healthy adolescent subjects aged 11 through 19 years, ENGERIX-B given at 0, 1, and 6 months produced a seroprotection rate of 97% at Month 8 with a GMT of 1,989 mIU/mL . Immunization with ENGERIX-B at 0, 1, and 6 months produced a seroprotection rate of 99% at Month 8 with a GMT of 7,672 mIU/mL .
Persons Aged 16 through 65 Years
Persons Aged 40 Years and Older
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Us Infant Hepatitis B Vaccine Schedules
*Please note that the first dose should be given as soon as possible. Additional doses require minimum time intervals between doses in order for the vaccine to be effective.
3-Dose Vaccine Series for Infants
Since 1991, ALL medically stable infants with a birth weight of at least 2,000 g in the U.S. are recommended to receive the first dose of hepatitis B vaccine within 24 hours of birth. The additional 2 doses are given at 1 month and 6 months of age.
4-Dose Vaccine Combination Series for Infants
Combination vaccines, such as the pentavalent and hexavalent vaccines, include protection against 5 or 6 diseases, including hepatitis B. The first shot is usually given at 6 weeks of age, but in order to protect infants from hepatitis B beginning at birth, a monovalent or single dose of the hepatitis B vaccine is also recommended within 24 hours of birth. The hepatitis B vaccine series can then be completed with the pentavalent or hexavalent vaccine with the recommended schedule.
Testing For Hepatitis B Immunity
Generally a serology result of 10 IU/L is considered immunity to hepatitis B. Vaccinated individuals who have laboratory confirmation of anti-HBs 10 IU/L are considered to have lifetime immunity to hepatitis B even if antibody levels wane to undetectable levels in subsequent serology. This is because an anamnestic immune response will be protective against future hepatitis B exposure.
Refer to the current Immunisation Handbook for information on post-vaccination serology testing and management of non-responders. Non-responders require case-by-case consideration.
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Vaccine Side Effects & Injury Lawyers
If you or a loved one has been the victim of a vaccine side effect, you should contact a vaccine lawyer with experience in this type of complex litigation.
We have recently partnered with Schmidt & Clark, LLP a Nationally recognized law firm who handles vaccine lawsuits in all 50 states.
The lawyers at the firm offer a Free Confidential Case Evaluation and may be able to obtain financial compensation for you or a loved one by filing a vaccine lawsuit or claim with The National Vaccine Injury Compensation Program. Contact Schmidt & Clark today by using the form below or by calling them directly at .
How Do Inactivated Viral Vaccines Work
Inactivated viralvaccines are sterile biologic products that provide immunity against viral infections. Inactivated viral vaccines work by stimulating the bodys immune system to produce antibodies against specific types of viruses, and protect a person from becoming infected when exposed to these viruses.
In the case of SARS-CoV-2 coronavirus that causes respiratory illness and has led to the COVID-19 pandemic, vaccines do not entirely prevent infection but protect vaccinated individuals from serious illness and hospitalization from the disease.
Inactivated viral vaccines contain particles of proteins or genetic material from viruses. Inactivated viral vaccines may also contain substances that preserve and stabilize the vaccine, and enhance immune response. Some viral vaccines are delivered in inactivated harmless viruses such as human adenovirus.
Inactivated viral vaccines may be made from:
- Surface proteins of the viruses enable the virus to hold on to a human cell, enter inside and replicate.
- Modified RNA particles from the virus can enter host cells and induce the production of viral antigen, which stimulates an immune response from the body.
- Recombined DNA material from multiple strains and subtypes of viruses, killed to eliminate disease-causing capability.
Currently, inactivated viral vaccines approved by the FDA protect against viral infectious diseases that include:
- Coronavirus disease , caused by SARS-Cov-2 virus
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Recording Two Coadministered Doses Of Energix
- Order two doses of Engerix-B 20 mcg/mL for one 40mcg dose
- Administer two doses of Engerix-B 20mcg/mL at the same visit using separate injection sites.
- Record the vaccination in the PMS immunisation section by selecting the DLK eligibility and recording the batch number, expiry date and injection site used for one dose and writing “Engerix-B 20mcg x 2 given” in the note section.
- Record the vaccination in the PMS clinical notes, explain that two Engerix-B 20mcg doses were co-administered because a single 40mcg dose was not available, record the details of both injection sites and, if they are different, both vaccine batch numbers and/or expiry dates.
Why Should I Vaccinate My Newborn Child If I Know That I Am Not Infected With Hepatitis B Virus
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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Indications For Hepatitis B Vaccine
HepB vaccine is a routine childhood vaccination .
HepB vaccine also is indicated for adults who have not been previously vaccinated when any of the following is present:
A desire for protection from hepatitis B in people who have not been previously vaccinated
A sexually active lifestyle in people who are not in a long-term, mutually monogamous relationship
Need for evaluation or treatment of a sexually transmitted infection
Current or recent use of illicit injection drugs
Sex between men
Employment in which workers may be exposed to blood or other potentially infectious body fluids
Diabetes in people < 60 years and sometimes in those 60 years
End-stage renal disease
A chronic liver disorder
Household contact and/or sexual contact with people who are positive for hepatitis B surface antigen
Travel to endemic areas
Time spent in correctional facilities or in facilities that provide sexually transmitted infection treatment, HIV testing and treatment, drug abuse treatment and prevention services, services to injection-drug users or men who have sex with men, or care for patients with developmental disabilities or with end-stage renal disease
Pregnant women if at risk of infection or severe outcome resulting from infection during pregnancy
The combination HepA and HepB vaccine can be used in people 18 years who have indications for either hepatitis A or hepatitis B vaccine and who have not been previously vaccinated with one of the vaccine components.
General Information About Vaccination Outside The Us
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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