Selected Safety Information For Recombivax Hb 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.
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.
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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Other Reported Adverse Events And Conditions
While serious events and chronic illnesses such as chronic fatigue syndrome, multiple sclerosis, Guillain-Barré syndrome, rheumatoid arthritis and sudden infant death syndrome have been alleged or reported following HB vaccination, no evidence of a causal association has been demonstrated in a number of studies.
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Transmission Symptoms And Treatment
How is HBV transmitted?
HBV is transmitted through activities that involve percutaneous or mucosal contact with infectious blood or body fluids , including
- sex with a partner who has HBV infection
- injection drug use that involves sharing needles, syringes, or drug-preparation equipment
- birth to a person who has HBV infection
- contact with blood from or open sores on a person who has HBV infection
- exposures to needle sticks or sharp instruments and
- sharing certain items with a person who has HBV infection that can break the skin or mucous membranes , potentially resulting in exposure to blood.
How long does HBV survive outside the body?
HBV can survive outside the body and remains infectious for at least 7 days .
What should be used to clean environmental surfaces potentially contaminated with HBV?
Any blood spills should be disinfected using a 1:10 dilution of one part household bleach to 9 parts water. Gloves should be worn when cleaning up any blood spills.
Who is at risk for HBV infection?
The following populations are at increased risk for becoming infected with HBV:
- Infants born to people with HBV infection
- Sex partners of people with HBV infection
- Men who have sex with men
- People who inject drugs
- Household contacts or sexual partners of known people with chronic HBV infection
- Health care and public safety workers at risk for occupational exposure to blood or blood-contaminated body fluids
- Patients on hemodialysis
Who should be screened for HBV?
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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.
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.
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How And When Do Doctors Give Vaccines
For the hepatitis A vaccine:
You should get two doses, given as shots, 6 months apart for complete protection. The virus in the vaccine is killed .
Children should get the first dose between 12 and 23 months of age. Children older than age 2 can get the first dose at their next doctorâs visit.
If you need the vaccine because of upcoming travel, get it at least 1 month before you go.
For the hepatitis B vaccine:
For long-lasting immunity, you need three to four doses, depending on which type of vaccine is used. You get them as shots.
Children should get their first dose at birth and complete the series by age 6 months. Usually, the baby would get a second dose at 1 month old and the third dose at 6 months.
Babies born to women who have hepatitis B need a shot of hep B antibodies, as well as their first hep B vaccine shot, when theyâre born. They will also need follow-up blood tests to make sure theyâre OK.
Catch-up vaccinations are recommended for children and teens who were never vaccinated or who did not get all three shots.
If you’re an adult who wants to be vaccinated, you should talk about it with your doctor or pharmacist. If you are considering both vaccines, ask your doctor about vaccines that combine hep A and B.
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When To Delay Or Avoid Hepb Immunization
Doctors delay giving the vaccine to babies who weigh less than 4 pounds, 7 ounces at birth whose mothers do not have the virus in their blood. The baby will get the first dose at 1 month of age or when the baby is discharged from the hospital.
The vaccine is not recommended if your child:
- is currently sick, although simple colds or other minor illnesses should not prevent immunization
- had a serious allergic reaction after an earlier dose of the vaccine or is allergic to baker’s yeast
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For Children And Adolescents
The dosage for both MMR and MMRV is 0.5 mL. All three vaccines are administered by the subcutaneous route.
The minimum age for both MMR vaccines and MMRV is 12 months of age. The typical age for the second dose of either vaccine is at 4 to 6 years of age. The maximum age for administration of MMRV is 12 years. It should not be administered to anyone 13 years of age or older. Both MMR vaccines may be administered to anyone 12 months of age or older.
The minimum interval between MMR doses is 4 weeks . The minimum interval between MMRV doses is 3 months.
The preferred injection site in small children is the anterolateral aspect of the thigh. The posterior triceps aspect of the upper arm is the preferred site for older children and adolescents.
Who Should Get The Hepatitis B Vaccine
Any child up to 18 years of age who did not get the vaccine or all of the needed doses should get the vaccine.
- Your adolescent should get the vaccine if:
- He or she gets a stick from an infected needle, including for illegal drugs and for procedures such as tattooing
- He or she has unprotected sex with an infected person, sex with more than one partner, or is a male who has sex with males
- She is pregnant or breastfeeding and is at risk for hepatitis B
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Who Should Receive Hepatitis B Vaccination
- All newborns before hospital discharge. Infants born to hepatitis B-positive women need hepatitis B vaccine and HBIG within 12 hours of birth.
- All children and adolescents not previously vaccinated.
- Children born in the U.S. to individuals born in a country with high hepatitis B endemicity.
- All individuals at risk of hepatitis B infection:
- Sex partners of hepatitis B-positive persons
- Sexually active persons who are not in a long-term, mutually monogamous relationship
- Persons seeking evaluation or treatment for a sexually-transmitted disease
- Men who have sex with men
- Persons who inject drugs
- Household contacts of hepatitis B-positive persons
- Persons born in countries where hepatitis B infection is endemic should be tested and vaccinated if susceptible
- International travelers to regions with high or intermediate rates of endemic hepatitis B infection
- Health care and public safety workers that may be exposed to blood or blood-contaminated body fluids
- Residents and staff of facilities for developmentally disabled persons, corrections facilities, and other facilities that serve adults at risk for hepatitis B infection
- Persons with end-stage renal disease, including pre-dialysis, hemodialysis, peritoneal dialysis, and home dialysis patients
- Persons with chronic liver disease
- Persons to age 60 years with diabetes
- Persons with HIV infection
- All other persons seeking protection from hepatitis B infection.
Hepatitis B Vaccination Schedule For Children And Infants
The Centers for Disease Control and Prevention recommends that babies and children receive three 0.5 milliliter doses of either Engerix-B or Recombivax HB, starting just after birth.
The current recommended hepatitis B vaccine schedule for children and infants is as follows:
| Hepatitis B Vaccination Schedule for Infants and Children | |
|---|---|
| Hepatitis B Vaccine Dose | |
| 3 | 618 months old |
If your child is undergoing hemodialysis, your healthcare provider may recommend that they receive additional doses of the HBV vaccine.
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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
Adults
Use In Special Populations
Pregnancy
There are no adequate and well-controlled studies designed to evaluate RECOMBIVAX HB in pregnant women. Available post-approval data do not suggest an increased risk of miscarriage or major birth defects in women who received RECOMBIVAX HB during pregnancy.
Nursing Mothers
Data are not available to assess the effects of RECOMBIVAX HB on the breastfed infant or on milk productions/excretion. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for RECOMBIVAX HB and any potential adverse effects on the breastfed child from RECOMBIVAX HB or from the underlying maternal condition.
Pediatric Use
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Why Is The Hepb Vaccine Recommended
People who dont know they’re infected can spread the hepatitis B virus. So it cant be avoided just by being careful. That’s why health experts recommend that all babies get the vaccine right from birth.
The HepB injection usually creates long-term immunity. Most infants who get the HepB series are protected from hepatitis B infection beyond childhood, into their adult years.
Eliminating the risk of infection also decreases risk for cirrhosis of the liver, chronic liver disease, and liver cancer.
I Am A Healthcare Worker Who Did Not Develop Hepatitis B Antibodies After Immunization What Should I Do
Two versions of hepatitis B vaccine are available. One, called Heplisav-B, contains a novel adjuvant that was not present in previous versions used by adults . Some people did not respond to the older version hepatitis B vaccine. In fact, in a group of adults younger than 40 years of age who received two doses of the older version vaccine 75 of 100 were protected. Following the third dose, this number increased to 90 of 100. However, people older than 40 years of age were less likely to respond to the vaccine with increasing age. On the other hand, 90 to 100 of 100 adults 18 years of age and older respond to Heplisav-B, which was approved for use in 2018.
About 5-10 of every 100 children and adults younger than 40 years of age do not respond to the third dose of the hepatitis B vaccine. Some of these people will be recommended to get vaccinated again. About 5 of 100 people will still not respond after getting all recommended doses of both series. Note that children younger than 18 years of age cannot get Heplisav-B.
If the people who do not respond to vaccination are determined not to have chronic hepatitis B, they will be reliant on taking precautions to reduce the chance of exposure and relying on those around them for protection. In other words, these people will be reliant on herd immunity.
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