What If There Is A Serious Problem
An allergic reaction could occur after the vaccinated person leaves the clinic. If you see signs of a severe allergic reaction , call 9-1-1 and get the person to the nearest hospital.
For other signs that concern you, call your health care provider.
Adverse reactions should be reported to the Vaccine Adverse Event Reporting System . Your health care provider will usually file this report, or you can do it yourself. Visit the VAERS website at or call . VAERS is only for reporting reactions, and VAERS staff members do not give medical advice.
Incidence Of Acute Hepatitis B In Australia
Newly acquired cases of hepatitis B virus infection in Australia mostly occur in young adults, through:65
- injecting drug use
- skin penetration procedures
- sexual contact
Between 2006 and 2015, the notification rate of newly acquired hepatitis B in Australia declined from 1.4 to 0.6 per 100,000 population.64
Since 2001, the rate of diagnosis of newly acquired infections has declined substantially among people aged < 29 years. The decline has been less among people aged 30 years.64,66,67 However, some new hepatitis B virus infections are asymptomatic and may go undetected.
Similar to chronic infection, the incidence of, and hospitalisation rates due to, acute hepatitis B are higher among Aboriginal and Torres Strait Islander people than the general Australian population.64
Hepatitis B vaccines are prepared using recombinant technology. After purification, the hepatitis B surface antigen protein is adsorbed onto elemental aluminium . Hepatitis B vaccines may contain up to 1% yeast proteins (but no yeast DNA
The Engerix-B and H-B-Vax II vaccines are manufactured by different processes, and the HBsAg content of equivalent doses of these 2 vaccines is different. The HBsAg content of the paediatric formulations of these 2 vaccines is half that of the corresponding manufacturers adult formulation.
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.
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Persons With Inadequate Immunization Records
Evidence of long term protection against HB has only been demonstrated in individuals who have been vaccinated according to a recommended immunization schedule. Independent of their anti-HBs titres, children and adults lacking adequate documentation of immunization should be considered susceptible and started on an immunization schedule appropriate for their age and risk factors. Refer to Immunization of Persons with Inadequate Immunization Records in Part 3 for additional information.
Immunogenicity In Hemodialysis Patients:
Hemodialysis patients given hepatitis B vaccines respond with lower titers,12 which remain at protective levels for shorter durations than in normal subjects. In a study in which patients on chronic hemodialysis received 40 mcg of the plasma-derived vaccine at months 0, 1, and 6, approximately 50% of patients achieved antibody titers 10 mIU/mL.12 Since a fourth dose of ENGERIX-B given to healthy adults at month 12 following the 0-, 1-, and 2-month schedule resulted in a substantial increase in the GMT , a 4-dose regimen was studied in hemodialysis patients. In a clinical trial of adults who had been on hemodialysis for a mean of 56 months , 67% of patients were seroprotected 2 months after the last dose of 40 mcg of ENGERIX-B given on a 0-, 1-, 2-, and 6-month schedule the GMT among seroconverters was 93 mIU/mL.
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Why Do You Need A Hepatitis B Shot
Hepatitis B is a viral infection that cant be transferred person-to-person unless you have contact with an infected persons bodily fluids. Annual infection rates of HBV are going down in the United States thanks to vaccines. So you might be wondering if you or your child needs a shot to protect against hepatitis B.
Aboriginal And Torres Strait Islander People
Aboriginal and Torres Strait Islander people are recommended to:
- have their risks and vaccination status for hepatitis B reviewed
- receive testing for previous hepatitis B virus infection
- receive vaccination if non-immune
Aboriginal and Torres Strait Islander people have a higher risk of acquiring new hepatitis B virus infection than non-Indigenous Australians.2,3
Adult-formulation hepatitis B vaccine should be given in a 3-dose schedule.
Children with HIV are recommended to receive 3 doses of hepatitis B vaccine using an adult formulation. This is double the recommended dose for children. In a limited number of studies, children who were immunocompromised responded better when given higher doses in a 3-dose schedule.4,5
Levels of antibody to hepatitis B surface antigen should be checked after the vaccination course. See Serological testing after hepatitis B vaccination.
Adults with HIV are recommended to receive larger-than-usual doses of hepatitis B vaccine. They should receive 2 injections of the standard adult dose on each occasion at 0, 1, 2 and 6 months. Limited studies in adults with HIV have revealed an improved and accelerated serological response to a schedule that consists of 4 double doses.6,7
A 3-dose schedule at 6, 8 and 12 months after transplant is required using:
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Burden Of Chronic Hepatitis B In Australia
Chronic infection and its sequelae, including cirrhosis and hepatocellular carcinoma, contribute to most of the hepatitis B disease burden in Australia. The burden from chronic disease has been increasing with the increasing number of immigrants from regions of high hepatitis B prevalence.62
First-generation immigrants from countries of high hepatitis B endemicity usually retain the prevalence of chronic hepatitis B virus infection of the country they are from. Migrants born in Asian, Pacific islands, North African, Middle Eastern and Mediterranean countries have a significantly higher prevalence of chronic hepatitis B virus infection than the Australian-born population.62
Other population groups with higher prevalence of hepatitis B virus infection include:63,64
- Aboriginal and Torres Strait Islander people
- people with HIV
- people who injected drugs between 1980 and 1990
- household contacts of someone diagnosed with hepatitis between 1980 and 1990
Notification of chronic hepatitis B virus infection depends on hepatitis B testing and reporting. Many people with chronic hepatitis B virus infection remain undiagnosed. Mathematical modelling suggests that, in Australia in 2015:64
- about 230,000 people were living with hepatitis B virus infection
- about 419 deaths were due to hepatitis B virus infection
Hepatitis B Adult Vaccine Dosing Information
Usual Adult Dose for Hepatitis B Prophylaxis:
Primary Vaccination:Engerix-B:19 years and younger: Three doses intramuscularly on a 0, 1, and 6 month schedule20 years and older: Three doses intramuscularly on a 0, 1, and 6 month scheduleHeplisav-B: Two doses intramuscularly one month apartRecombivax-HB: 19 years and younger: Three doses intramuscularly on a 0, 1, and 6 month schedule 20 years and older: Three doses intramuscularly on a 0, 1, and 6 month schedule Known or Presumed Hepatitis B Exposure:Engerix-B : Use recommended doses of on a 0, 1, and 6 month schedule OR a 0, 1, 2, and 12 month schedule.Recombivax-HB: Refer to recommendations of the Advisory Committee on Immunization Practices
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Common And Local Adverse Events
HB vaccine
HB vaccine is well tolerated. Reactions are generally mild and transient, and include: irritability, headache, fatigue and injection site reactions in 10% or more of recipients.
HAHB vaccine
There is no increase in adverse events when HAHB vaccine is compared with HA vaccine given alone or concomitantly with HB vaccine at a different injection site. When the adult formulation of HAHB vaccine is given to children in the 2 dose schedule, there is no increase in adverse events compared with those occurring after administration of the pediatric formulation of HAHB vaccine.
DTaP-HB-IPV-Hib vaccine
Reactions are usually mild and transient, and include fever, irritability, restlessness and injection site reactions .
HBIg
Headache, diarrhea, fever, urticaria, angioedema and injection site reactions may occur.
Tetanus Diphtheria And Pertussis Vaccination
Routine vaccination
- Previously did not receive Tdap at or after age 11 years: 1 dose Tdap, then Td or Tdap every 10 years
Special situations
- Previously did not receive primary vaccination series for tetanus, diphtheria, or pertussis: At least 1 dose Tdap followed by 1 dose Td or Tdap at least 4 weeks after Tdap and another dose Td or Tdap 612 months after last Td or Tdap Td or Tdap every 10 years thereafter
- Pregnancy: 1 dose Tdap during each pregnancy, preferably in early part of gestational weeks 2736
- Wound management: Persons with 3 or more doses of tetanus-toxoid-containing vaccine: For clean and minor wounds, administer Tdap or Td if more than 10 years since last dose of tetanus-toxoid-containing vaccine for all other wounds, administer Tdap or Td if more than 5 years since last dose of tetanus-toxoid-containing vaccine. Tdap is preferred for persons who have not previously received Tdap or whose Tdap history is unknown. If a tetanus-toxoid-containing vaccine is indicated for a pregnant woman, use Tdap. For detailed information, see www.cdc.gov/mmwr/volumes/69/wr/mm6903a5.htm
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Dosage And Vaccination Schedule
Dosage varies according to age and type of vaccine used: follow manufacturer’s instructions.Child: one dose = 5 to 10 microgramsAdult: one dose = 10 to 20 micrograms
Standard schedule Neonate and infant:One dose as soon as possible after birth then a 2nd dose at 6 weeks and a 3rd dose at 14 weeksorOne dose as soon as possible after birth then 3 doses administered 4 weeks apart with the 1st at 6 weeks, the 2nd at 10 weeks and the 3rd at 14 weeks Child, adolescent, adult: schedule 0-1-62 doses 4 weeks apart, then a 3rd dose 6 months after the 1st dose
Accelerated schedule, when rapid protection is required in the event of post-exposure prophylaxis3 doses administered during the same month on D0-D7-D21, then a 4th dose one year after the 1st dose
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.
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Which Adults Should Be Vaccinated Against Hepatitis B
According to CDC recommendations, adults in the following groups are recommended to receive hepatitis B vaccine:
General
- All people age 18 years and younger.
- Anyone 19 years and older who wants to be protected from hepatitis B.
People at risk for infection by sexual exposure
- Sex partners of people who are hepatitis B surface antigen -positive.
- Sexually active people who are not in long-term, mutually monogamous relationships.
- People seeking evaluation or treatment for a sexually transmitted disease.
- Men who have sex with men.
People at risk for infection by percutaneous or permucosal exposure to blood or body fluids
- Current or recent illegal injection drug users.
- Household contacts of people who are HBsAg-positive.
- Residents and staff of facilities for developmentally challenged people.
- Healthcare and public safety workers with reasonably anticipated risk for exposure to blood or blood-contaminated body fluids.
- People with end-stage renal disease, including predialysis, hemo-, peritoneal- and home-dialysis patients.
Others
- International travelers to regions with intermediate or high levels of endemic HBV infection.
- People with chronic liver disease.
- People with HIV infection.
- People with diabetes who are age 19 through 59 years. For those age 60 and older, clinicians should make a determination of need for
- vaccination based on their patients’ situation.
In a future issue, we will review the various hepatitis B serologic tests, who needs testing, and when they need it .
Use With Other Vaccines:
The ACIP states that, in general, simultaneous administration of certain live and inactivated pediatric vaccines has not resulted in impaired antibody responses or increased rates of adverse reactions.17 Separate sites and syringes should be used for simultaneous administration of injectable vaccines.
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International 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.
The hepatitis B vaccine is an injection that is generally given in the arm and as a three-dose series. The World Health Organization recommends a 0, 1, and 6-month vaccine schedule, though schedules may vary based on a countrys national immunization program. Completing the hepatitis B vaccine series, preferably beginning at birth, will ensure protection against hepatitis B, hepatitis delta and lower the lifetime risk of liver cancer. Greater than 90% of babies and up to 50% of young children who are not vaccinated and are infected with hepatitis B will have lifelong infection, which makes the birth dose essential to their protection. Please note that the vaccine brand name, manufacturer and associated schedules for adults, children and infants may be unique to different countries, though there is a list of WHO prequalified vaccines.
3-Dose Vaccine Series for Infants
The World Health Organization recommends all infants receive the first dose of the hepatitis B vaccine within 24 hours of birth and to complete the vaccine series with additional shots at 1 month and 6 months of age. Beginning the hepatitis B vaccine at birth will ensure protection against hepatitis B for life.
3-Dose Vaccine Series for Children and Adults
4-Dose Combination Vaccine Series for Infants
Additional Resource Links:
Who Strategy For Hepatitis B Immunization
Although major progress has been achieved in hepatitis B immunization, a number of challenges remain. That is why the WHO called for comprehensive prevention and control of HBV infection and the development of time-specific immunization goals in its member states. The strategy includes the following: universal vaccination of infants within 24 hours of birth, full immunization of infants by routine immunization programs, catch-up vaccination of unimmunized cohorts, and monitoring progress and assessing the impact of immunization .
Universal Vaccination of Infants Within 24 Hours of Birth: a Real Challenge
Full Immunization of Infants by Routine Immunization Programs and Catch-Up Vaccination of Unimmunized Cohorts
Wider provision of the existing, safe and effective HBV vaccine, through universal childhood vaccination and by catch-up vaccination of unimmunized cohorts, will further reduce new hepatitis B infections, reducing rates of chronic illness and death. However, to achieve and/or sustain high coverage, stronger and resilient immunization delivery systems will be needed. Still, some countries adopt risk-grouptargeted vaccination only, instead of adding a universal vaccination program. However, changing demography, increasing immigration, and the current vaccine costs make the cost-benefit ratios in these remaining low-endemicity countries strongly in favor of universal HBV vaccination.
Monitoring Progress and Assessing the Impact of Immunization
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Guidance On Reporting Adverse Events Following Immunization
Vaccine providers are asked to report, through local public health officials, any serious or unexpected adverse event temporally related to vaccination. An unexpected AEFI is an event that is not listed in available product information but may be due to the immunization, or a change in the frequency of a known AEFI.
Refer to Reporting Adverse Events Following Immunization in Canada and Adverse events following immunization in Part 2 for additional information about AEFI reporting.
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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Infants Born To Mothers Who Have Hepatitis B: 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.
Protecting Your Baby
Infants born to women with hepatitis B must receive accurate doses of hepatitis B vaccine and hepatitis B immune globulin to ensure complete protection. In order to protect these infants, medications should be given immediately after birth in the delivery room or within the first 12-24 hours of life*.
* See Testing and Treatment During Pregnancy section for details. Please note that testing of all pregnant women for hepatitis B is a global recommendation.
3-Dose Vaccine Series for Infants
The World Health Organization recommends that infants born to hepatitis B positive mothers receive the first dose of the hepatitis B vaccine within 24 hours of birth, and ideally a dose of hepatitis B immunoglobulin . These shots must be followed by the additional vaccine doses given on the recommended schedule. In the U.S., infants should follow a 1 month and 6-month schedule for the additional two doses.
4-Dose Combination Vaccine Series for Infants