In the United States, there are two hepatitis B vaccines that have been approved for use in infants, children and adults. Both are equally safe and effective.
- Engerix-B (GlaxoSmithKline)
- Recombivax HB (Merck)These vaccines are synthetically prepared and do not contain blood products – you cannot get hepatitis B from either of these vaccines.
In November 2017, a third vaccine was approved by the FDA for use in the U.S. Heplisav-B (Dynavax) is a two-dose vaccine approved for use in adults aged 18 and over.
Three-Dose Hepatitis B Vaccine Schedule of Administration
The hepatitis B vaccine is an injection (or shot) that is generally given in the arm and as a three-dose series on a 0, 1, and 6-month schedule. The recommended doses depend on the vaccine brand and the person's age.
1st Shot - At any given time, but newborns should receive this dose in the delivery room
2nd Shot - At least one month (or 28 days) after the 1st shot
3rd Shot - At least 4 months (16 weeks) after the 1st shot (or at least 2 months after the 2nd shot). Infants should be a minimum of 24 weeks old at the time of the 3rd shot.
Heplisav-B (Dynavax) is a two-dose vaccine approved and recommended in the U.S. for use in adults aged 18 and older. The vaccine is administered as two doses given one month (at least 28 days) apart.
Alternate Hepatitis B Vaccine Schedule for Adolescents
There is a two-dose schedule of the hepatitis B vaccine called “Recombivax HB” (Merck) that has been approved for children and adolescents 11 through 15 years of age. After the first dose is given, the second dose is given 4 to 6 months later.
U.S. Hepatitis B Vaccine Guidelines
The U.S. Centers for Disease Control and Prevention have made the following HBV vaccine recommendations in order to protect all babies, children, teens and adults from infection with the hepatitis B virus.
Universal Infant Vaccination ("Birth Dose")
ALL infants should receive the first dose of hepatitis B vaccine at birth in the delivery room (called the “birth dose") or within the first 12- 24 hours of life before they leave the hospital.
In 1991, universal hepatitis B vaccination of all infants born in the U.S. was recommended because newborns and babies are at the greatest risk of developing a lifelong chronic infection if they are exposed to the hepatitis B virus. Giving the "birth dose" of the hepatitis B vaccine after a baby is born helps to reduce the risk of transmission from a woman who is infected with hepatitis B to her newborn baby at the time of delivery. Unfortunately, most pregnant women do not know if they are infected with hepatitis B; therefore, it is very important that all newborns be protected against a possible exposure to the hepatitis B virus. There is no second chance to protect a newborn from a chronic hepatitis B infection after the first 12 - 24 hours of life.
Children and Adolescents (0 - 18 years)
Since 1997, the CDC has recommended that ALL children and adolescents up to age 18 years should receive the hepatitis B vaccine.
Young children are at high risk for developing a lifelong chronic infection if they are exposed to the hepatitis B virus. Currently, one-third of all chronically infected adults were exposed in childhood. Adolescents are included in this recommendation as well because of their potentially experimental lifestyle choices that place them at greater risk of a hepatitis B infection.
Adults (18 or 19 years and older, depending on vaccine administered)
A schedule of routine adult vaccinations was first published in 2002. The hepatitis B vaccine is now included in the current list of adult recommendations (> 19 years for the three-dose series and (> 18 years for the Heplisav-B two-dose series).
In 2011, the CDC added the recommendation the hepatitis B vaccine be given to all adults with diabetes (type 1 or 2) who are between 19 - 59 years. Clinicians can decide whether or not their diabetic patients 60 years or older should receive the hepatitis B vaccine. This recommendation has also been adopted by the Americans Diabetes Association. Learn more.
International Hepatitis B Vaccine Considerations
The World Health Organization recommends all infants receive the first dose of the hepatitis B vaccine within 24 hours of birth (often called the “birth dose”) and to then complete the vaccine series at 2 and 6 months. In order to meet this requirement, the first dose of the hepatitis B vaccine must be the “monovalent vaccine,” which means it is only the hepatitis B vaccine.
Many countries, however, are offering a “pentavalent vaccine” which protects against 5 diseases, including hepatitis B. Unfortunately, the first dose of the “pentavalent vaccine” is given at 6 weeks, which means babies are not being protected at birth against the hepatitis B virus.
It is very important that babies receive the “monovalent” hepatitis B vaccine at birth (not the “pentavalent vaccine”) in order to protect against a lifelong chronic hepatitis B infection. Infants born to moms who are infected with hepatitis B are at extremely high risk of becoming chronically infected after delivery, unless they receive the first dose of the hepatitis B vaccine within the first 12-24 hours of life.
There is no second chance to protect a newborn or baby from hepatitis B!
Pentavalent help: WHO writeup
A hepatitis B vaccine “non-responder" refers to a person who does not develop protective surface antibodies after completing two full series of the hepatitis B vaccine and for whom an acute or chronic hepatitis B infection has been ruled out.
Although the majority of persons vaccinated against hepatitis B successfully respond to vaccination, an estimated 5-15% of persons may not respond due to older age, obesity, smoking, and other chronic illness.
It is also possible that a person who does not respond to the vaccine may already be infected with hepatitis B. Therefore, testing for the presence of the hepatitis B virus (hepatitis B surface antigen or HBsAg) is recommended before diagnosing a person as a "vaccine non-responder."
CDC Recommendations for Hepatitis B Vaccine Non-Responders
- Persons who do not respond to the primary hepatitis B vaccine series (i.e., anti-HBs <10 mIU/mL) should complete a second 3-dose vaccine series or be evaluated to determine if they are HBsAg-positive. Persons who do not respond to an initial 3-dose vaccine series have a 30%--50% chance of responding to a second 3-dose series.
- Revaccinated persons should be retested at the completion of the second vaccine series, 1-2 months following the last shot of the series.
- Persons exposed to HBsAg-positive blood or body fluids who are known not to have responded to a primary vaccine series should receive a single dose of hepatitis B immunoglobulin (HBIG) and restart the hepatitis B vaccine series with the first dose of the hepatitis B vaccine as soon as possible after exposure. Alternatively, they should receive two doses of HBIG, one dose as soon as possible after exposure, and the second dose 1 month later.
- The option of administering one dose of HBIG and restarting the vaccine series is preferred for non-responders who did not complete a second 3-dose vaccine series.
- For persons who previously completed a second vaccine series but failed to respond, two doses of HBIG are preferred.
Another vaccine option is the two-dose hepatitis B vaccine, HEPLISAV-B. This vaccine is administered over a one-month period, and could provide greater seroprotection, which can mean a greater antibody response - especially in adults who may be older, obese or live with type 2 diabetes.
Hepatitis B vaccine “non-responders” who test negative for hepatitis B infection are at risk for being infected and should be counseled regarding how to prevent a hepatitis B infection and to seek immediate medical care to receive a dose of hepatitis B immunoglobulin (HBIG) if they have been exposed to potentially infected blood.
Individuals who test positive for hepatitis B infection should be counseled regarding how to prevent transmitting the hepatitis B virus to others and the need for regular medical care and monitoring for their chronic infection.