What to Know About Hepatitis B Vaccines

Hepatitis B vaccines are used to prevent hepatitis B, a viral infection of the liver that can lead to cirrhosis, liver failure, and liver cancer in some people. Around 850,000 people are estimated to be living with hepatitis B in the United States, 67% of whom do not realize they have been infected.

There are three hepatitis B vaccines approved for use by the U.S. Food and Drug Administration (FDA):

• Engerix B, approved in 1989
• Heplisav-B, approved in 2017
• Recombivax HB, approved in 1986

The vaccines are all recombinant vaccines, meaning that they deliver DNA coding to cells to "teach" them how to build hepatitis-B-specific antibodies. By generating enough antibodies, the body can ward off infection if exposed to the virus.

The vaccines are each delivered by injection.

Uses

Hepatitis B vaccines prevent all subtypes of the hepatitis B virus (HBV). The vaccines are used for primary immunization, meaning the process of making a person immune to a disease. Two of the vaccines (Engerix-B, Recombivax HB) can be used from birth, while one (Heplisav-B) is used in adults only.

By contrast, only 2% to 6% of infected adults will develop chronic HBV infection; the rest will spontaneously clear the virus with no long-term consequence.

ACIP Recommendations

The vaccine recommendations in the United States are made by the Advisory Committee on Immunization Practices (ACIP), an independent panel of experts within the Centers for Disease Control and Prevention (CDC). In 2018 and again in 2021, the ACIP updated its guidelines for hepatitis B following the FDA approval of Heplisav-B.

Infants should get their first dose of the hepatitis B vaccine at birth and ideally complete the vaccination series by up to 18 months of age.

Children and adolescents under 19 who have not gotten the vaccine should also be vaccinated.

Adults 19 through 59 who have not been previously vaccinated should also be vaccinated.

Certain unvaccinated adults over age 60 should also receive the hepatitis B vaccine, including:

• Sexually active adults in non-monogamous relationships
• People whose sex partners have hepatitis B
• Those seeking the diagnosis or treatment of a sexually transmitted disease
• Men who have sex with men
• People who share or have recently shared needles, syringes, or other drug paraphernalia
• People in households with someone who has hepatitis B
• Healthcare workers and others at occupational risk of blood exposure
• Incarcerated people
• Victims of sexual assault or abuse
• Travelers to regions with increased rates of hepatitis B
• People with chronic liver disease, including hepatitis C
• People with chronic kidney disease, particularly those on dialysis
• People with HIV
• People with diabetes
• Anyone who wants to be protected from hepatitis B

Before Use

Hepatitis B vaccines are considered safe but should not be used in people who have had an allergic reaction to a previous dose of the vaccine or any of the components of the vaccine. This includes people with a severe yeast allergy, as the vaccines are cultivated in yeast cells.

People with severe latex allergy should avoid Engerix-B in prefilled syringes or Recombivax HB in prefilled syringes or vials as the devices contain latex. For these people, Engerix-B is offered in latex-free vials, while Heplisav-B is available in latex-free pre-filled syringes.

Other Vaccines

The FDA has also approved a combination vaccine called Twinrix that protects against both hepatitis A and hepatitis B. It is approved for use in adults 18 and over and is given in series of either three or four injections.

HepaGam B is not used for primary immunization but rather as a form of immunoglobulin therapy in which HBV antibodies are harvested from donated blood to treat acute infections.

Dosage

Engerix-B and Recombivax HB are available in single-use vials or prefilled syringes, while Heplisav B only comes in a pre-filled syringe.

The vaccine dose ranges from 0.5 milliliters (mL) to 1.0 mL based on the vaccine type, the person's age, and other factors.

The vaccines are given in either two or three doses as follows:

• Engerix-B and Recombivax HB are given in three doses over six months. The vaccines can be used interchangeably (meaning you can use Engerix-B for one dose and Recombivax HB for another).
• Heplisav-B can be used as a substitute in the above-listed vaccine series. For people 18 and over, Heplisav-B can be used on its own, delivered in two doses over four weeks.

The vaccines are given by intramuscular injection by a healthcare professional, typically in the thigh muscle in younger children and the shoulder muscle in older children and adults.

Modifications

Adults on dialysis (or preparing to undergo dialysis) require a larger dose to achieve a protective level of HBV antibodies. Options include:

• Engerix B: Three 2.0-mL doses
• Recombivax HB: Three 1.0-mL doses

The safety of Heplisav-B in adults on dialysis has not been established.

Adults who are immunocompromised may benefit from an additional dose of Heplisav-B if the level of HBV antibodies following the vaccination series is below 10 milli-international units per milliliter (mIU/mL).

No recommendations have been made with respect to the use of Engerix-B or Recombivax HB in immunocompromised people.

Side Effects

Hepatitis vaccines may cause side effects, although they tend to be mild and resolve within a day or two. Severe side effects are rare.

Common

The list of common side effects are similar for all three hepatitis B vaccines. They include:

• Injection site pain
• Injection site swelling
• Headache
• Fatigue
• Malaise
• Nausea
• Diarrhea
• Dizziness
• Fever over 100 degrees F

Injection site reactions are more common with Heplisav-B, in part because it contains a substance called cytosine phosphoguanine. This acts as an adjuvant, an ingredient that amplifies the body's response to vaccines.

Even so, local reactions tend to be relatively mild.

Severe

Severe side effects of hepatitis vaccines are rare. According to the World Health Organization, there is no evidence of serious adverse events linked to hepatitis B vaccination. This includes the risk of a potentially life-threatening allergic reaction known as anaphylaxis.

Warnings and Interactions

There are no well-controlled human studies assessing the safety of hepatitis B vaccines during pregnancy. With that said, the potential benefits may warrant their use in pregnant women despite potential risks.

Even so, it is important to speak with your healthcare provider to make an informed choice if you are pregnant, breastfeeding, or planning to get pregnant.

There are no major drug interactions associated with Engerix-B, Heplisav-B, or Recombivax HB. Still, it is important to advise your healthcare provider if you are on an immunosuppressive therapy of any sort. Such a treatment may in theory impair your body's ability to produce antibodies.

Examples include:

• Biologic drugs like Humira (adalimumab)
• Chemotherapy drugs
• Cyclosporine
• High-dose corticosteroids
• Methotrexate
• Radiation therapy

Despite these concerns, there are no recommendations regarding the adjustment of dosages for people on any immunosuppressant drug or therapy.