Hepatitis B Vaccine (Recombinant Or Plasma Derived)
Pronunciation: (heh-puh-TY-tis B VAK-seen).
- Generic name
- Hepatitis B vaccine (recombinant or plasma-derived)
- Brand names
- Euvax-B, H-B-Vax II, Engerix B, GeneVac-B, Fendrix, Engerix-B
- Drug class
- Vaccine (Inactivated Viral Vaccine)
Availability and supply rules vary by country
Trade names by country: India
Australia: · Full directory
What Hepatitis B vaccine (recombinant or plasma-derived) is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how Hepatitis B vaccine (recombinant or plasma-derived) works
The Hepatitis B vaccine contains purified hepatitis B surface antigen (HBsAg), which stimulates the immune system to produce specific antibodies against the hepatitis B virus. This immune response provides protection against future exposure to HBV by neutralizing the virus and preventing infection. (1)
What Hepatitis B vaccine (recombinant or plasma-derived) is used for
Prevention of Hepatitis B infection
Prevention of Hepatitis B infection (2)
Prevention of chronic Hepatitis B infection
Prevention of chronic Hepatitis B infection (2)
Prevention of liver cancer caused by Hepatitis B
Prevention of liver cancer caused by Hepatitis B (2)
Prevention of cirrhosis caused by Hepatitis B
Prevention of cirrhosis caused by Hepatitis B (2)
Before taking Hepatitis B vaccine (recombinant or plasma-derived)
Do not take / not appropriate for
- a history of severe allergic reaction (anaphylaxis) to a previous dose or any component of the vaccine (such as yeast). (Contraindication) (2)
- vaccination should be postponed until recovery. (Contraindication) (2)
- Immunocompromised patients may have a reduced response and may require post-vaccination serologic testing. (Contraindication) (2)
Tell your clinician about
(2)How to take Hepatitis B vaccine (recombinant or plasma-derived)
- General Instructions: The Hepatitis B vaccine is given as an intramuscular injection, usually in the upper arm (deltoid muscle) for adults and older children, or the thigh for infants.. Adult Dosing: Standard schedule: 3 doses at 0, 1, and 6 months. Alternative accelerated schedules may be used in certain situations.. Pediatric Dosing: Infants: First dose at birth, followed by additional doses at 1–2 months and 6–18 months of age. Catch-up schedules are available for older children.. Administration: Administered by a healthcare professional as an intramuscular injection. Do not inject intravenously or subcutaneously.. When To Stop: Complete the full vaccine series for optimal protection. Do not discontinue unless advised by your healthcare provider due to a serious adverse reaction.. Storage: Store in a refrigerator at 2–8°C (36–46°F). Do not freeze. Protect from light.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
If you miss a scheduled dose, receive it as soon as possible. You do not need to restart the series; continue with the remaining doses as scheduled.
Overdose
Overdose is unlikely with vaccines. If an overdose is suspected or multiple doses are given in error, monitor for side effects and seek medical advice. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Injection site pain
Incidence: Reported in the clinician-authored database; frequency not established
Fever
Incidence: Reported in the clinician-authored database; frequency not established
Headache
Incidence: Reported in the clinician-authored database; frequency not established
Fatigue
Incidence: Reported in the clinician-authored database; frequency not established
Nausea
Incidence: Reported in the clinician-authored database; frequency not established
Dizziness
Incidence: Reported in the clinician-authored database; frequency not established
Allergic reaction
Incidence: Reported in the clinician-authored database; frequency not established
Serious warnings
Severe allergic reactions are rare but possible — serious
Symptoms: Severe allergic reactions are rare but possible. Immunocompromised individuals may have a reduced response. Inform your provider of any allergies, especially to yeast. Report any unusual or severe side effects promptly. Pregnant or breastfeeding women should consult their doctor before vaccination.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindications include a history of severe allergic reaction (anaphylaxis) to a previous dose or any component of the vaccine (such as yeast). Precautions should be taken in individuals with moderate or severe acute illness; vaccination should be postponed until recovery. Immunocompromised patients may have a reduced response and may require post-vaccination serologic testing.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Syncope (fainting), sometimes with falls and injury, can occur after vaccination — serious
Symptoms: Syncope (fainting), sometimes with falls and injury, can occur after vaccination; the clinic administering the vaccine should have procedures in place to prevent injury from fainting. Vaccination is deferred in infants who weigh less than 2,000 g and were born to HBsAg-negative mothers. Premature infants may be at increased risk of apnea after vaccination, and the treating clinician should individually assess the risks and benefits before vaccinating. A lower antibody response is expected in people over 60 years old. Medical treatment for a severe allergic reaction (anaphylaxis) must be immediately available whenever the vaccine is given.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | The Hepatitis B vaccine can generally be given with other vaccines. However, immunosuppressive medications (such as corticosteroids, chemotherapy, or biologics) may reduce the immune response to the vaccine. Always inform your healthcare provider about all medicines and vaccines you are taking. | (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Available data from pregnancies with first- or second-trimester vaccine exposure show a miscarriage rate consistent with background rates and no increase in major birth defects; animal studies showed no adverse fetal effects. The vaccine is generally considered acceptable during pregnancy for those at risk of hepatitis B infection, but the decision should be made with the treating clinician. (2)
Breastfeeding
There is no data on whether this vaccine passes into human breast milk or on its effects on the breastfed infant or on milk production. Discuss the benefits and risks with your healthcare provider before vaccination while breastfeeding. (2)
Children
Frequency: Administer the first dose, then the second dose at 1 month, and the third dose at 6 months.. Weight Based: Not applicable; standard dosing is used.. Max Daily Dose: Not applicable as doses are given at specific intervals.. Max Single Dose: 0.5 mL for persons from birth through 19 years of age (this corrects an earlier internal figure that had mistakenly carried over the adult 1.0 mL dose into the pediatric field). Age Restrictions: Recommended for infants, children, and adolescents starting at birth. (2)
Renal_impairment
Hemodialysis patients and other immunocompromised individuals may have a reduced antibody response and may be given a higher dose (2 mL, i.e., two standard adult doses combined) on an extended 0-, 1-, 2-, and 6-month schedule, and may need post-vaccination antibody testing, as directed by the treating clinician. No general hepatic-impairment dosing adjustment is established. (2)
Hepatic_impairment
Hemodialysis patients and other immunocompromised individuals may have a reduced antibody response and may be given a higher dose (2 mL, i.e., two standard adult doses combined) on an extended 0-, 1-, 2-, and 6-month schedule, and may need post-vaccination antibody testing, as directed by the treating clinician. No general hepatic-impairment dosing adjustment is established. (2)
Monitoring
(2)Storage
Store refrigerated at 2-8C (36-46F). Do not freeze; discard the vaccine if it has been frozen. Protect from light.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General — birth through 19 years
Indication: Prevention of Hepatitis B infection
Dose summary: 3 doses of 0.5 mL (10 mcg) each at 0, 1, and 6 months, administered intramuscularly.
Renal context: No specific renal-impairment dose adjustment established for this pediatric schedule. (1) (2)
General — 20 years and older
Indication: Prevention of Hepatitis B infection
Dose summary: 3 doses of 1.0 mL (20 mcg) each at 0, 1, and 6 months, administered intramuscularly.
Renal context: Hemodialysis patients and other immunocompromised adults may receive a higher dose (2 mL, i.e., two standard 1 mL doses combined) on an extended 0-, 1-, 2-, and 6-month schedule, with post-vaccination antibody testing considered. (1) (2)
Frequently asked questions
Who should get the Hepatitis B vaccine?
All infants, unvaccinated children, and adults at risk of hepatitis B infection (such as healthcare workers, people with chronic liver disease, and travelers to high-risk areas) should receive the vaccine.
How effective is the Hepatitis B vaccine?
The vaccine is highly effective, with over 90% of healthy individuals developing protective antibodies after completing the series.
Can I get hepatitis B from the vaccine?
No. The vaccine does not contain live virus and cannot cause hepatitis B infection.
Is the vaccine safe during pregnancy?
Yes, the Hepatitis B vaccine is considered safe during pregnancy and is recommended for pregnant women at risk of infection.
What should I do if I miss a dose?
Receive the missed dose as soon as possible. You do not need to restart the series; continue with the remaining doses as scheduled.
Are booster doses needed?
Booster doses are not routinely recommended for immunocompetent individuals, but may be considered for certain high-risk groups.
What are the signs of a serious allergic reaction?
Signs include difficulty breathing, swelling of the face or throat, rapid heartbeat, severe rash, or dizziness. Seek emergency medical attention if these occur.
What happens if I take too much Hepatitis B vaccine?
Overdosing on the Hepatitis B vaccine is highly unlikely as it is administered by a healthcare professional. However, if an unusually large dose were to be given, it might lead to an exaggerated local reaction at the injection site or systemic symptoms. In any case of suspected overdose or unusual reaction, it is crucial to seek emergency medical help immediately for proper evaluation and management.
Can I drink alcohol while taking Hepatitis B vaccine?
Generally, there are no known direct interactions between alcohol consumption and the Hepatitis B vaccine itself. However, excessive alcohol intake can suppress the immune system, which theoretically might reduce the effectiveness of any vaccine. It's always advisable to discuss alcohol consumption with your healthcare provider, especially around the time of vaccination, to ensure optimal immune response and overall health.
Is Hepatitis B vaccine safe during pregnancy?
The Hepatitis B vaccine is generally considered safe during pregnancy, particularly when the mother is at high risk of infection. It falls under a category where benefits often outweigh potential risks. However, the decision to vaccinate during pregnancy should always be made in consultation with a healthcare provider, who can assess individual risk factors and provide personalized guidance based on the latest medical recommendations.
What is the mechanism of action of Hepatitis B vaccine (recombinant or plasma-derived)?
The Hepatitis B vaccine contains purified hepatitis B surface antigen (HBsAg), which stimulates the immune system to produce specific antibodies against the hepatitis B virus. This immune response provides protection against future exposure to HBV by neutralizing the virus and preventing infection. (1)
What is the generic name of Hepatitis B Vaccine (Recombinant Or Plasma Derived)?
The generic name is Hepatitis B vaccine (recombinant or plasma-derived). It is sold under brand names including Euvax-B, H-B-Vax II, Engerix B, GeneVac-B, Fendrix, Engerix-B.
What class of drug is Hepatitis B vaccine (recombinant or plasma-derived)?
Hepatitis B Vaccine (Recombinant Or Plasma Derived) is classed as: Vaccine (Inactivated Viral Vaccine).
References
- Hepatitis B vaccine — clinician-authored medicine recordMedGuideGlobal · Global (internal medicine record) · accessed 2026-08-06 · source 1
- ENGERIX-B [Hepatitis B Vaccine (Recombinant)] — prescribing informationU.S. Food and Drug Administration · United States · accessed 2026-08-06 · source 2
- ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 3
- Hepatitis B (Recombinant) Vaccine — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 4
- Hepatitis B vaccine — RxNorm normalized drug concept (RXCUI 797752)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient Hepatitis B vaccine (recombinant or plasma-derived) names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
India
- Bevac10 mL multidose vial · Biological E Limited