HBVAXPRO: Uses, Dosage & Side Effects
A recombinant hepatitis B vaccine for active immunization against hepatitis B virus infection in individuals from birth through 15 years of age
HBVAXPRO is a recombinant hepatitis B vaccine manufactured by Merck Sharp & Dohme. It contains purified hepatitis B surface antigen (HBsAg) produced in yeast cells (Saccharomyces cerevisiae) using recombinant DNA technology. The 5-microgram formulation is specifically designed for children and adolescents from birth through 15 years of age who are at risk of hepatitis B virus exposure. HBVAXPRO provides reliable seroprotection and is a cornerstone of global hepatitis B elimination strategies as recommended by the World Health Organization.
Quick Facts: HBVAXPRO
Key Takeaways
- HBVAXPRO is a recombinant hepatitis B vaccine that protects against all known subtypes of the virus, and also indirectly against hepatitis D
- The 5-microgram formulation is indicated for individuals from birth through 15 years of age at risk of hepatitis B exposure
- A complete vaccination course requires at least 3 doses, typically given at 0, 1, and 6 months; a rapid 4-dose schedule (0, 1, 2, 12 months) is also available
- The most common side effects are mild injection site reactions (tenderness, redness, and hardening), which resolve within days
- The vaccine must be stored at 2–8°C and must never be frozen; the vial stopper contains latex, which may affect latex-sensitive individuals
What Is HBVAXPRO and What Is It Used For?
HBVAXPRO belongs to a class of biological products known as recombinant vaccines. Unlike traditional vaccines that use inactivated or attenuated viral material, HBVAXPRO contains a purified protein — hepatitis B surface antigen (HBsAg) — that is produced using recombinant DNA technology. The HBsAg protein is manufactured in Saccharomyces cerevisiae (baker’s yeast) cells that have been genetically engineered to express the hepatitis B surface antigen gene. This biotechnological approach ensures that the vaccine contains no live viral material, making it inherently safe with respect to transmitting infection.
The vaccine works by stimulating the body’s immune system to produce antibodies (anti-HBs) against the hepatitis B surface antigen. When a vaccinated individual subsequently encounters the actual hepatitis B virus, these preformed antibodies rapidly neutralize the virus before it can establish infection. The immune response also generates immunological memory through specialized memory B cells and T cells, which provide long-lasting protection even after circulating antibody levels have declined.
Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). The virus is transmitted through contact with infectious blood or body fluids, including perinatal transmission from mother to infant, sexual contact, sharing of contaminated needles, and occupational exposure. Chronic hepatitis B infection can lead to serious complications including cirrhosis, liver failure, and hepatocellular carcinoma (liver cancer). The World Health Organization estimates that approximately 254 million people worldwide are living with chronic hepatitis B infection, and over 1 million deaths occur annually from HBV-related liver disease.
HBVAXPRO protects against all known subtypes of hepatitis B virus. Importantly, vaccination against hepatitis B also provides indirect protection against hepatitis D (delta hepatitis), since hepatitis D virus can only replicate in the presence of hepatitis B virus co-infection. However, HBVAXPRO does not protect against infection caused by other hepatitis viruses (hepatitis A, C, or E) or other pathogens that affect the liver.
The WHO recommends universal hepatitis B vaccination for all infants as part of the global strategy to eliminate hepatitis B by 2030. Vaccination starting at birth is the most effective measure to prevent perinatal and early childhood transmission, which carries the highest risk of progressing to chronic infection (up to 90% in neonates versus less than 5% in healthy adults).
What Should You Know Before Taking HBVAXPRO?
Before receiving HBVAXPRO, it is important to discuss your child’s medical history and any known allergies with your healthcare provider. Certain conditions may require postponement of vaccination or the use of additional precautions. Understanding these considerations helps ensure that vaccination is both safe and effective.
Contraindications
HBVAXPRO must not be administered in the following circumstances:
- Known hypersensitivity: The vaccine should not be given to individuals who have had an allergic reaction to hepatitis B surface antigen or to any of the excipients (inactive ingredients) listed in the vaccine formulation, including sodium chloride, sodium borate, or the aluminium adjuvant
- Acute febrile illness: Vaccination should be postponed in individuals who have a severe illness accompanied by fever. Minor infections such as a mild cold are generally not a reason to delay vaccination, but this should be assessed by a healthcare professional
The vial stopper of HBVAXPRO contains latex rubber. Latex can cause serious allergic reactions, including anaphylaxis, in latex-sensitive individuals. If you or your child has a known latex allergy, inform your healthcare provider before vaccination. Alternative hepatitis B vaccines with latex-free packaging may be available.
Warnings and Precautions
Healthcare providers should be aware of the following precautions when administering HBVAXPRO:
- Anaphylaxis preparedness: As with all injectable vaccines, appropriate medical treatment and supervision should be readily available in case of a rare anaphylactic reaction following administration
- Immunocompromised individuals: Patients with compromised immune systems (such as those receiving immunosuppressive therapy, with HIV infection, or with certain genetic immune deficiencies) may have a diminished immune response to the vaccine. Higher doses or additional booster doses may be required in these populations
- Thrombocytopenia and bleeding disorders: HBVAXPRO is administered by intramuscular injection, which can cause bleeding at the injection site in individuals with thrombocytopenia (low platelet count) or bleeding disorders. In exceptional cases, the vaccine may be given subcutaneously (under the skin) to reduce this risk
- Premature infants: Very premature infants (born at or before 28 weeks of gestation) may experience apnoea (longer than normal pauses between breaths) for 2–3 days after vaccination. These infants should be monitored following immunization
Pregnancy and Breastfeeding
HBVAXPRO should be prescribed with caution to pregnant or breastfeeding women. While recombinant hepatitis B vaccines do not contain live virus and are generally considered to have a favorable safety profile, vaccination during pregnancy should only be undertaken when the potential benefit clearly outweighs any theoretical risk. Pregnant women at high risk of hepatitis B exposure (such as healthcare workers or partners of HBV-positive individuals) may benefit from vaccination during pregnancy.
There is limited data on the excretion of vaccine components in human breast milk. However, since HBVAXPRO contains only a recombinant protein and no live virus, it is generally considered compatible with breastfeeding. Consult your healthcare provider for individualized advice.
Sodium Content
HBVAXPRO contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially sodium-free. This is relevant for individuals on sodium-restricted diets, though the amount is clinically negligible.
How Does HBVAXPRO Interact with Other Drugs?
Vaccine interactions differ from typical drug interactions because vaccines work by stimulating the immune system rather than being metabolized by the liver or kidneys. HBVAXPRO has been studied for co-administration with several other biological products and vaccines, and the following interactions are clinically relevant:
Co-administration with Hepatitis B Immunoglobulin
HBVAXPRO can be administered simultaneously with hepatitis B immunoglobulin (HBIG) at separate injection sites. This combination is particularly important for post-exposure prophylaxis, including neonates born to hepatitis B surface antigen-positive (HBsAg-positive) mothers. The passive immunity provided by HBIG gives immediate protection, while the vaccine stimulates the development of active, long-lasting immunity. When both are administered together, different anatomical sites must be used to avoid interference with the immune response.
Co-administration with Other Vaccines
HBVAXPRO can be administered concurrently with other routine childhood vaccines, including diphtheria-tetanus-pertussis (DTP/DTaP), polio (IPV/OPV), measles-mumps-rubella (MMR), Haemophilus influenzae type b (Hib), and pneumococcal conjugate vaccines. When multiple vaccines are given at the same visit, separate injection sites and syringes must be used for each vaccine.
Interchangeability with Other Hepatitis B Vaccines
HBVAXPRO can be used to complete a primary immunization course that was started with another hepatitis B vaccine. It can also be used as a booster dose in individuals who previously received a different hepatitis B vaccine for their primary series. This interchangeability is supported by the similar immunogenic properties of licensed recombinant hepatitis B vaccines.
| Co-administered Product | Interaction Type | Clinical Guidance |
|---|---|---|
| Hepatitis B immunoglobulin (HBIG) | Compatible | Use separate injection sites; important for post-exposure prophylaxis |
| DTP/DTaP vaccines | Compatible | Separate injection sites and syringes required |
| IPV/OPV (polio vaccines) | Compatible | Can be given at the same visit |
| MMR vaccine | Compatible | Separate injection sites and syringes required |
| Hib conjugate vaccine | Compatible | Separate injection sites and syringes required |
| Immunosuppressive drugs | Reduced response | May need higher doses or additional boosters; monitor anti-HBs titers |
Always inform your healthcare provider about all medications, vaccines, and supplements you or your child are currently taking. This includes prescription medicines, over-the-counter medications, herbal products, and any recent vaccinations.
What Is the Correct Dosage of HBVAXPRO?
The dosage and schedule of HBVAXPRO depend on the age of the patient, the clinical situation, and national immunization recommendations. Healthcare providers will determine the most appropriate schedule based on individual circumstances.
Children and Adolescents (Birth to 15 Years)
The recommended dose for each injection is 5 micrograms of HBsAg in 0.5 mL of suspension. A complete primary vaccination course includes at least three injections. Two immunization schedules are approved:
Standard Schedule (0, 1, 6 Months)
The first dose is given on the chosen date. The second dose is administered one month after the first dose. The third dose is given six months after the first dose. This schedule provides the highest and most durable antibody response and is the most commonly recommended approach.
Rapid Schedule (0, 1, 2, 12 Months)
When rapid immunization is required (such as before travel to high-risk areas or following recent exposure), three doses are given at one-month intervals, followed by a fourth booster dose at 12 months after the first injection. This schedule achieves protective antibody levels earlier but requires a fourth dose for long-term protection.
| Schedule | Dose | Timing | Indication |
|---|---|---|---|
| Standard (3 doses) | 5 μg (0.5 mL) | 0, 1, 6 months | Routine immunization |
| Rapid (4 doses) | 5 μg (0.5 mL) | 0, 1, 2, 12 months | Accelerated protection needed |
| Post-exposure (with HBIG) | 5 μg (0.5 mL) | First dose ASAP + HBIG | Recent hepatitis B exposure |
Administration
HBVAXPRO is administered by intramuscular injection. The preferred injection site depends on the age of the recipient:
- Neonates and infants: The anterolateral thigh (vastus lateralis muscle) is the recommended injection site. The deltoid muscle is not adequately developed in young infants
- Children and adolescents: The deltoid muscle of the upper arm is the preferred injection site, as it provides reliable intramuscular absorption
The vaccine should never be injected into a blood vessel. In exceptional circumstances, it may be administered subcutaneously (under the skin) to patients with thrombocytopenia (low platelet count) or those at risk of bleeding following intramuscular injection.
Before administration, the vial should be shaken well until a slightly opaque white suspension is obtained. Once the vial has been penetrated, the vaccine drawn into the syringe must be used immediately, and the remaining contents of the vial must be discarded.
Missed Dose
If you or your child misses a scheduled dose, contact your healthcare provider as soon as possible. Your doctor or nurse will determine when the missed dose should be given. It is generally not necessary to restart the entire vaccination series if a dose is missed — the course can be continued from where it was interrupted, regardless of the interval since the last dose.
Booster Doses
Current national vaccination schedules in many countries include recommendations for booster doses of hepatitis B vaccine. Your healthcare provider will advise whether a booster dose is needed based on local guidelines and your child’s vaccination history. The WHO currently does not recommend routine booster doses for immunocompetent individuals who have completed a primary vaccination series, as immune memory typically persists for at least 20–30 years or longer.
HBVAXPRO should only be administered by a qualified healthcare professional in a clinical setting equipped to manage allergic reactions. The vaccine must not be mixed with other vaccines in the same syringe. Always verify the expiry date and inspect the vaccine for abnormal appearance before use.
What Are the Side Effects of HBVAXPRO?
Like all vaccines, HBVAXPRO can cause side effects, although not everyone experiences them. The majority of reported side effects are mild, localized to the injection site, and resolve without treatment within a few days. It is important to note that for many reported adverse events, a definitive causal relationship with the vaccine has not been established.
As with other hepatitis B vaccines, extensive post-marketing surveillance has been conducted over many decades, providing a well-characterized safety profile. The benefits of hepatitis B vaccination in preventing a potentially life-threatening infection overwhelmingly outweigh the risks of adverse effects in the vast majority of individuals.
Side Effects by Frequency
Most Common
Injection site reactions reported in clinical trials
- Tenderness at the injection site
- Redness (erythema) at the injection site
- Induration (hardening) at the injection site
Very Rare
Reported very rarely during post-marketing surveillance
- Blood and lymphatic system: Thrombocytopenia (low platelet count), lymphadenopathy (swollen lymph nodes)
- Immune system: Allergic reactions including anaphylaxis, serum sickness-like reactions
- Nervous system: Paraesthesia (numbness and tingling), facial palsy (Bell’s palsy), peripheral neuropathy including Guillain-Barré syndrome, optic neuritis (inflammation of the optic nerve leading to impaired vision), encephalitis (brain inflammation), exacerbation of multiple sclerosis, multiple sclerosis, seizures, headache, dizziness, and syncope (fainting)
- Cardiovascular: Hypotension (low blood pressure), vasculitis (inflammation of blood vessels)
- Respiratory: Bronchospasm (asthma-like symptoms)
- Gastrointestinal: Vomiting, nausea, diarrhoea, abdominal pain
- Skin: Eczema, rash, alopecia (hair loss), pruritus (itching), urticaria (hives), bullous eruption (skin blisters)
- Musculoskeletal: Arthralgia (joint pain), arthritis (joint inflammation), myalgia (muscle pain), pain in extremities
- General: Fatigue, fever, malaise (general feeling of unwellness), influenza-like symptoms
- Hepatic: Elevated liver enzymes
- Eye: Eye inflammation (uveitis) with pain and redness
Special Populations
Additional considerations for specific groups
- Very premature infants (born at ≤28 weeks of gestation): Longer than normal pauses between breaths (apnoea) may occur for 2–3 days after vaccination. These infants require respiratory monitoring following immunization
Contact your healthcare provider or seek emergency medical care immediately if you or your child develops signs of a severe allergic reaction (anaphylaxis) after vaccination. Symptoms may include difficulty breathing, swelling of the face, lips, tongue, or throat, rapid heartbeat, dizziness, or collapse. These reactions are extremely rare but require immediate treatment.
Reporting Adverse Reactions
It is important to report suspected adverse reactions after the vaccine has been authorized. This allows continuous monitoring of the benefit-risk balance of the vaccine. Healthcare professionals and patients are encouraged to report any suspected adverse reactions to their national pharmacovigilance authority (such as the EMA in Europe, the MHRA in the United Kingdom, or VAERS in the United States).
How Should You Store HBVAXPRO?
Proper storage of vaccines is critical to maintaining their efficacy and safety. HBVAXPRO contains an adsorbed antigen that is sensitive to both temperature extremes and light exposure. Incorrect storage can reduce the potency of the vaccine or render it completely ineffective.
The following storage requirements must be observed:
- Temperature: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not place the vaccine near the freezer compartment or directly against the cold wall of the refrigerator, as this may cause accidental freezing
- Freezing: The vaccine must never be frozen. Freezing causes irreversible damage to the aluminium adjuvant, which aggregates and loses its ability to enhance the immune response. If the vaccine has been accidentally frozen, it must be discarded
- Light protection: Keep the vaccine in its original packaging to protect it from light. Prolonged exposure to light can degrade the HBsAg protein
- Expiry date: Do not use the vaccine after the expiry date printed on the label and carton (indicated as EXP). The expiry date refers to the last day of that month
- Keep out of reach of children: Store the vaccine where children cannot access it
Do not dispose of HBVAXPRO in household waste or down the drain. Return unused or expired vaccine to your pharmacist or healthcare provider for proper disposal in accordance with local regulations. This helps protect the environment.
What Does HBVAXPRO Contain?
Active Substance
The active ingredient in HBVAXPRO 5 micrograms is:
- Hepatitis B virus surface antigen, recombinant (HBsAg): 5 micrograms per 0.5 mL dose
The HBsAg protein is produced in Saccharomyces cerevisiae (yeast strain 2150-2-3) using recombinant DNA technology. This means the yeast cells have been genetically modified to produce the hepatitis B surface antigen protein, which is then purified and formulated into the vaccine. No live viral material is present in the final product.
Adjuvant
The active substance is adsorbed onto amorphous aluminium hydroxyphosphate sulfate (0.25 milligrams Al3+ per dose). This aluminium salt serves as an adjuvant — a substance that enhances, accelerates, and prolongs the protective immune response to the vaccine. Aluminium adjuvants have been used safely in vaccines for over 70 years and are among the most extensively studied vaccine components.
Excipients (Inactive Ingredients)
- Sodium chloride (NaCl)
- Sodium borate
- Water for injections
Appearance and Packaging
HBVAXPRO 5 micrograms is a suspension in a single-dose vial. When properly shaken, it appears as a slightly opaque white suspension. It is available in pack sizes of 1 and 10 vials without syringe or needle. Not all pack sizes may be marketed in every country.
| Component | Type | Amount per Dose |
|---|---|---|
| Hepatitis B surface antigen (HBsAg) | Active substance | 5 micrograms |
| Aluminium hydroxyphosphate sulfate (Al3+) | Adjuvant | 0.25 mg |
| Sodium chloride | Excipient | <1 mmol Na |
| Sodium borate | Excipient (buffer) | Trace |
| Water for injections | Solvent | To 0.5 mL |
Does HBVAXPRO Affect Driving or Using Machines?
Clinical studies and extensive post-marketing experience indicate that HBVAXPRO has no significant impact on the ability to drive vehicles or operate machinery. However, as with any vaccine, temporary side effects such as dizziness, lightheadedness, or fatigue can occasionally occur. If you or your child experiences any of these symptoms, it is advisable to wait until they resolve before driving or engaging in activities that require full alertness. These symptoms are typically mild and short-lived, resolving within hours to a day after vaccination.
Frequently Asked Questions About HBVAXPRO
HBVAXPRO is a recombinant hepatitis B vaccine used for active immunization against hepatitis B virus infection. The 5-microgram formulation is specifically designed for individuals from birth through 15 years of age who are at risk of exposure to the hepatitis B virus. It protects against all known subtypes of hepatitis B and also provides indirect protection against hepatitis D, which requires hepatitis B co-infection to replicate. HBVAXPRO does not protect against other types of viral hepatitis (A, C, or E).
A complete vaccination course requires at least three injections. The standard schedule consists of doses at 0, 1, and 6 months, which provides the strongest and most durable immune response. When rapid protection is needed, an accelerated four-dose schedule at 0, 1, 2, and 12 months can be used. Each dose consists of 5 micrograms of hepatitis B surface antigen in 0.5 mL. Seroprotection rates exceed 95% in healthy children who complete the full course.
The most common side effects of HBVAXPRO are local reactions at the injection site, including tenderness, redness, and induration (hardening). These reactions are typically mild and resolve on their own within a few days without any treatment. Serious adverse reactions are very rare and may include allergic reactions, neurological effects (such as numbness, tingling, or facial palsy), or blood disorders. If you notice any unusual or severe symptoms after vaccination, contact your healthcare provider promptly.
Yes, HBVAXPRO can be administered concurrently with most other routine childhood vaccines, including DTP/DTaP, polio, MMR, Hib, and pneumococcal vaccines. The key requirement is that each vaccine must be given at a separate injection site using a separate syringe. HBVAXPRO can also be given at the same time as hepatitis B immunoglobulin (HBIG) at different injection sites, which is particularly important for post-exposure prophylaxis in newborns of HBV-positive mothers.
HBVAXPRO must be stored in a refrigerator at 2–8°C (36–46°F). It must never be frozen, as freezing permanently damages the vaccine and renders it ineffective. The vaccine should be kept in its original packaging to protect it from light. Once the vial has been punctured, the drawn-up dose must be used immediately and any remaining vaccine discarded. Always check the expiry date before administration.
HBVAXPRO should be prescribed with caution during pregnancy and breastfeeding. Since it is a recombinant vaccine containing no live virus, it is generally considered to have a favourable safety profile. However, vaccination during pregnancy should be limited to situations where the benefit clearly outweighs any potential risk, such as in women at high risk of hepatitis B exposure. The vaccine is generally considered compatible with breastfeeding. Always consult your healthcare provider for personalized advice.
References
- European Medicines Agency (EMA). HBVAXPRO – Summary of Product Characteristics. Last updated 2025. Available from: EMA EPAR.
- World Health Organization (WHO). Hepatitis B vaccines: WHO position paper – July 2017. Weekly Epidemiological Record. 2017;92(27):369–392.
- Centers for Disease Control and Prevention (CDC). Prevention of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2018;67(1):1–31.
- Schillie S, Vellozzi C, Reingold A, et al. Prevention of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2018;67(No. RR-1):1–31. doi:10.15585/mmwr.rr6701a1.
- Liang TJ. Hepatitis B: the virus and disease. Hepatology. 2009;49(5 Suppl):S13–S21. doi:10.1002/hep.22881.
- World Health Organization (WHO). Global Hepatitis Report 2024. Geneva: WHO; 2024.
- Mast EE, Margolis HS, Fiore AE, et al. A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States. MMWR Recomm Rep. 2005;54(RR-16):1–31.
- Bruce MG, Bruden D, Hurlburt D, et al. Antibody Levels and Protection After Hepatitis B Vaccine: Results of a 30-Year Follow-up Study and Response to a Booster Dose. J Infect Dis. 2016;214(1):16–22. doi:10.1093/infdis/jiv748.
- European Association for the Study of the Liver (EASL). EASL Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017;67(2):370–398. doi:10.1016/j.jhep.2017.03.021.
- British National Formulary (BNF). Hepatitis B Vaccine. NICE Evidence Services. Available from: bnf.nice.org.uk.
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