Hepatitis B Vaccine

The Hepatitis B vaccine is a prescription medication belonging to the vaccine class.

Hepatitis B vaccine is approved for the prevention of hepatitis B infection.

The hepatitis B vaccine introduces some hepatitis B virus into the body. This triggers a response, causing the production of antibodies. After it is given, the vaccine is absorbed into the bloodstream, distributed throughout the body and metabolized by the immune cells. Finally, it is eliminated through bodily processes. It is a part of national routine immunization programmes.

The common side effects of the hepatitis B vaccine include discomfort at the injection site, fever, fatigue, etc.

Hepatitis B vaccine is available in the form of injectable solutions.

The Hepatitis B vaccine is available worldwide in countries like the US, EU, China, India, Russia, and South Africa.

Hepatitis B vaccine belonging to the vaccine class acts as an inactivated virus.

The hepatitis B vaccine stimulates the immune system by introducing a harmless part of the hepatitis B virus. It acts as a prophylactic therapeutic agent. The vaccine acts by activating the B cells and producing antibodies against the hepatitis B virus surface antigen.

The effectiveness of the hepatitis B vaccine varies from person to person. Typically, it involves antibody production over several weeks after vaccination. These antibodies remain in circulation for a period, often lasting for years and providing lasting protection. While immunity from the vaccine can last for years, periodic booster shots may be recommended for protection against infection. It is a part of .national routine immunization programmes.

The levels of antibodies in the body after vaccination Cmax and Tmax can differ from person to person. However, these concentrations typically occur within a week after getting vaccinated.

Hepatitis B vaccine is administered through intramuscular injection.

Hepatitis B vaccine can be used in the prevention of hepatitis B infection.

Hepatitis B vaccine can help to prevent hepatitis B, which helps to reduce the risk of liver disease and liver cancer.

Hepatitis B vaccination has been approved for use in the following clinical indications:

• People who are at risk of contracting transmitted diseases
• Individuals who are incarcerated
• People whose sexual partners have tested positive for hepatitis B surface antigen (HBsAg)
• Household members who have tested positive for HBsAg
• Men who engage in sexual activities with other men
• Individuals who use intravenous drugs
• Healthcare professionals, including those undergoing dialysis treatment
• Individuals aged 19 to 59 with diabetes
• People with hepatitis C infection
• Travelers visiting countries where hepatitis B is prevalent
• Individuals living with HIV
• People with chronic liver disease
• Anyone seeking protection against hepatitis B infection

Intramuscularly: The Hepatitis B vaccine is available as an injection solution and is typically administered intramuscularly via injection into the arm's deltoid muscle.

It is usually given as 2, 3, or 4 shots over six months.

For pediatric dose

• 5mcg/0.5mL (Recombivax HB)
• 10mcg/0.5mL (Engerix B)

For Adult Dose:

• 10mcg/mL (PreHevbrio)
• 10mcg/mL (Recombivax HB)
• 20mcg/mL (Engerix B)
• 40mcg/mL (Recombivax HB [dialysis formulation])
• 20mcg HBsAg and 3000mcg of CpG 1018 adjuvant per 0.5mL (Heplisav-B)

DOSAGE ADJUSTMENTS FOR ADULT PATIENTS

For Adults with Diabetes Mellitus:

The CDC ACIP guidelines strongly recommend that all unvaccinated adults with diabetes mellitus up to age 59 should receive immunization against hepatitis B. People with diabetes have an increased risk of contracting hepatitis B infection. For diabetics aged ≥60 years, treating clinicians should decide whether to vaccinate based on factors such as the need for blood glucose monitoring in long-term care facilities and the likelihood of acquiring hepatitis B infection or its complications/chronic sequelae. Vaccination of patients who haven't been vaccinated can be done at physician's discretion.

For Adults Receiving Dialysis or Other Conditions that Weaken the Immune System:

The initial immunization involves a series of 4 doses (40 mcg) given at 0, 1, 2 and 6 months.

It is important to note that patients undergoing hemodialysis may have a lower antibody response than individuals in health. The protection provided by the vaccine might only last long as the antibody levels remain above ten mIU/mL.

Antibody testing is recommended to determine if booster doses are necessary.

If the antibody levels fall below ten mIU/mL, a booster dose of 2 mL should be administered.

Hepatitis B Vaccine is available in the form of intramuscular injection.

Hepatitis B vaccines should be used in the prevention of hepatitis B infection, along with appropriate dietary restrictions.

Hepatitis B Vaccine, When administered, has little effect on dietary or food ingredients. Regular diet, including nursing or formula feeding, is safe for infants before and after vaccination. Conversely, adults can consume normal foods and liquids before and after taking the vaccine.

It is often recommended to stay hydrated by drinking water or other drinks. A healthy diet can assist in increasing the body's immune response to the vaccine and overall health during vaccination.

The dietary restriction should be individualized as per patient requirements.

Hepatitis B Vaccine may be contraindicated in the following condition:

The treating physician must closely monitor the patient and keep pharmacovigilance as follows:

1. Latex Allergy Caution: The vaccine contains latex rubber components, which may cause responses in those who are allergic to latex.

2. Apnea in premature infants: After getting the vaccine by intramuscular injection, certain premature newborns may experience breathing pauses (apnea). The vaccination should be administered to newborns based on their condition, possible benefits, and hazards. If the mother tests positive for HBsAg (a hepatitis B antigen), timely vaccination is critical.

3. Infants Weighing Less Than 2000 g: If an infant weighs less than 2000 g at birth and the mother tests negative for HBsAg, hepatitis B immunization should be delayed until the infant is one month old or is discharged from the hospital. Suppose the mother's HBsAg status is positive or unknown. In that case, the newborn should receive both the vaccine and hepatitis B immune globulin (HBIG) as recommended if their HBsAg status cannot be ascertained.

4. Managing Allergic responses: Adequate medical treatment and monitoring should be readily available for vaccination-related responses.

5. Vaccine Effectiveness Limitations: It's important to note that the hepatitis B virus has an incubation period. Therefore, individuals who unknowingly already have a hepatitis B infection during vaccination may not be fully protected by the vaccine. Additionally, while highly effective, the vaccine may not provide protection for all individuals.

There is no sufficient scientific evidence traceable regarding the use and safety of the Hepatitis B Vaccine in concurrent use with alcohol.

There is no sufficient scientific evidence regarding the use and safety of the Hepatitis B Vaccine in concurrent use with any particular food.

The adverse reactions related to Hepatitis B Vaccine can be categorized as:

• Common: headache, tiredness, redness, and hardness at the site of injection, loss of appetite, pain, fever, swelling or bruising at the injection site, diarrhoea, etc
• Less common: dizziness, muscle ache, flu-like symptoms
• Rare: low blood pressure, joint pain, hives, rash or itchiness, paraesthesia, lymphadenopathy

The clinically relevant drug interactions of the hepatitis B vaccine are briefly summarized here:

• Other Vaccines: Do not mix the hepatitis B vaccine with other vaccines in the syringe or container. For each immunization, use different injection sites and syringes. Clinical experiments have proven that delivering the hepatitis B vaccine alongside licensed vaccines is safe and effective.
• Immunoglobins: Hepatitis B globulin (HBIG) can be administered concurrently with the hepatitis B vaccine. Just make sure you administer the shots in the appropriate areas.
• Interference with Laboratory Testing: Keep in mind that Hepatitis B surface antigen (HBsAg) might be present in blood samples after getting the hepatitis B vaccine.

The common side effects of the Hepatitis B vaccine include the following:

• Headache
• Mild Fever
• Diarrhea
• Fatigue
• Burning in the stomach
• Pain, tenderness, redness, swelling, or bruising where shot was given
• Tiredness

The use of the hepatitis b vaccine should be prudent in the following group of special populations:

Pregnancy:

Every pregnancy comes with a risk of birth defects, loss, or unfavourable outcomes. Extensive studies have been conducted to evaluate the use of the hepatitis B vaccine in women.

However, available data does not indicate any increased likelihood of miscarriage or major birth defects in women who received the vaccine during their pregnancy.

Lactation:

It is currently unknown whether the hepatitis B vaccine is excreted in human breast milk.

No data assesses its impact on breastfed infants or milk production/excretion.

When considering breastfeeding, it is important to weigh the benefits against any effects on the nursing child and the mother's vulnerability to the disease that vaccination can prevent.

Pediatric Use:

The hepatitis B vaccine has been deemed safe and effective for all age groups within paediatrics. The antibodies passed from mother to child do not hinder the vaccine's response. However, there is no established evidence regarding the safety and effectiveness of using the Dialysis Formulation in children.

Geriatric Use:

The use of this medication in adults (aged 65 and above) was not extensively studied. It is unclear if their response differs from younger individuals. However, recent research indicates that people over 60 may have an antibody response.

The physician should be vigilant about the knowledge pertaining to identifying and treating overdosage of the hepatitis B vaccine.

Pharmacodynamics:

The main purpose of the hepatitis B vaccine is to stimulate the body's system to produce antibodies against the hepatitis B virus surface antigen (HBsAg). These antibodies play a role in neutralizing the virus, preventing hepatitis B infection effectively.

The pharmacodynamics of the vaccine include:

1. Activation of the system to generate HBsAg antibodies.

2. Initiation of B lymphocytes and helper T lymphocytes.

3. Establishment of long-term immunity against the hepatitis B virus.

Pharmacokinetics

Absorption: The administration method for the hepatitis B vaccine involves injecting it into a muscle (where its components are absorbed into the bloodstream through the muscle tissue.

Distribution: The distribution process ensures that antigens and adjuvants are transported to tissues, where they initiate a response. This helps activate cells, including B lymphocytes.

Metabolism: There is metabolism within the body for this vaccine as it contains purified HBsAg and adjuvants designed to enhance response.

Elimination: The vaccine components are gradually cleared from the body through processes.

The immune system has a role in getting rid of antigens and building lasting immunity to hepatitis B.

• Szmuness W, Stevens CE, et al. Hepatitis B vaccine: demonstration of efficacy in a controlled clinical trial in a high-risk population in the United States. N Engl J Med. 1980 Oct 9;303(15):833-41. doi: 10.1056/NEJM198010093031501.

• Immunogenicity of yeast-derived hepatitis B vaccine from two different producers.Dahl-Hansen E, Siebke JC, Frøland SS, Degré M.Epidemiol Infect. 1990 Feb;104(1):143-9. doi: 10.1017/s0950268800054625.

• Reactogenicity and immunogenicity of a new recombinant yeast-derived hepatitis B vaccine. Scheiermann N, Gesemann KM, Paar D, Maurer C.Zentralbl Bakteriol Mikrobiol Hyg A. 1988 Nov;269(3):411-21. doi: 10.1016/s0176-6724(88)80184-6.

• Please discuss the advantages and disadvantages of immunization to the patient, parent, or guardian. Emphasize the significance of finishing the course of vaccines.
• Please ask the vaccine recipient's parent or guardian whether they have noticed any symptoms or indicators of reactions following a dose of the hepatitis B vaccine.
• Instruct the patient, parent, or guardian to notify their healthcare provider or the clinic where they received the immunization if any adverse effects occur.

• Before administering the vaccination, make sure to provide the patient, parent, or guardian with the vaccination Information Statements mandated by the National Vaccine Injury Act of 1986. These resources are free to download from the CDC's website at www.cdc.gov/vaccines.

https://www.fda.gov/files/vaccines, blood & biologics/published/package-insert-recombivax-hb.pdf

https://www.ncbi.nlm.nih.gov/books/NBK554400/

https://www.cdc.gov/vaccines/hcp/vis/vis-statements/hep-b.html

https://www.hepb.org/prevention-and-diagnosis/vaccination/