Hepatitis A and B vaccine

The Hepatitis A and B vaccine is a prescription medication in the vaccine class.

The Hepatitis A and B vaccine is approved to prevent hepatitis A and B infections, protecting against certain illnesses caused by viruses and limiting the risk of transmission and subsequent liver damage.

It is administered as part of routine national immunization programs.

The Hepatitis A and B vaccine is administered by injection, prompting an immune response without undergoing typical drug metabolism and elimination. It triggers the production of antibodies, providing long-term defence immunity against hepatitis A and B viruses, with varying durations of protection.

The common side effects of the Hepatitis A and B vaccine may include low-grade fever, fatigue, headache, mild gastrointestinal symptoms, including nausea or diarrhoea, and moderate soreness or swelling at the injection site.

Hepatitis A and B vaccines are available as a suspension for injection.

Hepatitis A and B vaccines are available in countries like the United States, Canada, Europe, Australia and India.

The Hepatitis A and B vaccine class stimulates immunity by producing antibodies against hepatitis A and B infections.

Inactivated hepatitis A virus particles are present in the hepatitis A vaccination. It stimulates the immune system to produce antibodies against these viral particles when administered. By eliminating the virus, these antibodies can stop an infection from occurring. Also, the immune system develops a memory of the virus's composition, which helps it respond quickly in future when it comes into contact with a live hepatitis A virus. A fragment of the hepatitis B viral surface antigen (HBsAg) is included in the hepatitis B vaccination. Antibodies against HBsAg are produced as a result of it. As they travel through the circulation, these antibodies protect by eliminating any viruses that may be present. Long-lasting protection is also provided via the vaccine's activation of immunological memory cells. Both immunizations stimulate the immune system to detect and kill off the hepatitis A and B viruses, preventing disease and lowering the risk of transmission.

The length of disease protection is long-lasting (years), although the onset of it is relatively slow.

Hepatitis A and B vaccines are available as a suspension for injection.

Suspension for injection: To be administered parenterally, as applicable.

Hepatitis A and B vaccines can be used as follows:

• To prevent the transfer of hepatitis B from the mother to the baby during childbirth.
• For people with chronic liver disease who are at higher risk of complications from hepatitis infections.
• Hepatitis A or B post-exposure prophylaxis for possible exposure.
• When travelling to areas with a more significant disease incidence, travellers should get hepatitis A and B vaccinations.
• Individuals working in healthcare are at risk of contracting hepatitis B through blood exposure.

Hepatitis A and B vaccines can help support the following health benefits:

• Protection: The hepatitis A and B vaccination completely protects against hepatitis A and B. While hepatitis B can be transmitted through blood, sexual contact, or other bodily fluids, hepatitis A is primarily spread through tainted food or water. For those who risk contracting any or both of these viruses, the hepatitis A and B vaccination provides a complete treatment.
• Immunity: Long-lasting immunity to hepatitis A and hepatitis B is provided by the hepatitis A and B vaccination. Individuals often experience strong and lasting immune responses after completing the prescribed immunization series. Immunity can last a lifetime or even many years, which eliminates the need for booster doses. People with continuing exposure hazards, such as healthcare professionals or people who often travel to high-risk locations, benefit the most due to its long-term protection.
• Cost-effective: As it combines the two important vaccines for hepatitis A and B into a single dose, the hepatitis A and B vaccine is very convenient. People can save time and effort by obtaining both vaccinations in one injection rather than getting separate shots for each virus. This vaccine simplifies the immunization process, which can be beneficial for busy travellers or medical professionals and can enhance adherence to the recommended vaccination regimen, ensuring that individuals get all the shots to be fully protected against both viruses.

Hepatitis A and B vaccines are indicated for use in the following:

• It is recommended that people over 18 get vaccinated against hepatitis A and B in areas where these viruses are expected or where outbreaks have occurred.
• High-risk sexually active individuals, such as male homosexuals and bisexuals.
• People who take illegal drugs.
• Persons at risk due to their work, such as laboratory workers who handle live hepatitis A and B virus, police, people who provide medical assistance, and workers who come into contact with faeces or sewage.
• People who live in drug and alcohol treatment institutions, staff members in hemodialysis units, and those who work in child care centres and prisons.
• Those in close contact with hepatitis A or B patients are at elevated risk for HBV infection.
• Individuals who have haemophilia.
• Patients with chronic liver disease.

Parenterally: Hepatitis A and B vaccine is available as a suspension for injection. It should be shaken thoroughly before use to ensure that it is appropriately suspended and administered by intramuscular injection only as a 1-mL dose. It should not be injected into the GLUTEAL MUSCLE-like buttock areas as it may result in a suboptimal response.

It should be administered intramuscularly only and not intravenously, intradermally or subcutaneously.

It can be only given by a healthcare professional in a hospital setting or during routine immunization programs.

After administration, the healthcare provider will document the vaccination, including the date, time, dose, and injection site.

The dosage and duration of treatment should be as per the treating physician's clinical judgment.

Hepatitis A and B vaccine is available as a suspension for injection.

Suspension for injection: (720 ELISA units/20mcg)/1mL

Dosage Adjustment for Adult Patients

Immunization against Hepatitis A & B

The standard dose is 1 mL intramuscularly at 0, 1, and 6 months.

Dosing accelerated: 1 mL intramuscularly on days 0, 7, and 21–30, then a fourth dosage at 12 months.

Hepatitis A and B vaccine is available as a suspension for injection.

Hepatitis A and B vaccines should be used to prevent infection from the hepatitis A and B viruses, along with no appropriate dietary restrictions. Consuming regular foods and drinks before and after receiving the vaccine is safe.

However, staying fully hydrated and maintaining a healthy, balanced diet rich in fruits, vegetables, whole grains, and lean proteins that can help support overall immune system function is always recommended, which can boost the effectiveness of vaccines.

The dietary restriction should be individualized as per patient requirements.

Hepatitis A and B vaccine may be contraindicated in the following conditions: -

• Anaphylaxis reactions (Hypersensitivity to drugs or excipients including yeast and neomycin)
• Allergic to latex rubber (pre-filled syringe form)
• Immunodeficiency disorders like HIV/AIDS infection
• Guillain-Barré Syndrome (rarely)

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

• Individuals with weak immune systems, such as those with HIV/AIDS infection or cancer or who are taking certain drugs, may not respond as well to the Hepatitis A and B vaccines and may consult a healthcare professional who might suggest modifying the vaccine schedule or giving additional doses to these people to improve protection.
• It may be advisable to postpone the vaccination if the child is currently experiencing a fever, minor infections or a moderate to severe sickness.
• Contains thimerosal (<1 mcg mercury); take caution while taking the vaccine.
• Healthcare professionals should assess the risks and benefits of the vaccination in case of any severe allergic reactions or a severe reaction to a previous dose of the Hepatitis A and B vaccine to determine whether further immunization is required.
• When administering the hepatitis A and B vaccine simultaneously with HPV immunoglobulin or other vaccines, it is recommended to use separate syringes and distinct injection sites.

Caution is advised when consuming alcohol with the Hepatitis A and B vaccine

There is no sufficient scientific evidence traceable regarding the use and safety of the Hepatitis A and B vaccines in the breastfeeding population.

Safe to use during pregnancy.

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

The adverse reactions related to Hepatitis A and B vaccine can be categorized as

• Common: Pain, erythema, swelling or itching at the injection site, headache, soreness, headache and fatigue
• Less Common: Redness, diarrhoea, nausea, fever, swelling
• Rare: Severe allergic reactions, Syncope (fainting), Guillain-Barré Syndrome (GBS) and thrombocytopenia (low blood platelet count).

The clinically relevant drug interactions of the Hepatitis A and B vaccine are briefly summarized here:

• Immunosuppressants- Drugs like prednisone or cyclosporine, when used in very high doses, suppress the immune system and may reduce the effectiveness of the Hepatitis A and B vaccines when used.
• Other Vaccines: Children are administered different vaccines to reduce risk; it is generally recommended to help them at separate sites and times from the Hepatitis A and B vaccines to minimize the risk of interference and potentially reduce the effectiveness of one or more vaccines.

The common side of the Hepatitis A and B vaccine includes the following-

• Pain, erythema or swelling where the shot was given
• Feeling tired
• Headache
• Nausea
• Loss of appetite
• Muscle pain
• Dizziness
• Vomiting
• Diarrhea
• Fever
• Rash
• Sore throat
• Fainting
• Vision changes
• Ringing in the ears just post-vaccine injection

The Hepatitis A and B vaccine should be prudent in the following group of special populations.

• Pregnancy:

Pregnancy Category: C. Safe during pregnancy, but when taken in high doses, use with caution if the benefits outweigh the risks.

Hepatitis A and B vaccine is usually considered safe during pregnancy; it is mainly advised when there is a significant risk of Hepatitis A and B virus exposure. Unless the risk of exposure is very high, routine vaccinations are commonly not recommended during pregnancy.

• Paediatrics: There is no sufficient scientific evidence traceable regarding the use and safety of the Hepatitis A and B vaccine for pediatric populations.

Dosage Adjustment for Paediatric Patients

There are no specific dosage adjustments provided.

• Geriatrics: There is no sufficient scientific evidence traceable regarding the use and safety of the Hepatitis A and B vaccines for geriatric populations. Avoid taking unless advised to do so by a healthcare professional.
• Lactating mothers: There is no sufficient scientific evidence traceable regarding the use and safety of the Hepatitis A and B vaccine for lactating mother populations.

Dosage Adjustment in Kidney Impairment

There are no specific dosage adjustments provided.

Dosage Adjustment in Hepatic Impairment

There are no specific dosage adjustments provided.

Overdosage of the Hepatitis A and B vaccines rarely occurs as healthcare professionals administer them according to specific or precise dosing guidelines.

There is no specific antidote or treatment for excessive intake of the Hepatitis A and B vaccine. Medical attention should be sought immediately when an overdose is suspected, followed by monitoring any adverse effects or allergic reactions. Supportive therapy should also be given, addressing any symptoms that persist or worsen. Physical treatment might be added if necessary.

Pharmacodynamics of Hepatitis A and B vaccine:

The Hepatitis A and B vaccines have a physiological mechanism that plays a role in their pharmacodynamics.

The pharmacodynamics of hepatitis A and B vaccinations involve stimulating the immune system to protect against these viral diseases. Inactivated hepatitis A virus particles present in hepatitis A vaccinations induce the development of certain antibodies and memory cells. These antibodies protect against the virus if it occurs later, and memory cells produce continuous protection. Similarly, hepatitis B vaccines contain a recombinant variant of the hepatitis B viral surface antigen (HBsAg), triggering an immune response that produces antibodies and memory cells. When exposed to hepatitis B, the body may detect it and develop an immune response. Both vaccines give prolonged protection without actively transmitting the diseases. Their pharmacodynamics show the effectiveness of vaccination in enhancing the immune system's defence against hepatitis A and B, reducing the risk of liver diseases associated with these viruses.

Pharmacokinetics of Hepatitis A and B vaccine:

Absorption: Vaccines for hepatitis A and hepatitis B are commonly given intramuscularly, facilitating adequate bloodstream absorption.

Distribution: Inactivated viral particles or surface antigens, which are included in vaccines, are dispersed throughout the body once they enter the bloodstream. When the immune system recognizes these components as foreign material, an immune system response is triggered.

Metabolism: Unlike drugs, Hepatitis A and B vaccines don't involve metabolism processes because vaccines contain inert viral proteins, not active drugs. The vaccine's effectiveness comes from the body's immune response and antibody production against hepatitis A and hepatitis B infections.

Elimination: The vaccine's active ingredients are eliminated from the body, but the immunological memory is activated to provide long-term defence against hepatitis A and B and related diseases.

• Ambrosch, F. et al. "Simultaneous vaccination against hepatitis A and B: results of a controlled study." Vaccine vol. 10 Suppl 1 (1992): S142-5. doi:10.1016/0264-410x(92)90570-a
• Murdoch, David L et al. "Combined hepatitis A and B vaccines: a review of their immunogenicity and tolerability." Drugs vol. 63,23 (2003): 2625-49. doi:10.2165/00003495-200363230-00008
• Ghaswalla, Parinaz K et al. "Hepatitis A, B, and A/B vaccination series completion among US adults: A claims-based analysis." Human Vaccines & immunotherapeutics vol. 14,11 (2018): 2780-2785. doi:10.1080/21645515.2018.1489189

• Inform the caregivers of the schedule for administering the Hepatitis A and B vaccine, which usually involves two doses for hepatitis A and a series of three or four doses for hepatitis B, depending on the specific vaccine used.
• Confirm the patient has been informed of the details provided and approve the immunization before proceeding. Obtain their willingness and informed consent based on their awareness of the risks and benefits.
• Assure caregivers that Hepatitis A and B vaccine immunizations are generally safe, with only minor, short side effects. Encouraging them to immediately report any unexpected or severe responses to the healthcare physician and, whenever applicable, to use reporting systems like the Vaccine Adverse Event Reporting System (VAERS)
• Inform caregivers of the recommended immunization schedule, which usually consists of two or three doses, depending on the vaccine brand. Also, mention the ages at which the doses should be administered and give the Vaccine Information Statements, which must be disclosed before immunization by the National Childhood Vaccine Injury Act of 1986 about the Centres for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines), these resources are freely accessible.

http://www.cdc.gov/vaccines/schedules/hcp/index.html

https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5037a4.htm

https://www.indianpediatrics.net/oct2014/785 figure1.pdf

https://www.pediatriconcall.com/drugs/drugs-a-to-z/h