MedPath

Hepatitis A Vaccine

Generic Name
Hepatitis A Vaccine
Brand Names
Avaxim, Havrix, Twinrix, Vaqta
Drug Type
Biotech

Overview

Hepatitis A viral infection can lead to significant morbidity and mortality, with signs and symptoms that include anorexia, nausea, vomiting, and liver failure. Known by several trade names, such as Havrix and Twinrix, the Hepatitis A vaccine has been formulated for immunization against hepatitis A virus (HAV) infection and safely confers strong protection against the disease caused by infection with this virus. In the US, the approved vaccine is inactivated while live Hepatitis A vaccines are currently available in other countries.

Indication

Hepatitis A vaccine is indicated for immunization against hepatitis A virus (HAV) infection in patients aged 12 months and older, and the first dose should be administered at least 2 weeks before expected exposure to the Hepatitis A virus.

Associated Conditions

  • Hepatitis A
  • Disease caused by Salmonella typhi

Research Report

Published: Jul 30, 2025

Hepatitis A Vaccine (DB10989): A Comprehensive Monograph on a Foundational Public Health Intervention

Executive Summary

The Hepatitis A Vaccine (DrugBank ID: DB10989) represents a pivotal achievement in modern biotechnology and public health, offering robust protection against infection by the Hepatitis A virus (HAV). Classified as an inactivated viral vaccine, this biotech product is engineered to elicit a potent and durable immune response without posing a risk of causing the disease it is designed to prevent.[1] Clinical evidence has consistently demonstrated its high efficacy, preventing approximately 95% of clinical cases in vaccinated individuals.[1] The vaccine is highly immunogenic, inducing protective antibody levels in the vast majority of recipients after the first dose and approaching 100% seroprotection following the standard two-dose series.

The immunity conferred is remarkably long-lasting, with studies and mathematical models projecting protection for at least 30 to 40 years, and potentially for the recipient's entire life, obviating the need for routine booster doses after completion of the primary series.[1] This exceptional durability distinguishes it as one of the most effective long-term immunizations available. Furthermore, the vaccine possesses an outstanding safety profile, confirmed by decades of post-marketing surveillance involving tens of millions of doses. The most common adverse events are mild, transient, and localized to the injection site, with severe reactions being exceedingly rare.[1]

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/03/03
Phase 3
Recruiting
2025/02/13
Phase 3
Recruiting
2025/02/13
Phase 3
Recruiting
2025/02/03
Phase 3
Recruiting
2024/12/18
Phase 3
Recruiting
2024/11/18
Phase 3
Recruiting
2024/03/07
Phase 3
Completed
2023/04/03
Phase 3
Active, not recruiting
2021/10/19
Phase 2
Completed
2019/04/17
Phase 2
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

HSA Drug Approvals

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
VIVAXIM
02248361
Solution ,  Suspension - Intramuscular
160 UNIT / 0.5 ML
11/9/2005
EPAXAL
berna biotech ltd
02239910
Liquid - Intramuscular
500 UNIT / 0.5 ML
1/11/2000
AVAXIM - PEDIATRIC -(5ML VIAL)
02243750
Suspension - Intramuscular
800 UNIT / 5 ML
N/A
HAVRIX - 720UNIT/ML SUS
02108216
Suspension - Intramuscular
720 UNIT / ML
12/31/1994
AVAXIM - PEDIATRIC
02243741
Suspension - Intramuscular
80 UNIT / 0.5 ML
4/9/2003
VAQTA
Merck Canada Inc
02229702
Suspension - Intramuscular
50 UNIT / ML
11/10/1996

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.