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
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]
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. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 2/10/1997 | ||
Authorised | 8/30/2002 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
AVAXIM VACCINE | SIN10611P | INJECTION | 160 u/0.5 ml | 1/6/1999 | |
HAVRIX JUNIOR VACCINE 720 elisa units/0.5 ml | SIN09728P | INJECTION | 720 elisa units/0.5ml | 5/4/1998 | |
HAVRIX 1440 VACCINE 1440 elisa units/ml | SIN08683P | INJECTION | 1440 elisa units/ml | 4/30/1996 | |
VAQTA VACCINE 50U/ml | SIN13717P | INJECTION | 50U/ml | 10/30/2009 | |
VAQTA VACCINE 25 u/0.5 ml | SIN10007P | INJECTION | 25 u/0.5 ml | 9/17/1998 |
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. |
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