Vaccine Safety Registry
Hepatitis A Vaccine Safety
Professional safety data on Hepatitis A vaccines. Clinical trial outcomes, manufacturer formulations (Havrix, Vaqta), and long-term surveillance metadata.
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Clinical Overview
Professional summary
Hepatitis A is a significant liver disease induced by the Hepatitis A Virus (HAV). HAV transmission occurs primarily through the fecal-oral route, often via contaminated water or food modules.
Pathology ranges from mild, self-limiting illness to severe clinical hepatic failure lasting several months. While pediatric cohorts may present as asymptomatic, they serve as critical nodes for viral transmission.
Vaccine Formulations
Module specifics & formulations
Formulation Node
Havrix
GlaxoSmithKline
- Authorized for cohorts 12 months +.
- Pediatric: 720 ELISA units / 0.5 mL.
- Adult: 1440 ELISA units / 1.0 mL.
- Interval: 2-dose series (6-12 months).
Formulation Node
Vaqta
Merck & Co.
- Authorized for cohorts 12 months +.
- Pediatric: 25 units / 0.5 mL.
- Adult: 50 units / 1.0 mL.
- Interval: 2-dose series (6-18 months).
Clinical Triage
Eligibility & contraindications
Routine Protocol
- Pediatric cohorts (12-23 months)
- Catch-up immunization (2-18 years)
High-Risk Adult Triage
- International travelers to endemic zones
- Men who have sex with men (MSM)
- Illicit drug users (injection/non-injection)
- Chronic liver disease patients
Absolute & Relative Contraindications
- Hypersensitivity to previous Hepatitis A dose
- Acute moderate-to-severe febrile illness
- Known allergies to registry module components
Adverse Events
Reported reactions & surveillance
Local Reactions
- Injection site pain
- Localized erythema
- Induration (Swelling)
Systemic Profile
- Generalized fatigue
- Cephalalgia (Headache)
- Low-grade pyrexia
- Anorexia (Loss of appetite)
Surveillance Analytics
Post-market surveillance metrics
1995
Registry Entry
25+ Years
Surveillance Data
Millions
Doses Synchronized
Institutional Surveillance
Decades of VAERS data and active surveillance studies confirm an exemplary safety profile across all global recommended cohorts.
Editorial Governance
Clinical Reviewers & Authors
Dr. Sanjay Iyer
MBBS, MD (General Medicine), DM (Gastroenterology)
Gastroenterology & Hepatology
All vaccine safety monographs are authored and reviewed by credentialed medical specialists in infectious disease, immunology, and pediatrics.
Browse All Clinical Authors & Medical Reviewers DirectoryEvidence Base
Sources & References
The clinical guidance, contraindications, and safety surveillance statistics in this monograph are synthesized directly from authoritative public health agencies, regulatory package inserts, and peer-reviewed clinical studies:
- 1CDC2024Prevention of Hepatitis A Virus Infection in the United States: Recommendations of the ACIP
MMWR Recommendations and Reports, 69(5):1-38
- 2WHO2024WHO position paper on hepatitis A vaccines — June 2022
Weekly Epidemiological Record, 97(40):493-512
- 3FDA2024HAVRIX and VAQTA Prescribing Information & Safety Profile
U.S. Food and Drug Administration CBER
Cite & Reference This Monograph
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HCP Connect. Content licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0). See our Content Licensing & Reuse Policy for details.
Authored by Dr. Sanjay Iyer and clinically reviewed by Dr. Ritu Saxena, in alignment with HCP Connect Clinical Faculty & Reviewers Directory. Content verified against 2026 CDC ACIP and WHO SAGE safety protocols.
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