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.
Translate this vaccine safety monograph into your preferred language:
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
Authoritative References & Clinical Citations
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
Authored by Dr. Sanjay Iyer and clinically reviewed by Dr. Ritu Saxena, in alignment with HCP Connect Clinical Reviewers & Authors Directory. Content verified against 2026 CDC ACIP and WHO safety protocols.
Content Licensing: Available for non-commercial clinical, academic, and educational reuse under CC BY-NC-ND 4.0.
Vaccine Safety Enquiries & Direct Response
HCP Connect welcomes clinical questions, public health inquiries, and feedback regarding our vaccine safety monographs. Our clinical editorial staff and medical reviewers actively monitor all incoming communications.
Guaranteed Enquiry Response Timeline
We commit to responding in writing to all clinical and public enquiries within 2–3 business days (guaranteed within 5 calendar days, well within the 10 calendar day international assessment standard). Urgent clinical sourcing corrections are triaged within 24 hours.